Page 2 of 16

EXECUTIVE SUMMARY

The Antimicrobials Division (AD) Registration Review Team has evaluated the status 

of the human health assessments for the 1H-Pyrazole-1-methanol, 3,5-dimethyl 

(DMHMP) case (registration review case 5035). One active ingredient (PC Code 129074)

and one registered product exists in the DMHMP case. DMHMP is sold for use as an incan preservative that contains 93% active ingredient. The registered label indicates that 

DMHMP is formulated as a solid granular product intended as a preservative for emulsion 

paints, latex emulsions, polishes and waxes, papermaking chemicals and coatings, 

detergents, inks, textiles, and construction materials. 

EPA examined the hazard and exposure databases for the DMHMP case to determine 

whether changes in science policy or deficiencies in the databases materially affected the 

overall risk picture. DMHMP was first registered as a pesticide in August 19, 1996. A 

Reregistration Eligibility Decision (RED) document has not been issued for DMHMP

since this chemical was registered after November 1, 1984. The primary source of 

information for this assessment was registration records for the only registered product 

(EPA Reg. 1448-351) and applicable Agency risk assessment memoranda pertaining to 

this registration. The Agency did an open literature search and no relevant toxicological or 

exposure studies for DMHMP were available. 

The Agency did not select any dermal, inhalation or oral toxicological endpoints for 

short-term, intermediate-term occupational, residential and dietary exposures as indicated 

in the 1995 Toxicology Selection Endpoint Document (U.S. EPA, 1995b). However, for 

registration review, the Agency believes that additional studies will be needed and new 

toxicological endpoints will be needed. If relevant toxicological endpoints are available 

for dermal and inhalation, EPA will anticipate the need that new occupational and 

residential risk assessments will be needed (see section 5).

According to the label, DMHMP “may NOT be used for the preservation of materials 

which may contact food” in papermaking and adhesives. Therefore, AD will not need to 

do an indirect dietary assessment for these uses. No FDA clearances are available for this 

compound.

Section 1. Chemical Identity

DMHMP is a white solid, granular (93% active ingredient) end-use product (EP).

Busan 1104 is registered for non-food, indoor uses as a material preservative primarily for

liquid emulsions subject to microbial degradation. DMHMP is a solid at room temperature 

and has a melting point of 77 oC. No boiling point is available since the product chemistry 

chapter indicates that it sublimes or transitions from the solid phase to the gas phase 

without passing through an intermediate liquid phase. DMHMP has a log Kow of 0.93 and 

is very soluble in water as well as organic chemicals (MRID 41832503). The vapor 

pressure is listed as 3.4 x 10-3 hPa or 2.55 x 10-3 mm Hg (0.00255 mm Hg) at 20°C. The 

only registered product contains 93% active ingredient (a.i.). Table 2 presents the 

chemical identity of DMHMP.
Page 3 of 16

Table 1. Chemical Identity

Common 

Name

1H-Pyrazole-1-methanol, 3,5-dimethyl

Synonyms DMHMP

PC Code 129074

CAS registry 

number

85264-33-1

Registration 

Review Case 

No.

5035

Structure

Vapor 

Pressure

2.55 x 10-3 mm Hg at 20°C

Section 2. Toxicology

The Agency has reviewed toxicity studies submitted for the one DMHMP active 

ingredient (PC Code 129074) in the DMHMP case (Case # 5035). The toxicological 

database for DMHMP is currently comprised of registrant submitted studies submitted to 

the Agency during registration. The Agency did an open literature search and no 

additional relevant toxicological information for DMHMP was available. 

Acute Toxicity

Table 2 summarizes the acute toxicity of DMHMP. 

Table 2: Acute Toxicity Studies

STUDY GLN RESULTS TOXICITY 

CATEGORY

Acute Oral GLN 81-1/

MRID 418321-01

LD50 = combined: 2.6 gm/kg III

Acute Dermal GLN 81-2/

MRID 418321-01

LD50 > 2.0 gm/kg III

Acute Inhalation GLN 81-3/ Waiver granted NA
Page 4 of 16

Primary Eye

Irritation 

GLN 81-4/

MRID 418321-03

Corrosive I

Primary Dermal 

Irritation

GLN 81-5/

MRID 418321-04

Irritation I

Dermal 

Sensitization

GLN 81-6/

MRID 418321-05

Not a skin sensitizer NA

Mutagenicity

An Ames test was conducted on a series of nonactivated and S9 activated Salmonella 

typhimurium assays were dosed up to 1000 μg/plate (MRID 41832401). DMHMP was not 

mutagenic in strains TA1535, TA1538, and TA98, but histidine revertants were found for 

strain TA100. According to the EPA review, the initial findings were equivocal and the 

study was unacceptable according to 84-2a guidelines. However, on August 26, 1993 the 

study was later upgraded to acceptable. 

DMHMP was tested for its potential to induce gene mutation in cultured Chinese 

hamster ovary cells (CHO/HGPRT) (MRID 4182403) and reviewed in accordance with 

Series 870.5100. According to the review (U.S. EPA 1992) the study was suggestive of a 

mutagenic effect. However, the study was unacceptable based on the following reasons: 1)

failure to reproduce dose related mutagenic responses; 2) improper dose selection; and 3) 

marked increase in mutation at cytotoxic levels. A follow up study (MRID 43639101) was 

conducted and positive mutagenicity was confirmed and the study was regarded as 

acceptable.

A micronucleus assay was administered in mice (MRID 41832402; Guideline 84-2b). 

A single oral gavage administration of 100, 200, 400 mg/kg was administered to male 

mice and doses of 250, 500, and 1,000 mg/kg was administered to female mice. In the 

study there was no significant increase in the frequency of micronucleated polychromatic 

erythrocytes in bone marrow cells harvested 24, 48, or 72 hours post-treatment. DMHMP 

was found to be nonclastogenic.

An in vivo/in vitro unscheduled DNA synthesis (UDS) primary rat hepatocyte assay 

(MRID 43636601) was submitted in 3 groups of rats dosed at 300, 600, and 900 mg/kg 

Busan 1104 by oral gavage. Clinical signs of toxicity in the rats included prostration and 

hypoactivity. Cytotoxicity was evident in both the cell wall and increased vacuoles in the 

hepatocytes. There was however no evidence of increased genotoxicity at any dose. This 

study was classified as acceptable as per 84-4 guidelines. Based on the review of the 

submitted studies, no additional mutagenicity studies are anticipated as needed

(D215585). DMHMP was confirmed to have genotoxicity in vitro, but not in vivo.

Subchronic Toxicity

A 91-day dermal study with groups of 10 rats/sex/dose were administered the 

DMHMP at concentrations of 50, 250, and 500 mg/kg/day for 5 days/week for 91 days. 

Severe dermal irritation, ulceration and eschar formation occurred at all treatment 

levels. Necrosis extended through the dermis and into the subcutaneous tissue. A 

number of parameters were affected either by the test material or by stress (increased 

platelets, polychromatophilia, hematopoietic activity of the spleen and bone marrow). The
Page 5 of 16

Agency stated that direct systemic effects of this chemical were difficult to determine

since the chemical is corrosive. The Agency believed the effects were stress related based 

on the severe dermal irritation. The systemic NOEL was 50 mg/kg and the systemic 

NOEL was 250 mg/kg. The Agency considered the dermal sub-chronic study to be 

acceptable (GDLN 82-2)

The Agency anticipates the need for another dermal study since the previous study 

identified dermal irritation at all the doses tested. AD commonly considers dermal 

irritation as a toxicity endpoint for material preservatives used in consumer goods (e.g., 

treated paints and textiles). Assumptions involved in this calculation include body weight 

of the rat and area of skin exposed. If it is decided during the registration review risk 

assessment process that the Agency will use irritation as the endpoint for short-term 

dermal exposure (e.g. treated paints and textiles), the Agency will likely need to convert 

the NOAEL to a dermal endpoint in the units of μg/cm2 to do the risk assessment.

Developmental

DMHMP was orally dosed to pregnant rats at dose levels of 0, 25, 75, and 150 

mg/kg/day (20 rats/group) during gestation days 6-15 (MRID 41833001). Maternal 

toxicity was evidenced by decreased body weight and food consumption in the 150 mg/kg 

dose group. The mean numbers of implants and corpora lutea in the test groups were

comparable to controls. No treatment related effects were noted in the number of viable 

fetuses/dam, or the mean fetal body weights in the test group were either lower than or 

comparable to the control group. At a dose of 150 mg/kg, DMHMP appeared to have 

effects on developmental toxicity by increased litter incidence of rudimentary ribs at a 

dose response relationship, reduced ossification of the 13th rib, and 14th full rib and the 

27th presacral vertebrae. The developmental NOEL was 75 mg/kg and the maternal 

NOEL is 75 mg/kg. The study was guideline (84-2) acceptable.

DMHMP was orally dosed to pregnant rabbits at dose levels of 0, 10, 30, and 60 

mg/kg/day (20 rats/group) during gestation days 6-18 (MRID 41833002). Possible 

maternal toxicity was evidenced by statistically decreased body weight gain and food 

consumption in the 30 and 60 mg/kg dose groups. The mean number of implantations and 

corpora lutea in the test groups were comparable to controls. No treatment related effects 

were noted in the number of viable fetuses/dam, the mean fetal body weights, or fetal sex 

ratios in any of the test groups. No evidence of developmental toxicity was noted in the 

highest dose tested (60 mg/kg), developmental NOEL= 60 mg/kg and maternal NOEL= 

75 mg/kg. The study was guideline (84-2) acceptable.

Section 3. Dietary Assessment

Dietary

According to the label (EPA Reg 1448-351), DMHMP or Busan 1104 “may NOT be 

used for the preservation of materials which may contact food” for adhesives and 

papermaking uses. Therefore, EPA anticipates that an indirect dietary assessment will not 

be needed. Currently, no FDA clearances are available for this compound.
Page 6 of 16

Drinking Water

Although likely to be infrequent, dietary exposures via drinking water may occur in 

the event of a down-the-drain discharge. The contaminated water could pass through 

wastewater treatment facilities into the drinking water or may be discharged directly to 

surface water which is later treated. However, at this time there are no environmental fate 

data to determine whether DMHMP can pass through wastewater treatment facilities into 

drinking water or migrate into residential groundwater wells as a result of its current use 

patterns. Since the product is used as an industrial preservative in slurries, the Agency 

anticipates that the effluent wastewater could discharge directly to surface water and 

exposures could occur. 

Section 4. Occupational/Residential Exposure

The Agency did an open literature search and did not identify any relevant exposure 

studies in the existing literature that could be used to supplement the existing Agency 

exposure database. There are potential short- and intermediate-term exposures for 

occupational and residential uses. There are potential dermal and inhalation occupational 

handler exposure scenarios identified by the Agency after review of the labels. The 

potential occupational handler scenarios (both short-term (1-30 days) and intermediateterm (>30 days) include: 

• Mixing/loading solid granulars for paints; 

• Mixing/loading solid granulars for slurries (e.g., adhesives, polishes/waxes, 

construction materials, detergents, inks, papermaking chemicals/coatings, textile 

emulsions);

• Applying detergents (trigger sprays, mopping and wiping); and,

• Applying paints (airless sprayer, paint brush, and aerosol can)

The potential postapplication scenarios (both short-term (1-30 days) and intermediate-term 

(>30 days) include: 

• Inhalation exposure to paints (e.g. bystander exposure indoors); and

• Dermal postapplication exposures to treated clothing made from impregnated 

textiles with DMHMP.

Section 5. Aggregate and Cumulative Exposure

In examining aggregate exposure, EPA takes into account the available and reliable 

information concerning exposures to residues in food and drinking water, and nonoccupational pesticide exposures. EPA expects that the residential risks and drinking 

water risks will be the only exposures to be aggregated.

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 DMHMP and any other substances and DMHMP does not appear to 

produce a toxic metabolite produced by other substances. For the purposes of this 
Page 7 of 16

tolerance action, therefore, EPA has not assumed that DMHMP has a common mechanism 

of toxicity with other substances. For the purposes of this action, therefore, EPA has not 

assumed that DMHMP has a common mechanism of toxicity with other substances. For 

information regarding EPA’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/.

Section 6. Incidents

There have been no human incidents reported in any of the OPP databases (e.g. OPP 

Incident Data System (IDS)) associated with exposure to DMHMP.

Section 7. Anticipated Data Needs

The Antimicrobial Division (AD) anticipates requiring further toxicity and exposure

studies for DMHMP for registration review. The studies and a brief rationale are listed 

below in Table 3. Further clarification of the rationale for these studies are provided in 

Appendix A and B. 

Table 3: Human Health Data Needs Based on End Use Labels

Study Needed Guideline Rationale (also see Appendix B)

90-day Inhalation Toxicity 870.3465 As a result of inhalation exposures to aerosol sprays and 

the volatility of the chemical; the Agency anticipates 

that a 90-day inhalation study will be needed to develop 

short- and intermediate- toxicity inhalation endpoints. 

90-day Dermal Toxicity 870.3250 EPA is concerned about the corrosivity of DMHMP and 

may need an additional dermal subchronic toxicity study 

to select dermal toxicity endpoints since dermal 

irritation was found in all dose levels in the rat dermal 

91-day study. The Agency needs to identify the dermal 

risks to activities which involve prolonged dermal 

exposure (particularly to dermal postapplication to 

treated clothing from preserved textiles).

Indoor Exposure 

(applicators)

875.1200 (Dermal)

875.1400 (Inhalation)

875.1600 (Data Reporting)

Exposure studies are needed for painting (brush/roller, 

airless sprayer, and for using disinfectants (mopping and 

wiping).

Indoor Exposure 

(mixer/loaders)

875.1200 (Dermal)

875.1400 (Inhalation)

875.1600 (Data Reporting)

Exposure may occur while mixing/loading granular

preservatives in a manufacturing setting for slurries 

(paint, disinfectants)

Indoor Exposure 875.2400 (Dermal)

875.2500 (Inhalation)

875.2900 (Data Reporting)

Bystander inhalation exposure may occur after painting. 

Dermal exposure to treated textiles that are used for 

clothing. 

Product Use 875.1700 (Handler)

875.2700 (Postapplication)

Product use data will be needed to characterize any 

uncertainties with regard to the use or application of this 

chemical (e.g., detergent use).

Section 8. Tolerances
Page 8 of 16

There are no pesticide tolerances or exemptions from the requirement of tolerance for 

DMHMP. 

Section 9. Endocrine Disruption

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential 

adverse outcomes from exposure to chemicals. Collectively, these studies include acute, 

subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, 

developmental, reproductive, and general or systemic toxicity. These studies include 

endpoints which may be susceptible to endocrine influence, including effects on endocrine 

target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, 

pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard 

assessments, EPA evaluates acute tests and chronic studies that assess growth, 

developmental and reproductive effects in different taxonomic groups. As part of its

reregistration decision, EPA reviewed these data and selected the most sensitive endpoints 

for relevant risk assessment scenarios from the existing hazard database. However, as 

required by FFDCA section 408(p), DMHMP is subject to the endocrine screening part of 

the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including 

pesticide active and other ingredients) may have an effect in humans or wildlife similar to 

an effect produced by a “naturally occurring estrogen, or other such endocrine effects as 

the Administrator may designate.” The EDSP employs a two-tiered approach to making 

the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays 

to identify the potential of a chemical substance to interact with the estrogen, androgen, or 

thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and 

are found to have the potential to interact with E, A, or T hormonal systems will proceed 

to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests 

are necessary based on the available data. Tier 2 testing is designed to identify any adverse 

endocrine-related effects caused by the substance, and establish a dose-response 

relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. 

Between October 2009 and February 2010, EPA issued test orders/data call-ins for the 

first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert 

ingredients. DMHMP is not among the group of 58 pesticide active ingredients on the 

initial list to be screened under the EDSP. Accordingly, as part of registration review, 

EPA will issue future EDSP orders/data call-ins, requiring the submission of EDSP 

screening assays for DMHMP. For further information on the status of the EDSP, the 

policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the 

Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/.
Page 9 of 16

Section 10. References

United States Environmental Protection Agency (U.S. EPA 1995a). Memorandum from 

George Z. Ghali, PhD., Toxicologist, HED to Joanne Miller, RD. RfD/Peer Review 

Report of Busan 1104 [3,5-Dimethyl-1-hydroxymethylpyrazole]. January 10, 1995

United States Environmental Protection Agency (U.S. EPA 1995b). Toxicology Endpoint 

Selection Document. Busan 1104. J. Rowe, HED. File R073459. June 14, 1995.
Page 10 of 16

APPENDIX A: TOXICITY

Guideline Numbers: 870.3465

Study Titles: 90-day Inhalation Toxicity Study 

Rationale for Requiring the Data

The Agency does not have a full picture of the potential effects which DMHMP could 

occur as a result of exposure via the inhalation route. The needed study which was not 

previously available would provide insight into concerns regarding toxicity via the 

inhalation route. It may also provide a toxicity endpoint applicable to an inhalation risk 

assessment. The Agency previously used an oral toxicological endpoint from a maternal 

toxicity endpoint from a developmental study and assumed 100% absorption. Inhalation 

exposure is high for workers who apply paint through airless sprayers and brushes. 

These applicators would likely to be exposed to aerosols from paint applications. In 

addition, an inhalation study is required to address uncertainties around the inhalation 

toxicity to refine the Agency’s risk assessment. Currently for inhalation exposures an 

extra 10 X uncertainty factor is added for a lack of an inhalation toxicity endpoint. The 

study may result in a change in how risks are quantified and removal of a 10X 

uncertainty. The data would allow the Agency to conclude more definitively whether or 

not there would be any concerns for inhalation toxicity in the rat. This would provide a 

more complete hazard characterization of DMHMP in regards to the potential risks to the 

U.S. general population.

Practical Utility of the Data

How will data be used?

An inhalation study may result in changes to the endpoints and how the risks are 

quantified. 

How could the data impact the Agency’s future decision-making?

The study would form the foundation for hazard characterization and toxicity endpoints 

selection for risk assessment through all exposure routes (oral, inhalation, and dermal). 

The data would allow the Agency to conclude more definitively whether or not there 

would be any concerns for inhalation toxicity in rodent species. It is possible that the 

database uncertainty factor be reduced or removed, resulting in different magnitude of the 

value of the endpoint used for regulation. . In many cases, toxicity observed via the 

inhalation route is higher than toxicity observed via oral exposure, which means that the 

route-to-route extrapolation used in the RED risk assessment could have resulted in an 

underestimation of risks from inhalation. It is particularly important to properly assess 

inhalation risks for DMHMP because there is high inhalation exposure for workers 

applying paints.
Page 11 of 16

Guideline Numbers: 870.3465

Study Titles: 90-day Dermal Toxicity Study 

Rationale for Requiring the Data

The Agency does not have a full picture of the potential effects which DMHMP could 

occur as a result of exposure via the dermal route. The needed study which was not 

previously available would provide insight into concerns regarding toxicity via the 

dermal route. It may also provide a toxicity endpoint applicable to a dermal risk 

assessment. The Agency previously did not develop a dermal toxicological endpoint. 

EPA is concerned about the corrosivity of DMHMP and may need an additional dermal 

subchronic toxicity study to select dermal toxicity endpoints since dermal irritation was 

found in all dose levels in the rat dermal 91-day study. The Agency needs to identify the 

dermal risks to activities which involve prolonged dermal exposure (particularly to 

dermal postapplication to treated clothing from preserved textiles).

The data would allow the Agency to conclude more definitively whether or not there 

would be any concerns for dermal toxicity in the rat. This would provide a more 

complete hazard characterization of DMHMP in regards to the potential risks to the U.S. 

general population.

Practical Utility of the Data

How will data be used?

A dermal study may result in changes to the endpoints and how the risks are quantified. 

How could the data impact the Agency’s future decision-making?

The study would form the foundation for hazard characterization and toxicity endpoints 

selection for risk assessment through all exposure routes (oral, inhalation, and dermal). 

The data would allow the Agency to conclude more definitively whether or not there 

would be any concerns for dermal toxicity in rodent species. It is possible that the 

database uncertainty factor be reduced or removed, resulting in different magnitude of the 

value of the endpoint used for regulation. . In many cases, toxicity observed via the 

dermal route is higher than toxicity observed via oral exposure. EPA is concerned about 

the corrosivity of DMHMP and may need an additional dermal subchronic toxicity study 

to select dermal toxicity endpoints since dermal irritation was found in all dose levels in 

the rat dermal 91-day study. The Agency needs to identify the dermal risks to activities 

which involve prolonged dermal exposure (particularly to dermal postapplication to 

treated clothing from preserved textiles).
Page 12 of 16

APPENDIX B: EXPOSURE
Page 13 of 16

Guideline Number: 875.1200 

Study Titles: Dermal Exposure (Indoor)

Rationale for Requiring the Data

Note: Dermal exposure data are needed for both residential and occupational uses. The selection 

of an outdoor versus an indoor site is based on the high end exposure scenario. In almost all 

cases, repeating an exposure study for the same scenario outdoors and indoors is not necessary.

The potential for dermal exposure is very likely for exposure scenarios involving painting. The 

existing CMA data base and PHED for these scenarios are limited in scope for QA/QC and number 

of monitoring units. EPA presented the need for additional handler exposure data to the January 

2007 Science Advisory Panel (SAP) as well as to the April 2007 Human Studies Review Board 

(HSRB) and both groups agreed that additional data are warranted. 

The criteria for the dermal exposure data are based on the potential for dermal exposure from the 

labeled uses (e.g., occupational and residential exposures from painting) and evidence of toxicity. 

If the toxicological endpoints from DMHMP are used to assess the risks, there is an endpoint 

selected for the dermal route.

Practical Utility of the Data

1. How will the data be used?

The dermal exposure data will be used to assess dermal exposures from painting. For occupational 

uses, the dermal exposure data will be used to assess the short-, and intermediate- term exposures. 

The dermal exposure data will be used to determine the accuracy of the dermal risks to both 

residential and occupational workers.

2. How could the data impact the Agency’s future decision-making?

If risks warrant mitigation, the dermal exposure data will provide the types of mitigation necessary 

such as chemical resistant gloves or closed systems for commercial uses, or potential removal of 

uses from the label.

Guideline Number: 875.1400 

Study Titles: Inhalation Exposure (Indoor)

Rationale for Requiring the Data

Note: Inhalation exposure data are needed for both residential and occupational uses. The 

selection of an outdoor versus an indoor site is based on the high end exposure scenario (for 

inhalation the selection is typically indoors). In almost all cases, repeating an exposure study for 

the same scenario outdoors and indoors is not necessary.

The inhalation exposure route is very important for exposure scenarios such application of paints or 

metalworking fluids where aerosols would be generated. In addition, inhalation exposures from 

application are evident in exposure studies in the Pesticide Handlers Exposure Database (PHED). 

The significance of these exposures is directly affected by the severity of the inhalation 

toxicological endpoint of concern. At this point in time, no toxicological data are available to 

assess the inhalation risk. The existing Chemical Manufacturer Association (CMA) data base and 

PHED for these scenarios are limited in scope for QA/QC and number of monitoring units. EPA 

presented the need for additional handler exposure data to the January 2007 Science Advisory 

Panel (SAP) as well as to the April 2007 Human Studies Review Board (HSRB) and both groups 

agreed that additional data are warranted. 

The criteria for the inhalation exposure data are based on the potential for respiratory exposure 

from the labeled uses (e.g., exposure to paints) and evidence of toxicity. If no toxicological 

endpoints of concern were identified, then the inhalation exposure data would not be needed.

Practical Utility of the Data

1. How will the data be used?
Page 14 of 16

The inhalation exposure data would be used to assess the residential short-term duration of painting 

with a paint brush/roller and an airless sprayer. For occupational uses, the inhalation exposure data 

would be used to assess the short- and intermediate-term exposure

2. How could the data impact the Agency’s future decision-making?

If risks warrant mitigation, the inhalation exposure data will provide the types of mitigation 

necessary such as full face respirators or closed systems for commercial uses, or potential removal 

of uses from the label.

Guideline Number: 875.1600

Study Title: Data Reporting and Calculations 

Rationale for Requiring the Data

For all exposure studies this data need is needed to facilitate the review of the data.

The study report and all raw data/calculations would be reviewed for the adequacy of the 

data.

Practical Utility of the Data

1. How will the data be used?

The data are needed to interpret the dermal and inhalation exposure data collected.

2. How could the data impact the Agency’s future decision-making?

This data need is triggered if an exposure study is conducted. It would aid the Agency to 

make accurate interpretations of the studies to develop an accurate and refined risk 

assessment and refined mitigation.
Page 15 of 16

Guideline Number: 875.1700 and 870.2700

Study Title: Product Use Information

Rationale for Requiring the Data

Product use information is a description of how the product is actually applied; it is not 

afield study. A description of how this product is used would provide for a 

comprehensive realistic assessment of its potential applications. The description of the 

application techniques would be used to define the exposure scenarios to be assessed in 

the risk assessment.

Practical Utility of the Data

1. How will the data be used?

A complete description of product use would ensure that the risk assessment is inclusive 

of the types of exposures occurring during residential and occupational use.

2. How could the data impact the Agency’s future decision-making?

The need for a risk assessment as needed under Registration Review would require that 

the risk assessor understands how the product is applied.

Guideline Number: 875.2500

Study Title: Inhalation Exposure

Rationale for Requiring the Data

The post application inhalation exposure may be required if it is determined that the use of 

these products have the potential to release DMHMP during the product use conditions 

(e.g., painting).

Practical Utility of the Data

1. How will the data be used?

The post application inhalation exposure data will be used to assess the residential and/or 

occupational inhalation risks to estimate reentry exposure to painting. This data is needed to 

conduct an inhalation postapplication assessment

2. How could the data impact the Agency’s future decision-making?

The inhalation exposure data will be used to determine the accuracy of the post 

application inhalation risks to occupational bystanders. If risks warrant mitigation, the 

inhalation exposure data will provide the types of mitigation necessary such as respiratory 

protection from respirators or closed systems for commercial uses to potential removal of 

uses from the label.
Page 16 of 16

Guideline Number: 875.2900 

Data Requirement: Data Reporting and Calculations

Rationale for Requiring the Data

For all exposure studies, these data are needed occupationally and in the residential setting to 

facilitate the review of the data. 

Practical Utility of the Data

1. How will the data be used? 

The study report and all raw data/calculations will be reviewed for the adequacy of the data. 

2. How could the data impact the Agency’s future decision-making?

The data are needed to define and interpret the inhalation and dermal exposure data collected. 

This data need is triggered any time an exposure study is conducted. It would aid the Agency to 

make accurate interpretations of the studies to develop an accurate and refined risk 

assessment and refined mitigation.