### 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 re place the instructions that appear in**  **green , i.e., “**  **[ insert**  **company name ]**  **,” with the information specific to your action. TEMPLATE:**  **Baker Petrolite LLC I** **N -**  **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 CF R 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 requir ed 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 LD**  **50 values ranging**  **from 544 mg/kg to > 25,000 mg/kg. Undiluted A** **AA 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 C**  **14 -**  **15 EO**  **7 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 C**  **9 -**  **11 EO**  **6 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 47**  **0 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 Screen ing 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 Screeni ng 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 fo**  **r 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 s**  **urfactant 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 co ncert**  **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 sim ilar**  **oxidation reactions to their corresponding carboxylic acid, which then undergoes**  **me tabolism 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 recep tor 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 chroni c 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) exposur es 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 prop osed 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 NOAEL**  **1** 

### mg/kg **bw/day cPAD**  **2**

**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:**  **1 NOAEL** 

**– 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**  **fo rmulations 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 fo**  **r 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**  **l evel**  **m ethodology (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**  **fa ctor**  **may be**  **reduced or**  **removed. An**  **evaluation of**  **susc eptibility**  **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**  **s ubstantial**  **and scientifically**  **so und**  **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**  **w ere 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 clas s 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 endo**  **crine 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 Alkoxy lates.]**