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EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR PESTICIDE PETITIONS
PUBLISHED IN THE FEDERAL REGISTER

EPA Registration Division contact : [Donald Leming 816-510-5231 (alternate 931-231- 7900)]

TEMPLATE:

Lamberti USA Inc.

Company Number: 86861

EPA has received a pesticide petition IN-10675 from Lamberti USA Inc, 161 Washington St., Conshohocken, PA 19428 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.

2. to establish an exemption from the requirement of a tolerance for

[40CFR§ 180.910 Alkyl polyglucoside esters (AGEs) group, formed by DGlucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy- 1,2,,3-propanetricarboxylate), 1- (C 8 -C 20 linear and branched alkyl) ethers, sodium salts (C AS No. 1079993-97-7); DGlucopyranose, oligomeric, 6-(hydrogen sulfobutaned ioate), 1-(C 8 -C 20 linear and branched alkyl) ethers, sodium salts (CAS No. 10799 93-92-2); D-Glucopyranose, oligomeric, Propanoic acid, 2-hydroxy-, 1-(C 8 -C 20 linear and branched alkyl) ethers (CAS No. 1079993-94-4);

in or on the raw agricultural commodity [ in primarily herbicide formulations, but also fungicides, insecticides and plant growth regulator s as an inert ingredient to reduce water-surface tension] . EPA has determined that the petition contains da ta or information regarding the elements set forth in sec tion 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. Additio nal data may be needed before EPA rules on the petition.Page 2 of 5 2

A. Residue Chemistry

1. Plant metabolism. . [No plant metabolism studies have been submitted i n support of this petition since an exemption from th e requirement of a tolerance is being requested. Based on available physicochemical data (measured and calculated) it is anticipated that AGEs will degrade rapidly an d result in no appreciable crop residues]

2. Analytical method. [ No analytical method is needed because requirements for an analytical method are not applicable to a re quest to establish an exemption from the requirement of a tolerance]

.

3. Magnitude of residues. [ Not Applicable]

B. Toxicological Profile

1. Acute toxicity. [ Based on acute oral data are available for read across substances correlated with for Alkyl polyglucoside esters (AGEs) in this category the acute Toxicity for oral route is defined in LD 50 >5,000(mg/kg-bw) taking in account the result of Acute Oral Toxicity study on three surrog ate chemicals: D-Glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetr icarboxylate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-51-2), D-Gluc opyranose, oligomeric, 6- (hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethe rs, sodium salts (CAS No. 151911- 53-4) and D-Glucopyranose, oligomeric, 6-[hydrogen (2R,3R)-2,3- dihydroxybutanedioate], 1-(coco alkyl) ethers, sodi um salts (CAS No. 151911-52-3). Surrogate chemicals are considered acceptable in re ad across approach becasue the their carbon chain lengths are in the range C 8 -C 20 and they are the same sulfosuccinate or carboxylate esters. No data are available for a cute inhalation studies. The commercial materials are liquids and will not be ae rosolized until they are sprayed in a final, very dilute spray solution. At this point th e concentration is minimal and the AGEs are not expected to pose an inhalation danger as applied using good agricultural field practices. The acute toxicity of these substa nces is low]

2. Genotoxicty. [ Mutagenicity data are available for read across sub stances correlated with Alkyl polyglucoside esters (AGEs) i n this category. In three different Bacterial Reverse Mutation Test assays performed o n D-Glucopyranose, oligomeric, 6- (dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-51-2), D-Glucopyranose, olig omeric, 6-(hydrogen 2- sulfobutanedioate), 1-(coco alkyl) ethers, sodium s alts (CAS No. 151911-53-4) and D-Page 3 of 5 3

Glucopyranose, oligomeric, 6-[hydrogen (2R,3R)-2,3- dihydroxybutanedioate], 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-52-3) n o mutagen effects were detected.]

3. Reproductive and developmental toxicity. [ Based on available data obtained on surrogate substance (C9-11) alkyl polyglycosides solfosuccinate sodium salts (CAS No. 1228577-41-0) in a Combined Repeated Dose Oral Tox icity Study with the Reproduction / Developmental Toxicity Screening Tes t in Wistar Rats (OECD 422), the NOAEL Oral P and F1 generation is 1000 mg/kg-bw/day Alkylpolyglucoside esters (AGEs)

. Surrogate chemical is considered acceptable in read across approach becasue the chemical physical properties of the AlkylpolyGlucos ide Esters are very similar for the different chain lengths in the range C 8 -C 20 , the Alkylpoliglucoside is the first degradation product in the biodegradation pathway o f the AlkylpolyGlucoside Esters and the toxicity data of the Alkyl polyGlucoside ar e very similar for the different chain lengths in the range C 8 -C 20 and the Alkylpolyglucoside Sulfosuccinate appears the more critical one for health effects in comparison with other Alkylpolyglucoside Esters]

4. Subchronic toxicity. [Based on available data obtained on surrogate substance (C9-11) alkyl polyglycosides solfosuccinate sodium salts (CAS No. 1228577- 41-0) in a Combined Repeated Dose Oral Toxicity St udy with the Reproduction / Developmental Toxicity Screening Test in Wistar Rat s (OECD 422), the NOAEL Oral
systemic is 1000 mg/kg-bw/day Alkylpolyglucoside esters (AGEs)

. Surrogate chemical is considered acceptable in read across approach becas ue the chemical physical properties of the AlkylpolyGlucoside Esters are ver y similar for the different chain lengths in the range C 8 -C 20 , the Alkylpoliglucoside is the first degradation p roduct in the biodegradation pathway of the AlkylpolyGlucosid e Esters and the toxicity data of the AlkylpolyGlucoside are very similar for the dif ferent chain lengths in the range C 8 - C 20 and the Alkylpolyglucoside Sulfosuccinate appears the more critical one for health effects in comparison with other Alkylpolyglucoside Esters]

5. Chronic toxicity. [ No chronic/oncogenicity studies are submitted for t hese category members. However, information based on the metabolites of these category members (alkylpolyglucosides and organic acids) do n’t show significant toxicity at chronic levels]

6. Animal metabolism. [In the Alkylglycosides the β-glycosidic bond was rapidly hydrolyzed in intestine and liver. The cleavage pro ducts, sugars and long-chain alcohols, entered the pathways of lipid and carbohy drate metabolism. .]Page 4 of 5 4

7. Metabolite toxicology

. [The cleavage products are sugars and long-chain alcohols, with very low toxicity .]

8. Endocrine disruption

. [Not predicted any endocrine disruption effects.]

C. Aggregate Exposure

1. Dietary exposure. [Based on model based on predicted use the final di etary exposure is considered very low]

i. Food. [Based on model based on predicted use the final di etary food exposure is = 3.39E-04 mg/kg-bw/day.]

ii. Drinking water. [Based on model based on predicted use the drinking water exposure is = 7,00E-06 mg/kg/day.]

2. Non-dietary exposure

. [Based on model based on predicted use the nondietary exposure is considered very low.]

D. Cumulative Effects

[ From the results of the tests conducted on AGEs as a class and from testing the main degradation products, no evidence of any s pecific target organ toxicity has
been observed. There is no evidence of a common mec hanism of toxicity compared to any other substance. There is no reason to expect that the use of alkyl polyglucoside (coco) tartrate ester or other AGEs will contribute to any cumulative toxicity ]

E. Safety Determination

1. U.S. population. [The results of the acute, genotoxic, subacute and developmental toxicity studies conducted on AGEs or similar chemicals indicate a relatively low order of toxicity. A similar AGE est er and structurally similar alkyl glucopyranosides currently exempted from the requir ement of a tolerance, also appear on EPA's List 4B Inert List, and in Inert I ngredients Permitted for Use in Nonfood Use Pesticide Products Last Updated January 27, 2009. Therefore, due to the low order of toxicity of AGEs and the lack of known adverse human health effects associated with this class of chemicals, the exempt ion from the requirement of a tolerance on growing crops only is not expected to result in any new, or adverse effects to human health or the environment..]Page 5 of 5 5

2. Infants and children

. [ Exposure to AGEs to infants and children is not expected to occur. The substances will be used as a n inert ingredients at low levels on growing crops only, and any residual levels are exp ected to be insignificant and consistent with structurally similar alkyl glucopyr anosides currently exempted from the requirement of a tolerance.]

F. International Tolerances

[ There are no known international tolerance for AGEs . Alkylpolyglucoside esters are present in EPA inert list and are regist rered under TSCA.]