**Reregistration Eligibility Decision**

**Exposure and Risk Assessment on Lower Risk Pesticide Chemicals**

**CASE: Aliphatic Solvents (3004)**

**Active Ingredients: Mineral Oils (063502) & Aliphatic Petroleum
Hydrocarbons (063503)**

**Special Review and Reregistration Division**

**Office of Pesticide Programs**

**U.S. Environmental Protection Agency**

**One Potomac Yard, 2777 Crystal Drive**

**Arlington, VA 22202**

Interim Reregistration Eligibility Decision (IRED) Document for
Aliphatic Solvents

(Mineral Oil and Aliphatic Petroleum Hydrocarbons)

Approved by: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Debra Edwards, Ph. D.

Director

Special Review and Reregistration Division

Date: \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

**[Table of Contents]{.underline}**

**[Background]{.underline}:**
.........................................\.............................................
**4**

**[I. Executive Summary]{.underline}:**
.......................................................................
**4**

**[II. Use Information]{.underline}:**
...................................................................\........
**7**

**[III. Physical/Chemical Properties]{.underline}:**
.............................................\.......... **12**

**[IV. Hazard Assessment]{.underline}:**
..................................................................\...
**14**

**[V. Exposure Assessment]{.underline}:**
................................................................. **17**

**[VI. Dietary (Food) Exposure]{.underline}:**
............................................................. **18**

**[VII. Drinking Water Exposure]{.underline}:**
................................................\........... **18**

**[VII. Aggregate Exposure Assessment]{.underline}:**
...............................................\... **19**

**[IX. Cumulative Exposure]{.underline}:**
..............................................................\...
**20**

**[X. Environmental Fate/Ecotoxicity/Environmental Risk
Assessment]{.underline}:** ...\...\... **20**

**[X.I. Environmental Fate and Transport]{.underline}:**
.......................\.............. **20**

**[X.II. Ecological Effects Toxicity Data]{.underline}:**
.............................\...\........ **20**

**[X.III. Estimated Environmental Concentrations]{.underline}:**
......................... **24**

**[X.IV. Ecological Risk Assessment]{.underline}:**
...................................\......... **27**

**[XI. Mosquito Larvicide/Pupacide Uses]{.underline}:**
.....................\...\...............\...\...\...\... **30**

**[XII. Labeling for Aliphatic Solvents Products]{.underline}:**
....................................... **32**

**[XIII. Tolerance Reassessment]{.underline}:**
..................................................\......... **32**

**[XIV. References]{.underline}:**
.............................................................................
**33**

**[Appendix A. SLUA]{.underline}**
.......................................................................\...
**36**

**[Appendix B. Health Effects]{.underline}**
................................................................ **40**

**[Appendix C. Detailed Information on Use Rates for Aliphatic
Solvents]{.underline}** ......\..... **53**

**[Background:]{.underline}**

This document represents the Reregistration Eligibility Decision (RED)
document for aliphatic solvents. The Aliphatic Solvents Case (3004)
includes two closely related chemicals, the mineral oils and aliphatic
petroleum hydrocarbons, which are products of various types of petroleum
distillation processes, and thus, represented by several different CAS
Numbers. This assessment summarizes available information on the uses,
physical and chemical properties, toxicological effects, dietary
assessment, and the environmental fate and ecotoxicity of these
aliphatic solvents. These chemicals have insecticide and/or larvicide
uses as spray oils on agricultural crops and by residential homeowners,
as well as occupational and residential uses as acaricides, fungicides,
herbicides, and virucides, in addition to aquatic uses as mosquito
larvicides/pupacides. There are also inert ingredient uses for many of
these same CAS Number chemicals; the exemption from the requirement for
a tolerance for the inert ingredient uses of Mineral Oil has already
been reassessed during 2005, and the exemptions from the requirement for
tolerances for the inert ingredient uses of most of the other chemicals
in this RED are being reassessed in a separate document.

**[I. Executive Summary:]{.underline}**

The Aliphatic Solvents (Case 3004) includes both mineral oil (OPP
Chemical Code 063502) and aliphatic petroleum hydrocarbons (063503).
Twelve chemicals (individual CAS Numbers) are covered in this group.

These aliphatic solvents are the product of petroleum distillations
processes, and thus, they are complex mixtures of long-chain aliphatic
(paraffinic) compounds. They are formulated as liquid concentrates for
use as insecticides and/or larvicides on crops, animal premises,
commercial/industrial premises, medical premises, aquatic areas, and
residential premises, as well as occupational and residential uses as
acaricides, fungicides, herbicides, and virucides (for plant pathogens).
The aquatic area applications are for usage as a mosquito
larvicide/pupacide. Application equipment includes the following: for
agricultural crops, by airplane, groundboom sprayer, airblast sprayer,
handgun sprayer, low-pressure handwand sprayer, and/or high-pressure
handwand sprayer; for use at commercial/industrial sites, by
low-pressure handwand sprayer, handgun sprayer, airplane, truck-mounted
ULV sprayer, airblast sprayer, rights-of-way sprayer, and/or high
pressure handwand sprayer; and for residential settings, by hose-end
sprayer, low pressure handwand sprayer, and trigger-pump sprayer. For
the aliphatic petroleum hydrocarbons, several end-use products allow for
application to agricultural crops via chemigation, and some products can
be applied via dip to ornamental nursery stock, pineapples, and citrus.

These chemicals have a low degree of acute toxicity. For example, there
was no mortality in rats at acute oral doses of 28,000 mg/kg body
weight, and only slight eye irritation in rats and rabbits. Based on
subchronic and chronic toxicity, these chemicals are virtually non-toxic
by the oral or dermal route, and they have limited toxicity via the
inhalation route, caused by their physical properties (i.e., the
observed effects are not due to chemical toxicity, but due to irritating
effects, such as interstitial inflammation and alveolar histiocytosis,
related to the body's defense mechanism against the exposure to a
foreign material, when the aliphatic oils enter the lungs).

There is a short-term dermal NOAEL of 2000 mg/kg/day, from a 28-day
dermal toxicity study. However, this is a very conservative estimate of
dermal exposures, because it is based on a study in which no effects
were seen even at the highest test concentration (2000 mg/kg/day). The
actual NOAEL could potentially be much higher, with possibly virtually
no adverse effects at any dose at which these oils might be applied to
the skin.

There is a short-term inhalation LOAEL of 146.64 mg/kg/day, based on a
28-day inhalation study, in which effects were observed, even at the
lowest inhalation dose tested, 0.52 mg/L, including the following: (1)
various effects in the lungs, (2) increased white blood cell counts in
males, (3) increased absolute liver weight, (4) accessory spleens and/or
abnormally colored spleens, and (5) additional microscopic findings.
There is also an intermediate-term inhalation NOAEL of 26.1 mg/kg/day,
derived from a 90-day inhalation study, based on effects observed at 0.9
mg/L, with no adverse effects observed at 0.1 mg/L.

An HED memo by OREB (USEPA 1995a) determined that "because toxicity is
very low (the FDA has recommended mineral oil for GRAS status), dermal
exposure does not warrant an exposure study at this time for
reregistration." In the same memo, it also was stated that "OREB does
not require an inhalation exposure study for reregistration at this
time," and the "OREB does not require a mixer/loader/applicator exposure
study for reregistration." Consequently, this RED does not present any
assessment for the potential occupational or residential handler dermal
or inhalation exposures, nor any assessment for any occupational or
residential postapplication exposures. Instead the Agency has
qualitatively assessed these exposures, and has determined that risks
are not of concern.

The overall dietary exposure, and the drinking water (only) dietary
exposure, have also each been qualitatively assessed, based on the
absence of acute and chronic oral effects from exposures to mineral oils
and aliphatic petroleum hydrocarbons. These dietary exposures are not of
concern to the Agency, nor does the Agency have concerns for the
aggregate exposures to these chemicals.

The environmental fate assessment of these chemicals indicates they have
low to very low vapor pressures, very low solubility in water, high
octanol-water partition coefficients, and high sorption to organic
matter. Thus, these chemicals will exhibit very poor migration, due to
their high sorption, and low solubility in water, as well as low
potential for volatility. Fugacity modeling suggests they would remain
partitioned to the terrestrial phase, remaining sorbed to soil or the
foliar surfaces to which they are applied.

The ecological toxicity assessment of these chemicals indicates they
have virtually no toxic effects to mammals or birds (however, there is
potential for impairing the hatching of bird eggs, if the spray oils are
applied directly to the eggs in the nests). These chemicals are also
virtually non-toxic to honey bees, based on the results from contact
toxicity testing. Testing of phytotoxic effects have not been submitted
to the Agency, but very high levels of materials are applied to many
different types of plants, without effects reported by applicators or
growers, so the Agency does not have concerns for phytotoxicity, other
than warnings which appear on a few of the labels among the many
currently formulated products. (Evidence is available that most
registrants have been moving to cleaner technical grade formulations,
with lower amounts of polynuclear aromatic hydrocarbons (PAHs), those
components of the spray oils which had historically been thought to
contribute to phytotoxicity). The results of toxicity testing with fish,
both estuarine/marine and freshwater species, have shown virtually no
toxic effects, and there were no toxic effects in testing with
estuarine/marine mysid shrimp. There is a study showing adverse effects
on oyster shell deposition (EC50 = 6 mg/L), but this might be due to the
mineral oils coating the surfaces of the food sources for the oysters,
impairing their ability to digest their food. Studies with daphnia have
shown effects, even at very low exposure concentrations, but many of the
studies submitted to the Agency had been conducted with products no
longer produced as registered products. In the most recently submitted
study with daphnia, the effects observed included immobilization in the
water column and/or floating on the surface, but visual observations
with a microscope revealed the daphnia hearts were still beating. Thus,
while immobilization and floating effects were observed even at the
lowest test concentration (EC50 = \< 0.9 mg/L), the study reported that
"the test compound, VHVI-4, was not lethal to Daphnia magna at the
highest test concentration (14 mg/L) after 48 hours exposure."

Three of the products are also registered solely as mosquito
larvicides/pupacides, acting as surface film agents. Information has
been received from the US Centers for Disease Control and Prevention
(CDC) that these products have important public health benefits,
compared with the various other mosquito larvicides, because these
products are among the only pupacides, and "surface films provide a
valuable option to an integrated mosquito control program." In addition,
information was presented by CDC that "surface film larvicides generally
have a shorter environmental persistence (approx. 2-3 days) than most
chemical larvicide alternatives." The transient nature of these surface
films may have a mitigating effect on the potential adverse impacts upon
daphnia observed above.

The overall Ecological Risk Assessment for these mineral oils and
aliphatic petroleum hydrocarbons indicates essentially no concerns for
terrestrial effects (other than the potential for adverse effects on
bird egg-hatching, if spray oils are applied directly to the nests). In
addition, there were no effects on most aquatic organisms, including
fish (both freshwater and marine) and water-column marine/estuarine
invertebrates (mysid shrimp); however, some impacts were noted in an
oyster shell deposition study, and there is a potential for adverse
effects in daphnids, including immobilization and floating of the
daphnia, in the transient surface films which might result from the
applications of these end-use products, including off-site drift from
airblast applications to orchards (the EFED Memo stated that "9.7% of
the total amount of a product applied" is assumed to drift off-site).
The Agency is proposing to mitigate these potential adverse impacts on
aquatic invertebrates, effects which might be caused by off-site spray
drift, by placing spray drift language on the revised labels to be
submitted as part of the reregistration process.

**[II. Use Information]{.underline}:**

The Aliphatic Solvents (Case 3004) include both "Mineral Oil -- includes
paraffin oil from 063503" (OPP Chemical Code 063502) and "Aliphatic
Petroleum Hydrocarbons" (OPP Chemical Code 063503). In addition,
according to the "[Status of Pesticides in Registration, Reregistration,
and Special Review]{.underline}" (Spring 1998), commonly called the
Rainbow Report, the Case also includes Kerosene (063501), Mineral
Spirits (063506), and Isoparaffinic Hydrocarbons (505200), although each
of which are each listed in the Rainbow Report as "cancelled."

Note, however, that OPPIN Query does list some products in the Kerosene
OPP Chemical Code; however, some of these products contain kerosene only
as an inert ingredient, according to their Confidential Statements of
Formula (CSFs). Based on their respective CSFs, each of the other
products in OPPIN Query within the Kerosene Chemical Code are end-use
products which are be formulated with various Technical Grade Active
Ingredients (TGAIs) from each of the other two supported OPP Chemical
Codes, 063502 and 063503, but none of these end-use products actually
contains Kerosene as the active ingredient. Thus, while these products
are clearly misclassified within OPPIN Query as "Kerosene", this
information also suggests that the various TGAIs within each of these
supported OPP Chemical Codes have very similar chemical characteristics,
especially considering that these end-use product registrants are able
to utilize these "Mineral Oil" and "Aliphatic Petroleum Hydrocarbon"
TGAIs interchangeably on their respective CSFs.

There are currently about 165 products listed in OPPIN within OPP
Chemical Codes covered in this Case (063501, 063502 \[and 063503\]).
Based on a thorough search of the CSFs for the 165 products (a total of
about 225 CSFs, accounting for both Basic and Alternate formulations),
there are twelve different CAS Numbers included in this Case (Table 1).
Each of these CAS Numbers is listed on one or more of the CSFs for one
or more of the TGAIs within this Case. Some of these CAS Numbers have
very similar components, because different CAS Numbers may represent
petroleum distillates which are very closely related to each other,
since the assigning of CAS Numbers for petroleum distillation products
(by the Chemical Abstract Service (CAS) of the American Chemical
Society) is based on the last step in the refining process. Thus,
virtually identical distillation products, produced via alternative
refining pathways, will have different CAS Numbers, although being
essentially identical "oils." The materials represented by these CAS
Numbers also have other uses, in addition being pesticide active
ingredients and as pesticidal inert ingredients, including as various
other types of oil-based products; for example, all these CAS Numbers
(except for the mineral oils) are in the High Production Volume (HPV)
data set submitted under the name Lubricating Oil Basestocks Category).

  ----------------------------------------------------------------------------
  **Table 1.                     
  Description of                 
  Chemicals                      
  included in the                
  Aliphatic                      
  Solvents Case**                
  ----------------- ------------ ---------------------------------------------
  Chemical Name     CAS number   Description

  Mineral oil; Oil  8012-95-1    Liquid hydrocarbons from petroleum.
  mist (mineral)                 

  Mineral oil;      8020-83-5    A mixture of liquid hydrocarbons obtained
  Hydrocarbon oils;              from petroleum.
  paraffin liquid                

  White mineral     8042-47-5    A highly refined petroleum mineral oil
  oil, petroleum                 consisting of a complex combination of
                                 hydrocarbons obtained from the intensive
                                 treatment of a petroleum fraction with
                                 sulphuric acid and oleum, or by
                                 hydrogenation, or by a combination of
                                 hydrogenation and acid treatment. Additional
                                 washing and treating steps may be included in
                                 the processing operation. It consists of
                                 saturated hydrocarbons having carbon numbers
                                 predominantly in the range of C15 through
                                 C50.

  Lubricating oils, 72623-84-8   A complex combination of hydrocarbons
  petroleum C15-30,              obtained by treating light vacuum gas oil,
  hydrotreated                   heavy vacuum gas oil, and solvent deasphalted
  neutral oil                    residual oil with hydrogen in the presence of
  based,                         a catalyst in a two stage process with
  containing.                    dewaxing being carried out between the two
  solvent                        stages. It consists predominantly of
  deasphalted                    hydrocarbons having carbon numbers
  residual oil                   predominantly in the range of C15 through C30
                                 and produces a finished oil having a
                                 viscosity of approximately 10cSt at
                                 40.degree.C (104.degree.F). It contains a
                                 relatively large proportion of saturated
                                 hydrocarbons.

  Lubricating oils, 72623-86-0   A complex combination of hydrocarbons
  petroleum,                     obtained by treating light vacuum gas oil and
  C15-30,                        heavy vacuum gas oil with hydrogen in the
  hydrotreated                   presence of a catalyst in a two stage process
  neutral oil-based              and dewaxing being carried out between the
                                 two stages. It consists predominantly of
                                 hydrocarbons having carbon numbers
                                 predominantly in the range of C15 through C30
                                 and produces a finished oil having a
                                 viscosity of approximately 15cSt at 40°C. It
                                 contains a relatively large proportion of
                                 saturated hydrocarbons.

  Lubricating oils, 72623-87-1   A complex combination of hydrocarbons
  petroleum,                     obtained by treating light vacuum gas oil,
  C20-50,                        heavy vacuum gas oil and solvent deasphalted
  hydrotreated                   residual oil with hydrogen in the presence of
  neutral oil-based              a catalyst in a two stage process with
                                 dewaxing being carried out between the two
                                 stages. It consists predominantly of
                                 hydrocarbons having carbon numbers
                                 predominantly in the range of C20 through C50
                                 and produces a finished oil with a viscosity
                                 of approximately 32cSt at 40°C. It contains a
                                 relatively large proportion of saturated
                                 hydrocarbons.

  Distillates,      64741-88-4   A complex combination of hydrocarbons
  petroleum,                     obtained as the raffinate from a solvent
  solvent-refined                extraction process. It consists predominantly
  heavy paraffinic               of saturated hydrocarbons having carbon
                                 numbers predominantly in the range of C20
                                 through C50 and produces a finished oil with
                                 a viscosity of at least 100 SUS at 100°F
                                 (19cSt at 40°C).

  Distillates,      64741-89-5   A complex combination of hydrocarbons
  petroleum,                     obtained as the raffinate from a solvent
  solvent-refined                extraction process. It consists predominantly
  light paraffinic               of saturated hydrocarbons having carbon
                                 numbers predominantly in the range of C15
                                 through C30 and produces a finished oil with
                                 a viscosity of less than 100 SUS at 100°F
                                 (19cSt at 40°C).

  Distillates,      64742-54-7   A complex combination of hydrocarbons
  petroleum,                     obtained by treating a petroleum fraction
  hydrotreated                   with hydrogen in the presence of a catalyst.
  heavy paraffinic               It consists of hydrocarbons having carbon
                                 numbers predominantly in the range of C20
                                 through C50 and produces a finished oil of at
                                 least 100 SUS at 100°F (19cSt at 40°C). It
                                 contains a relatively large proportion of
                                 saturated hydrocarbons.

  Distillates,      64742-55-8   A complex combination of hydrocarbons
  petroleum,                     obtained by treating a petroleum fraction
  hydrotreated                   with hydrogen in the presence of a catalyst.
  light paraffinic               It consists of hydrocarbons having carbon
                                 numbers predominantly in the range of C15
                                 through C30 and produces a finished oil with
                                 a viscosity of less than 100 SUS at 100°F
                                 (19cSt at 40°C). It contains a relatively
                                 large proportion of saturated hydrocarbons.

  Distillates,      64742-56-9   A complex combination of hydrocarbons
  petroleum,                     obtained by removal of normal paraffins from
  solvent-dewaxed                a petroleum fraction by solvent
  light paraffinic               crystallization. It consists predominantly of
                                 hydrocarbons having carbon numbers
                                 predominantly in the range of C15 through C30
                                 and produces a finished oil with a viscosity
                                 of less than 100 SUS at 100°F (19cSt at
                                 40°C).

  Distillates,      64742-65-0   A complex combination of hydrocarbons
  petroleum,                     obtained by removal of normal paraffins from
  solvent-dewaxed                a petroleum fraction by solvent
  heavy paraffinic               crystallization. It consists predominantly of
                                 hydrocarbons having carbon numbers
                                 predominantly in the range of C20 through C50
                                 and produces a finished oil with a viscosity
                                 not less than 100 SUS at 100.degree.F (19cSt
                                 at 40.degree.C).
  ----------------------------------------------------------------------------

Based on this review of the approximately 225 CSFs, it was observed that
most of these CSFs have been recently submitted (within the last 10
years or so), even for products with a long history of registration.
Discussions at the SMART Meeting indicated that many registrants have
been converting their processes to produce TGAIs and to formulate
end-use products which have lower amounts of undesirable components
(i.e., with lower amounts of sulfur- and nitrogen-containing groups, and
with fewer side-chains containing polynuclear aromatic hydrocarbons).
These polyaromatic hydrocarbons have been found to be the source of some
phytotoxicity, formerly causing concerns among growers using these spray
oil products. (Some of the newer CSFs continue to show aliphatic
petroleum distillates with some side-chains containing naphtha-groups
\[cyclic saturated rings, as opposed to unsaturated aromatic rings\],
because it has been reported by some registrants that small amounts of
naphtha-containing side-chains are necessary for pourability; thus, with
no naphtha-containing groups within these aliphatic materials, the
petroleum distillates would have poor pourability, and would be
classified as "waxes".)

These aliphatic solvents are formulated as liquid concentrates, with
each TGAI being listed on the respective CSF as 100% active ingredient,
with no impurities (Table 2). These TGAIs are then formulated into
end-use products (often only with an emulsifier), usually with the
active ingredient at 97% or greater, for use as insecticides and/or
larvicides on crops, animal premises, commercial/industrial premises,
medical premises, aquatic areas, and residential premises. In addition,
there are three products specifically registered as mosquito
larvicides/pupacides, thus there is direct application to water bodies.
For the various OPP Chemical Codes, the number of total products (TGAIs,
Manufacturing Use Products (MUPs), and end-use products) are as follows:
Chemical Code 063502 (Mineral Oil), 130 total products; Chemical Code
063503 (Aliphatic Petroleum Hydrocarbon), 30 total products; and as
indicated above, 5 total products in Chemical Code 063501 (Kerosene).

+---------+--------------+--------------+-----------------------------+
| Table   |              |              |                             |
| 2.      |              |              |                             |
| Info    |              |              |                             |
| rmation |              |              |                             |
| on      |              |              |                             |
| TGAIs   |              |              |                             |
| Within  |              |              |                             |
| Each    |              |              |                             |
| OPP     |              |              |                             |
| C       |              |              |                             |
| hemical |              |              |                             |
| Code    |              |              |                             |
+=========+==============+==============+=============================+
| Chem    | Name         | Number of    | CAS Numbers Represented on  |
| Code    |              | TGAIs        | the Various CSFs within     |
| Number  |              |              | each Chemical Code          |
+---------+--------------+--------------+-----------------------------+
| 063501  | Kerosene     | None         | (See text for explanation   |
|         |              |              | of this                     |
|         |              |              |                             |
|         |              |              | Chemical Code.)             |
+---------+--------------+--------------+-----------------------------+
| 063502  | Mineral Oil  | 10           | 64742-55-8                  |
|         |              | (including 1 |                             |
|         |              | MUP)         | 64742-56-9                  |
|         |              |              |                             |
|         |              |              | 64742-65-0                  |
|         |              |              |                             |
|         |              |              | 72623-84-8                  |
|         |              |              |                             |
|         |              |              | 72623-86-0                  |
|         |              |              |                             |
|         |              |              | 72623-87-1                  |
|         |              |              |                             |
|         |              |              | 8012-95-1                   |
|         |              |              |                             |
|         |              |              | 8042-47-5                   |
+---------+--------------+--------------+-----------------------------+
| 063503  | Aliphatic    | 16           | 64741-88-4                  |
|         | Petroleum    | (including 4 |                             |
|         | Hydrocarbon  | MUPs)        | 64741-89-5                  |
|         |              |              |                             |
|         |              |              | 64742-54-7                  |
|         |              |              |                             |
|         |              |              | 64742-55-8                  |
|         |              |              |                             |
|         |              |              | 72623-84-8^1^               |
|         |              |              |                             |
|         |              |              | 8002-05-9                   |
|         |              |              |                             |
|         |              |              | 8020-83-5                   |
+---------+--------------+--------------+-----------------------------+

1.  When revised CSFs are submitted during reregistration, it is likely
    that CAS Numbers 72623-86-0 and 72623-87-1 will also be included,
    because these newer CAS Nos. are not currently listed on the older
    CSFs from one registrant, but those CAS Nos. are listed on the CSFs
    for the TGAIs from which these products are formulated.

Based on the information in Table 2, many of the CAS Numbers are listed
on the CSFs for the various TGAIs within both of the two different
Chemical Codes; thus, there is overlap. In fact, one company has four
TGAIs, all within 063502, while all five of their end-use products
(formulated from only those four TGAIs) are within the other Chemical
Code, 063503. Plus, as described in the section above, the end-use
products within 063501 (Kerosene) do not contain kerosene as an active
ingredient, but each product is formulated with TGAIs from both of the
other two OPP Chemical Codes. Consequently, as part of this
Reregistration Eligibility Decision, the Agency is planning to place all
these products within the "Aliphatic Solvents" Case into a single OPP
Chemical Code (possibly in a new Chemical Code, 063500, currently an
unused, unassigned number designation for an OPP Chemical Code, and
actually the number at the lower end of the series for most of these
"aliphatic solvents" products).

These aliphatic solvents containing products are formulated as liquid
concentrates. The application equipment includes airplane, groundboom
sprayer, airblast sprayer, handgun sprayer, low-pressure handwand
sprayer, and/or high-pressure handwand sprayer for applications to
agricultural crops; for commercial/industrial sites, application
equipment includes low-pressure handwand sprayer, handgun sprayer,
airplane, truck-mounted ULV sprayer, airblast sprayer, rights-of-way
sprayer, and/or high pressure handwand sprayer. In residential settings,
typical application equipment includes hose-end sprayer, low pressure
handwand sprayer, and trigger-pump sprayer. For petroleum hydrocarbons,
several products have product labels which allow for application to
agricultural crops via chemigation. In addition, some products can be
applied via dip to ornamental nursery stock, pineapples, and citrus. The
three currently registered mosquito larvicide/pupacide products are
applied by ground equipment, with one product also having a label
listing aerial applications.

Appendix C contains more detailed information on the crops/use sites,
application equipment, timing of application, maximum application rate,
and re-entry interval (if applicable). These data were derived by the
Biological and Economic Assessment Division (BEAD) in the EFED
spreadsheets (for the Environmental Fate and Effects Division). In some
cases, the entries in the EFED table did not provide pounds active
ingredient per gallon for the mineral oils or the aliphatic petroleum
hydrocarbons. A review of the physical/chemical characteristics obtained
through a literature search provided a range of densities for both
chemicals. As a default, the highest density found for each chemical
(7.7 lb ai/gal for mineral oil, and 8.0 lb ai/gal for aliphatic
petroleum hydrocarbons, respectively) was used as an estimate for
adjusting the application rates for the respective active ingredient,
when necessary.

[]{.mark}

The information presented in Appendix C indicates many different types
of application methods and many different use sites for these Mineral
Oil and Aliphatic Petroleum Hydrocarbon products. According to the BEAD
Screening Level Usage Assessment (SLUA), there may be as much as 75
million pounds of these products used in the United States annually.
(See Appendix A for additional details concerning the BEAD SLUA.)

Mineral oil (8012-95-1) has recently been designated by the US Food and
Drug Administration (U.S. FDA) as Generally Recognized as Safe (GRAS);
the specific usage which is GRAS is as a release agent sprayed on potato
processing equipment, resulting in a presence on food of no more than 5
ppm (GRAS Notice No. GRN 00071; April 21, 2001). In addition, there are
many other uses for Mineral Oil listed in USFDA website, Everything
Added to Food in the United States (EAFUS), under their FDA regulations
pertaining to food additives, especially 21CFR 172.878, specifically
describing the uses of "White Mineral Oil", but there are many other
listings identified in EAFUS, including listings as food additives for
direct addition (172.842), as well as for secondary additives (173.340),
various indirect additives (175.105, 175.210, 175.230, 175.300, 176.170,
177.1200, 177.2260, 177.2600, 177.2800, 178.2010, 178.3570, 178.3620,
178.3740, 178.3910), and food additives permitted in feed and drinking
water of animals (573.680). The citations in EAFUS specifically refer to
"Mineral oil, white" CAS No. 8012-95-1, and not any of the other mineral
oil CAS Numbers; in addition, a search by CAS Number of EAFUS indicates
there are no listings for any of the other chemicals in this RED, the
aliphatic petroleum hydrocarbons.

The tolerance exemptions being reassessed in this RED, with the
respective citation in the Code of Federal Regulations (CFR) and use
pattern as an active ingredient, are listed in Table 3. Table 3 also
includes the inert ingredient uses of these chemicals. The exemptions
from the requirement of a tolerance for the inert ingredient uses of
Mineral Oils (180.910 and 180.930) have already previously been
reassessed, in a document dated December 30, 2005, while the other
petroleum hydrocarbon exemptions as inert ingredients are currently
undergoing reassessment, within the Registration Division, with a
completion date on or before August 3, 2006.

  ------------------------------------------------------------------------------------
  **Table 3.                                                            
  Tolerances and                                                        
  Exemptions Being                                                      
  Reassessed for                                                        
  the Aliphatic                                                         
  Solvents**                                                            
  ---------------- ---------------------------- ----------- ----------- --------------
  Tolerance                                     40 CFR      PC Code     Use Pattern
  Expression; and                                                       
  Specific                                                              
  Tolerance                                                             

  **Active                                                              
  Ingredient**                                                          

  Mineral oil      "Corn, grain, post-harvest": 180.149     063502      Insecticide
                   200 ppm                                              

                   "Sorghum, grain, grain,                              
                   postharvest": 200 ppm                                

  Petroleum oils   Exempt from the requirement  180.905     063502 /    Pesticide
                   for a tolerance                          063503      

  ***"Inert (or                                                         
  occasionally                                                          
  active)                                                               
  Ingredient"***                                                        

  *"Mineral oil,                                *180.910*   *063502*    *Diluent,
  U.S.P., or                                                            carrier and
  conforming to 21                                                      solvent*
  CFR 172.878 or                                                        
  178.3620(a) (CAS                                                      
  Reg. No.                                                              
  8012-95-1)"*                                                          

  *"Petroleum                                   *180.910*   *063503*    *Solvent,
  hydrocarbons,                                                         diluent*
  light odorless                                                        
  conforming to 21                                                      
  CFR 172.884"*                                                         

  *"Petroleum                                   *180.910*   *063503*    *Solvent,
  hydrocarbons,                                                         diluent*
  synthetic                                                             
  isoparaffinic,                                                        
  conforming to 21                                                      
  CFR 172.882"*                                                         

  *"Mineral oil,                                *180.930*   *063502*    *Solvent,
  U.S.P., or                                                            diluent*
  conforming to 21                                                      
  CFR 172.878 or                                                        
  178.3620(a)                                                           
  (b)"*                                                                 

  *"Petroleum                                   *180.930*   *063503*    *Solvent,
  hydrocarbons,                                                         diluent*
  light odorless                                                        
  conforming to 21                                                      
  CFR 172.884 or                                                        
  178.3650"*                                                            

  *"Petroleum                                   *180.930*   *063503*    *Solvent,
  hydrocarbons,                                                         diluent*
  synthetic                                                             
  isoparaffinic,                                                        
  conforming to 21                                                      
  CFR 172.882 or                                                        
  178.3530"*                                                            
  ------------------------------------------------------------------------------------

The active ingredient use listed in Table 3 for 180.149 predates the
establishment of the Environmental Protection Agency. Spray Oils
(petroleum oils) have been utilized for insect control on crops and
trees for over 130 years, while the post-harvest uses on corn and
sorghum to combat storage insect infestation were in a Tolerance
Petition in the 1950s. BEAD and SRRD conducted a review of the EFED
spreadsheets (data complied based on the existing labels), and this
search did not detect any Mineral Oils products with a current label for
this grain storage use, as listed at 40 CFR 180.149; thus, as part of
the RED process, SRRD will publish a notification in the Federal
Register proposing to cancel this use, and to revoke this tolerance at
40 CFR 180.149.

Some of the maximum application rates on some of the labels are very
high. For example, for one suite of pests on citrus, in Florida, Texas,
and California, various labels indicate that applications may be made at
up to 4500 gallons of spray mix (prepared as a thorough coverage spray
mix of up to 1.5 gallons of end-use product in 100 gallons of water).
These registrants have voluntarily agreed to reduce this maximum amount
applied to only 1500 gallons in Florida and Texas, and to 1800 gallons
in California. This higher rate in California was proposed by
researchers at the University of California, Kearney Ag Center, due to a
unique citrus pest found in California; this feedback resulted from the
Agency requesting that USDA seek guidance from researchers, growers, and
other stakeholders.

There currently are few labels with application restrictions on the
number of applications per year, or the timing between applications,
although there are some residential products for homeowner use that do
include such reapplication restrictions.

**[III. Physical/Chemical Properties]{.underline}:**

Table 4 provides physical/chemical properties that are available for
certain aliphatic solvents. Information was not found for all CAS
Numbers included in this RED.

Based on the data in Table 4, as well as various estimates derived from
EPIWIN and other models for developing physical and chemical properties
information (and characterizations for the CAS Numbers in the HPV
submission), it is not feasible to report specific data for each
property, due to the diversity of different compounds present as
components within each of these mineral oils and aliphatic petroleum
hydrocarbons. However, certain patterns are evident in describing these
oils. The melting points (pour point, or temperature at which flow
characteristics appear) are below 0 °C. The actual boiling points listed
are a reflection that they are mixtures of compounds, dependent on the
types and order of distillation and refining processes employed, with
constituent hydrocarbons of these oils having boiling points ranging
from 300 to 800°C. Similarly, their vapor pressures exhibit a very wider
range, ranging from 10^-4^ Pa to 10^-16^ Pa (about 10^-3^ to 10^-14^ mm
Hg), ranging from the smaller to larger constituents. Their
octanol-water partition coefficients are high, with log K~ow~ values
ranging from about 5 to about 20, from the smaller chain-length to the
larger chain length molecules. The constituents of the oils are also
very poorly water soluble, with solubility values ranging from 0.001 to
0.6 mg/L, being least soluble for the larger constituents.

  -------------------------------------------------------------------------------------------------------------------------------------------------
  **Table 4.                                                                                                                          
  Physical/Chemical                                                                                                                   
  Properties of the                                                                                                                   
  Aliphatic                                                                                                                           
  Solvents**                                                                                                                          
  ------------------- ------------- ------------- ------------ ------------- -------------- ------------- ------------- ------------- -------------
  CAS No.             8012-95-1     8042-47-5     64742-55-8   64741-97-5    72623-87-1     72623-84-8    64742-56-9    64741-88-4    Various^1^

  Appearance,         Oily,         Clear, water  Bright,      Liquid        Clear and      Light straw   White, clear  Amber,        Viscous
  Physical State,     colorless     white liquid  clear, straw               bright neutral               liquid        viscous       liquid;
  Color                                           colored                                                               liquid        colourless to
                                                                                                                                      light yellow

  Odor                Odorless      Essentially   Mild lube    \--           None           Hydrocarbon   Hydrocarbon   Mild or       Odourless or
                                    odorless      oil odor                                  odor                        faint;        mild
                                                                                                                        petroleum     petroleum oil
                                                                                                                                      like

  Solubility in water Insoluble     Insoluble     Insoluble    \--           Negligible     Insoluble     Nil           Insoluble     Insoluble

  Boiling point       360^o^C       \>260^0^C /   \>500^o^F    150-600^o^C   600-894        0^o^F         560 --        150-600^o^C   Not available
                                    500^o^F                                  (temperature                 760^o^F                     
                                                                             scale not                                                
                                                                             provided)                                                

  Density/ Specific   0.875-0.905   \<1           0.86         \~0.84-0.94   0.8493         0.875         0.86          \~0.84-0.94   0.851 to
  Gravity                                                      at 15^o^C                                                at 15^o^C     0.863 kg/L at
                                                                                                                                      15^o^C

  Vapor density       \--           \>1           \--          \--           NA             NA            \>1           \>5           Not available

  Vapor pressure      \<0.5 mmHg    \--           \--          \--                          0.0225 mmHg @ NA            \<1 mmHg      Negligible at
                      \@20^o^C                                                              20^o^C                      \@68^o^F      ambient
                                                                                                                                      temperature
                                                                                                                                      and pressure
  -------------------------------------------------------------------------------------------------------------------------------------------------

1: Various CAS #s are listed, as follows: 8042-47-5, 64742-46-7,
64742-52-5, 64742-54-7, 72623-84-8, 72623-85-9, 72623-86-0, 72623-87-1,
178603-64-0, 178603-65-1, 178603-66-2, 445411-73-4

References: 8012-95-1: HSDB, 2002

8042-47-5: MSDS, 2002b

64742-55-8: MSDS, 1994

64741-97-5: ICSC, 2001a

72623-87-1: MSDS, 2003a

72623-84-8: MSDS, 2004

64742-56-9: MSDS, 2003b

64741-88-4: ICSC, 2001b; MSDS, 2002a

**[IV. Hazard Assessment]{.underline}:**

The toxicity data available for various chemicals in the aliphatic
solvents group are provided in Appendix B. These data were obtained from
the MRIDs submitted by registrants and EPA's Health Effects Division
(HED) Toxicity Data Evaluation Reviews (DERs) of these MRIDs, as well as
from the Registry of Toxic Effects of Chemical Substances (RTECS) of the
National Institute for Occupational Safety and Health, and from High
Production Volume (HPV) Robust Summaries, various Material Safety Data
Sheets (MSDSs), and the open literature.

Acute toxicity data for representative chemical constituents are
provided in Table 5. In general, these mineral oils and aliphatic
petroleum hydrocarbons exhibit a very low degree of acute toxicity in
mammalian testing.

+-------+---------+---------------+----------+---------------+------+
| **    |         |               |          |               |      |
| Table |         |               |          |               |      |
| 5.    |         |               |          |               |      |
| Su    |         |               |          |               |      |
| mmary |         |               |          |               |      |
| of    |         |               |          |               |      |
| Repr  |         |               |          |               |      |
| esent |         |               |          |               |      |
| ative |         |               |          |               |      |
| Acute |         |               |          |               |      |
| Tox   |         |               |          |               |      |
| icity |         |               |          |               |      |
| Data  |         |               |          |               |      |
| for   |         |               |          |               |      |
| the   |         |               |          |               |      |
| Alip  |         |               |          |               |      |
| hatic |         |               |          |               |      |
| Sol   |         |               |          |               |      |
| vents |         |               |          |               |      |
| (Mi   |         |               |          |               |      |
| neral |         |               |          |               |      |
| Oil   |         |               |          |               |      |
| and   |         |               |          |               |      |
| Alip  |         |               |          |               |      |
| hatic |         |               |          |               |      |
| Petr  |         |               |          |               |      |
| oleum |         |               |          |               |      |
| Hydro |         |               |          |               |      |
| carbo |         |               |          |               |      |
| ns)** |         |               |          |               |      |
|       |         |               |          |               |      |
| *     |         |               |          |               |      |
| *(See |         |               |          |               |      |
| App   |         |               |          |               |      |
| endix |         |               |          |               |      |
| B for |         |               |          |               |      |
| addit |         |               |          |               |      |
| ional |         |               |          |               |      |
| data  |         |               |          |               |      |
| and   |         |               |          |               |      |
| fu    |         |               |          |               |      |
| rther |         |               |          |               |      |
| detai |         |               |          |               |      |
| ls)** |         |               |          |               |      |
+=======+=========+===============+==========+===============+======+
| Study | Species | Data Source   | CAS      | Results       | Toxi |
| Type  |         |               | Number   |               | city |
|       |         | (MRID, or     |          |               | Cate |
|       |         | citation)     |          |               | gory |
+-------+---------+---------------+----------+---------------+------+
| Acute | Rat     | (Hine and     | Various  | LD~50~ \>     | I    |
| oral  |         | Zuidema       |          | 25.0 mL/kg    | V^a^ |
|       |         | (1970); also  | (lower   | (\>28,000     |      |
|       |         | cited in      | range of | mg/kg)        |      |
|       |         | INCHEM (WHO), | carbon   |               |      |
|       |         | 1982)         | lengths) | no deaths     |      |
|       |         |               |          | observed      |      |
+-------+---------+---------------+----------+---------------+------+
| Acute | Rabbit  | (NIOSH,       | 64       | LD50 \>5 g/kg | IV   |
| d     |         | 1997a)        | 742-54-7 |               |      |
| ermal |         |               |          |               |      |
+-------+---------+---------------+----------+---------------+------+
|       | Rat     | (EPA, 1994a)  | 64       | LD50 \> 5     | IV   |
|       |         |               | 742-56-9 | g/kg for      |      |
|       |         |               |          | males and     |      |
|       |         |               |          | females       |      |
+-------+---------+---------------+----------+---------------+------+
| Acute | Rat     | (NIOSH, 2000) | 64       | LD~50~ =      | III  |
| inhal |         |               | 742-55-8 | 3,900 mg/m^3^ |      |
| ation |         |               |          | (3.9 mg/L)    |      |
|       |         |               |          | for 4 hr ^1^  |      |
+-------+---------+---------------+----------+---------------+------+
| Acute | Rabbit  | (NIOSH, 2003) | 8        | Moderate      | III  |
| eye   |         |               | 012-95-1 | effect at 500 |      |
| irrit |         |               |          | mg            |      |
| ation |         |               |          |               |      |
+-------+---------+---------------+----------+---------------+------+
|       | Rat     | (EPA, 1994c)  | "Mineral | Slight eye    | III  |
|       |         |               | Oil"     | irritation;   |      |
|       |         |               |          | did not clear |      |
|       |         |               |          | at day 14     |      |
|       |         |               |          | (last day of  |      |
|       |         |               |          | observation)  |      |
+-------+---------+---------------+----------+---------------+------+
| Acute | Guinea  | (NIOSH, 2003) | 8        | Mild effect   | IV   |
| d     | pig     |               | 012-95-1 | at 100 mg for |      |
| ermal |         |               |          | 24 hour       |      |
| irrit |         |               |          |               |      |
| ation |         |               |          |               |      |
+-------+---------+---------------+----------+---------------+------+
|       | Rabbit  | (NIOSH, 2003) | 8        | Mild effect   | IV   |
|       |         |               | 012-95-1 | at 100 mg for |      |
|       |         |               |          | 24 hour       |      |
+-------+---------+---------------+----------+---------------+------+
| Skin  | Guinea  | (EPA, 1994a)  | 64       | Not a dermal  |      |
| sen   | pig     |               | 742-56-9 | sensitizer    |      |
| sitiz |         |               |          |               |      |
| ation |         |               |          |               |      |
+-------+---------+---------------+----------+---------------+------+

1\. Most other reports from inhalation toxicity testing indicated no
lethality was observed.

Based on the subchronic toxicity data in Appendix B, representative data
are presented in Table 6. For certain specific aliphatic solvents, it
has been reported that the effects of short-term exposure include mild
irritation to the skin, and if swallowed, aspiration into the lungs may
result in chemical pneumonitis. The effects of long-term exposure
include possible dermatitis with repeated or prolonged contact with skin
(Inchem, 2001a,b; MSDS, 1994, 2002).

+---------+----------+--------------+------------------+--------------+
| **Table |          |              |                  |              |
| 6.      |          |              |                  |              |
| Summary |          |              |                  |              |
| of      |          |              |                  |              |
| S       |          |              |                  |              |
| elected |          |              |                  |              |
| Sub-    |          |              |                  |              |
| Chronic |          |              |                  |              |
| T       |          |              |                  |              |
| oxicity |          |              |                  |              |
| Tests   |          |              |                  |              |
| for     |          |              |                  |              |
| Al      |          |              |                  |              |
| iphatic |          |              |                  |              |
| Sol     |          |              |                  |              |
| vents** |          |              |                  |              |
+=========+==========+==============+==================+==============+
| Study   | Test     | Test animal  | Doses            | Results      |
|         | material |              |                  |              |
+---------+----------+--------------+------------------+--------------+
| 28-day  | Light    | C3H/HeNCrlBR | Undiluted test   | **NOEL \>    |
| dermal  | neutral  | mice         | material or      | 2000         |
|         | oil,     |              | 42.5% (w/v)      | mg/kg/day**  |
| MRID    | Gulf     | (            | solution in      |              |
| 41      |          | 15/sex/dose) | heavy mineral    |              |
| 3688-22 | (purity  |              | oil once daily,  |              |
|         | not      |              | 3x/week for 4    |              |
| (EPA,   | p        |              | weeks            |              |
| 1996)   | rovided) |              |                  |              |
+---------+----------+--------------+------------------+--------------+
| 28-day  | Light    | Fischer 344  | 0, 0.52, 0.76,   | LOEL = 520   |
| inh     | Neutral  | rats         | or 1.53 g/m^3^   | mg/m^3^ or   |
| alation | Oil,     | (            | or g/mL for      | mg/mL        |
|         | Gulf     | 10/sex/dose) | 6-hours/day.     |              |
| MRID    |          |              | Five days/week,  | (**146.64    |
| 41      | (purity  |              | for total of 28  | mg/kg/day**) |
| 3688-24 | not      |              | days             |              |
|         | p        |              |                  |              |
| (EPA,   | rovided) |              |                  |              |
| 1996)   |          |              |                  |              |
+---------+----------+--------------+------------------+--------------+
| 90-day  | GB-1111  | Crl:         | Target           | NOEL = 0.1   |
| inh     |          | CD^®^(SD)IGS | concentrations:  | mg/L         |
| alation |          | BR rats      | 0.01, 0.1, and   |              |
|         |          |              | 1.0 mg/L         | (**26.1      |
| MRID    |          |              |                  | mg/          |
| 45      |          |              | Actual           | kg/day**)^a^ |
| 0029-01 |          |              | concentrations:  |              |
|         |          |              | 0.012, 0.10, and |              |
| (       |          |              | 0.9 mg/L         |              |
| Ulrich, |          |              |                  |              |
| 1999)   |          |              | 6 hr exposure    |              |
+---------+----------+--------------+------------------+--------------+

A short-term exposure duration dermal NOAEL of 2000 mg/kg/day was
observed in a 28-day repeat-dose study, in which no adverse effects were
observed at the highest test concentration (2000 mg/kg/day) (EPA, 1996;
MRID 413688-22). The actual NOAEL could potentially be very much higher,
because it is quite possible that there would be no adverse effects from
dermal exposures, even at the highest possible dosage which could be
applied to the skin.

A short-term exposure duration inhalation LOAEL of 146.64 mg/kg/day was
observed in a 28-day inhalation study. Adverse effects were reported at
the lowest exposure dosage, 0.5 mg/L, based on the following
observations: (1) multiple lung effects, (2) increased white blood cell
counts in males, (3) increased absolute liver weight, (4) accessory
spleens and/or abnormally colored spleens, and (5) additional
microscopic findings (EPA, 1996; MRID 413688-24). An intermediate-term
exposure duration inhalation NOAEL of 26.1 mg/kg/day was observed in a
90-day inhalations study, in which effects were observed at 0.9 mg/L,
but there were no adverse effects observed at 0.1 mg/L (EPA, 1996; MRID
450029-01).

[Metabolism / absorption:]{.underline}

Oral doses of mineral oils and aliphatic petroleum hydrocarbons are
poorly absorbed across the gastrointestinal tract lining, and most are
rapidly eliminated unchanged in the feces (75 to 98%, within 8 hours to
4 days). In addition, these materials also show very poor permeability
across the dermal barrier (very little is absorbed through the skin).
Similarly, any of these materials which enter the lungs are also
generally not absorbed, but there may be phagocytosis by the surrounding
lung cells, with some materials then being transported to the spleen and
liver, with eventual elimination occurring, mostly unmetabolized, within
the feces.

The April 1997 data call-ins for the Mineral Oils (GCDI-063502-17721)
and for Aliphatic Petroleum Hydrocarbons (GCDI-063503-17722) did not
require data for various types of repeat dose toxicity studies,
including either reproductive/developmental or carcinogenicity toxicity
testing, via either oral or dermal exposure dosing. Thus, these data
have not been submitted by registrants, and the information presented
was derived from various review documents. Data were required for
Mutagenicity/Genotoxicity (Gene mutation -- Ames \[84-2a; 870.5100\])
and for Structural Chromosomal Aberration \[84-2b; 870.5375\]); a number
of studies have been submitted, and DERs written for most.

[Reproduction/Developmental Effects]{.underline}:

In the HPV Submission for Lubricating Oils Basestocks (for most of the
CAS Numbers as in this RED), various repeat dose studies were reviewed
for reproductive and developmental toxicity effects. It was concluded
from dermal dosing studies, that mineral oil had no effects (on
mortality, clinical signs of toxicity, on body weight, food consumption,
absolute organ weights, microscopic changes in reproductive organs of
parental animals, number of corpora lutea, implantation sites, live pups
per litter, no gross anomalies, and body weights of pups or weight gains
of pups). In a 4-week inhalation study, there were no treatment related
effects on sperm morphology. In a one-generation reproduction study,
both males and females were dosed by gavage, and there were no adverse
effects (no clinical findings, growth weights and food consumption was
normal, no effects on fertility and mating indices in either males or
females, and at necropsy, organ weights and histopathology were
considered normal by the study authors). Two other studies were reported
with white mineral oil, both via single daily gavage doses. In one
study, both sexes were dosed, and some effects were observed, which the
study authors concluded were within the "spectrum of malformations
\[which\] occurs spontaneously in Sprague-Dawley rat." In the companion
study in which only pregnant females were dosed, fetal effects were
noted, but "the study authors considered these malformations to be minor
and within the normal ranges for the strain of rat" (Sprague-Dawley). In
general, these studies were performed at very high dosages, from about
900 mg/kg-bw/day (1 mL/kg-bw/day) to about 4500 mg/kg-bw/day (5
mL/kg-bw/day).

[Carcinogenicity:]{.underline}

The following information has been reported for the aliphatic solvents
with regards to carcinogenicity (IARC, 1987):

> Untreated and mildly-treated oils are carcinogenic to humans (Group
> 1), and
>
> Highly-refined oils are not classifiable as to their carcinogenicity
> to humans (Group 3).

The chemicals included in this RED are categorized as highly to severely
refined oils and, therefore, are classified as Group 3, meaning the
evidence of carcinogenicity is inadequate in humans and inadequate or
limited in experimental animals.

[Mutagenicity/Genotoxicity]{.underline}:

In DERs written by HED (EPA, 1994d), the mutagenicity of various test
materials were all characterized as being in general non-mutagenic, but
with problems due to the presence of suspended oil droplets, due to the
poor water solubility of the test materials. Results reported show the
following: no treatment related increases in the number of revertants to
histidine in either the plate incorporation or liquid suspensions assays
(Ames tests); in a mouse lymphoma forward mutation assay, there were no
adverse effects (but problems were encountered in removing the test
material from the cells, due to the insolubility with the aqueous
media); the test material did not appear to be clastogenic in an *in
vivo* mammalian cytogenetics assay with bone marrow, but the DER stated
evidence must be submitted to indicate that the test material is
absorbed from the gastrointestinal tract and transports to target tissue
\[bone marrow\] in effective concentrations.

In the HPV Submission for Lubricating Oils Basestocks (HPV, 2004), it
was concluded that the *in vitro* (mutagenicity) tests, the results had
low mutagenicity indices, and that the *in vivo* results would probably
be negative, due to the low bioavailability of these test materials, and
due to the negative results observed in *in vitro* mutagenicity testing
and dermal carcinogenicity studies.

[Special Considerations for Infants and Children]{.underline}:

The data found on reproductive or developmental toxicity for the
aliphatic solvents (the mineral oils and aliphatic petroleum
hydrocarbons) indicate that for most CAS Numbers, there are few effects
that suggest any reproductive impairment or adverse fetal impacts that
occur at doses not also having maternal impacts. In general, most of the
studies reported in the HPV submission were conducted at very high
dosing levels, whether by the dermal, inhalation, or oral route of
exposure. Overall, therefore, there are no concerns at the present time
for potential sensitivity of infants and children to these mineral oils
and aliphatic petroleum hydrocarbons, because any reproductive and
developmental toxicity effects only occurred at doses much greater than
those expected from use of these chemicals as active ingredients.

**[V. Exposure Assessment]{.underline}:**

There is a potential for dermal and inhalation exposure to aliphatic
solvents (both mineral oils and aliphatic petroleum hydrocarbons) in
occupational scenarios from handling aliphatic solvent-containing
products during the mixing, loading and application process (i.e.,
mixers/loaders/applicators). Short-term exposures are likely (from 1 to
30 days); however, it is less certain that pesticide handlers would have
intermediate-term exposures (i.e., continuous exposures of greater than
30 days, that is, from 1 month to 6 months). However, as part of the
earlier Phase 4 Reregistration Process, the Occupational and Residential
Exposure Branch (OREB) of HED (USEPA 1995b) determined that, for the
Mineral Oils and Aliphatic Petroleum Hydrocarbons the "toxicity is very
low (the FDA has recommended mineral oil for GRAS status), dermal
exposure does not warrant an exposure study at this time for
reregistration." In addition "OREB does not require an inhalation
exposure study for reregistration at this time," and "OREB does not
require a mixer/loader/applicator exposure study for reregistration."
Thus, various Guidelines were waived by OREB, and not required as part
of a GDCI, including Guidelines 133-4, Inhalation Exposure (new \#
875.2500), as well as the following applicator exposure monitoring:
Guideline 231, Estimation of Dermal Exposure at Outdoor Sites (new \#
875.1100), Guideline 232, Estimation of Inhalation Exposure at Outdoor
Sites (new \# 875.1300), Guideline 233, Estimation of Dermal Exposure at
Indoor Sites (new \# 875.1200), and Guideline 234, Estimation of
Inhalation Exposure at Indoor Sites (new \# 875.1400).

Thus, the Agency has determined that only a qualitative exposure
assessment is required for these scenarios, and that the application
rates, anticipated use patterns, and current labels for the aliphatic
solvents products are not of concern to the Agency. This qualitative
exposure/risk assessment suggests there are no concerns for handlers,
reentry workers, or residential homeowners.

A review of many of the current labels indicates that about half of
these labels list requirements for gloves as Personal Protective
Equipment (PPE). This qualitative assessment of human exposure risk has
indicated there are no risk concerns; any PPE requirements needed for
end-use products will be determined based on the acute toxicity testing
review data developed during reregistration for these end-use products.

Cancer risks were not calculated, since no toxicological endpoint for
cancer was selected, because these materials described in this RED are
not carcinogens.

**[VI. Dietary (Food) Exposure]{.underline}:**

There has been a tolerance of 200 ppm established for mineral oil, for
post harvest uses on corn and sorghum (40 CFR 180.149). However, an HED
Memo (EPA, 1995a) indicated that residue data would not be required for
Mineral Oil, and specifically that the following data requirements were
"not applicable": 171-4(a), Nature of residue -- plants; 171-4(b),
Nature of residue -- animals: 171-4(c), Residue analytical method --
plant; 171-4(d), Residue analytical method -- animals; 171-4(e), Storage
stability; 171-4(f), Magnitude of residue -- potable water; 171-4(g),
Magnitude of residue -- fish; 171-4(h), Magnitude of residue --
irrigated crop; 171-4(i), Magnitude of residue -- food handling;
171-4(j), Magnitude of residue -- meat/milk/poultry/eggs; 171-4(k/l),
Crop field trials/process.

The Agency has no concerns for food uses of these mineral oils and
aliphatic petroleum hydrocarbons, as a result of their use as an active
ingredient. As described in previous sections, the acute and chronic
oral toxicity of these materials is extremely low, and thus, no
quantitative assessment of dietary (food only) risk is deemed necessary.

**[VII. Drinking Water Exposure]{.underline}:**

The HED Memo (EPA, 1995a), which indicated that various types of residue
data would not be required for Mineral Oil, specifically indicated that
the data requirement for Magnitude of residue -- Potable water (Old
Guideline Number: 171-4(f), New Guideline Number 860.1400) was "not
applicable": Thus, residue data have not been collected for drinking
water concentrations of these active ingredients. One use of mineral oil
has been granted GRAS status, and many other uses of mineral oil have
been permitted under various other food use regulations by US FDA. Based
on the available data concerning the absence of acute and chronic oral
toxicity for both mineral oil and aliphatic petroleum hydrocarbons,
these active ingredients are not of concern to the Agency.

**[VIII. Aggregate Exposure Assessment]{.underline}:**

For aggregate exposure, the Federal Food, Drug, and Cosmetic Act (FFDCA)
section 408 directs the Agency to consider available information
concerning exposures from the pesticide residue in food and all other
non-occupational exposures, including drinking water from ground water
or surface water and exposure through pesticide use in gardens, lawns,
or buildings (residential and other indoor uses). The Food Quality
Protection Act amendments to the Federal Food, Drug, and Cosmetic Act
\[FFDCA, Section 408(b)(2)(A)(ii)\] require "that there is a reasonable
certainty that no harm will result from aggregate exposure to pesticide
chemical residue, including all anticipated dietary exposures and other
exposures for which there are reliable information." In assessing the
aggregate exposure for the aliphatic solvents, the Agency has determined
in the preceding sections that risks from food, drinking water,
residential uses of a pesticide, and other non-occupational sources of
exposure are minimal, having virtually insignificant impact on human
health.

**[IX. Cumulative Exposure]{.underline}:**

Section 408(b)(2)(D)(v) of the FFDCA requires that, when considering
whether to establish, modify, or revoke a tolerance, the Agency consider
"available information" concerning the cumulative effects of a
particular pesticide's residues and "other substances that have a common
mechanism of toxicity."

EPA does not have, at this time, available data to determine whether the
Aliphatic Solvents have a common mechanism of toxicity with other
substances. Unlike other pesticides for which EPA has followed a
cumulative risk approach based on a common mechanism of toxicity, EPA
has not made a common mechanism of toxicity finding as to the Aliphatic
Solvents and any other substances, and the Aliphatic Solvents do not
appear to produce toxic metabolites produced by other substances.

For the purposes of this tolerance action, therefore, EPA has not
assumed that Aliphatic Solvents have a common mechanism of toxicity with
other substances. For information regarding the Agency's efforts to
determine which chemicals have a common mechanism of toxicity and to
evaluate the cumulative effects of such chemicals, see the policy
statements released by EPA's Office of Pesticide Programs concerning
common mechanism determinations and procedures for cumulating effects
from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.

**[X. Environmental Fate/Ecotoxicity/Ecological Risk
Assessment]{.underline}:**

**[X.I. Environmental Fate and Transport]{.underline}:**

There is a wide range of components present in each of these various
mineral oils and aliphatic petroleum hydrocarbons products, but the EFED
Memorandum concluded that "based on the broad descriptions of the CAS
Numbers, it appears that the composition of the oils are similar across
the two PC Codes. Therefore, the toxicological and fate properties may
be similar."

The information for most of the physical and chemical properties (Table
4) is based on various estimates derived from EPIWIN and other models
for developing physical and chemical properties information. Thus, any
description of the environmental fate and transport of these mixtures of
components will require some degree of generalization in characterizing
the environmental fate. For example, their vapor pressures exhibit a
very wide range, from somewhat volatile to very poorly volatile (i.e.,
10^-4^ Pa to 10^-16^ Pa \[about 10^-3^ to 10^-14^ mm Hg\]). Their
octanol-water partition coefficients are, in general, high, with log
K~ow~ values ranging from about 5 to about 20, for the smaller
chain-length to the larger chain length molecules. Thus, these
components are also likely to have high K~oc~ values, indicating a high
degree of sorption to the organic matter in soils, as well as to foliar
surfaces onto which they are sprayed. In addition, their constituent
components are also very poorly water soluble, with solubility values
ranging from 0.001 to 0.6 mg/L, being least soluble for the larger
constituents. Thus, these sorption characteristics and water solubility
data suggest very poor migration in dissolved phase of water. Fugacity
modeling to determine the distribution of these components in the
environment suggest that most would partition to the terrestrial phase,
and remain sorbed to soil or the foliar surfaces onto which they are
sprayed.

These aliphatic oils do not contain functional groups which would
undergo photo-degradation in the ultraviolet or visible light ranges,
although if any have aromatic components, they can undergo direct
photolysis (however, most registrants now produce TGAIs with
substantially reduced amounts of aromatic components, compared with the
spray oils formerly formulated). While many of the components are poorly
volatile, if some do volatilize, they might contain substituent groups
that may undergo atmospheric gas-phase oxidation reactions. While these
components are poorly soluble in water, they do not contain functional
groups that are susceptible to hydrolysis in aqueous suspensions. Due to
the complexity in size of the components of these oils, they may slowly
undergo some primary biodegradation, but do not readily undergo rapid
mineralization (i.e., complete breakdown to carbon dioxide and water).

**[X.II. Ecological Effects Toxicity Data]{.underline}:**

Based on their review of the environmental effects data submitted to the
Agency and on the literature from other sources consulted to augment
these submitted data, the EFED Memorandum Describing the Ecological Risk
Assessment on Aliphatic Oils (PC Codes 063502 and 063503) compiled a
summary table concerning the toxic effects data with the key biological
components of the terrestrial and aquatic ecosystem (Table 7).

+----------+---------------+-----------------------------+-------------+
| **Table  |               |                             |             |
| 7.       |               |                             |             |
| Summary  |               |                             |             |
| of       |               |                             |             |
| eco-     |               |                             |             |
| toxicity |               |                             |             |
| values   |               |                             |             |
| used in  |               |                             |             |
| the      |               |                             |             |
| A        |               |                             |             |
| liphatic |               |                             |             |
| Oils     |               |                             |             |
| s        |               |                             |             |
| creening |               |                             |             |
| level    |               |                             |             |
| ec       |               |                             |             |
| ological |               |                             |             |
| risk     |               |                             |             |
| asses    |               |                             |             |
| sment.** |               |                             |             |
+==========+===============+=============================+=============+
| S        | Toxicity Data | Comment                     | Data Source |
| urrogate | Used in the   |                             | for         |
| Species  | Ecological    |                             | toxicity    |
|          | Risk          |                             | value used  |
|          | Assessment    |                             | in          |
|          | ^a^           |                             | assessment  |
+----------+---------------+-----------------------------+-------------+
| Fish     | None used     | No effects were observed in | Weight of   |
|          | (Essentially  | fish species in any of the  | evidence    |
|          | no lethality  | multiple studies conducted  | was used to |
|          | observed to   | at the limit concentrations | estimate    |
|          | any fish      | for these types of studies. | potential   |
|          | species)      |                             | risks.      |
+----------+---------------+-----------------------------+-------------+
| Daphnia  | EC50 = \< 0.9 | LC50s: 0.02, 0.1, 0.41,     | 44637337    |
|          | mg/L          | "\<0.9", and 2.4 mg/L. (The |             |
|          |               | data for the three lowest   |             |
|          | LC50 = \>     | values are based on test    |             |
|          | 14.0 mg/L     | materials no longer         |             |
|          |               | appropriate for risk        |             |
|          |               | estimation, and therefore,  |             |
|          |               | the next highest LC50 was   |             |
|          |               | utilized.)                  |             |
+----------+---------------+-----------------------------+-------------+
| Oysters  | 6 mg/L        | EC50: 6 mg/L                | Number      |
|          |               |                             | range       |
|          |               |                             | CHAP        |
|          |               |                             | TER44762002 |
+----------+---------------+-----------------------------+-------------+
| Aquatic  | No data       | None                        | N/A         |
| Plants   |               |                             |             |
+----------+---------------+-----------------------------+-------------+
| Mammals  | \> 28 g/kg-bw | Data obtained from          | Hine and    |
|          |               | secondary literature; no    | Zuidema     |
|          | (no deaths    | chronic or reproduction     | (1970)      |
|          | occurred at   | toxicity studies were       |             |
|          | 25 mL/kg-bw)  | submitted to the Agency.    |             |
|          |               | (See Appendix C of EFED     |             |
|          |               | Memorandum for discussion   |             |
|          |               | of various of these data.)  |             |
+----------+---------------+-----------------------------+-------------+
| Birds    | LD50: \>2250  | No chronic or reproduction  | 4460800     |
|          | mg/kg-bw      | toxicity studies were       | 1;41793202; |
|          |               | submitted.                  | 41742101;   |
|          | LC50: \>5620  |                             | 4780903;    |
|          | ppm           |                             | 44780902    |
+----------+---------------+-----------------------------+-------------+
| Ter      | No data       | None                        | N/A         |
| restrial |               |                             |             |
| Plants   |               |                             |             |
+----------+---------------+-----------------------------+-------------+
| a No     |               |                             |             |
| chronic  |               |                             |             |
| or       |               |                             |             |
| repr     |               |                             |             |
| oduction |               |                             |             |
| studies  |               |                             |             |
| have     |               |                             |             |
| been     |               |                             |             |
| s        |               |                             |             |
| ubmitted |               |                             |             |
| to the   |               |                             |             |
| Agency.  |               |                             |             |
+----------+---------------+-----------------------------+-------------+

In general, these aliphatic oils (mineral oils and aliphatic petroleum
hydrocarbons) are not toxic to most aquatic and terrestrial organisms.
There was essentially no lethality observed in any of the tests
conducted with fish species (both with freshwater and with
estuarine/marine species), mammals (rats and mice), or birds (in both
acute, oral, single-dose and subchronic dietary feeding tests). Data
were cited in the EFED Memorandum that in one fish toxicity test, up to
a 50% mixture (500,000 mg/L) did not result in any observed mortality.
Data were also presented indicating no treatment-related effects in
various honey bee contact studies. The EFED memo did report that some
types of oils have been tested on bird eggs, and have caused smothering
(lack of oxygen transport, and impaired hatching ability); however, the
data provided in that EFED memo do not appear to indicate the likelihood
that off-site drift of spray applications would have demonstrated
impacts on bird egg hatching.

The EFED memo indicated that no testing information had been submitted
on the effects of these oils on plants. However, there is some
information in the EFED EIIS (Ecological Incidents Information System)
database concerning reports of incidents involving plant damage. The HPV
submission did review data on toxicity testing with various freshwater
algae, and reported there were "no adverse effects" at the levels
tested. There does not appear to be much information on actual testing
with terrestrial plants, however, it is clear that for some crops, high
amounts of spray oils are applied onto the foliar surfaces for
insecticidal purposes. Historically, there had been reports of
phytotoxic effects on plants ("burned" leaves, and some labels currently
list phytotoxicity warnings); however, many of the newer TGAIs being
formulated by most Technical registrants do not appear to have these
same adverse effects (possibly because of the reductions in the amounts
of polyaromatic hydrocarbons (PAHs) present in newer TGAIs, the PAHs
postulated as having been the cause of some of the phytotoxic effects).

There was an oyster shell deposition study, in which there was
statistically significant reduction of shell deposition, with the 96-hr
EC~50~ reported in the study as 5.57 mg/L. This study was conducted in
1998-99 for Golden Bear Oil Specialties, Inc. with a test material which
is no longer formulated, and thus not applied to the environment. (The
registrant for this test material, GB-1111, is now Clark Mosquito
Products.) It is possible that one reason for the reduced oyster shell
deposition could be due to the oils coating onto the outer surface of
the algal materials made available of food to these filter-feeding
oysters, thus, rendering the oysters less able to break-down and utilize
these food materials for nutrition.

There are also two toxicity studies available with mysid shrimp
(*Mysidopsis bahia*, an estuarine/marine species of invertebrates). One
study (MRID 446254-01), conducted in 1998-99 for Golden Bear Oil
Specialties, Inc. (with the same no-longer formulated test material as
described above), yielded a 96-hr LC~50~ value of 1.2 mg/L. Another
study MRID 450513-02) was conducted in 1997, for Petro-Canada (with a
test material still being utilized as a TGAI, and described as severely
hydrotreated \[i.e., more highly refined that the Golden Bear
product\]); for this test material, a 96-hr LC~50~ value could not be
calculated, because the data reported did not indicate 50% mortality,
even at the highest test concentration, (nominal) 500,000 mg/L. The
study reported that "most observed mortality appeared to occur when
organisms swam toward the top of the test container and became trapped
in the overlying layer." The nominal concentrations, and mortality data,
were reported as follows: control, 10%; 31,250 mg/L, 20%; 62,500 mg/L,
20%; 125,000 mg/L, 15%; 250,000 mg/L, 25%; and 500,000 mg/l, 30%
mortality.

The organism utilized for the ecological risk assessment was the water
flea, *Daphnia magna*. Based on the data reported in the EFED Memorandum
(Table 7), a number of different studies have been submitted, describing
the results of daphnia toxicity testing. However, detailed analyses of
some of the studies submitted reveal that a few of the test materials
utilized in aquatic toxicity testing are no longer used in formulating
TGAIs or end-use products for spray oils. For example, the lowest LC~50~
value reported in Table 7 for Daphnia, 0.02 mg/L, was from a 1990-91
study, conducted for Unocal Corporation / PureGro Company, with 90
Neutral Oil; however, according to the Agency REFS database, this
product was apparently cancelled in 1993. The next higher LC~50~ value
reported in Table 7, 0.1 mg/L, was a test conducted for Golden Bear Oil
Specialties, Inc. (with a test material no longer formulated, and thus
not applied to the environment). (Note also that the registrant for this
test material, GB-1111, is now Clark Mosquito Products, and a review of
the CSF for their product indicates their product is formulated with an
unregistered technical; thus, RD and SRRD have suggested that when Clark
submits a revised CSF as part of the reregistration process, that the
CSF utilize a registered TGAI.) The next higher LC~50~ value for
Daphnia, 0.41 mg/L, is from a toxicity test conducted in 1983, with a
product called 100 Paraffine Oil. This study was submitted in support of
four products, two of which have since been cancelled (Chevron Ag Base
Lite Neutral and Chevron Ag 100), and for the two other products,
revised CSFs have been submitted in the 1990s (Valent Orchard Spray,
with a revised CSF submitted in 1992, and Volck Supreme Spray, with a
newer, revised CSF in 1996); therefore, it is clear that daphnia
toxicity testing data developed with "100 Paraffine Oil" is no longer
still appropriate for characterizing currently formulated TGAIs and
end-use products.

The daphnia toxicity study (MRID 446373-37) with the next higher
toxicity results was conducted for Petro-Canada, in 1997, with a product
designated in the report as VHVI-4, referred to as "N100DW basestock
which is one of the raw materials used to make the final Spray Oil 10,
13, 15, 22 products." These products are still being formulated by
Petro-Canada, with their most recent CSFs dating from 1995 and 1997, so
clearly this test material is representative of Petro-Canada's currently
formulated TGAIs and end-use products, as well as the TGAIs and
end-use-products for some other registrants who also purchase their
TGAIs from Petro-Canada. The static testing (i.e., not with continuous
flow conditions) was conducted for 48 hours, and samples were collected
for "later verification of the test concentrations if required", but
test concentrations were not clearly reported, so the reported levels
will be considered to be only nominal (i.e., unmeasured, or estimated).
The highest concentration tested, 14 mg/L, was reported to be "the
maximum solubility of VHVI-4 in water;" however, the text reported that
the "test solutions had a thin film of oil on the surface prior to
addition of test organisms." In describing the test results, the report
stated "there was no mortality in any of the test treatments. This was
confirmed by examination under a microscope for the presence of a
heartbeat. Several neonates in all test concentrations were floating on
the surface of the test solutions in all VHVI-4 concentrations, at 24
hours and 48 hours." The actual data results reported in Appendix C of
MRID 446373-37 also list a number of daphnia being counted as I for
"immobilized," or F for "floating", with 20 of 20 test organisms
floating in both 14 mg/L and 7 mg/L, 19 floating and 1 immobilized at
3.5 mg/L, 10 floating and 10 immobilized at 1.8 mg/L, 17 floating and 3
immobilized at 0.9 mg/L (the lowest nominal test concentration), and all
20 normal in the control. Based on these data, it is clear that there
are some effects on the daphnia, although apparently not lethality, even
at the lowest test concentration, so the EC~50~ is \< 0.9 mg/L. It is
also possible that these effects may be transient, and might be
reversible, with the daphnia becoming free of their "immobilized"
conditions when the surface films break up. Thus, in light of the
absence of any significant mortality, even at the highest concentration
tested, it might also be inferred that the LC~50~ could be reported as
"\> 14 mg/L." (The EFED Memorandum had indicated that the LC~50~ was
"\<0.9 mg/L (100% mortality occurred at all concentrations)", but that
is not in agreement with the actual text reported in the body of MRID,
or with the data, as report in the body and appendix of the MRID.)

The EFED Memorandum did conclude that there was uncertainty whether the
effects observed in the daphnid toxicity studies were caused by the
physical effects resulting from the oils coating the organism or from a
different mode of action (such as the organisms becoming entrapped in
the oils floating on the surface), although some studies did report that
daphnids were also immobile in the bottom or in the middle of the test
containers. The EFED memo concluded that entrapment in surface oil
slicks would be less likely to occur in streams and rivers (moving water
bodies), and oil slicks would be a higher concern in quiescent waters,
such as wetlands and stagnant lakes.

It is not surprising that there would be some disparity among the
various MRIDs reporting the results of toxicity tests with daphnia.
These mineral oils and aliphatic petroleum hydrocarbons have very low
water solubility, based on information available, including for 10 of
these same CAS Numbers reported in the Lubricating Oils Basestocks
Category for the HVP submissions. In fact, the HPV submission dataset
provides data indicating that these CAS Numbers are essentially
non-toxic to daphnid invertebrates, with the following reported data in
the Test Plan and Robust Summaries: no mortality, based on Water
Accommodated Fractions (WAFs), for 48-hr at 1000 mg/L exposures to
*Daphnia magna* and 96-hr at 10,000 mg/L exposures to *Gammarus pulex*;
and for various CAS Numbers, there were no effects on mortality or
reproduction after 21 days exposure at 1000 mg/L for *Daphnia magna* in
static renewal tests (with the following CAS Nos.: 64741-88-4;
64741-89-5, 64742-55-8, and 64742-65-0). The differences observed in the
toxicity between the registrant-submitted MRIDs and the HVP data may be
partly due to the methods of attempting to get these poorly soluble oils
into the water column into a solution/suspension.

**[X.III. Estimated Environmental Concentrations]{.underline}:**

***Terrestrial Concentration Estimates***

The EFED Memorandum described the procedure utilized to develop Number
range CHAPTERestimated environmental concentrations (EECs) on
terrestrial systems by using the Tier I exposure model, T-REX (Version
1.2.3.). This procedure was utilized to estimate the potential dietary
exposures for terrestrial organisms, as a result of applications of
mineral oils and aliphatic petroleum hydrocarbons (aliphatic spray oils)
at various applications rates, 10, 50, 150, and 477 lbs/acre (single
application) (Table 8).

  -------------------- ------------- ------------ ------------ ------------
  **Table 8. EECs for                                          
  Selected Terrestrial                                         
  Animal Food Items                                            
  After Applications                                           
  of Oils .**                                                  

  Food Item            EEC (ppm), as                           
                       predicted,                              
                       resulting                               
                       from                                    
                       application                             
                       rates of 10                             
                       to 477 lbs                              
                       a.i./Acre                               

                       10 lbs        50 lbs       150 lbs      477 lbs
                       a.i./Acre     a.i./Acre    a.i./Acre    a.i./Acre

  Short grass          2400          12,000       36,000       114,000

  Tall grass           1100          5500         17,000       52,000

  Broadleaf forage,    1350          6800         20,000       64,000
  small insects                                                

  Fruits, seeds, pods, 150           750          2300         7200
  large insects                                                
  -------------------- ------------- ------------ ------------ ------------

This estimation procedure analysis indicates that the aliphatic spray
oils may be found on animal feed items at extremely high concentrations
(up to 114,000 ppm). These concentrations were then converted to doses
(mg/kg-bw) for 15-, 35-, and 1000-gram mammals, and 20-, 100-, and
1000-gram birds. (See Appendix B of the EFED Memorandum for details
concerning these calculations, including the body weight adjusted EECs
for 10, 150, and 477 lbs/acre applications for both the birds and
mammals.)

***Aquatic Concentration Estimates***

The EFED Memorandum also described the procedure utilized to develop
Number range CHAPTEREECs in aquatic systems. EFED performed separate
modeling efforts for spray drift alone, and for off-site runoff. For the
off-site spray drift alone, the modeling to develop EECs was performed
for airblast applications, known to have the highest off-site drift for
the various ground application procedures (Table 9). EFED assumed that
"9.7% of the mass applied to a 10 hectare field would drift off-site
into an adjacent 20,000,000 L water body (standard drift assumption in
GENEEC2 for orchard airblast applications, and EFED's standard
ecological water body volume)." The EECs in Table 9 assume no runoff,
but do assume an off-site drift of 9.7% of the total amount of a product
applied, and also assume no degradation, partitioning, or differential
distribution of the various components within the spray oil end-use
product. It is known that some components of these spray oils (the lower
molecular weight fractions) may be more volatile than others, but this
model also does not take into consideration any volatilization of
components during off-site drift.

  -----------------------------------------------------------------------
  **Table 9. Preliminary Aquatic 
  EECs from Spray Drift Into a   
  Standard Ecological Pond**     
  ------------------------------ ----------------------------------------
  Application Rate               EEC: Resulting Only from Off-Site Spray
                                 Drift (9.7% of Amount Applied)

  477 lbs a.i./Acre              2.6 mg/L

  150 lbs a.i./Acre              0.82 mg/L

  50 lbs a.i./Acre               0.27 mg/L

  10 lbs a.i./Acre               0.05 mg/L
  -----------------------------------------------------------------------

The EFED Memorandum reported that the simple screening level analysis,
GENEEC, was the procedure used to qualitatively evaluate the
contribution of off-site runoff to the overall aquatic EECs. GENEEC was
run assuming that these aliphatic spray oils were being applied by
granular application (not a labeled use), explaining that this procedure
was a convenience to minimize spray drift in the model run to zero. In
the absence of environmental fate data for these complex mixtures, EFED
assumed that the relevant processes (aerobic soil and aquatic
metabolism, hydrolysis, and photolysis) were all stable. GENEEC was run
across a very wide potential range of Koc values that might be expected
for the various constituents within the aliphatic spray oils (Table 10).

  ------------------------------------------------------------------------
  **Table 10. EECs                              
  Predicted Using                               
  GENEEC, Assuming Only                         
  Off-Site Runoff ^1^**                         
  --------------------- ----------------------- --------------------------
  Koc                   Application Rate (lbs   EEC (ppm)
                        a.i./Acre)              

  0.001                 477                     26.79

                        150                     8.44

                        50                      2.82

  0.01                  477                     26.79

                        150                     8.44

                        50                      2.82

  0.1                   477                     26.79

                        150                     8.44

                        50                      2.82

  1                     477                     26.76

                        150                     8.43

                        50                      2.81

  10                    477                     26.35

                        150                     8.30

                        50                      2.77

  100                   477                     22.79

                        150                     7.18

                        50                      2.39

  1000                  477                     10.04

                        150                     3.16

                        50                      1.05

  10,000                477                     2.51

                        150                     0.79

                        50                      0.26

  100,000               477                     1.41

                        150                     0.44

                        50                      0.15
  ------------------------------------------------------------------------

1\. GENEEC Model with No Spray Drift, and with a "Complete Stability"
Assumption for All Dissipation Processes

The GENEEC modeling analysis (Table 10) suggests that even with the wide
range of Koc values used, the predicted EECs vary by only a factor of 20
(from 26.79 ppm to 1.41 ppm, at the current maximum application rate,
477 lbs a.i./Acre). This analysis also indicates that from a Koc of
0.001 and 100, there is very little difference in resulting EECs, but as
Koc increases from 100 to 1000, there is a dramatic drop in EEC. This
pattern is significant, because most of the components which make up the
spray oils will be in the higher Koc range. The EFED Memorandum
presented estimates from the Horticultural Oil Spray Task Force (HSOTF),
that the typical Koc would be 47,860. The EFED Memorandum also presented
data from a study (Nudelman et al., 2002, as cited by HSOTF) which
reported that for many aliphatic spray oils, the Koc values range from
900 to 6600. The EFED Memorandum concluded, based on the weight of
evidence for the aliphatic spray oils, that a reasonable estimate of Koc
for these complex mixtures would be between 1000 and 100,000, with a
GENEEC estimate based on a Koc of 10,000 being a reasonable assumption
of exposure due to runoff. Thus, at the current highest single
application of 477 lbs a.i./Acre, the contribution to the EEC from
runoff would not be expected to exceed 2.5 ppm (mg/L), at 150 lbs
a.i./Acre predicted to be 0.97 ppm, and for the more typical average
application rate, 50 lbs a.i./Acre, the EEC would be 0.26 ppm (Table
10).

The registrants with the highest maximum application rates have
voluntarily agreed to lower these rates by about a third. Thus, their
maximum rates are now more in line with the 150 lbs a.i./Acre estimates
included in Tables 9 and 10, with off-site spray drift and off-site
runoff EECs of 0.82 ppm and 0.79 ppm, respectively, and a combined
estimate of off-site EEC of 1.6 ppm, resulting from a single application
with 150 lbs a.i./Acre.

**[X.IV. Ecological Risk Assessment]{.underline}:**

***Terrestrial Organisms***

The EFED Memorandum compiled a summary of terrestrial risk estimates
(Table 11), based on the toxic effects data for terrestrial animals
(Table 7) and the EECs of aliphatic spray oils which would occur on
animal food items (Table 8). Table 11 shows the application rate
associated with the following key toxicity endpoints, respectively: for
birds, a behavioral endpoint (specifically a "slightly reduced reaction
to external stimuli (sound and movement)"), and data from an acute
gavage test and from a dietary feeding test, and for mammals, data from
an acute gavage test.

  ------------- ---------------------------------- ------------------------
  **Table 11.                                      
  Application                                      
  Rates                                            
  Associated                                       
  with Key                                         
  Toxicity                                         
  Endpoints in                                     
  Terrestrial                                      
  Organisms**                                      

  Application   Toxicity Endpoint                  Comment
  Rate                                             

  Birds                                            

  4 lbs         Application rate associated with   Toxic effects in
  a.i./Acre     lowest dietary concentration that  bobwhite quail included
                produced a toxic effect in birds   a slight reduced
                (NOAEC 1000 ppm, and LOAEC 1780    reaction to external
                ppm; MRID 417421-01).              stimuli. (However, no
                                                   mortality occurred at
                                                   the highest dose tested,
                                                   5620 ppm.)

  6 lbs         Application rate associated with   No mortality occurred at
  a.i./Acre     highest body weight adjusted dose  this dose.
                tested in available acute oral     
                gavage bird studies (1620          
                mg/kg-bw; adjusted from 2250       
                mg/kg-bw for a 20-gram bird).      

  23 lbs        Application rate associated with   No mortality occurred at
  a.i./Acre     highest dietary concentration      this concentration.
                tested in available bird studies   
                (5620 ppm).                        

  Mammals                                          

  12.7 lbs      Application rate associated with   No mortality occurred at
  a.i./Acre     EECs on short grass that is 1/10th this concentration.
                of the limit dose tested in        (Hine and Zuidema, 1970)
                mammals, 28,000 mg/kg-bw.          
  ------------- ---------------------------------- ------------------------

The EFED Memorandum stated that the toxic effects data available for
acute risk to terrestrial organisms are difficult to use, because no
mortality was observed at the limit dose in acute and subacute bird
studies, even though the levels tested in the various studies were not
as high as the potential exposures from the high application rates.
However, it could be interpreted that because there was no mortality
observed in any of the studies, these test materials are innocuous
(virtually without any toxic effects, even at very elevated doses,
except for the self-limiting aspects of producing diarrhea or vomiting).
In addition, utilizing a startle reflex in birds or even assessing the
potential risk based on limit doses, at which no mortality was observed,
would result in an overestimate of the potential for terrestrial risks
of these potentially innocuous test materials.

The EFED Memorandum concluded that there was much uncertainty in the
ecological risk assessment, due to the absence of mortality. However,
the information presented also did postulate that there might be a
potential for risks to the eggs of egg-laying animals, in or adjacent to
the treated field, although the Agency does not generally regulate based
on egg-smothering within application sites. Further, there was limited
information on which to predict the off-site drift estimates of the
amount of the test material which would impair egg-hatching in off-site
nests. In addition, it is stated that the high application rates
(especially the 477 lbs a.i./Acre currently on some labels, but even
some lower rates) "do not allow for a definitive conclusion with respect
to potential risks to terrestrial animals," because the concentrations
estimated (by modeling) to be on food items could actually be higher
than levels tested in submitted studies in birds and mammals. (However,
as stated above, these test materials may be "innocuous," at virtually
any dose administered, because none of the testing data have revealed
any mortality in birds or mammals.) In addition, the EFED Memorandum
pointed out that no chronic or reproduction toxicity data in terrestrial
animals have been submitted to the Agency under FIFRA (although
apparently none have ever been required under a GDCI), and that no plant
toxicity data have been submitted; therefore, the EFED Memorandum
continued, "definitive risk conclusions cannot be made at this time with
respect to these surrogate species."

In conclusion, the following factors characterize the terrestrial risk
assessment for the spray oils: 1) a lack of mortality data observed in
any testing with mammalian and avian species; 2) the absence of current
reports of phytotoxicity data in these important agricultural crops,
even at high application rates; and 3) the reductions which have been
voluntarily proposed by registrants for the very high, maximum
application rates. Based on this weight of evidence, the Agency has
concluded that it does not have any concerns regarding the
reregistration of these mineral oil and aliphatic petroleum hydrocarbon
products, due solely to terrestrial risk assessment.

***Aquatic Organisms***

The EFED Memorandum presented preliminary aquatic risk estimations. The
available data from various toxicity studies had revealed no mortality,
including for various fish species and for estuarine/marine
invertebrates, mysid shrimp. The aquatic risk assessment information
presented in the EFED Memorandum was preliminary risk quotients (RQs)
based on the reported toxicity data for aquatic invertebrates. These RQ
values were based on EECs developed on only the off-site spray drift and
on the direct application to water. The EFED Memorandum pointed out that
the contribution of runoff to the EEC is only discussed qualitatively,
because the composition of the runoff component might not be
toxicologically similar to the composition of oils that enters water via
spraydrift or those which were used in the available toxicity studies.
The EFED Memorandum also acknowledged by that during runoff, there may
be a differential separation of the components, due to differences in
solubility, or some components becoming very highly sorbed to soil
and/or foliar surfaces, or that some components might degrade, or others
become volatilized, and enter the atmosphere.

  ---------------- --------------- --------- --------- ---------- ---------
  **Table 12.                                                     
  Preliminary                                                     
  Aquatic EECs                                                    
  from Drift Into                                                 
  a Standard                                                      
  Ecological Pond                                                 
  Compared with                                                   
  Aquatic                                                         
  Invertebrate                                                    
  Toxicity Data**                                                 

  Application Rate EEC from 9.7%   Daphnid                        Oyster
                   Drift Only into RQs,                           RQ, based
                   a 20,000,000 L  based on:                      on EC50
                   ecological pond                                of 6 mg/L

                                   EC50 =    EC50: \<  LC50: \>   
                                   0.02 mg/L 0.9 mg/L  14 mg/L    

  477 lbs          2.6 mg/L        130       2.9       0.19       0.43
  a.i./Acre                                                       

  150 lbs          0.82 mg/L       41        0.91      0.059      0.14
  a.i./Acre                                                       

  50 lbs a.i./Acre 0.27 mg/L       14        0.31      0.02       0.045

  10 lbs a.i./Acre 0.05 mg/L       2.5       0.056     0.0036     \<0.01

  Direct           2.1 mg/L        105       2.3       0.15       0.35
  Application EEC                                                 
  ---------------- --------------- --------- --------- ---------- ---------

For their daphnia RQs, the EFED Memorandum relied only on the toxicity
data reported for 90 Neutral Oil (MRID 419028-03; EC50 = 0.02 mg/L);
however, Table 12 lists additional RQ estimates from a study with a
different test material, VHVI-4. These estimates are included because,
as explained in the section above describing the Ecological Effects
Toxicity Data, many of the available daphnia toxicity studies,
previously submitted to the Agency, had been conducted with materials
which are no longer appropriate for risk assessment purposes (the
products tested are no longer registered, or registrants have agreed to
submit revised CSFs with different TGAIs). Thus, a range of RQs are
presented in Table 12, with the data for the EC50 = 0.02 mg/L retained
for comparative purposes (although that product was cancelled in 1993,
thus, these values are no longer appropriate and are overly
restrictive).

There should be some clarification presented on the other two data
columns. In the study with VHVI-4 (MRID 446373-37), almost all the
daphnia were either immobilized or floating, so the EC~50~ is less than
0.9 mg/l, the lowest nominal test concentration; however, the RQs
reported in Table 12 are based on the actual 0.9 mg/L value, the lowest
nominal concentration tested. The actual situation is that
immobilization/floating may actually occur at even lower concentrations,
so based on the "immobilization/floating" endpoint, the true RQs might
be higher than in that data column. It is not known from the study
report how long the daphnia would remain immobilized, or how long the
surface film would remain in place, which is contributing to their
entrapment. However, the CDC stated in a letter, dated June 13, 2006,
that "surface film larvicides generally have a shorter environmental
persistence (approx. 2-3 days) than most chemical larvicide
alternatives." Thus, the surface film should break up within a few days.
In addition, that study did report microscope observations of the
daphnia, revealing that their hearts were still beating, thus that they
were not dead at the conclusion of the 2-day test period. Therefore, the
actual LC~50~ value would be greater than the highest dose tested, 14
mg/L, also reported to be the "the maximum solubility of VHVI-4 in
water." If the daphnia survive their immobilization, and are able to
break-free from the oils, then the RQs presented in that data column in
Table 12 may actually be overestimates of the true RQs, and even for
daphnia, the Agency would not have any concerns regarding the
reregistration of these mineral oil and aliphatic petroleum hydrocarbon
products, based on the aquatic risk assessments.

**[XI. Mosquito Larvicide/Pupacide Uses]{.underline}:**

There are three end-use products with labels solely for mosquito
larvicide/pupacide applications:

-   Bonide Mosquito Larvicide, EPA Reg. No. 4-195;

-   Clarke Mosquito Control Products, Mosquito Larvicide GB-1111, EPA
    Reg. No. 8329-72; and

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-   BVA 2 Mosquito Larvicide Oil, EPA Reg. No. 70589-1.

These registered products (at least one is each of the OPP Chemical
Codes, in Mineral Oils and in Aliphatic Petroleum Hydrocarbons) have
labeled uses for direct application to water bodies. To address this
use, the EFED Memorandum described a process which assumed that the
maximum labeled application rate (37 lbs/acre, the highest among the
three products) would be applied directly to the treated water body. In
order to develop EECs for the ecological risk assessment, EFED assumed
that the application would occur to EFED\'s standard EXAMS water body of
20,000,000 L. (See the EFED Memorandum for additional details of the
EXAMS model). According to the results of this model, assuming
instantaneous equilibrium, the EEC for these mosquito larvicide/pupacide
products, when applied directly to the water body, would be 2.1 mg/L
(ppm), based on the description from the EFED Memorandum (see Table 12
for RQs, based on this EEC).

Due to the characteristics of these mosquito control products, however,
it is likely that the oils would not mix within the water column, and
that the exposures would be restricted to a much higher concentration at
the film layer on the surface of the water. Thus, there would be a
higher EEC exposure at the surface, but in a smaller proportion of the
entire water body, and a lower EEC throughout the vertical extent of the
water body. Thus, any possible adverse effects on the critical
components of the aquatic ecosystem would be much lower within the water
column.

Concerning these mosquito larvicide/pupacide uses, the Agency has
solicited a benefits consultation from the Centers for Disease Control
and Prevention (CDC). In a letter (dated June 13, 2006), Dr. Michael A.
McGeehin described the comparative benefits of Aliphatic Oils, as
follows:

-   "Surface film larvicides generally have a shorter environmental
    persistence (approx. 2-3 days) than most chemical larvicide
    alternatives."

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-   "They are very quick acting, making them well suited to situations
    where rapid control is required, such as habitats in which most of
    the mosquitoes are in late larval or pupil stages, or in ephemeral
    habitats in which the active ingredient need not be present for a
    long time."

-   "Surface film larvicides like the oils kill all immature mosquito
    stages (all larval stages and pupae). Therefore, timing of
    application is not as critical as with other products that require
    the active ingredient be consumed by feeding larvae (e.g., those
    containing *Bacillus thurinigensis israelensis, Bti*) or during key
    periods in larval development (e.g., the insect growth regulators)."

-   "Surface films kill pupae, while most other products do not. As
    such, they often provide the only alternative for control of
    immature mosquitoes in certain habitats before they become adults."

-   "Surface films perform effectively under most field conditions,
    regardless of water quality (pH, turbidity, and BOD don't impact
    performance), and on all mosquito species that use the water surface
    to breathe (e.g., excluding members of the genera *Mansonia* or
    *Coquillettidia*). Other larvicides, such as those using *BTI,
    bacillus sphaericus*, and methoprene, often don't perform well in
    highly polluted water that can produce large numbers of *Culex
    pipiens* or *Culex quinquefasciatus* mosquitoes (important West Nile
    virus vectors). *Bti* doesn't work well with anophelines, because of
    their habit of feeding near the water surface. As such, surface
    films provide a valuable option to an integrated mosquito control
    program."

The letter from McGeehin of CDC further went on to describe the types of
areas where these surface film mosquito larvicides/pupacides have
advantages. For example, these surface film mosquito
larvicides/pupacides are utilized in any habitat where pupae and late
4^th^ instar larvae are found and/or the organic content of the water is
extremely high. The most common type of this situation would be where
the organic matter in the water would reduce the efficacy of other types
of larvicides (sites such as storm sewer catch basins, sewage treatment
plants, storm water impoundments collecting runoff in urban areas, dairy
lagoons, or agricultural processing facilities where waste water
accumulates, such as sugar beet plants in the Great Plains States). The
surface film mosquito larvicides/pupacides are also effective in areas
known to produce mosquitoes for only a very short time duration, sites
which are expected to be dry for some time periods, or where the use of
longer duration products would not be warranted, such as swales along
rivers and lakes, and certain types of floodwater habitats. If longer
term control is needed, surface film oils would not be reapplied, but
instead, a product would be used which would provide a longer duration
of control (such as *Bti*, *B. sphaericus*, or methoprene). These
surface film oils would not be routinely utilized in marsh or swamp
habitats, unless the mosquitoes were found to be in the pupil stage and
concentrated within a discrete area, and in these situations, the
surface film products would be targeted in that discrete area, rather
than broadcast over a very large area.

In conclusion, the CDC letter from McGeehin summarized the findings by
stating that the "mineral oils and aliphatic petroleum hydrocarbons used
as surface films provide a valuable option in integrated mosquito
control programs that target mosquitoes of public health importance."

**[XII. Labeling for Aliphatic Solvents Products]{.underline}:**

A summary of the various label changes are included in the Label Table.
Key changes, and the important reasons, are as follows:

-   Due to concerns that maximum label rates for citrus on some labels
    that were as high as 4500 gallons of spray mix per acre (equal to
    477 lbs a.i../Acre), these registrants have voluntarily agreed to
    reduce their highest rate on citrus, with revised labels which will
    indicate that applications in Texas and Florida should not exceed
    1500 gallons of spray mix, and in California, should not exceed 1800
    gallons of spray mix (based on Thorough Coverage Spray, with 1.5
    gallons of product mixed in 100 gallons of water).

-   Due to concerns for the potential for spray drift to travel
    off-site, and deposit onto surface waters, possibly resulting in
    toxic effects to aquatic invertebrates, the revised labels submitted
    in fulfillment of reregistration activities should include the
    following statement concerning the restrictions on the use of
    airblast equipment on the outer edges of orchards: "For airblast
    applications, turn off outward pointing nozzles at row ends and when
    spraying the outer two rows. To minimize spray loss over the top in
    orchard applications, spray must be directed into the canopy. For
    aerial applications of agricultural products, do not release spray
    at a height greater than 10 feet above the ground, top of crops, or
    above the orchard canopy, when spraying within 1000 feet of water
    bodies or aquatic habitat."

**[XIII. Tolerance Reassessment]{.underline}:**

The Tolerance Expression at 40 CFR 180.149 for active ingredient use for
Mineral Oil (Table 3), the post-harvest uses on corn and sorghum (to
combat storage insect infestation) predates the establishment of the
Environmental Protection Agency, having been first proposed in the
1950s. A review of the EFED spreadsheets developed by BEAD and an
extensive search of the existing labels failed to detect any Mineral Oil
products with a current label for this grain storage usage. Thus, as
part of the reregistration process, SRRD will publish a notice of intent
to revoke this tolerance (40 CFR 180.149) in the Federal Register.

Taking into consideration all available information presented herein on
the aliphatic solvents, including the mineral oils and aliphatic
petroleum hydrocarbons, the Agency has determined that there is a
reasonable certainty that no harm to any population subgroup will result
from aggregate exposure to these chemicals when considering exposure
through food commodities and as well as any occupational or
non-occupational sources for which there is reliable information.
Therefore, the current exemption from the requirement of a tolerance
established for "Petroleum Oils" when applied to growing crops, in
accordance with good agricultural practice, under 40 CFR 180.905, is
reassessed as being safe under section 408(q) of the FFDCA.

**[XIV. References]{.underline}:**

EFED (2006). Environmental Fate and Effects Division. Memorandum
Describing the Environmental Fate and Effects Division's Ecological Risk
Assessment on Aliphatic Oils (PC Codes 063502 and 063503) in Support of
Reregistration Eligibility Decision. Memorandum from Brain
Anderson/Stephen Carey/Mark Corbin (ERB III/EFED) to Mark Perry/Bentley
Gregg (SRRD). April 25, 2006. DP Barcodes: 327645, 313161.

EPA (1992). Environmental Protection Agency. EPA File Symbol/EPA Reg.
No.: 10163-RLU Gowan Spray Oil. Memorandum from Mark Perry (Biologist,
Precautionary Review Section/Registration Support Branch/Registration
Division) to Dennis Edwards (Insecticide/Rodenticide Branch/Registration
Division). File: 009979.

EPA (1994a). Environmental Protection Agency. EPA ID#063503: Aliphatic
Petroleum Hydrocarbons -- Review of Ten Acute Toxicity Studies.
Memorandum from Paul Chin, Ph.D. (Section 2/Toxicity Branch I/HED) to
Kathryn Davis/Bonnie Adler (Reregistration Division). File: 010813.

EPA (1994b). Environmental Protection Agency. EPA ID#063502: Mineral Oil
-- Review of Acute Toxicity Studies. Memorandum from Paul Chin, Ph.D.
(Section 2/Toxicity Branch I/HED) to Kathryn Davis/Bonnie Adler
(Reregistration Division). File: 13000 Tox Reviews: 032895.

EPA (1994c). Environmental Protection Agency. EPA ID#063502: Mineral Oil
-- Review of Acute Toxicity Studies. Memorandum from Paul Chin, Ph.D.
(Section 2/Toxicity Branch I/HED) to Kathryn Davis/Bonnie Adler
(Reregistration Division). File: 13000 Tox Reviews: 032894.

EPA (1994d). Environmental Protection Agency. EPA ID#063503-000862:
Mutagenicity Studies for Petroleum Distillates, Oils, Solvents, or
Hydrocarbons. Memorandum from Sheryl K. Reilly, Ph.D. (Review Section
II, Toxicology Branch I, HED) to Kathryn Davis/Bonnie Adler
(Reregistration Division). File: 13000 Tox Reviews: 033210.

EPA (1995a) Environmental Protection Agency. OPP Official Record, Health
Effects Division, Scientific Data Reviews, EPA Series 361. CBRS
Transmittal Sheet for Phase 4 Reviews. Case No. 3004; Chemical No(s):
63502/63503.

EPA (1995b) Environmental Protection Agency. OPP Official Record, Health
Effects Division, Scientific Data Reviews, EPA Series 361. OREB
Transmittal Sheet for Phase 4 Reviews. Case No. 3004; Chemical No(s):
63502/63503.

EPA (1996). Environmental Protection Agency. Petroleum Oils. Review of
Toxicology Data. Memorandum from Raymond K. Locke (Section 2/Toxicity
Branch I/HED) to Kathryn Davis/Bonnie Adler (Reregistration Division).
File: 13000 Tox Reviews: 001714.

HPV (2004). High Production Volume (HPV) Chemical Challenge Program.
Lubricating Oil Basestocks Category Test Plan, Revised March 2, 2004
(201-15135A), and Robust Summary of Information, Revised January 13,
2004 (201-15135B).

http://www.epa.gov/chemrtk/lubolbse/c14364tc.htm

HSDB (2002). Hazardous Substance Database: Mineral Oil (CAS# 8012-95-1).

http://toxnet.nlm.nih.gov/cgi-bin/sis/search/f?./temp/\~QKsJzx:1

IARC (1987). International Agency for Research on Cancer -- Summaries
and Evaluations. Mineral oils: Untreated and Mildly Treated Oils
(Group 1) and Highly Refined Oils (Group 3). Supplement 7: p. 252.

ICSC (2001a). International Chemical Safety Cards. Distillates,
petroleum, solvent-refined light naphthenic (CAS# 64741-97-5).
http://www.cdc.gov/niosh/ipcsneng/neng1430.html

ICSC (2001b). International Chemical Safety Cards. Distillates,
petroleum, solvent-refined heavy paraffinic (CAS# 64741-88-4).
http://www.cdc.gov/niosh/ipcsneng/neng1431.html

Inchem (1982). IPSC (International Programme on Chemical Safety)
Environmental Health Criteria 20: Selected Petroleum Products.

http://www.inchem.org/documents/ehc/ehc/ehc020.htm

Inchem (2001a). Distillates, petroleum, solvent-refined heavy paraffinic
(CAS# 64741-88-4). ISCS: 1431.

Inchem (2001b). Distillates, petroleum, solvent-refined light naphthenic
(CAS# 64741-97-5). ISCS: 1430

MSDS (1994). Material Safety Data Sheet: Pennzar 71. Hydrotreated light
paraffinic distillate (CAS# 64742-55-8).
http://www.stlucieco.gov/msq/fog/chemicals/ULV_oil_msds.pdf

MSDS (2002a). Material Safety Data Sheet: Adams Iso #100 Motor Oil.
Distillates, petroleum, solvent-refined heavy paraffinic (CAS#
64741-88-4).
http://www.adamselevator.com/Adams/AdamsWeb.nsf/D2B44C9D84212C4B85256BD1004DE52C/\$File/motor%20100.pdf?openelement

MSDS (2002b). Material Safety Data Sheet: Ergon-West Virginia, Inc.
Hyprene P70N. (CAS# 64742-56-9). http://www.adapcoinc.com/pdf/ulvm.pdf

MSDS (2003a). Material Safety Data Sheet: BVA Spray Oils. (CAS#
72623-87-1). http://www.adapcoinc.com/pdf/BVA13m.pdf

MSDS (2003b). Material Safety Data Sheet: Lamp Fuel used in Hollowick
HD8 and HD 12 Disposable Cells. (CAS# 8042-47-5).
http://www.hollowick.com/newimages/HD8_HD12MSDS2003_b.pdf

MSDS (2004). Material Safety Data Sheet: Vacuum Pump Oil. (CAS#
72623-84-8)

> <http://www.fjcinc.com/msds22vacuumpumpoil.htm>

MSDS (2006). Material Safety Data Sheet: Spray Oil 10, 13, 15, 22.
(CAS#: "The base oil may be a mixture of the following CAS#s: 8042-47-5,
64742-46-7, 64742-52-5, 64742-54-7, 72623-84-8, 72623-85-9, 72623-86-0,
72623-87-1, 178603-64-0,

178603-65-1, 178603-66-2, 445411-73-4")

http://www.online.petro-canada.ca/datasheets/en_us/spray10.pdf

NIOSH (1997a). National Institute for Occupational Safety and Health:
The Registry of Toxic Effects of Chemical Substances. Mineral oil,
petroleum distillates, hydrotreated (mild) heavy paraffinic (CAS#
64742-54-7). RTECS#: PY8035500.

NIOSH (2000). National Institute for Occupational Safety and Health: The
Registry of Toxic Effects of Chemical Substances. Mineral oil, petroleum
distillate, hydrotreated (severe) light paraffinic (CAS# 64742-55-8).
RTECS#: PY8036501.

NIOSH (2003). National Institute for Occupational Safety and Health: The
Registry of Toxic Effects of Chemical Substances. Mineral Oil (CAS#
8012-95-1). RTECS#: PY8030000.

Ulrich, Charles (1999). A 90-day (with Recovery) Nose-only Inhalation
Toxicity Study of GB-1111 Technical in Albino Rats. MRID 450029-01.

WHO (1996). World Health Organization, International Programme on
Chemical Safety, "Toxicological Evaluation of Certain Food Additives and
Contaminants in Food," WHO Food Additives Series 35, "Mineral Oils
(Food-Grade), Paraffin Waxes and Microcrystalline Waxes."

<http://www.inchem.org/documents/jecfa/jecmono/v35je10.htm>

WHO (2003). World Health Organization, International Programme on
Chemical Safety, "Safety Evaluation of Certain Food Additives," WHO Food
Additives Series 50, "Mineral Oils (Medium- and Low-Viscosity) and
Paraffin Waxes."

http://www.inchem.org/documents/jecfa/jecmono/v50je04.htm

**Appendix A. SLUA**

**[Paraffin Oil (063503)]{.underline}**

Screening-level Usage Analysis (SLUA)

**Date: 12/13/05**

**What is a** **Screening Level Usage Analysis (SLUA)?**

-   Available estimates of pesticide usage data for a particular active
    ingredient that is used on **agricultural** crops in the United
    States.

    **What does it contain?**

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-   Pesticide usage data for a **single** active ingredient only.

-   Agricultural use sites (crops) that the pesticide is *reported* to
    be used on.

-   Available pesticide usage information (i.e., does not include all of
    the United States).

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-   Annual percent of crop treated **(average** **&** **maximum)** for
    each agricultural crop.

-   Average annual pounds of the pesticide applied for each agricultural
    crop (i.e., for the states surveyed, not for the entire United
    States).

    **What assumptions can I make about the reported data?**

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-   **Average pounds of active ingredient applied** - Values are
    calculated by merging pesticide usage data sources together;
    averaging by year, averaging across all years, & then rounding.
    ***Note:*** *If the estimated value is less than 500, then that
    value is labeled \<500. Estimated values between 500 & \<1,000,000
    are rounded to 1 significant digit. Estimated values of 1,000,000 or
    greater are rounded to 2 significant digits.)*

-   **Average percent of crop treated** - Values are calculated by
    merging data sources together; averaging by year, averaging across
    all years, & rounding to the nearest multiple of 5. ***Note:** If
    the estimated value is less than 1, then the value is labeled \<1.*

-   **Maximum percent of crop treated** - Value is the single maximum
    value reported across all data sources, across all years, & rounded
    up to the nearest multiple of 5. ***Note:** If the estimated value
    is less than 2.5, then the value is labeled \<2.5.*

    **What are the data sources used?**

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-   **USDA-NASS** (United States Department of Agriculture's National
    Agricultural Statistics Service) -- pesticide usage data from 1999
    to 2004.

-   **NCFAP** (National Center for Food and Agricultural Policy) --
    pesticide usage data from 1997 and used ***only*** if data are not
    available from the other sources.

-   **Private Pesticide Market Research** -- pesticide usage data from
    1999 to 2004.

-   California DPR data can be requested separately.

    **What are the data limitations?**

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-   Additional registered uses may exist but are not included because
    the available surveys do not report usage (e.g., small acreage
    crops).

-   Lack of reported usage data for the pesticide on a crop **does not
    imply** zero usage.

-   Usage data on a particular site may be noted in data sources, but
    **not quantified**. In these instances, the site would not be
    reported in the SLUA.

-   Non-agricultural use sites (e.g., turf, post-harvest, mosquito
    control, etc.) are not reported in the SLUA. A separate request must
    be made to receive these estimates.

-   Some sites show some use, even though they are not on the label.
    This usage could be due to Section 18 requests, existing stocks of
    the chemical, data collection errors, experimental use permit (EUP),
    and/or because of an illegal use.

    **Who do I contact for further information and/or questions on this
    SLUA?**

```{=html}
<!-- -->
```
-   Jenna Carter (703 308-8370)

-   Art Grube (703 308-8095)

Thursday, December 8, 2005 10:28

Screening Level Estimates of Agricultural Uses of Paraffin Oil (063503)

Sorted Alphabetically

**Crop Lbs A.I. Percent Crop Treated**

**Avg. Max.**

1 Almonds 8,300,000 25 60

2 Apples 6,600,000 30 65

3 Apricots 400,000 35 65

4 Avocados 600,000 20 35

5 Beans, Green 6,000 \<1 5

6 Blackberries 3,000 5 10

7 Blueberries 6,000 5 5

8 Broccoli 30,000 \<1 \<2.5

9 Cabbage 5,000 \<1 \<2.5

10 Cantaloupes 2,000 \<1 \<2.5

11 Carrots 5,000 \<1 \<2.5

12 Cauliflower 90,000 5 5

13 Celery 20,000 5 5

14 Cherries 1,300,000 15 30

15 Corn 60,000

16 Cotton 30,000

17 Cucumbers 10,000 \<1 5

18 Grapefruit 4,900,000 40 80

19 Grapes 1,200,000 5 10

20 Hazelnuts (Filberts) 90,000 5 10

21 Lemons 2,100,000 30 45

22 Limes 100,000 80 80

23 Nectarines 1,200,000 60 75

24 Olives 90,000 5 10

25 Onions 5,000 \<1 \<2.5

26 Oranges 35,700,000 40 75

27 Peaches 2,100,000 25 45

28 Pears 3,700,000 45 85

29 Peas, Green \<500 \<1 \<2.5

30 Pecans 200,000 \<1 \<2.5

31 Peppers 7,000 \<1 \<2.5

32 Pistachios 1,100,000 15 40

33 Prunes & Plums 2,000,000 30 50

34 Pumpkins 7,000 \<1 \<2.5

35 Raspberries 10,000 5 10

36 Squash 50,000 5 10

37 Strawberries 7,000 \<1 5

38 Sweet Corn 20,000 \<1 \<2.5

39 Tangelos 600,000 80 95

40 Tangerines 1,400,000 60 70

41 Tomatoes 100,000 \<1 \<2.5

42 Walnuts 200,000 5 10

43 Watermelons 20,000 \<1 \<2.5

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

All numbers rounded.

\'\<500\' indicates less than 500 pounds of active ingredient.

\'\<2.5\' indicates less than 2.5 percent of crop is treated.

**Appendix B. Mammalian Toxicity Data for Aliphatic Solvents**

**[ACUTE TOXICITY]{.underline}**

+------+-------------------+---+------+---------+---+---------------+
| **T  |                   |   |      |         |   |               |
| able |                   |   |      |         |   |               |
| B-1. |                   |   |      |         |   |               |
| Sum  |                   |   |      |         |   |               |
| mary |                   |   |      |         |   |               |
| of   |                   |   |      |         |   |               |
| A    |                   |   |      |         |   |               |
| cute |                   |   |      |         |   |               |
| Toxi |                   |   |      |         |   |               |
| city |                   |   |      |         |   |               |
| for  |                   |   |      |         |   |               |
| the  |                   |   |      |         |   |               |
| A    |                   |   |      |         |   |               |
| liph |                   |   |      |         |   |               |
| atic |                   |   |      |         |   |               |
| Solv |                   |   |      |         |   |               |
| ents |                   |   |      |         |   |               |
| (Min |                   |   |      |         |   |               |
| eral |                   |   |      |         |   |               |
| Oil  |                   |   |      |         |   |               |
| and  |                   |   |      |         |   |               |
| P    |                   |   |      |         |   |               |
| etro |                   |   |      |         |   |               |
| leum |                   |   |      |         |   |               |
| Hyd  |                   |   |      |         |   |               |
| roca |                   |   |      |         |   |               |
| rbon |                   |   |      |         |   |               |
| s)** |                   |   |      |         |   |               |
+======+===================+===+======+=========+===+===============+
| S    | Test species:     |   |      |         |   |               |
| tudy | Result            |   |      |         |   |               |
| Type |                   |   |      |         |   |               |
|      | Reference         |   |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| PC   |                   |   |      |         |   |               |
| C    |                   |   |      |         |   |               |
| ode: |                   |   |      |         |   |               |
| 06   |                   |   |      |         |   |               |
| 3502 |                   |   |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| Test | CAS#: 8012-95-1   | G |      | MRD-    |   | 90 Neutral    |
| M    |                   | o |      | 87-984; |   | Oil ; mineral |
| ater |                   | w |      | mineral |   | oil           |
| ial: |                   | a |      | oil     |   |               |
| Min  |                   | n |      |         |   | (100% purity) |
| eral |                   | S |      |         |   |               |
| Oil  |                   | p |      |         |   |               |
|      |                   | r |      |         |   |               |
|      |                   | a |      |         |   |               |
|      |                   | y |      |         |   |               |
|      |                   | O |      |         |   |               |
|      |                   | i |      |         |   |               |
|      |                   | l |      |         |   |               |
|      |                   |   |      |         |   |               |
|      |                   | ( |      |         |   |               |
|      |                   | E |      |         |   |               |
|      |                   | P |      |         |   |               |
|      |                   | A |      |         |   |               |
|      |                   | R |      |         |   |               |
|      |                   | e |      |         |   |               |
|      |                   | g |      |         |   |               |
|      |                   | . |      |         |   |               |
|      |                   | 1 |      |         |   |               |
|      |                   | 0 |      |         |   |               |
|      |                   | 1 |      |         |   |               |
|      |                   | 6 |      |         |   |               |
|      |                   | 3 |      |         |   |               |
|      |                   | - |      |         |   |               |
|      |                   | R |      |         |   |               |
|      |                   | L |      |         |   |               |
|      |                   | U |      |         |   |               |
|      |                   | ) |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | Mouse: LD~50~ =   | R |      | Rat:    |   | NF^a^         |
| cute | 22 g/kg           | a |      | LD50 \> |   |               |
| oral |                   | t |      | 5 g/kg  |   |               |
|      | (NIOSH, 2003      | : |      | for     |   |               |
|      | \[document cited  | L |      | males   |   |               |
|      | is in German;     | D |      | and     |   |               |
|      | translation       | 5 |      | females |   |               |
|      | indicates that    | 0 |      |         |   |               |
|      | mineral oil was   | \ |      | (EPA,   |   |               |
|      | not tested alone, | > |      | 1994c)  |   |               |
|      | only in           | 5 |      |         |   |               |
|      | combination with  | g |      |         |   |               |
|      | other             | / |      |         |   |               |
|      | chemicals\])      | k |      |         |   |               |
|      |                   | g |      |         |   |               |
|      | Rat: LD~50~ = \>  |   |      |         |   |               |
|      | 25 mL/kg (\> 28   | ( |      |         |   |               |
|      | g/kg) no deaths   | E |      |         |   |               |
|      | observed (Hine    | P |      |         |   |               |
|      | and Zuidema       | A |      |         |   |               |
|      | (1970) also cited | , |      |         |   |               |
|      | in INCHEM (WHO),  | 1 |      |         |   |               |
|      | 1982)             | 9 |      |         |   |               |
|      |                   | 9 |      |         |   |               |
|      |                   | 2 |      |         |   |               |
|      |                   | ) |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | NF^a^             | R |      | Rat:    |   | Rat: LD50 \>2 |
| cute |                   | a |      | LD50    |   | g/kg for      |
| de   |                   | b |      | \>2     |   | males and     |
| rmal |                   | b |      | g/kg    |   | females       |
|      |                   | i |      | for     |   |               |
|      |                   | t |      | males   |   | (EPA, 1994b)  |
|      |                   | : |      | and     |   |               |
|      |                   | L |      | females |   |               |
|      |                   | D |      |         |   |               |
|      |                   | 5 |      | (EPA,   |   |               |
|      |                   | 0 |      | 1994c)  |   |               |
|      |                   | \ |      |         |   |               |
|      |                   | > |      |         |   |               |
|      |                   | 2 |      |         |   |               |
|      |                   | g |      |         |   |               |
|      |                   | / |      |         |   |               |
|      |                   | k |      |         |   |               |
|      |                   | g |      |         |   |               |
|      |                   |   |      |         |   |               |
|      |                   | ( |      |         |   |               |
|      |                   | E |      |         |   |               |
|      |                   | P |      |         |   |               |
|      |                   | A |      |         |   |               |
|      |                   | , |      |         |   |               |
|      |                   | 1 |      |         |   |               |
|      |                   | 9 |      |         |   |               |
|      |                   | 9 |      |         |   |               |
|      |                   | 2 |      |         |   |               |
|      |                   | ) |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | NF^a^             | R |      | Rat:    |   | Rat: LC50 \>  |
| cute |                   | a |      | LC50 \> |   | 3.5 mg/L      |
| in   |                   | t |      | 4.7     |   |               |
| hala |                   | : |      | mg/L    |   | (EPA, 1994b)  |
| tion |                   | L |      |         |   |               |
|      |                   | C |      | (EPA,   |   |               |
|      |                   | 5 |      | 1994c)  |   |               |
|      |                   | 0 |      |         |   |               |
|      |                   | \ |      |         |   |               |
|      |                   | > |      |         |   |               |
|      |                   | 4 |      |         |   |               |
|      |                   | . |      |         |   |               |
|      |                   | 6 |      |         |   |               |
|      |                   | m |      |         |   |               |
|      |                   | g |      |         |   |               |
|      |                   | / |      |         |   |               |
|      |                   | L |      |         |   |               |
|      |                   |   |      |         |   |               |
|      |                   | ( |      |         |   |               |
|      |                   | E |      |         |   |               |
|      |                   | P |      |         |   |               |
|      |                   | A |      |         |   |               |
|      |                   | , |      |         |   |               |
|      |                   | 1 |      |         |   |               |
|      |                   | 9 |      |         |   |               |
|      |                   | 9 |      |         |   |               |
|      |                   | 2 |      |         |   |               |
|      |                   | ) |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | Rabbit: Moderate  | N |      | Rat:    |   | NF^a^         |
| cute | effect at 500 mg  | F |      | Slight  |   |               |
| eye  |                   | ^ |      | eye     |   |               |
| ir   | (NIOSH, 2003)     | a |      | irri    |   |               |
| rita |                   | ^ |      | tation; |   |               |
| tion |                   |   |      | did not |   |               |
|      |                   |   |      | clear   |   |               |
|      |                   |   |      | at day  |   |               |
|      |                   |   |      | 14      |   |               |
|      |                   |   |      | (last   |   |               |
|      |                   |   |      | day of  |   |               |
|      |                   |   |      | obser   |   |               |
|      |                   |   |      | vation) |   |               |
|      |                   |   |      | (EPA,   |   |               |
|      |                   |   |      | 1994c)  |   |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | Guinea pig: Mild  | N |      | NF^a^   |   | NF^a^         |
| cute | effect at 100     | F |      |         |   |               |
| de   | mg/24 hour        | ^ |      |         |   |               |
| rmal |                   | a |      |         |   |               |
| ir   | (NIOSH, 2003)     | ^ |      |         |   |               |
| rita |                   |   |      |         |   |               |
| tion |                   |   |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
|      | Rabbit: Mild      |   |      |         |   |               |
|      | effect at 100     |   |      |         |   |               |
|      | mg/24 hour        |   |      |         |   |               |
|      |                   |   |      |         |   |               |
|      | (NIOSH, 2003)     |   |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| Skin |                   | N |      | NF^a^   |   | NF^a^         |
| s    |                   | F |      |         |   |               |
| ensi |                   | ^ |      |         |   |               |
| tiza |                   | a |      |         |   |               |
| tion |                   | ^ |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| PC   |                   |   |      |         |   |               |
| C    |                   |   |      |         |   |               |
| ode: |                   |   |      |         |   |               |
| 06   |                   |   |      |         |   |               |
| 3503 |                   |   |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| Test | Hydrotreated      |   | Hydr |         | P |               |
| M    | light paraffinic  |   | otre |         | a |               |
| ater | petroleum         |   | ated |         | r |               |
| ial: | distillates       |   | h    |         | a |               |
|      |                   |   | eavy |         | f |               |
| P    | (64742-55-8)      |   | pa   |         | f |               |
| etro |                   |   | raff |         | i |               |
| leum |                   |   | inic |         | n |               |
| hydr |                   |   | p    |         | i |               |
| ocar |                   |   | etro |         | c |               |
| bons |                   |   | leum |         | o |               |
|      |                   |   | dis  |         | i |               |
|      |                   |   | till |         | l |               |
|      |                   |   | ates |         |   |               |
|      |                   |   |      |         | ( |               |
|      |                   |   | (647 |         | A |               |
|      |                   |   | 42-5 |         | P |               |
|      |                   |   | 4-7) |         | I |               |
|      |                   |   |      |         | 7 |               |
|      |                   |   |      |         | 8 |               |
|      |                   |   |      |         | - |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | / |               |
|      |                   |   |      |         | 6 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | 7 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | 2 |               |
|      |                   |   |      |         | - |               |
|      |                   |   |      |         | 5 |               |
|      |                   |   |      |         | 6 |               |
|      |                   |   |      |         | - |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | \ |               |
|      |                   |   |      |         | * |               |
|      |                   |   |      |         | ) |               |
|      |                   |   |      |         |   |               |
|      |                   |   |      |         | \ |               |
|      |                   |   |      |         | * |               |
|      |                   |   |      |         | C |               |
|      |                   |   |      |         | A |               |
|      |                   |   |      |         | S |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | u |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | b |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | f |               |
|      |                   |   |      |         | o |               |
|      |                   |   |      |         | u |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | d |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | H |               |
|      |                   |   |      |         | P |               |
|      |                   |   |      |         | V |               |
|      |                   |   |      |         | R |               |
|      |                   |   |      |         | o |               |
|      |                   |   |      |         | b |               |
|      |                   |   |      |         | u |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | S |               |
|      |                   |   |      |         | u |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | y |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | NF^a^             |   | Rat: |         | R |               |
| cute |                   |   | LD   |         | a |               |
| oral |                   |   | ~50~ |         | t |               |
|      |                   |   | =    |         | : |               |
|      |                   |   | \>15 |         | L |               |
|      |                   |   | g/kg |         | D |               |
|      |                   |   |      |         | 5 |               |
|      |                   |   | (NI  |         | 0 |               |
|      |                   |   | OSH, |         | \ |               |
|      |                   |   | 19   |         | > |               |
|      |                   |   | 97a) |         | 5 |               |
|      |                   |   |      |         | g |               |
|      |                   |   |      |         | / |               |
|      |                   |   |      |         | k |               |
|      |                   |   |      |         | g |               |
|      |                   |   |      |         | f |               |
|      |                   |   |      |         | o |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | l |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | d |               |
|      |                   |   |      |         | f |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | l |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         |   |               |
|      |                   |   |      |         | ( |               |
|      |                   |   |      |         | E |               |
|      |                   |   |      |         | P |               |
|      |                   |   |      |         | A |               |
|      |                   |   |      |         | , |               |
|      |                   |   |      |         | 1 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | ) |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | NF^a^             |   | Rab  |         | R |               |
| cute |                   |   | bit: |         | a |               |
| de   |                   |   | LD   |         | t |               |
| rmal |                   |   | ~50~ |         | : |               |
|      |                   |   | =    |         | L |               |
|      |                   |   | \>5  |         | D |               |
|      |                   |   | g/kg |         | 5 |               |
|      |                   |   |      |         | 0 |               |
|      |                   |   | (NI  |         | \ |               |
|      |                   |   | OSH, |         | > |               |
|      |                   |   | 19   |         | 5 |               |
|      |                   |   | 97a) |         | g |               |
|      |                   |   |      |         | / |               |
|      |                   |   |      |         | k |               |
|      |                   |   |      |         | g |               |
|      |                   |   |      |         | f |               |
|      |                   |   |      |         | o |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | l |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | d |               |
|      |                   |   |      |         | f |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | l |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         |   |               |
|      |                   |   |      |         | ( |               |
|      |                   |   |      |         | E |               |
|      |                   |   |      |         | P |               |
|      |                   |   |      |         | A |               |
|      |                   |   |      |         | , |               |
|      |                   |   |      |         | 1 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | ) |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | Rat: LD~50~ =     |   | N    |         | N |               |
| cute | 3,900 mg/m^3^     |   | F^a^ |         | F |               |
| in   | (3.9 mg/L) for 4  |   |      |         | ^ |               |
| hala | hr                |   |      |         | a |               |
| tion |                   |   |      |         | ^ |               |
|      | (NIOSH, 2000      |   |      |         |   |               |
|      | \[from an OTS     |   |      |         |   |               |
|      | document,         |   |      |         |   |               |
|      | published in      |   |      |         |   |               |
|      | 01/06/83,         |   |      |         |   |               |
|      | submitted by BP   |   |      |         |   |               |
|      | Oil, conducted by |   |      |         |   |               |
|      | Gulf Life         |   |      |         |   |               |
|      | Sciences Center   |   |      |         |   |               |
|      | 1983; original    |   |      |         |   |               |
|      | document not      |   |      |         |   |               |
|      | seen\])           |   |      |         |   |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | NF^a^             |   | N    |         | R |               |
| cute |                   |   | F^a^ |         | a |               |
| eye  |                   |   |      |         | b |               |
| ir   |                   |   |      |         | b |               |
| rita |                   |   |      |         | i |               |
| tion |                   |   |      |         | t |               |
|      |                   |   |      |         | : |               |
|      |                   |   |      |         | N |               |
|      |                   |   |      |         | o |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | y |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         |   |               |
|      |                   |   |      |         | ( |               |
|      |                   |   |      |         | E |               |
|      |                   |   |      |         | P |               |
|      |                   |   |      |         | A |               |
|      |                   |   |      |         | , |               |
|      |                   |   |      |         | 1 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | ) |               |
+------+-------------------+---+------+---------+---+---------------+
| A    | NF^a^             |   | N    |         | R |               |
| cute |                   |   | F^a^ |         | a |               |
| de   |                   |   |      |         | b |               |
| rmal |                   |   |      |         | b |               |
| ir   |                   |   |      |         | i |               |
| rita |                   |   |      |         | t |               |
| tion |                   |   |      |         | : |               |
|      |                   |   |      |         | S |               |
|      |                   |   |      |         | l |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | g |               |
|      |                   |   |      |         | h |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         | k |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         |   |               |
|      |                   |   |      |         | ( |               |
|      |                   |   |      |         | E |               |
|      |                   |   |      |         | P |               |
|      |                   |   |      |         | A |               |
|      |                   |   |      |         | , |               |
|      |                   |   |      |         | 1 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | ) |               |
+------+-------------------+---+------+---------+---+---------------+
| Skin | NF^a^             |   | N    |         | G |               |
| s    |                   |   | F^a^ |         | u |               |
| ensi |                   |   |      |         | i |               |
| tiza |                   |   |      |         | n |               |
| tion |                   |   |      |         | e |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | p |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | g |               |
|      |                   |   |      |         | : |               |
|      |                   |   |      |         | N |               |
|      |                   |   |      |         | o |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | d |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         | m |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | l |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | n |               |
|      |                   |   |      |         | s |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | t |               |
|      |                   |   |      |         | i |               |
|      |                   |   |      |         | z |               |
|      |                   |   |      |         | e |               |
|      |                   |   |      |         | r |               |
|      |                   |   |      |         |   |               |
|      |                   |   |      |         | ( |               |
|      |                   |   |      |         | E |               |
|      |                   |   |      |         | P |               |
|      |                   |   |      |         | A |               |
|      |                   |   |      |         | , |               |
|      |                   |   |      |         | 1 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 9 |               |
|      |                   |   |      |         | 4 |               |
|      |                   |   |      |         | a |               |
|      |                   |   |      |         | ) |               |
+------+-------------------+---+------+---------+---+---------------+

^a^ NF = Not found

**[Description of Specific Acute Toxicity References from Table
B-1:]{.underline}**

Hine CH, Zuidema HH. (1970) The toxicological properties of hydrocarbon
solvents. Industrial Medicine. 39(5):39-44.

NIOSH (1997a). National Institute for Occupational Safety and Health:
The Registry of Toxic Effects of Chemical Substances. Mineral oil,
petroleum distillates, hydrotreated (mild) heavy paraffinic (CAS#
64742-54-7). RTECS#: PY8035500.

NIOSH (2000). National Institute for Occupational Safety and Health: The
Registry of Toxic Effects of Chemical Substances. Mineral oil, petroleum
distillate, hydrotreated (severe) light paraffinic (CAS# 64742-55-8).
RTECS#: PY8036501.

NIOSH (2003). National Institute for Occupational Safety and Health: The
Registry of Toxic Effects of Chemical Substances. Mineral Oil (CAS#
8012-95-1). RTECS#: PY8030000.

INCHEM (1982) WHO. Environmental Health Criteria 20. Selected Petroleum
Products. IPCS (International Programme on Chemical Safety)

EPA (1992). EPA File Symbol/EPA Reg. No.: 10163-RLU Gowan Spray Oil.
Memorandum dated 9/1/92 from Mark Perry (Precautionary Review Section,
Registration Support Branch, Registration Division) to Dennis Edwards
(Insecticide-Rodenticide Branch, Registration Division). (HED Doc#
009979)

> [Summary:]{.underline} Acute toxicity tests on product: Gowan Spray
> Oil (EPA Reg. 10163-RLU -- not found in PPIS nor in HED label
> spreadsheet), which contains 99% [mineral oil]{.underline} (no CAS
> number provided) by weight.

-   Acute oral, acute dermal and eye irritation studies accepted as core
    guideline data.

-   Acute inhalation and dermal irritation studies acceptable as core
    minimum data.

    -   Acute inhalation study: particle size distribution only
        determined once during exposure period

    -   Dermal irritation: study failed to include a 48 hour evaluation
        period

-   Eye and dermal irritation studies do not support product
    registration because of the presence of an inert.

  ----------------------- ------------------------ -----------------------
  **Acute Toxicity data                            
  for Gowan Spray Oil                              
  (99% mineral oil) (EPA,                          
  1992)**                                          

  Study Type              Results                  Toxicity Category

  Acute oral -- rat       LD50 \>5 g/kg            IV

  Acute dermal -- rabbit  LD50 \> 2 g/kg           III

  Acute inhalation -- rat LC50 \> 4.6 mg/L         III
  ----------------------- ------------------------ -----------------------

EPA (1994a). EPA ID# 063503: Aliphatic petroleum hydrocarbons -- Review
of 10 Acute Toxicity Studies. Memorandum dated 3/3/94 from Paul Chin,
Ph.D. (Section 2, Toxicology Branch I, HED) to Kathryn Davis/Bonnie
Adler (PM52, Reregistration Division). (HED Doc# 010813; PC Code:
063503)

> \*\*CAS numbers were found in the HPV Robust Summaries. **API 78-10 is
> not included in the list of CAS numbers provided by EPA for the
> aliphatic solvents RED.**

+-------------+--------------------+---------+---------------+--------+
| **Summary   |                    |         |               |        |
| of Acute    |                    |         |               |        |
| Toxicity    |                    |         |               |        |
| data for    |                    |         |               |        |
| Aliphatic   |                    |         |               |        |
| Petroleum   |                    |         |               |        |
| H           |                    |         |               |        |
| ydrocarbons |                    |         |               |        |
| from EPA    |                    |         |               |        |
| (1994)**    |                    |         |               |        |
+=============+====================+=========+===============+========+
| Study Type  | Test material      | MRID    | Results       | To     |
|             |                    |         |               | xicity |
|             | (API               |         |               | Ca     |
|             | 78-9/64742-56-9    |         |               | tegory |
|             |                    |         |               |        |
|             | &                  |         |               |        |
|             |                    |         |               |        |
|             | API                |         |               |        |
|             | 78-10/64742-56-0)  |         |               |        |
+-------------+--------------------+---------+---------------+--------+
| 063503      |                    |         |               |        |
+-------------+--------------------+---------+---------------+--------+
| Acute oral: | Paraffinic oil     | 41      | LD50 \>5 g/kg | IV     |
| rat         |                    | 6853-13 | for males and |        |
|             | (API 78-10)        |         | females       |        |
+-------------+--------------------+---------+---------------+--------+
|             | Paraffinic oil     | 41      |               |        |
|             |                    | 6853-14 |               |        |
|             | (API 78-9)         |         |               |        |
+-------------+--------------------+---------+---------------+--------+
| Acute       | Paraffinic oil     | 41      | LD50 \>5 g/kg | IV     |
| dermal: rat |                    | 6853-15 | for males and |        |
|             | (API 78-9)         |         | females       |        |
+-------------+--------------------+---------+---------------+--------+
|             | Paraffinic oil     | 41      |               |        |
|             |                    | 6853-16 |               |        |
|             | (API 78-10)        |         |               |        |
+-------------+--------------------+---------+---------------+--------+
| Primary eye | Paraffinic oil     | 41      | Not an eye    | IV     |
| irritation: |                    | 6853-17 | irritant      |        |
| rabbit      | (API 78-9)         |         |               |        |
+-------------+--------------------+---------+---------------+--------+
|             | Paraffinic oil     | 41      |               |        |
|             |                    | 6853-18 |               |        |
|             | (API 78-10)        |         |               |        |
+-------------+--------------------+---------+---------------+--------+
| Primary     | Paraffinic oil     | 41      | Slight skin   | IV     |
| dermal      |                    | 6853-19 | irritant      |        |
| irritation: | (API 78-9)         |         |               |        |
| rabbit      |                    |         |               |        |
+-------------+--------------------+---------+---------------+--------+
|             | Paraffinic oil     | 41      |               |        |
|             |                    | 6853-20 |               |        |
|             | (API 78-10)        |         |               |        |
+-------------+--------------------+---------+---------------+--------+
| Dermal      | Paraffinic oil     | 41      | Not a dermal  | NA     |
| sen         |                    | 6853-21 | sensitizer    |        |
| sitization: | (API 78-10)        |         |               |        |
| guinea pig  |                    |         |               |        |
+-------------+--------------------+---------+---------------+--------+
|             | Paraffinic oil     | 41      |               |        |
|             |                    | 6853-22 |               |        |
|             | (API 78-9)         |         |               |        |
+-------------+--------------------+---------+---------------+--------+

EPA (1994b). EPA ID# 063502: Mineral Oil -- Review of Acute Toxicity
Studies. Memorandum from Paul Chin, Ph.D. (Section 2, Toxicology Branch
I, HED) to Kathryn Davis/Bonnie Adler (PM52, Reregistration Division).
(HED Doc# 010809; PC Code: 063502, No CAS numbers provided)

EPA (1994c). EPA ID# 063502: Mineral Oil -- Review of Acute Toxicity
Studies. Memorandum from Paul Chin, Ph.D. (Section 2, Toxicology Branch
I, HED) to Kathryn Davis/Bonnie Adler (PM52, Reregistration Division).
(HED Doc# 010810; PC Code: 063502, No CAS numbers provided.)

  ------------------------------------------------------------------------
  **Summary of                                                  
  Acute Toxicity                                                
  data for                                                      
  Mineral Oil                                                   
  (EPA, 1994b                                                   
  and 1994c)**                                                  
  -------------- ------------- -------------- ----------------- ----------
  Study Type     Test          MRID           Results           Toxicity
                 materials                                      Category

  Acute oral --  MRD-87-984;   416853-07      LD50 \> 5 g/kg    IV
  rat            mineral oil                  for males and     
                                              females           

  Acute dermal - 90 Neutral    416853-11      LD50 \>2 g/kg for III
  rat            Oil ; mineral                males and females 
                 oil (100%                                      
                 purity)                                        

                 MRD-87-984;   416853-08      LD50 \>2 g/kg for III
                 mineral oil                  males and females 

  Acute          90 Neutral    416853-12      LC50 \> 3.5 mg/L  IV
  inhalation -   Oil ; mineral                                  
  rat            oil (100%                                      
                 purity)                                        

                 MRD-87-984;   416853-09      LC50 \> 4.7 mg/L  IV
                 mineral oil                                    

  Primary eye    MRD-87-984;   416853-10      Slight eye        III
  irritation -   mineral oil                  irritation; did   
  rat                                         not clear at day  
                                              14 (last day of   
                                              observation)      
  ------------------------------------------------------------------------

**[SUB-CHRONIC TOXICITY]{.underline}**

**[Description of Data from Sub-chronic Toxicity Studies and Referenced
DERs]{.underline}:**

EPA (1996). Petroleum Oils. Review of Toxicology Data. Memorandum from
Raymond Locke (Section 2, Toxicology Branch I, HED) to Kathryn
Davis/Bonnie Adler (PM52, Reregistration Division). (HED Doc \# 012030)

> Petroleum oils -- Review of toxicology data (PC Code 063503; no CAS
> numbers provided)

+----------+---------+-----------+----------+-----------+------------+
| *        |         |           |          |           |            |
| *Summary |         |           |          |           |            |
| of       |         |           |          |           |            |
| Su       |         |           |          |           |            |
| bchronic |         |           |          |           |            |
| toxicity |         |           |          |           |            |
| tests    |         |           |          |           |            |
| for      |         |           |          |           |            |
| P        |         |           |          |           |            |
| etroleum |         |           |          |           |            |
| Hydr     |         |           |          |           |            |
| ocarbons |         |           |          |           |            |
| (EPA,    |         |           |          |           |            |
| 1996)**  |         |           |          |           |            |
+==========+=========+===========+==========+===========+============+
| Study    | Test    | Test      | Doses    | Results   | Study      |
|          | m       | animal    |          |           | clas       |
|          | aterial |           |          |           | sification |
+----------+---------+-----------+----------+-----------+------------+
| NOTE:    |         |           |          |           |            |
| Memo     |         |           |          |           |            |
| i        |         |           |          |           |            |
| ndicates |         |           |          |           |            |
| that for |         |           |          |           |            |
| MRIDs    |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-06, |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-29, |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-21, |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-22, |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-07, |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-23, |         |           |          |           |            |
| and      |         |           |          |           |            |
| 41       |         |           |          |           |            |
| 3688-24: |         |           |          |           |            |
| Since    |         |           |          |           |            |
| p        |         |           |          |           |            |
| etroleum |         |           |          |           |            |
| oils     |         |           |          |           |            |
| tests    |         |           |          |           |            |
| for      |         |           |          |           |            |
| in       |         |           |          |           |            |
| halation |         |           |          |           |            |
| toxicity |         |           |          |           |            |
| elicited |         |           |          |           |            |
| adverse  |         |           |          |           |            |
| lung     |         |           |          |           |            |
| effects  |         |           |          |           |            |
| in rats, |         |           |          |           |            |
| all of   |         |           |          |           |            |
| the      |         |           |          |           |            |
| a        |         |           |          |           |            |
| vailable |         |           |          |           |            |
| dermal   |         |           |          |           |            |
| and      |         |           |          |           |            |
| in       |         |           |          |           |            |
| halation |         |           |          |           |            |
| toxicity |         |           |          |           |            |
| data     |         |           |          |           |            |
| must be  |         |           |          |           |            |
| reviewed |         |           |          |           |            |
| by the   |         |           |          |           |            |
| HED's    |         |           |          |           |            |
| TES      |         |           |          |           |            |
| C        |         |           |          |           |            |
| ommittee |         |           |          |           |            |
+----------+---------+-----------+----------+-----------+------------+
| 28-day   | Light   | C3H       | U        | LOEL \>   | Una        |
| dermal   | neutral | /HeNCrlBR | ndiluted | 2000      | cceptable, |
|          | oil,    | mice      | test     | mg/kg/day | but        |
| MRID     | Gulf    |           | material |           | upgradable |
| 4        |         | (15/      | or 42.5% |           | due to     |
| 13688-22 | (purity | sex/dose) | (w/v)    |           | lack of    |
|          | not     |           | solution |           | purity and |
|          | pr      |           | in heavy |           | stability  |
|          | ovided) |           | mineral  |           | data on    |
|          |         |           | oil once |           | test       |
|          |         |           | daily,   |           | material.  |
|          |         |           | 3x/week  |           |            |
|          |         |           | for 4    |           | Based on   |
|          |         |           | weeks    |           | lack of    |
|          |         |           |          |           | toxicity,  |
|          |         |           |          |           | a          |
|          |         |           |          |           | repetition |
|          |         |           |          |           | of the     |
|          |         |           |          |           | study was  |
|          |         |           |          |           | not        |
|          |         |           |          |           | required   |
+----------+---------+-----------+----------+-----------+------------+
| 14-day   | 100     | New       | 0, 1 or  | Systemic  | Una        |
| dermal   | Pa      | Zealand   | 2        | LOEL      | cceptable, |
|          | raffine | white     | g/kg/day |           | but        |
| MRID     | Oil,    | rabbits   | for 5    | \> 2000   | upgradable |
| 4        | Gulf    |           | d        | mg/kg/day | due to     |
| 13688-29 |         | (3/       | ays/week |           | lack of    |
|          | (purity | sex/dose) | for 2    |           | purity and |
|          | not     |           | week     |           | stability  |
|          | pr      |           | period   |           | data on    |
|          | ovided) |           |          |           | test       |
|          |         |           |          |           | material.  |
|          |         |           |          |           |            |
|          |         |           |          |           | Based on   |
|          |         |           |          |           | lack of    |
|          |         |           |          |           | toxicity,  |
|          |         |           |          |           | a          |
|          |         |           |          |           | repetition |
|          |         |           |          |           | of the     |
|          |         |           |          |           | study was  |
|          |         |           |          |           | not        |
|          |         |           |          |           | required   |
+----------+---------+-----------+----------+-----------+------------+
| 14-day   | Gulf    | New       | 0, 1, or | Systemic  | Una        |
| dermal   | Orchard | Zealand   | 2        | LOEL      | cceptable, |
|          | Spray   | white     | g/kg/day |           | but        |
| MRID     | 70      | rabbits   | for 5    | \> 2000   | upgradable |
| 4        |         |           | d        | mg/kg/day | due to     |
| 13688-06 | (purity | (3/       | ays/week |           | lack of    |
|          | not     | sex/dose) | for      |           | purity and |
|          | pr      |           | 2-week   |           | stability  |
|          | ovided) |           | period   |           | data on    |
|          |         |           |          |           | test       |
|          |         |           |          |           | material.  |
|          |         |           |          |           |            |
|          |         |           |          |           | Based on   |
|          |         |           |          |           | lack of    |
|          |         |           |          |           | toxicity,  |
|          |         |           |          |           | a          |
|          |         |           |          |           | repetition |
|          |         |           |          |           | of the     |
|          |         |           |          |           | study was  |
|          |         |           |          |           | not        |
|          |         |           |          |           | required   |
+----------+---------+-----------+----------+-----------+------------+
| 5-day    | Light   | Fischer   | 0, 0.85, | Systemic  | Una        |
| dermal   | Neutral | 344 rats  | 1.0, or  | and       | cceptable, |
|          | Oil,    | (5/       | 2.0      | dermal    | but        |
| MRID     | Gulf    | sex/dose) | g/kg/day | LOEL      | upgradable |
| 4        |         |           | for 5    |           | due to     |
| 13688-21 | (purity |           | d        | \> 2000   | lack of    |
|          | not     |           | ays/week | mg/kg/day | purity and |
|          | pr      |           | for      |           | stability  |
|          | ovided) |           | 1-week   |           | data on    |
|          |         |           | period   |           | test       |
|          |         |           |          |           | material.  |
|          |         |           |          |           |            |
|          |         |           |          |           | Based on   |
|          |         |           |          |           | lack of    |
|          |         |           |          |           | toxicity,  |
|          |         |           |          |           | a          |
|          |         |           |          |           | repetition |
|          |         |           |          |           | of the     |
|          |         |           |          |           | study was  |
|          |         |           |          |           | not        |
|          |         |           |          |           | required   |
+----------+---------+-----------+----------+-----------+------------+
| 28-day   | Light   | Fischer   | 0, 0.52, | LOEL =    | Una        |
| in       | Neutral | 344 rats  | 0.76, or | 520       | cceptable, |
| halation | Oil,    | (10/      | 1.53     | mg/m^3^   | but        |
|          | Gulf    | sex/dose) | g/m^3^   | or mg/mL  | upgradable |
| MRID     |         |           | or g/mL  |           | due to     |
| 4        | (purity |           | for      | (146,640  | lack of    |
| 13688-24 | not     |           | 6-ho     | mg/k      | purity and |
|          | pr      |           | urs/day. | g/day)^a^ | stability  |
|          | ovided) |           | Five     |           | data on    |
|          |         |           | da       |           | test       |
|          |         |           | ys/week, |           | material.  |
|          |         |           | for      |           |            |
|          |         |           | total of |           |            |
|          |         |           | 28 days  |           |            |
+----------+---------+-----------+----------+-----------+------------+
| 9-day    | 70      | Fischer   | 0, 0.70, | LOEL ≤    | Una        |
| in       | Orchard | 344 rats  | 1.60     | 700       | cceptable, |
| halation | Spray   | (5/       | g/m^3^   | mg/m^3^   | but        |
|          |         | sex/dose) | or g/mL  | or mg/mL  | upgradable |
| MRID     | (purity |           | for      |           | due to     |
| 4        | not     |           | 6-h      | (197,400  | lack of    |
| 13688-07 | pr      |           | ours/day | mg/k      | purity and |
|          | ovided) |           | for      | g/day)^a^ | stability  |
|          |         |           | total of |           | data on    |
|          |         |           | 9        |           | test       |
|          |         |           | e        |           | material.  |
|          |         |           | xposures |           |            |
|          |         |           |          |           | Does not   |
|          |         |           |          |           | satisfy    |
|          |         |           |          |           | the        |
|          |         |           |          |           | guideline  |
|          |         |           |          |           | r          |
|          |         |           |          |           | equirement |
|          |         |           |          |           | for        |
|          |         |           |          |           | subchronic |
|          |         |           |          |           | inhalation |
|          |         |           |          |           | study, but |
|          |         |           |          |           | is         |
|          |         |           |          |           | sa         |
|          |         |           |          |           | tisfactory |
|          |         |           |          |           | for use as |
|          |         |           |          |           | a          |
|          |         |           |          |           | ran        |
|          |         |           |          |           | ge-finding |
|          |         |           |          |           | study      |
+----------+---------+-----------+----------+-----------+------------+
| 5-day    | Light   | Fischer   | 0, 0.54, | LOEL =    | Una        |
| in       | Neutral | 344 rats  | 1.70 or  | 1700      | cceptable, |
| halation | Oil,    | (5/       | 2.79     | mg/m^3^   | but        |
|          | Gulf    | sex/dose) | g/m^3^   | or mg/mL  | upgradable |
| MRID     |         |           | or g/mL  |           | due to     |
| 4        | (purity |           | for      | (479,400  | lack of    |
| 13688-23 | not     |           | 6-h      | mg/k      | purity and |
|          | pr      |           | ours/day | g/day)^a^ | stability  |
|          | ovided) |           | for      |           | data on    |
|          |         |           | total of | NOEL =    | test       |
|          |         |           | 5        | 540       | material.  |
|          |         |           | e        | mg/m^3^   |            |
|          |         |           | xposures | or mg/mL  | Does not   |
|          |         |           |          |           | satisfy    |
|          |         |           |          | (152,280  | the        |
|          |         |           |          | mg/k      | guideline  |
|          |         |           |          | g/day)^a^ | r          |
|          |         |           |          |           | equirement |
|          |         |           |          |           | for        |
|          |         |           |          |           | subchronic |
|          |         |           |          |           | inhalation |
|          |         |           |          |           | study, but |
|          |         |           |          |           | is         |
|          |         |           |          |           | sa         |
|          |         |           |          |           | tisfactory |
|          |         |           |          |           | for use as |
|          |         |           |          |           | a          |
|          |         |           |          |           | ran        |
|          |         |           |          |           | ge-finding |
|          |         |           |          |           | study      |
+----------+---------+-----------+----------+-----------+------------+

a Conversion of g/mL to g/kg/day performed using route-to-route
extrapolation method. Assumed default values for respiratory volume and
body weight based on test species.

Equation: mg/kg/day = mg/L \* A \* CF \* D \* AF

Where: mg/L = NOEL/LOEL in mg/L;

> A = absorption or ration of deposition and absorption in the
> respiratory tract compared to another route; assumed to be 100% ;

CF = Conversion factor based on default respiratory volume and body
weight (L/hr/kg);

D = Duration of exposure (hr/day);

AF = Activity factor -- default for animals = 1.

Ulrich, Charles. (1999) "A 90-day (with recovery) nose-only inhalation
toxicity study of GB-1111 Technical in Albino Rats". WIL Research
Laboratories, Inc., Ashland, OH. Project Number WIL-357008. December 2,
1999. MRID 450029-01.

Test Material: GB-1111; EPA Reg. #8239-72, lists active ingredient as
CAS# 8002-05-9: petroleum distillates, naptha)

EPA Reg. \# 8239-72 is listed as GB-1313 in HED label spreadsheet

+----------+----------+--------------+------------------+-----------+
| *        |          |              |                  |           |
| *Summary |          |              |                  |           |
| of       |          |              |                  |           |
| Su       |          |              |                  |           |
| bchronic |          |              |                  |           |
| toxicity |          |              |                  |           |
| test     |          |              |                  |           |
| (Ulrich, |          |              |                  |           |
| 1999)**  |          |              |                  |           |
+==========+==========+==============+==================+===========+
| Study    | Test     | Test animal  | Doses            | Results   |
|          | material |              |                  |           |
+----------+----------+--------------+------------------+-----------+
| 90-day   | GB-1111  | Crl:         | Target           | NOEL =    |
| in       |          | CD^®^(SD)IGS | concentrations:  | 0.1 mg/L  |
| halation |          | BR rats      | 0.01, 0.1, and   |           |
|          |          |              | 1.0 mg/L         | (26.1     |
|          |          |              |                  | mg/k      |
|          |          |              | Actual           | g/day)^a^ |
|          |          |              | concentrations:  |           |
|          |          |              | 0.012, 0.10, and |           |
|          |          |              | 0.9 mg/L         |           |
+----------+----------+--------------+------------------+-----------+

a Conversion performed using assumption of body weight and respiratory
volume since exact conversion factor is not known for this species of
rat. Used minimum default conversion factor provided for all species of
rats.

API (2004). High Production Volume: Robust Summary of Information on
Lubricating Oil Basestocks. Prepared by American Petroleum Institute
(API).

Summary: Provides acute as well as repeat dose testing. Not all identify
NOELs and LOELs, or assess the CAS numbers listed for the aliphatic
solvents RED.

+-----------+----------+---------+----------+-----------+------------+
| **Summary |          |         |          |           |            |
| of Robust |          |         |          |           |            |
| Summary   |          |         |          |           |            |
| Su        |          |         |          |           |            |
| b-chronic |          |         |          |           |            |
| In        |          |         |          |           |            |
| formation |          |         |          |           |            |
| from the  |          |         |          |           |            |
| HPV       |          |         |          |           |            |
| Sub       |          |         |          |           |            |
| mission** |          |         |          |           |            |
+-----------+----------+---------+----------+-----------+------------+
| Study     | Test     | Test    | Doses    | Results   | Study      |
|           | material | animal  |          |           | clas       |
|           |          |         |          |           | sification |
+-----------+----------+---------+----------+-----------+------------+
| 28-day    | WTO      | Male    | 0, 50,   | LOAEL:    | ?          |
| i         |          | /female | 220, and | 210       |            |
| nhalation | (white   | Sprague | 1000     | mg/m^3^   |            |
|           | oil,     | -Dawley | g/m^3^   |           |            |
| from HPV  | CAS#     | rats    | for 6    | (54,810   |            |
| Robust    | 80       |         | hr/day,  | m         |            |
| Summary   | 42-47-5) | (10/se  | 5        | g/kg/day) |            |
|           |          | x/dose) | da       |           |            |
|           | &        |         | ys/week, | NOAEL: 50 |            |
|           |          |         | 4 weeks  | mg/m^3^   |            |
|           | HBO      |         |          | (13,050   |            |
|           | (hydr    |         |          | m         |            |
|           | otreated |         |          | g/kg/day) |            |
|           | base     |         |          |           |            |
|           | oil,     |         |          |           |            |
|           | CAS#     |         |          |           |            |
|           | 647      |         |          |           |            |
|           | 42-54-7) |         |          |           |            |
+-----------+----------+---------+----------+-----------+------------+

**[Miscellaneous Toxicity Information provided:]{.underline}**

EPA (1995a). OPP Official Record, Health Effects Division, Scientific
Data Reviews, EPA Series 361. CBRS Transmittal Sheet for Phase 4
Reviews, Case No. 3004; Chemical No(s): 63502/63503, .

> [Summary:]{.underline} Residue data for mineral oil (PC code: 063502;
> no CAS number provided): Based on CBRS Transmittal Sheet for Phase 4
> Reviews dated 9/7/95, CBRS will not require residue data for mineral
> oil is the Toxicology Branch I, HED, concludes that there are no
> toxicological concerns. In addition, a recommendation will be made for
> the exemption of mineral oil from tolerance requirements for food/feed
> uses.

EPA (1995b). OPP Official Record, Health Effects Division, Scientific
Data Reviews, EPA Series 361. OREB Transmittal Sheet for Phase 4
Reviews, Case No. 3004; Chemical No(s): 63502/63503.

> [Summary:]{.underline} Aliphatic petroleum hydrocarbons (#63503; no
> CAS numbers provided) information specific to postapplication exposure
> monitoring test guidelines subdivision K:

-   Indicated that dermal exposure does not warrant an exposure study
    since mineral oil is applied by either low volume spray or high
    volume ground spraying and because toxicity is low (FDA recommended
    it for GRAS status).

-   Indicated that OREB does not require inhalation exposure study for
    same reasons.

**Appendix C. Detailed Information on the Use Rates for Aliphatic
Solvents**