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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-

(C8-C20 linear and branched alkyl) ethers, sodium salts (CAS No. 1079993-97-7); DGlucopyranose, oligomeric, 6-(hydrogen sulfobutanedioate), 1-(C8-C20 linear and 

branched alkyl) ethers, sodium salts (CAS No. 1079993-92-2); D-Glucopyranose, 

oligomeric, Propanoic acid, 2-hydroxy-, 1-(C8-C20 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 regulators as an inert ingredient to reduce 

water-surface tension]. 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.
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A. Residue Chemistry 

 1. Plant metabolism. . [No plant metabolism studies have been submitted in 

support of this petition since an exemption from the requirement of a tolerance is 

being requested. Based on available physicochemical data (measured and calculated) 

it is anticipated that AGEs will degrade rapidly and 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 request 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 LD50 >5,000(mg/kg-bw) taking in account the 

result of Acute Oral Toxicity study on three surrogate chemicals: D-Glucopyranose, 

oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alkyl) 

ethers, sodium salts (CAS No. 151911-51-2), D-Glucopyranose, oligomeric, 6-

(hydrogen 2-sulfobutanedioate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-

53-4) and D-Glucopyranose, oligomeric, 6-[hydrogen (2R,3R)-2,3-

dihydroxybutanedioate], 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-52-3). 

Surrogate chemicals are considered acceptable in read across approach becasue the 

their carbon chain lengths are in the range C8-C20 and they are the same sulfosuccinate 

or carboxylate esters. No data are available for acute inhalation studies. The 

commercial materials are liquids and will not be aerosolized until they are sprayed in a 

final, very dilute spray solution. At this point the 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 substances is low] 

 2. Genotoxicty. [Mutagenicity data are available for read across substances 

correlated with Alkyl polyglucoside esters (AGEs) in this category. In three different 

Bacterial Reverse Mutation Test assays performed on D-Glucopyranose, oligomeric, 6-

(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alkyl) ethers, sodium 

salts (CAS No. 151911-51-2), D-Glucopyranose, oligomeric, 6-(hydrogen 2-

sulfobutanedioate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-53-4) and D-
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Glucopyranose, oligomeric, 6-[hydrogen (2R,3R)-2,3-dihydroxybutanedioate], 1-(coco 

alkyl) ethers, sodium salts (CAS No. 151911-52-3) no 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 Toxicity Study with the 

Reproduction / Developmental Toxicity Screening Test 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 AlkylpolyGlucoside Esters are very similar for the 

different chain lengths in the range C8-C20, the Alkylpoliglucoside is the first 

degradation product in the biodegradation pathway of the AlkylpolyGlucoside Esters 

and the toxicity data of the Alkyl polyGlucoside are very similar for the different chain 

lengths in the range C8-C20 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 Study with the Reproduction / 

Developmental Toxicity Screening Test in Wistar Rats (OECD 422), the NOAEL Oral 

systemic 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 AlkylpolyGlucoside Esters are very similar for the different chain 

lengths in the range C8-C20, the Alkylpoliglucoside is the first degradation product in 

the biodegradation pathway of the AlkylpolyGlucoside Esters and the toxicity data of 

the AlkylpolyGlucoside are very similar for the different chain lengths in the range C8-

C20 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 these 

category members. However, information based on the metabolites of these category 

members (alkylpolyglucosides and organic acids) don’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 products, sugars and long-chain 

alcohols, entered the pathways of lipid and carbohydrate metabolism..]
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 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 dietary 

exposure is considered very low]

 i. Food. [Based on model based on predicted use the final dietary 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 specific target organ toxicity has 

been observed. There is no evidence of a common mechanism 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 ester and structurally similar alkyl 

glucopyranosides currently exempted from the requirement of a tolerance, also 

appear on EPA's List 4B Inert List, and in Inert Ingredients 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 exemption 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..]
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 2. Infants and children. [Exposure to AGEs to infants and children is not 

expected to occur. The substances will be used as an inert ingredients at low levels on 

growing crops only, and any residual levels are expected to be insignificant and 

consistent with structurally similar alkyl glucopyranosides 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 registrered under TSCA.]