EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [P.V. Shah, 703-308-1846]

INSTRUCTIONS: Please utilize this outline in preparing the pesticide petition. In 

cases where the outline element does not apply, please insert “NA-Remove” and 

maintain the outline. Please do not change the margins, font, or format in your 

pesticide petition. Simply replace the instructions that appear in green, i.e., “[insert 

company name],” with the information specific to your action.

TEMPLATE:

Baker Petrolite LLC

IN-10889

EPA has received a pesticide petition ([N-10889) from Baker Petrolite LLC, 

(12645 West Airport Boulevard, Sugar Land, TX 77478) proposing, pursuant to 

section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 

346a(d), to amend 40 CFR part 180.910, 40 CFR part 180.920, 40 CFR part 180.930,

40 CFR part 180.940(a), and 40 CFR part 180.960 to establish an exemption from the 

requirement of a tolerance for Alcohols, C>14, ethoxylated with CAS Number 

251553-55-6 in or on growing crops or to the raw agricultural commodity and to 

animals. EPA has determined that the petition contains data or information regarding 

the elements set forth in section 408 (d)(2) of FDDCA; however, EPA has not fully

evaluated the sufficiency of the submitted data at this time or whether the data supports 

granting of the petition. Additional data may be needed before EPA rules on the 

petition.

A. Residue Chemistry

1. Plant metabolism. [Not applicable/Not required for the establishment of a 

tolerance exemption for inert ingredients.]

2. Analytical method. [Not applicable/Not required for the establishment of a 

tolerance exemption for inert ingredients.]

3. Magnitude of residues. [There is no specific crop residue information available 

for AAA and this information is typically neither available nor required for the 

establishment of a tolerance exemption for inert ingredients.]

B. Toxicological Profile

1. Acute toxicity. [Human exposure from the use of AAAs as pesticide inert 

ingredients will primarily occur via the oral route through the consumption of food or 
2

drinking water. As a class AAA surfactants are not volatile. Thus, post-application 

inhalation exposure is unlikely. The AAAs show low to moderate acute toxicity by the 

oral route of exposure and the limited data available for dermal exposure also indicate 

low to moderate toxicity, especially for the diluted formulations. Irritation has been 

reported in animal laboratory studies. The AAAs did not cause skin sensitization when 

they were tested as diluted formulations. The acute oral LD50 values for rats range from 

600 mg/kg to 10,000 mg/kg (HERA 2007). Talmage (1994) reported LD50 values ranging 

from 544 mg/kg to > 25,000 mg/kg. Undiluted AAA compounds can be moderate to 

severe irritants to the skin; diluted products are not of concern and not expected to be 

irritating to the skin.]

2. Genotoxicty. [AAAs were not genotoxic or mutagenic in bacterial or mammalian in 

vitro cell systems (HERA 2007). Neither IARC, NTP nor OSHA listed AAA surfactants 

as a carcinogen.]

3. Reproductive and developmental toxicity. [Two AAA literature reviews (HERA 

2007, Talmage 1994) show that reproductive/developmental studies with oral exposure for 

C14-15EO7 with relatively low toxicity reported NOELs of 250 mg/kg/day for 

reproduction and 50 mg/kg/day for maternal toxicity. A dermal exposure 

reproductive study with C9-11EO6 also reported a low toxicity NOAEL of 250 

mg/kg/day for both reproductive and systemic toxicity.

OECD 421 Reproduction/Developmental Toxicity Screening Test of Secondary 

Alcohol Ethoxylate (CAS RN 84133-50-6) shows the reproductive/developmental 

NOEL is greater than 470 mg/kg/day as no effects on mating and fertility as well as 

on Fl generation up to day 4 post partum were observed at the highest dosage tested.

OECD 422 Oral (Gavage) Combined Repeated Dose Toxicity Study with a 

Reproduction/Developmental Toxicity Screening Test of CAS RN 9004-98-2 shows 

the NOEL for reproduction and developmental toxicity was 242 mg/kg/day, the 

highest dose tested.

OECD 4220ra1 (Gavage) Combined Repeated Dose Toxicity Study with a 

Reproduction/Developmental Toxicity Screening Test of CAS RN 103818-93-5 shows 

the NOEL for reproduction and developmental toxicity was 300 mg/kg/day, the highest 

dosage level tested.]

4. Subchronic toxicity. [Based on the Federal Register Notice (August 9, 2006, 

Volume 71, Number 153, pages 45415-45424), the Agency stated that the preferred test 

for repeat-dose toxicity is the "Combined Repeated Dose Toxicity Study with the 

Reproduction/Developmental Toxicity Screening Test (OECD Test Guideline 422)." 

AAAs (CAS RN 9004-98-2, and CAS RN 103818-93-5) have been tested in repeat 

dose studies (OECD 422 Combined Repeated Dose Toxicity Study with a 

Reproduction/Developmental Toxicity Screening Test) and an OECD 421 Oral 

(Gavage) Reproduction/Developmental Toxicity Screening Test of Secondary Alcohol 

Ethoxylate was conducted with CAS RN 84133-50-6. The paternal and maternal 

NOAEL for CAS RN 84133-50-6 was 60 mg/kg/day. The paternal and maternal 

NOAEL for CAS RN 9004-98-2 was 110 mg/kg/day. The paternal and maternal NOAEL 

for CAS RN 103818-93-5 was 48 mg/kg/day.]
3

5. Chronic toxicity. Based on the Federal Register Notice (August 9, 2006, 

Volume 71, Number 153, pages 45415-45424), the Agency stated that the 

preferred test for repeat-dose toxicity is the "Combined Repeated Dose Toxicity 

Study with the Reproduction/Developmental Toxicity Screening Test (OECD 

Test Guideline 422)."

Chronic dietary studies with rats showed no incidence of cancer and no effects at the 

concentrations tested (lowest dose tested was ca 50 mg/kg/day).]

6. Animal metabolism. [The metabolism of the AAA surfactant initially occurs by 

hydrolysis of the ether linkage to the corresponding long chain alkyl alcohol and 

polyalkoxylate, which subsequently undergo oxidative degradation and/or excretion. 

The higher molecular weight substances and highly polar (highly polyalkoxylated) AAA 

surfactants are not readily absorbed and metabolized.

Various oxidative pathways for aliphatic alcohol metabolism would work in concert 

with each other. Linear saturated and unsaturated alcohols are oxidized successively to 

their corresponding aldehydes and carboxylic acids, which then enter the fatty acid 

beta-oxidation pathway. Branched-chain aliphatic alcohols are converted by similar 

oxidation reactions to their corresponding carboxylic acid, which then undergoes 

metabolism via beta-oxidation and cleavage to yield carbon dioxide in the amino acid 

pathways, the fatty acid pathways, and the tricarboxylic acid pathways. Alternatively, 

alcohols having steric hindrance could undergo beta and gamma oxidative pathways 

and/or conjugation elimination pathways. 

7. Metabolite toxicology. [No metabolites of toxicological concern are expected based on 

the proposed animal metabolic pathway.]

8. Endocrine disruption. [The AAA surfactants do not belong to a class of chemicals 

known or suspected of having adverse effects on the estrogen receptor or endocrine 

system. AAAs have been evaluated in acute, repeated dose, developmental and 

reproductive studies capable of detecting effects on endocrine mediated events. The 

results of these studies did not give any indication of a treatment-related effect on the 

estrogen receptor or endocrine system.]

C. Aggregate Exposure

1. Dietary exposure. [The dietary (food plus drinking water) exposures for 

AAA surfactants are expressed as a percentage of the proposed chronic population 

adjusted dose (cPAD) for the general US population and children 1-2 years old, the 

subpopulation with the highest potential exposures.

Based on I-DEEM screening level calculations, the chronic dietary exposures for the 

AAA are estimated to be 25.4% of the cPAD for the general U.S. population and 

88.5% of the cPAD for children 1-2 years old.
4

These data demonstrate that the I-DEEM screening level chronic dietary (food 

and drinking water) exposures for both the AAAPD and AAASD are well below 100% 

of the cPAD, and are therefore below EPA's established level of concern for all U.S. 

subpopulations.

On the basis of the OECD 422 repeat dose toxicity study and comparison of 1-DEEM 

exposures to the proposed cPAD, the applicant asserts that there is sufficient basis for 

EPA to grant a tolerance exemption for AAA surfactants.

Chronic Dietary Safety Assessment, % cPAD

Study

Chronic 

Systemic

NOAEL1

mg/kg 

bw/day

cPAD2

mg/kg 

bw/day

Percent

cPAD 

Children 

1-2 years

of age

Percent

cPAD

U.S. Gen

Population

CASRN 103818-93-5

Repeated Dose Toxicity 

with

Reproduction/Developmen 

tal Toxicity Screening in

48 0.48 88.5 25.4

Rats- (OECD 422) CRL

Study number UPU00006 

(Lech, J. 2009c)

Note:

1NOAEL – No observed adverse effect level

2

cPAD — Chronic population adjusted dose, defined as:

 chronic NOAEL / (safety factor x FQPA factor)]

i. Food. [The available data demonstrate that the I-DEEM screening level chronic 

dietary (food and drinking water) exposures are well below 100% of the cPAD, and are 

therefore below EPA's established level of concern for all U.S. subpopulations.]

ii. Drinking water. [Drinking water is included in the I-DEEM exposure

assessment. Exposure to AAA via drinking water is expected to be negligible.]

2. Non-dietary exposure. [AAA surfactants are used in agricultural 

formulations as well as in non-pesticidal uses such as personal care products. Given 

the low estimate of dietary exposure, there is ample room in the overall aggregate MOE 

for non-dietary uses.]

D. Cumulative Effects

[For the purpose of the tolerance exemption actions cited herein, the applicant

has assumed that the AAA will not have a common mechanism of toxicity with other 

surfactant substances. It is therefore appropriate to consider only the potential risks of the 

compounds included in CST 1 in the exposure assessment.]
5

E. Safety Determination

1. U.S. population.

[A dietary exposure assessment using current EPA inert screening level 

methodology (1-DEEM) was conducted. Based on the conservative I-DEEM 

dietary exposure estimates, there is a reasonable certainty that no harm will 

result to the US population from the aggregate exposure to AAA.]

2. Infants and children. 

[The FFDCA Section 408 requires an additional tenfold margin of safety for the 

protection of infants and children in case of threshold effects to account for prenatal 

and postnatal toxicity, and an inadequate toxicity database. Where an adequate and 

reliable database is available and there is a lack of evidence for increased 

susceptibility, the FQPA safety factor may be reduced or removed. An evaluation of 

susceptibility and uncertainty issues associated with the Alkyl Alcohol Alkoxylates has 

been performed, and the applicant recommends that the FQPA safety factor be 

reduced to 1X for the following reasons:

 The availability of a substantial and scientifically sound mammalian 

toxicology database that includes acute, subchronic and chronic repeat dose, 

reproduction, developmental and carcinogenicity toxicity data for the CST 1 

AAAs, including CAS RN 84133-50-6, CAS RN 9004-98-2 and CAS RN 

103818-93-5.

 OECD 421/422 testing of CAS RI' 84133-50-6, CAS RN 9004-98-2 and CAS 

RN 103818-93-5 indicate that there were no reproductive effects and no evidence 

of malformations in the developing offspring.

 There was no evidence of effects on the nervous system in the acute, repeat 

dose or reproduction studies for the CST 1 supported surfactants.

There is no evidence of endocrine disruption for the AAA surfactants. The AAA 

surfactants do not belong to a class of chemicals known or suspected of having adverse 

effects on the estrogen receptor or endocrine system. AAAs have been evaluated in acute, 

repeated dose (subchronic and chronic), developmental and reproductive studies capable 

of detecting effects on endocrine mediated events. The results of these studies did not 

give any indication of a treatment-related effect on the estrogen receptor or endocrine 

system.]

F. International Tolerances

[There are no known international tolerances for Alkyl Alcohol Alkoxylates.]