**EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS**

**PUBLISHED IN THE FEDERAL REGISTER**
**EPA Registration Division contact: [**  **Dr. 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**
**[Joint Inerts Task Force, Cluster Support Team 8 (JITF CST8)**  **]**
**[ 2E8087**  **]**
EPA has received a pesticide petition **[ 2E8087**  **]** from **[ Joint**  **Inerts Task Force, Cluster Support Team 8, EPA Company Number 84942 ]**  **, [c/o**  **Huntsman Corp., 8600 Gosling Rd., The Woodlands, TX 77381 ]**  proposing, pursuant to section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 4 0 CFR part 180.

To amend existing exemption s from the requirement of a tolerance **[ by adding Chemical**  **Abstracts Service Registry Numbers (CASRNs) for pre**  **- harvest use on agricultural crops under**  **40 CFR §180.920 and when applied to animals under 40 CFR §180 .930 for the following**  **two chemistry descriptors that are used as surfactants: 1:**  **dimethylaminopropylamine,**2

**isopropylamine, ethanolamine** **, and triethanolamine salts of alkyl (C 8** **- C**  **24 ) benzenesulfonic acid**  **(without limits):**

**CAS RN**  **D imethylaminopropylamine,**  **isopropylamine, ethanolamine, and**

**triethanolamine salts of alkyl (C8 -**  **C24) benzenesulfonic acid**
**12068 -**  **12 -**  **1 Benzenesulfonic acid, dodecyl**  **- , compd. with N,N**  **- dimethyl**  **- 1,3**  **- propanediamine (1:1)** 
**121617 -** **08 -**  **1 Benzenesulfonic acid, 4**  **- C10**  **- 13**  **- sec**  **- alkyl derivs., compds. with**  **triethanolamine 193562**  **- 36**  **- 6**  **Benzenesulfonic acid, C16 -**  **24 -**  **alkyl derivs., compds. with ethanolamine (1:1) 26836**  **- 07**  **- 7**  **Benzenesulfonic acid, dodecyl -** **, compd. with 2 -**  **aminoethanol (1:1)**
**3088 -**  **30 -** **0 p**  **- dodecylbenzenesulphonic acid, compound with 2,2',2''**  **- nitrilotriethanol**  **(1:1) 58089**  **- 99**  **- 9**  **Benzenesulfonic acid, 4 -**  **dodecyl -** **, compd. with 2 -**  **aminoethanol (1:1) 61886**  **- 59**  **- 7**  **Benzenesulfonic acid, tridecyl -** **, compd. with 2,2',2'' -**  **nitrilotris[ethanol] (1:1) 61931**  **- 76**  **- 8**  **Benzenesulfonic acid, undecyl -** **, compd. with 2,2',2'' -**  **nitrilotris[ethanol] (1:1)**
**67924 -**  **05 -** **4 Benzenesulfonic acid, 4**  **- dodecyl**  **- , compd. with 2,2',2''**  **- nitrilotris[ethanol]**  **homopolymer 68110**  **- 32**  **- 7**  **Benzenesulfonic acid, 3 -**  **dodecyl -** **, compd. with 2 -**  **amino ethanol (1:1)**  **68259 -**  **35 -**  **8 Benzenesulfonic acid, undecyl**  **- , compd. with 2**  **- propanamine (1:1)**  **68442 -**  **72 -**  **8 Benzenesulfonic acid, dodecyl**  **- , reaction products with ethanolamine** 
**68567 -**  **69 -**  **1 Benzenesulfonic acid, 4**  **- sec**  **- dodecyl**  **- , compd. with**  **2,2',2'' -**  **nitrilotris[ethanol] (1:1) 68815**  **- 30**  **- 5**  **Benzenesulfonic acid, decyl -** **, branched, compds. with triethanolamine 68815**  **- 35**  **- 0**  **Benzenesulfonic acid, tetradecyl -** **, branched, compds. with triethanolamine 68953**  **- 98**  **- 0**  **Benzenesulfonic acid, dodecyl -** **, branched, compds. with ethanolamine**  **70528 -**  **84 -**  **6 Benzenesulfonic acid, dodecyl**  **- , branched, compds. with triethanolamine**  **72391 -**  **21 -**  **0 Benzenesulfonic acid, 4**  **- [2,4,4**  **- trimethyl**  **- 1**  **- (2**  **- methylpropyl)pentyl]**  **- , compd.** 3
**CAS RN**  **D imethylaminopropylamine,**  **isopropylamine, ethanolamine, and**

**triethanolamine salts of alkyl (C8 -**  **C24) benzenesulfonic acid with 2**  **- aminoethanol (1:1)** 
**84961 -**  **74 -**  **0 Benzenesulfonic**  **acid, 4 -**  **C10 -**  **13 -**  **sec -**  **alkyl derivs., compds. with 2 -**  **propanamine**
**85480 -**  **55 -**  **3 Benzenesulfonic acid, mono**  **- C10**  **- 13**  **- alkyl derivs., compds. with**  **ethanolamine**
**85480 -**  **56 -** **4 Benzenesulfonic acid, mono**  **- C10**  **- 13**  **- alkyl derivs., compds. with**  **triethanolamine 85995**  **- 82**  **- 0**  **Benzen esulfonic acid, 4**  **- C10**  **- 14**  **- alkyl derivs., compds. with ethanolamine** 
**90194 -**  **54 -**  **0 Benzenesulfonic acid, mono**  **- C10**  **- 13**  **- branched alkyl derivs., compds. with 2**  **- propanamine** 
**90194 -**  **55 -**  **1 Benzenesulfonic acid, mono**  **- C10**  **- 13**  **- branched alkyl derivs., compds. with**  **triethanolamine**
**90218 -**  **09 -**  **0 Benzenesulfonic acid, mono**  **- C8**  **- 24**  **- branched and linear alkyl derivs.,**  **compds. with ethanolamine**
**90218 -**  **11 -** **4 Benzenesulfonic acid, mono**  **- C16**  **- 24**  **- branched and lin**  **ear alkyl derivs., compds. with 2**  **- propanamine** 
**96687 -**  **54 -**  **6 tetrapropylenebenzenesulphonic acid, compound with 2,2',2''**  **- nitrilotriethanol (1:1)** 
**99924 -** **49 -**  **9 Benzenesulfonic acid, mono**  **- C10**  **- 14**  **- alkyl derivs., compds. with**  **ethanolamine**
**and 2: diethanolamine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid ( Not to exceed 7% of**  **pesticide formulation ):** 
**CAS RN**  **Diethanolamine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid 67815**  **- 95**  **- 6**  **Benzenesulfonic acid, 4 -**  **dodecyl -** **, compd. with 2,2' -**  **iminobis[ethanol] (1:1) 67889**  **- 94**  **- 5**  **Benzenesulfonic acid, isoundecyl -** **, compd. with 2,2' -**  **iminobis[ethanol] (1:1) 67889**  **- 95**  **- 6**  **Benzenesulfonic acid, isodecyl -** **, compd. with 2,2' -**  **iminobis[ethanol] (1:1)**4 **CAS RN**  **Diethanolamine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid 68259**  **- 34**  **- 7**  **Benzenesulfonic acid, undecyl -** **, compd. with 2,2' -**  **iminobis[ethanol] (1:1)**  **68478 -** **47 -**  **7 Benzenesulfonic acid, dodecyl**  **- , reaction products with diethanolamine** 
**68567 -**  **68 -**  **0 Benzenesulfonic acid, 4**  **- sec**  **- dodecyl**  **- , compd. with 2,2'**  **- iminobis[ethanol]**  **(1:1) 68815**  **- 34**  **- 9**  **Benzenesulfonic acid, tetradecyl -** **, branched, compds. with diethan olamine**  **68815 -**  **37 -**  **2 Benzenesulfonic acid, tridecyl**  **- , branched, compds. with diethanolamine** 
**68891 -**  **02 -**  **1 Benzenesulfonic acid, mono**  **- C10**  **- 16**  **- alkyl derivs., compds. with**  **diethanolamine**
**84989 -**  **15 -**  **1 Benzenesulfonic acid, 4**  **- C10**  **- 13**  **- sec**  **- alkyl derivs., compds. with**  **diethanolamine 85338**  **- 09**  **- 6**  **Benzenesulfonic acid, 4 -**  **C10 -**  **14 -**  **alkyl derivs., compds. with diethanolamine**
**90194 -**  **39 -**  **1 Benzenesulfonic acid, mono**  **- C10**  **- 13**  **- alkyl derivs., compds. with**  **diethanolamine**
**90194 -** **40 -** **4 Benzenesulfonic acid, mono**  **- C10**  **- 14**  **- alkyl derivs., compds. with**  **diethanolamine**
**90218 -**  **08 -**  **9 Benzenesulfonic acid, mono**  **- C8**  **- 24**  **- branched and linear alkyl derivs.,**  **compds. with diethanolamine**

in or on all the raw agricultural commodit ies. **Prior to the submission of this petition**  **to add missing CASRNs, Pesticide**  **Petition 8E7472 (Document ID EPA -**  **HQ -**  **OPP -**  **2008 -** **0889) was**  **submitted to the Agency and these CASRNs were missing from the petition. JITF CST8 is**  **relying on the information submitted in 8E7472 to support this petition which includes the**  **exact same chemistry of Alkylbenzene Sulfonates. JITF CST8 does not expect the addition of these CASRNs to result in additional exposure or risk.**  EPA has determined that the petition contains data or information regarding the elements set forth in section 408 (d)(2) of F F DCA; 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 Chemistry5

1. Plant metabolism. **[NA -**  **Remove based on the fact that this information is not required for the establishment of a tolerance exemption.]** 

2. Analytical method. **[NA -**  **Remove based on the fact that this information is not**  **required for the establishment of a tolerance exemption.]**

3. Magnitude of residues. **[NA -**  **Remove based on the fact that this information is not required for the establishment of a tolerance exemption**  . **]**
B. Toxicological Profile

1. Acute toxicity. **[Published data indicate that the parent acid of**  **Alkylbenzene Sulfonates**  **is not highly acutely toxic (EPA Categories III -**  **IV), is irritating to the eye and skin, and is a weak** **- moderate skin sensitizer and that the parent amine counter ions are acute**  **toxicit y EPA category II**  **- IV. Dermal toxicity EPA Category II.]** 

2. Genotoxicty. **[ Both**  **in vitro and**  **in vivo genotoxicity data show that Alkylbenzene**  **Sulfonates are not toxic to the gene or the chromosome** . **The Amine counter ions are also not mutagen**  **i c**  **.]**

3. Reproductive and developmental toxicity. **[ One representative compound for the**  **group of chemicals requested in 8E7472 (and 2E8087) is CASRN 26264 -** **05 -**  **1, the isopropylamine salt of dodecylbenzenesulfonic acid.**  **OECD 422 testing for CAS**  **RN 26264 -**  **05 -**  **1 indicates no reproductive effects and**  **no evidence of malformations in the developing offspring.**  **The NOEL for reproduction and developmental toxicity was 320 mg/kg/day, the highest dose tested**  **. ]**  4. Subchronic toxicity. **[No compound specific subchronic tox icology data are available**  **for these**  **Alkylbenzene Sulfonates .**  **Additionally, a search of the public literature did not reveal any available data.**  **However following repeated oral administration in an OECD 422 Combined Repeated Dose Toxicity Study with a Rep**  **roduction/Developmental Toxicity Screening Test**  **(i.e., at least 42 days in male rats and approximately 42 -** **44 days in female rats)**6

**for CASRN 26264**  **- 05**  **- 1** **, a systemic NOAEL of 80 mg/kg/day was identified , and a**  **NOEL for reproduction and developmental toxicity was 320 mg/kg/day, the highest dose tested**  **. ]** 

5. Chronic toxicity **[ Data reviewed by EPA for Alkylbenzene Sulfonates indicate that**  **they are not likely to be carcinogenic. ]** 

6. Animal metabolism. **[ The**  **amine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid rapidly**  **dissociate in vivo**  **aqueous solutions to form an alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid and a**  **counter ion amine (dimethylaminopropylamine, isopropylamine, mono**  **- , di**  **- , and**  **triethanolamine) . The two entitie**  **s would be absorbed and metabolized independently. The alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid should be readily conjugated and rapidly excreted with very**  **little alkyl aromatic chain degradation (EPA, 2006). The amine counter ions should undergo either: primar** **y, secondary, or tertiary amine metabolism, followed by excretion (Bury, 1998). ]** 

7. Metabolite toxicology . **[No metabolites of toxicological concern are expected based on the proposed animal metabolic pathway.]** 

8. Endocrine disruption . **[ The**  [ **amine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono**  **- , di**  **- , and triethanolamine) ,**  **additionally alkyl**  **(C 8** **- C**  **24 )**  **benzene sulfonic acids and the amines supported by CST8, do not belong to a class of chemicals known or susp**  **ected of having adverse effects on the estrogen receptor or endocrine system. An**  **amine salt, CASRN 26264 -**  **05 -**  **1: Benzenesulfonic acid, dodecyl -** **, compound with 2**  **- propanamine (1:1) of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid and amines have**  **been evaluated in acute , subchronic, developmental and reproductive studies capable of**  **detecting effects on endocrine mediated events. ]**  C. Aggregate Exposure

1. Dietary exposure. **[An assessment based on the EPA Inert’s Branch screening -**  **level dietary exposure model I**  **- DEEM**  **wa s**  **provided in the previously submitted Petition**  **PP 8E7472 (Document ID EPA** **- HQ** **- OPP**  **- 2008**  **- 0889)**  **. I -**  **DEEM uses a screening level dietary assessment of 57 of the most “significant” active ingredients as surrogates for inerts within the Dietary**  **Exposure Evaluation Model software with the Food Commodity Intake Database (DEEM**  **** **FCIDTM, Version 2.14). Exposure from food, animal commodities and drinking water are**7

**covered. Children 1 -**  **2 years old are found to be the most highly exposed subpopulation, with an estimated exp**  **osure of 0.425 mg/kg/day for drinking water and food. Formulated products are assumed to consist of 50% inert ingredients, and I**  **- DEEM exposures can be scaled based on**  **proposed limits in specific formulations.**
**Based on the low acute toxicity, no acute reference dose is established. The JITF recommends**  **that the FQPA safety factor can be reduced from 10X to 1X (see below). Based on a NOAEL of 80 mg/kg bw/day from the OECD 422 study with UF=100, a cRfD of 0.8 mg/kg/day = cPAD**  **(chronic population adjusted dose) is proposed.**  **The CST8 supported amine salts of alkyl (C 8** **- C**  **24 ) benzenesulfonic acids (dimethylaminopropylamine, isopropylamine, mono** **- , di**  **- , and**  **triethanolamine) are used primarily as surfactants in a variety of pesticide product**  **formulations typica**  **lly used in agriculture, but they are not typically formulated in pesticide products intended for use near residences. In agricultural products, these compounds are**  **included in formulated products at levels significantly lower than the 50% assumed by the I**  **** **DEEM screening level default model. Estimated dietary (food plus drinking water) exposures account for 15.3% of the**  **proposed chronic reference dose for the general population and 53.1% for the most exposed population, children aged 1**  **- 2 years.**  **Thus, sinc e less than the full chronic reference dose is used by dietary exposure, there is**  **additional room that is deemed adequate to cover any other aggregate exposures from non**   ** dietary pre** **- harvest and animal uses. The JITF**  **CST8 thus asserts that the** [ **amine salts of alkyl**  **(C 8** **- C**  **24 ) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono** **- , di**  **- , and**  **triethanolamine) s, as described in FR Notice Vol. 71 No. 153 p. 45422 § 180.920 [Amended], k and p. 45422**  **- 3 § 180.930 [Amended], f are supported by the pu**  **blished alkyl (C 8** **- C**  **24 )**  **benzenesulfonic acid and amines (dimethylaminopropylamine, isopropylamine, mono -**  **, di -**  **, and triethanolamine)**  **t oxicology, other data and newly conducted**  **CASRN 26264 -**  **05 -**  **1 OECD**  **422 study data and risk assessment.**8

**Chronic Dietary Safe ty 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**  **OECD 422 Combined Repeated**  **Dose Toxicity Study with a Reproduction/Developmental**  **Toxicity Screening Test**  **in Rats -**  **CASRN 26264 -**  **05 -**  **1. 80**  **0.8 53%**  **15%**

**Note: 1**  **NOAEL –**  **No observed adverse effect level**
**2 cPAD**  **– Chronic population adjusted dose, defined as: chronic NOAEL / (safety factor**   **FQPA factor)**  **]**

i. Food. **[ The dietary (food plus drinking water) exposures for**  **Alkylbenzene Sulfonates are expressed as a percentage of the proposed cPAD.**  **Chronic Safety Assessment, % cPAD for**  **the general U.S. population and children 1 -**  **2 years old, the subpopulation with the highes t**  **potential exposures. Based on I -**  **DEEM screening level calculations, the chronic dietary exposures are estimated to be 15% of the proposed cPAD for the general U.S. population and**  **53% of the cPAD for children 1 -**  **2 years old. These data demonstrate that th e I**  **- DEEM**  **screening -**  **level chronic dietary (food and drinking water) exposures are below 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.]** 

2. Non - dietary exposure . **[ Amine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono**  **- , di**  **- , and triethanolamine)**  **are used primarily as surfactant**  **s in pesticide formulations in 40 CFR §180.92**  **0 pre -**  **harvest applications to raw agricultural commodities and 40 CFR §180.930 animal applications.]** 9

D. Cumulative Effects
**[For the compounds included in CST8, EPA has not made a common mechanism finding. It is therefore appropriate to consider only**  **the potential risks of the compounds included in CST8 in the exposure assessment.]** 
E. Safety Determination

1. U.S. population. **[The JITF CST8 conducted a risk assessment using current EPA I**   ** DEEM methodology. The results of the risk assessment were acce** **ptable exposures for the use of CST8 compounds. Based on the chronic dietary exposure assessment, the**  **cPAD** s **calculated for the U.S. population were 15% (chronic).]** 

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**  **reliab le 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 use**  **of amine salts of**  **alkyl (C 8** **- C**  **24 ) benz**  **enesulfonic acid (dimethylaminopropylamine, isopropylamine, mono -**  **, di -**  **, and triethanolamine)**  **in pesticide formulations has been performed, and the JITF CST8**  **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, mutagenicity, reproduction, and developmental toxicity data for the amine counter ions comprising CST8 supported**  **surfactants.**  **OECD 422 tes ting for**  **CASRN 26264 -**  **05 -**  **1 indicates 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, subacute or reproduction studies for the amine counter ions compr**  **ising CST8 supported compounds**   **There is no evidence of endocrine disruption for CASRN 26264 -**  **05 -**  **1 and for the amine**  **counter ions comprising CST8 supported compounds. ]** 10

F. International Tolerances **[ There are no known international tolerances for**  **amine salts of alkyl (C**  **8 -**  **C 24**  **) benzenesulfonic acid (dimethylaminopropylamine, isopropylamine, mono** **- , di**  **- , and**  **triethanolamine). ]**