UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

 WASHINGTON, D.C. 20460 

OFFICE OF CHEMICAL SAFETY 

 AND POLLUTION PREVENTION 

 

March 17, 2015 

MEMORANDUM 

SUBJECT: PC Codes 911028, 911029, 911030: Alkyl (C8-C20) polyglucoside Esters (AGEs); 

Human Health Risk Assessment and Ecological Effects Assessment to Support 

Proposed Exemption from the Requirement of a Tolerance When Used as Inert 

Ingredients in Pesticide Formulations. 

All PC Code: 911028, 911029, 911030 DP Barcode: N/A

Decision No.: N/A Regulatory Action: Inert 

Tolerance Exemption; 40 

CFR 180.910 

Petition No: IN-10765 All CAS Nos: 1079993-

97-7, 1079993-92-2, 

1079993-94-4 

Inert Tracking No: 

 

FROM: 

 Jennifer Zielinski 

 Chemistry, Inerts and Toxicology Assessment Branch (CITAB) 

 Registration Division (7050P) 

Elizabeth Fertich 

 Invertebrate and Vertebrate Branch 1 

 Registration Division (7505P) 

Lisa Austin, Ph.D., Toxicologist

 Chemistry, Inerts and Toxicology Assessment Branch (CITAB) 

 Registration Division (7505P) 

THROUGH: Kerry Leifer, Team Leader 

 Chemistry, Inerts and Toxicology Assessment Branch (CITAB) 

 Registration Division (7505 P) 
Page 2 of 22

 

TO: Pv Shah, Ph.D., Branch Chief 

 Chemistry, Inerts and Toxicology Assessment Branch (CITAB) 

 Registration Division (7505P) 

Executive Summary 

On December 5, 2013, Lamberti USA Inc. submitted a petition (IN-10675) requesting an 

exemption from tolerance for residues for three substances collectively referred to as alkyl (C8-

C20) polyglucoside esters (AGEs) when used as inert ingredients (surfactants) in pesticide 

formulations applied pre- and post-harvest. The three AGEs are D-glucopyranose, oligomeric, 

6-(dihydrogen citrates), C8-20 branched and linear alkyl glycosides, sodium salts (CAS Reg. No. 

1079993-97-7); D-glucopyranose, oligomeric, 6-(hydrogen sulfosuccinates), C8-20 branched and 

linear alkyl glycosides, sodium salts (CAS Reg. No. 1079993-92-2); and D-glucopyranose, 

oligomeric, lactates, C8-20 branched and linear alkyl glycosides (CAS Reg. No. 1079993-94-4)

 

For the human health risk assessment and ecological effects assessment evaluation of the AGEs, 

since limited data are available on the AGEs, data on surrogate chemicals were considered, 

including other polyalkylglucoside ethers and polyalkylglucoside sulfosuccinates as well as 

metabolites lactic acid, citric acid and disodium sulfosuccinates. Lactic acid is exempted from 

tolerance under 40 CFR 180.910, 930 and 940 b,c. Citric acid is exempted from tolerance under 

40 CFR 180.950e. Disodium sulfosuccinates are exempted from tolerance under 40 CFR 

180.910 and 930. 

AGEs have low acute toxicity via the oral route (oral LD50 > 5,000 mg/kg). There is no available 

data regarding acute exposure via the dermal, eye or inhalation routes. 

In a combined repeated dose toxicity study with the reproduction/developmental toxicity 

screening test in rats there were no observed adverse effects for parental systemic or 

reproductive/developmental effects at 1000 mg/kg/day. 

A 2 year chronic oral study in rats treated with citric acid was available for review. Rats were 

administered 5% or 3% citric acid (approx. 2,000 or 1,200 mg/kg/d) in the diet. There were no 

adverse effects observed at 2,000 mg/kg/day. Chronic studies were also available for the rabbit 

and dog. There were no adverse effects observed in either study at doses up to 1500 and 1400 

mg/kg/day, respectively. 

Neurotoxicity studies with AGEs were not available for review. However, neurotoxicity was not 

observed in the OECD 422 study at concentrations as high as 1,000 mg/kg/day (limit dose). 
Page 3 of 22

Mutagenicity studies (Ames Test) were available for review for the surrogate chemicals, dglucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), l-(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) or dglucopyranose, oligomers, monosulfosuccinate, coco alkyl glycosides, sodium salts, dglucopyranose, oligomeric, 6-[hydrogen (2R,3R)-2,3-dihydroxybutanedioate), 1-( coco alkyl) 

ethers, sodium salts (CAS No. 151911-52-3). The results of these studies were negative. 

Studies on the metabolism of orally administered β-glucosides (metabolic cleavage of 

alkylglycosides) in mice show that rapid hydrolytic acetal cleavage takes place principally in the 

stomach and intestine of the mice. The cleavage products pass into the fatty acid and 

carbohydrate metabolic pathways. That assumption is also confirmed by another study on 

alkylglycosides where 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. 

The absence of toxicity is supported by studies in monographs and reports under World Health 

Organization (WHO), WHO Food Additives Series, and FAO Nutrition Meetings Reports on 

lactic acid and citric acid. Also, evidence of toxicity was not reported in peer reviewed studies in 

the Hazardous Substances Data Bank (HSDB). 

There was no hazard attributable to a single exposure seen in the toxicity database for AGEs. 

Therefore, AGEs are not expected to pose an acute risk. 

There was no endpoint of concern identified in toxicity studies up to 1,000 mg/kg/day. In 

addition, metabolism studies on alkylglycosides reported that 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. Based on the low acute toxicity, the body’s 

ability to rapidly metabolize the inert ingredient into expected metabolites that are normal 

constituents of the body, exempted as inert ingredients, and the lack of an endpoint of concern 

for repeat dose studies at the limit dose (1,000 mg/kg/day) a qualitative risk assessment was 

conducted. 

Dietary exposure to AGEs can occur from eating food treated with pesticide formulations 

containing this inert ingredient. Non-dietary exposure from the proposed use as inert ingredients 

(surfactants) in pesticide formulations applied pre- and post-harvest under 40 CFR 180.910 is not 

expected; however non-dietary exposure may occur from other approved uses of this chemical. 

Occupational exposure is also possible. However, the available data indicate that there are no 

adverse toxicological effects which occur at exposures less than 1,000 mg/kg bw/day, therefore a 

quantitative risk assessment is not conducted. 

AGEs are readily biodegradable, therefore it is not expected to persist in the environment. Also, 

potential to bioaccumulate is expected to be low/very low. 

Potential areas of environmental justice concerns, to the extent possible, were considered in this 

human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal Actions 
Page 4 of 22

to Address Environmental Justice in Minority Populations and Low-Income Populations," 

http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. 

Taking into consideration all available information on AGEs, EPA has determined that there is a 

reasonable certainty that no harm to any population subgroup will result from aggregate 

exposure to AGE when used as an inert ingredient in pesticide formulations applied during preand post-harvest when considering dietary exposure and all other nonoccupational sources of 

pesticide exposure for which there is reliable information. Therefore, the establishment of an 

exemption from tolerance under 40 CFR 180.910 for residues of AGEs (CAS Reg.Nos. 

1079993-97-7, 1079993-92-2, 1079993-94-4) when used as inert ingredients in pre- and postharvest applications in pesticide formulations, can be considered assessed as safe under section 

408(q) of the FFDCA. 

I. Background 

On December 5, 2013, Lamberti USA Inc. submitted a petition (IN-10675) requesting an 

exemption from tolerance for residues of AGEs when used as inert ingredients (surfactants) in 

pesticide formulations applied pre- and post-harvest. EPA published the Notice of Filing for this 

petition in the Federal Register on October 15, 2014 (79 FR 61844). One comment was received 

in response to this notice. The comment received was from a private citizen who opposed any 

pesticide product that leaves a residue above 0.00. The Agency understands the commenter's 

concerns and recognizes that some individuals believe that no residue of pesticides should be 

allowed. However, under the existing legal framework provided by FFDCA section 408, EPA is 

authorized to establish pesticide tolerances or exemptions where persons seeking such tolerances 

or exemptions have demonstrated that the pesticide meets the safety standard imposed by the 

statute. 

The AGE category consists of the following chemicals: 

D-glucopyranose, oligomeric, 6-(dihydrogen citrates), C8-20 branched and linear alkyl 

glycosides, sodium salts---CAS Reg. No. 1079993-97-7. This chemical will be referred to 

as AGE (C8-C20) citrate. 

D-glucopyranose, oligomeric, 6-(hydrogen sulfosuccinates), C8-20 branched and linear 

alkyl glycosides, sodium salts —CAS Reg. No. 1079993-92-2. This chemical will be 

referred to as AGE (C8-C20) sulfosuccinate. 

D-glucopyranose, oligomeric, lactates, C8-20 branched and linear alkyl glycosides —CAS 

Reg. No. 1079993-94-4. This chemical will be referred to as AGE (C8-C20) lactate. 

For the evaluation of the AGEs, other chemicals were considered in the toxicological and 

ecotoxicological assessment. These chemicals include other carboxylic esters obtained with 

specific fatty alcohols (coconut) and the main degradation products forming and environmental 

or metabolic degradation pathways (alkylpolyglucosides and carboxylic acids) The list of 

chemicals used in this evaluation are: 
Page 5 of 22

 D-glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 

1-(coco alky) 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) 

 D-glucopyranose, oligomeric, 6-[hydrogen (2R, 3R)-2,3-dihydroxybutanedioate], 1-

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

 (C9-11)alkyl polyslycosides solfosuccinate sodium salts (CAS No. 122857-41-0) 

 Lactic acid 

 Citric acid 

 Disodium sulfosuccinate and other sulfosuccinates 

Surogate chemicals d-glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-

propanetricarboxylate), 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-51-2), dglucopyranose, 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) are 

considered acceptable in read across approach becasue their carbon chain lengths are in the 

range C8-C20 and they are the same sulfosuccinate or carboxylate esters. 

Surrogate chemical (C9-11) alkyl polyglycosides solfosuccinate sodium salts (CAS No. 

1228577-41-0) is considered acceptable in the read across approach becasue the chemical 

physical properties of the alkyl polyglucoside Esters are very similar for the different chain 

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

biodegradation pathway of the Alkyl polyGlucoside Esters, and the toxicity data of the Alkyl 

polyGlucoside are very similar for the different chain lengths in the range C8-C20. It should be 

noted that the Alkyl polyglucoside Sulfosuccinate appears more critical for health effects in 

comparison with other Alkyl polyglucoside Esters. 

This document provides an assessment of the risk to human health and the environment for the 

AGEs when used as inert ingredients (surfactants) in pesticide formulations applied to pre- and 

post-harvest agricultural commodities. 

II. Use Information 

The AGEs are used is a wide variety of cosmetics, lubricants and other applications applied to 

skin, hair, nails and mucous membranes. Application of these products includes multiple daily 

uses with daily or occasional use extending over many years. The proposed use for the AGEs is 

as inert ingredients (surfactants) in pesticide formulations applied to pre- and post-harvest 

agricultural commodities. 

III. Physical and Chemical Properties 

The structures of each of the AGEs is provided in Table 1. 

Table 1. Structures of AGEs 
Page 6 of 22

Chemical Name Structure 

D-glucopyranose, 

oligomeric, 6-

(dihydrogen 2-

hydroxy-1,2,3-

propanetricarboxylate), 

1-(C8-C20 linear and 

branched alkyl) ethers, 

sodium salts—CAS 

Reg. No. 1079993-97-7 

D-glucopyranose, 

oligomeric, 6-

(hydrogen 

sulfobutanedioate), 1-

(C8-C20 linear and 

branched alkyl) ethers, 

sodium salts—CAS 

Reg. No. 1079993-92-2 
Page 7 of 22

D-glucopyranose, 

oligomeric, propanoic 

acid, 2-hydroxy-, 1-

(C8-C20 linear and 

branched alkyl) 

ethers—CAS Reg. No. 

1079993-94-4. 

Source: Laberti Group Read across rationale for Alkyl polyBlucoside Esters 

(AGE) group

Some of the physical and chemical characteristics of the AGEs are found in Table 2. 

Table 2. Physical and Chemical Properties of AGEs 

Parameter Value 

1079993-97-7 

AGE (C8-C20) citrate

1079993-92-2 

AGE (C8-C20) sulfosuccinate

1079993-94-4 

AGE (C8-C20) lactate

Appearance at 20°C and 

101.3 kPa 

Yellowish liquid (aqueous 

solution) 

Yellowish liquid (aqueous 

solution) 

Yellowish liquid (aqueous 

solution) 

Molecular Weight 670.59-839.92 660.61-828.94 562.58-694.91 

Melting Point ("C) -2°C (water solution) 1

349.84°C (substance)*

-2°C (water solution)

2 

349.84°C (substance)*

-2°C (water solution)

3

349.84°C (substance)*

Boiling Point (0C) ~ 100°C (water solution) 

>600°C (substance)*

98°C @101.3 kPa (water 

solution)1

>600°C (substance)*

~100° C (water solution) 

>600° C (substance)*

Log Kow -0.93 - 4.96 * log Pow at 20°C <-2.82

-1.41- 4.48 * 0.08- 5.98 * 

Water Solubility 

(mg/L at 25°C) 

395 mg/g at 25°C 1

1E+06 (C8) - 23297(C20)*

686 mg/g at 25°C2

1E+06 (C8) -1468.8 (C20)*

498 mg/g at 25°C3

1E+06 (C8) - 5612.2 (C20)*

Vapor Pressure 

(Pa at 25·C) 

3.89E-22-3.19E-27 

(substance)* 

0.34 kPa at 20°C2

3.22E-22 - 2.63E3.2E-16 - 3.72E-21 (substance)* 
Page 8 of 22

27(substance)* 

Soil Adsorption 

Coefficient (Kow method) Koc: 0.02457 - 44.5 L/kg* Koc: 0.01333 - 24.15 L/kg* Koc: 0.523 - 959.3 L/kg* 

Stability in Water 2.636(pH8)-26.363 (pH7) 

Days* 

218.566 (pH8)- 5.984 (pH7) 

Days* 

3.296 (pH8)- 32.960 (pH7) 

Days *

Source: As cited in Lamberti USA Inc. Petition #IN-10675 

1 read across data on AGE Coco Citrate 

2 read across data on AGE Coco Sulfosuccinate 

3 read across data on AGE Coco Tartrate 

* data calculated using EPIWIN (v. 4.00) for the range C8-C20 of alkyl par
Page 9 of 22

IV. HUMAN HEALTH ASSESSMENT 

A. Summary of Toxicity Data (Reproduced from AGEs_Assessment Lamberti) 

Acute Toxicity 

For AGE (C8-C20) citrate, a single study on a similar chemical (D-Glucopyranose, oligomeric,6-

dihydrogen 2 hydroxy-1,2,3-propanetricarboxylate), 1-(coco alkyl) ethers, sodium salt (CAS No. 

151911-51-2) was available. According to this study, a single dose of 5,000 mg/kg was given to 5 

Wistar Rats of each sex as an aqueous solution via gavage. No deaths occurred within 24 hours.. 

Two males and two females had slight piloereciton and mucosa enteritis in small intestine lesions 

was seen in two males at terminal necropsy. As such, the Oral LD50 was >5,000 mg/kg. (MRID 

48179203) 

For AGE(C8-C20) sulfosuccinate, a single study on a similar chemical (D-Glucopyranose, 

oligomeric, 6-(hydrogen, 2-sulfobutanedioate), 1-(coco alkyl) ethers, sodium salts (CAS No. 

151911-53-4) was available. According to this study, a single dose of 5,000 mg/kg was given to 5 

Wistar Rats of each sex as an aqueous solution via gavage.. No deaths occurred within 24 hours.. 

Four males and two females had slight piloereciton and mucosa enteritis was seen in two males. 

The acute oral LD50 in rats was >5,000 mg/kg. (MRID 48179202) 

In addition, a single study on a similar chemical (D-Glucopyranose, oligomeric, 6-[hydrogen, 2R, 

3R)-2,3-dihydroxybutanedioate], 1-(coco alkyl) ethers, sodium salts (CAS No. 151911-52-3) was 

available. According to this study, a single dose of 5,000 mg/kg was given to 5 Wistar Rats of 

each sex as an aqueous solution via gavage. No deaths occurred within 24 hours.. All treated 

animals had pilorection and slight diarrhea. Mucosa enteritis in small intestine lesions were seen 

in the surviving animals at terminal necropsy. The acute oral LD50 in rats was >5,000 mg/kg. 

(MRID 48179204) 

No specific acute dermal or inhalation studies are available. 

A summary of the acute toxicity data is presented in Table 2 below 

 

Table 2. Summary of Acute Toxicity Data for AGEs

Parameter Toxicity Value Reference 

Oral LD50, rat (AGE(C8-C20) citrate Not Available

Oral LD50, rat (AGE(C8-C20) 

sulfosuccinate

Not Available

Oral LD50, rat (AGE(C8-C20) lactate Not Available

Oral LD50, rat (151911-51-2) LD50 >5000 mg/kg Biolab SGS 1993 (MRID 

48179203) 

Oral LD50, rat (151911-53-4) LD50 >5000 mg/kg Biolab SGS 1993a (MRID 

48179202 
Page 10 of 22

Oral LD50, rat (1079993-94-4) LD50 >5000 mg/kg* Biolab SGS 1993 (MRID 

48179204) 

Dermal LD50 Not available 

Inhalation LC50, rat Not available 

Eye Irritation, rabbit Not available 

Skin Irritation, rabbit Not available 

Skin Sensitization-guinea pig 

(Modified Maguire method) Not available 

Subchronic Toxicity 

Sub-chronic or repeated dose toxicity data were not submitted for AGEs. However, 

information on a similar alkyl polyglucosides and organic acids (metabolites) show no 

significant toxicity. 

Carboxylic acids (lactic and citrate acid) have been studied for implication in use as food 

additives. No evidence of subchronic toxicity was reported in monographs and reports under 

World Health Organization (WHO) activities. (MRIDs 47867231, 47867232, 47867233, 

47867234, 47867235, 47867236, 47867237) 

Also, in the National Library of Medicine, Toxicology Data Network (TOXNET), Hazardous 

Substances Data Bank (HSDB), evidence of toxicity for lactic and citric acid was not reported in 

peer reviewed studies. 

Carcinogenicity (Reproduced from HSDB) 

No direct carcinogenicity data is available for the AGEs; however, carcinogenicity data is 

available for citric acid. A Chronic Exposure or Carcinogenicity/ A 2-year chronic oral study in 

rats given 5% or 3% citric acid (approx. 2 or 1.2 g/kg/d, 2000 or 1,200 mg/kg/day) in feed found 

slightly decreased growth in the higher dosage group but no tissue abnormalities in the major 

organs. As such, the NOAEL was determined to be 1200 mg/kg/d. Similarly, NOAELs of 1500 

mg/kg/d (rabbit) and of 1400 mg/kg/d (dog) have been determined [ 

The Agency further evaluated the carcinogenic potential of alkyl polyglucoside (C8-C20) esters by 

conducting a knowledge base qualitative structure activity relationship (SAR) database, DEREK 

Nexus Version 2.0, to determine if there were structural alerts. No structural alerts were identified 

including carcinogenicity. 

Reproduction/Developmental Toxicity 
Page 11 of 22

No Reproductive and Developmental toxicity data were submitted for AGES. However, alkyl 

polyglucoside and organic acids (metabolites) were used as surrogates.

For AGE (C8-C20) sulfosuccinate, data on a surrogate chemical , (C9-11) alkyl 

polyglycosides solfosccinate sodium salts, was obtained in a combined repeated dose toxicity 

study with the reproduction/developmental toxicity screening test, (MRID 492751-03-C/CA). , 

(C9-11) alkyl polyglycosides solfosccinate sodium salts (was administered to ten Wistar 

rats/sex/dose in corn oil by gavage at dose levels 0, 40, 200, or 1000 mg/kg bw/day for at least 14 

days prior to mating, throughout mating, and after mating, up to and including the day prior to 

sacrifice. Terminal sacrifices took place following at least 28 days of treatment for males, on 

lactation day (LD) 4 for females that littered, and on or after presumptive gestation day (GD) 26 

for mated females that did not litter. Evaluated parameters in the parental animals included 

functional observational battery (FOB), hematology, clinical chemistry, organ weights, and 

histopathology. 

There were no biologically relevant treatment-related effects on parental mortality, clinical signs, 

conducted neurological evaluations, body weight, body weight gain, food consumption, clinical 

pathology, reproductive performance, macroscopic findings, and histopathology of organs and 

tissues of the reproductive tract. Treatment-related increased (20-27%) absolute and relative 

thymus weights in males of the high-dose group, decreased (22%) relative right ovary weights in 

females of the high-dose group, and increased (20-56%) absolute and relative thyroid weights in 

females of the mid- and high-dose groups were observed. [Note: thyroid weights from males were 

not recorded.] However, because there were no correlated alterations in clinical chemistry 

parameters and/or histopathology, the differences are not considered adverse. Therefore under the 

conditions of this study, the parental systemic LOAEL for (C9-11) alkyl polyglycosides 

solfosccinate sodium salts in rats is not identified, and the parental systemic NOAEL is 1000 

mg/kg bw/day. 

Under the conditions of this study, there were no evident treatment-related effects on numbers of 

corpora lutea per dam, reproductive indices, precoital intervals, gestation length, number of 

corpora lutea and implantation sites, postimplantation losses, live litter size, pup sex ratio, pup 

weight, or pup survival to PND 4. Therefore under the conditions of this study, the 

reproductive/developmental LOAEL for (C9-11) alkyl polyglycosides solfosccinate sodium 

salts in rats is not identified, and the reproductive/developmental NOAEL is 1000 mg/kg bw/day.

Neurotoxicity 

Neurotoxicity studies with AGEs were not available for review. However, evidence of 

neurotoxicity was not observed in submitted studies at concentrations as high as 1,000 mg/kg/day 

(limit dose) of the test material. In addition, in the OCED 422 study it was reported that 

functional observational battery (FOB) parameters were not affected by treatment at 1,000 

mg/kg/day; however, no actual data was provided in the study report. 

Mutagenicity 
Page 12 of 22

Data for the mutagenic potential of AGEs were provided from data on surrogate chemicals dglucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-(coco alky) 

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 dglucopyranose, oligomeric, 6-[hydrogen (2R, 3R)-2,3-dihydroxybutanedioate], 1-(coco alkyl) 

ethers, sodium salts (CAS No. 151911-52-3). 

In an Ames Test salmonella typhimurium strains TA98, TA100, TA102, TA1535, and TA1537 

were exposed to concentrations up to 5000 ug/plate of CAS No. 151911-51-2 (surrogate for CAS 

No. 1079993-97-7). Cytotoxicity was observed at 1500 and 5000 ug/plate. No increases in 

mutation frequency were reported at any concentration tested with or without metabolic activation 

(MRID 48179210) 

In an Ames Test salmonella typhimurium strains TA98, TA100, TA102, TA1535, and TA1537 

were exposed to concentrations up to 5000 ug/plate of CAS No. 151911-53-4 (surrogate for CAS 

No. 1079993-92-2). Cytotoxicity was observed at 1500 ug/plate. No increases in mutation 

frequency were reported at any concentration tested with or without metabolic (MRID 48179211) 

In a non-guideline Ames Test salmonella typhimurium strains TA98, TA100, TA1538, TA1535, 

and TA1537 were exposed to concentrations up to 1000000 ug/plate of CAS No. 151911-52-3 

(surrogate for CAS No. 1079993-94-4). No Cytotoxicity was observed at 10 mg/plate (10000 

ug/plate). No increases in mutation frequency were reported at any concentration tested with or 

without metabolic activation (Instituto de Richerche Biomediches, 1995). (MRID 49549601) 

Metabolism 

 

 Studies on the metabolism of orally administered β -glucosides in mice show that rapid 

hydrolytic acetal cleavage takes place principally in the stomach and intestine of the mice. The 

cleavage products pass into the fatty acid and carbohydrate metabolic pathways. That assumption 

is also confirmed by another study on alkylglycosides where the β -glycosidic bond was rapidly 

hydrolyzed in intestine and liver. The cleavage p roducts, sugars and long-chain alcohols, entered 

the pathways of lipid and carbohydrate metabolism. 

A summary of the toxicology data for the AGEs is provided in Table 3 below. 

Table 3 Toxicology Profile for AGEs

Guideline No./ Study Type Classification /Doses Results 
Page 13 of 22

Table 3 Toxicology Profile for AGEs

Guideline No./ Study Type Classification /Doses Results 

Combined repeated dose toxicity study 

with the Reproduction/developmental 

Toxicity Screening test- Rat 

((C9-11)alkyl polyglycosides 

solfosuccinate sodium salts 

hexahydrate) 

0, 40, 200, or 1000 mg/kg/day NOAEL = 1000 mg/kg/day. 

LOAEL was not established. 

Reproduction NOAEL = 1000 

mg/kg/day. 

Reproduction LOAEL was not 

established. 

Chronic/Carcinogenicity Study-rat 

(citric acid) 

0, 3 or 5% 

(1,200 or 2,000 mg/kg/day) 

NOAEL = 2000 mg/kg/day. 

LOAEL was not established. 

Combined repeated dose toxicity study 

with the Reproduction/developmental 

Toxicity Screening test- Rat 

(disodium succinate hexahydrate) 

0, 300, 1000 mg/kg/day 

Reproduction NOAEL = 1000 

mg/kg/day. 

Reproduction LOAEL was not 

established. 

In vitro endocrine screening test 

(alkyl polyglucosides) Not estrogenic nor antiestrogenic. 

Ames test 

870.5100 

(CAS Reg. No. 151911-51-2 

Up to 5000 ug/mL in the 

absence and presence of 

metabolic activation. 

No increase in revertant 

colonies. 

Ames test 

870.5100 

(CAS Reg. No. 151911-53-4 

Up to 5000 ug/mL in the 

absence and presence of 

metabolic activation. 

No increase in revertant 

colonies. 

Ames test 

870.5100 

(CAS Reg. No. 151911-52-3) 

Up to 1000000 ug/mL in the 

absence and presence of 

metabolic activation. 

No increase in revertant 

colonies. 

D. Toxicity Endpoint Selection 

There was no endpoint of concern identified in toxicity studies up to 1,000 mg/kg/day. In addition, 

metabolism studies on alkylglycosides reported that 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. Based on the low acute toxicity, the body’s ability to rapidly 

metabolize the inert ingredient, the expected metabolites being fatty acids and carbohydrates which 

are normal constituents of the body, and the lack of an endpoint of concern for repeat dose studies 

at the limit dose (1,000 mg/kg/day) a qualitative risk assessment was conducted. 
Page 14 of 22

B. Special Considerations for Infants and Children 

Section 408 of the FFDCA provides that EPA shall apply an additional margin of safety for 

infants and children in the case of threshold effects to account for prenatal and post natal toxicity 

and the completeness of the database on toxicity and exposure unless EPA determines that a 

different margin of safety will be safe for infants and children. EPA concludes that the FQPA 

safety factor could be removed for AGEs for the following reasons: 

i. The database is considered adequate for FQPA assessment. The following acceptable 

studies are available: 

Ames tests-870.5100 

Combined repeated dose toxicity study with the Reproduction/developmental Toxicity 

Screening test 

ii. Fetal susceptibility was not observed in the combined repeated dose toxicity study with the 

reproduction/developmental toxicity screening test in the rat. There were no toxic effects 

were observed in either study at the highest doses tested, 1000 and 700 mg/kg/day, 

respectively. 

iii. Signs of neurotoxicity were not observed in any of the submitted studies. No treatment 

related effect on FOB and motor activity parameters evaluated in the OCED 422 study at 

doses up to 1,000 mg/kg/day; however, all of the supporting data was not provided in the 

study report. EPA concluded that the developmental neurotoxicity is not required. 

iv. Signs of potential immunotoxicity were not observed in any of the submitted studies. 

v. The dietary food exposure assessment utilizes proposed tolerance level or higher residues 

and 100% CT information for all commodities. By using these screening-level 

assessments, chronic exposures/risks will not be underestimated. 

Taking into consideration the available information, EPA concludes the additional 10X 

FQPA safety factor can be reduced to 1X. 

V. EXPOSURE ASSESSMENT 

A. Dietary Exposure 

Dietary exposure to AGEs can occur from eating food treated with AGEs or from drinking water. 

However, a quantitative assessment was not conducted since an endpoint of concern for risk 

assessment was not identified. 

 i. Acute exposure. No adverse effects attributable to a single exposure of similar chemicals to the 

AGEs were seen in the toxicity databases. Therefore, acute dietary risk assessment for AGEs is 

not required.
Page 15 of 22

 ii. Chronic exposure. A chronic dietary exposure assessment was not conducted for the AGEs 

because no toxicological endpoint of concern was identified for chronic dietary exposure. The 

available studies/literature contained no evidence of a chronic dietary endpoint of concern. 

iii. Dietary exposure from drinking water: Dietary exposure from drinking water to AGEs can 

occur by drinking water that has been contaminated by run-off from a pesticide treated area. Since 

an endpoint for risk assessment was not identified, a quantitative dietary exposure assessment from 

drinking water for AGEs was not conducted. 

iv. Cancer exposure. 

Based on the available toxicity data (carcinogenicity study in rats and mice) and lack of 

mutagenicity concerns, AGEs is not expected to be carcinogenic. Therefore, a cancer dietary 

exposure assessment is not necessary to assess cancer risk. 

B. Residential (Non-dietary) Exposure 

The term “residential exposure” is used in this document to refer to non-occupational, non-dietary 

exposure (e.g., textiles (clothing and diapers), carpets, swimming pools, and hard surface 

disinfection on walls, floors, tables). AGEs have reported uses in personal care products, such as 

antiperspirants, shampoos, conditioners, and moisturizers. 180.910. Residential exposure to AGEs 

is possible; however, since there are no toxicological effects of concern occurring below 1,000 

mg/kg bw/day, it is not necessary to conduct assessments of residential (non-occupational) 

exposures and risks. There are no dermal or inhalation toxicological endpoints of concern to the 

Agency therefore quantitative assessments have not been conducted. 

C. Occupational Exposure 

In the case of AGEs the Agency has reviewed the available toxicological information. The data 

indicate that there are no adverse toxicological effects (endpoints of concern) identified in the 

available database, therefore a quantitative risk assessment is not necessary and is not conducted. 

D. Aggregate Exposure 

In examining aggregate exposure, the Federal Food, Drug, and Cosmetic Act (FFDCA) section 

408 directs EPA to consider available information concerning exposures from pesticide residue in 

food and all other non-occupational exposures, including drinking water from ground water or 

surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and 

other indoor uses). 

In addition to pesticide use, the AGEs have reported uses in personal care products, such as 

antiperspirants, shampoos, conditioners, and moisturizers. 
Page 16 of 22

For the AGEs, a qualitative assessment for all pathways of human exposure (food, drinking water, 

and residential) is appropriate give the lack of human health concerns associated with exposure to 

AGEs when used as an inert ingredient in pesticide formulations. 

E. Cumulative Exposure 

 Cumulative effects from substances with a common mechanism of toxicity. Section 

408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke 

a tolerance, the Agency consider “available information” concerning the cumulative effects of a 

particular pesticide's residues and “other substances that have a common mechanism of toxicity.” 

 EPA has not found the AGEs to share a common mechanism of toxicity with any other 

substances, and does not appear to produce a toxic metabolite produced by other substances. For 

the purposes of this tolerance action, therefore, EPA has assumed that does not have a common 

mechanism of toxicity with other substances. For information regarding EPA's efforts to determine 

which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of 

such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative. 

VII. Environmental Justice Statement 

Potential areas of environmental justice concerns, to the extent possible, were considered in 

this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal 

Actions to Address Environmental Justice in Minority Populations and Low-Income Populations," 

http://www.eh.doe.gov/oepa/guidance/justice/eo12898.pdf. 

VIII. Environmental Fate Considerations 

No specific information regarding the environmental fate properties of the AGEs are available. 

However, there are several biodegradation studies available on the surrogate chemicals: 

 D-glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-propanetricarboxylate), 1-

(coco alky) 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). 

The results of these tests all indicate that the surrogate chemicals are readily biodegradable. 

(MRIDs 48179218, 48179212, 48179215, 48179214, 48179219 and 48179213) 

Alkylpolyglucosides were assessed in order to define aerobic and anaerobic biodegradability of 

APG, a series of standard laboratory tests, representing either discontinuous screening tests or 

continuous test systems with activated sludge. Evaluation of the results of sum parameters analysis 

(DOC removal, TOC removal, COD and BOD) allowed classification of alkylpolyglucosides as 

"readily biodegradable" according to OECD definitions. Ultimate biodegradation was proved by 

the coupled-units test (OECD 303A) giving a DOC removal of 89 % and even the anaerobic 

biodegradability testing (ECETOC screening test) indicated complete transformation into C02 and 
Page 17 of 22

CH4 amounting to 84 % theoretical gas production. The findings of these studies were confirmed 

in two other OECD studies. (Steber et al. (1995) and Garcia et al., 1997; Madsen et al., 1996.) 

The EPI (Estimation Programs Interface) SuiteTM is a Windows®-based suite of physical/chemical 

property and environmental fate estimation programs developed by the EPA’s Office of Pollution 

Prevention Toxics and Syracuse Research Corporation (SRC). EPI SuiteTM estimates for AGE 

(C20) citrate, AGE (C20) lactate, AGE (C20) sulfosuccinate, AGE (C8) citrate, AGE (C8) lactate, and 

AGE (C8) sulfosuccinate all provide further evidence that these chemicals are readily 

biodegradable. (MRIDs 47867225, 47867226, 47867227, 47867228, 47867229, and 47867230) 

VII. Ecotoxicity 

No specific ecotoxicity data are available for the AGEs, however there are several studies on 

surrogate chemicals D-glucopyranose, oligomeric, 6-(dihydrogen 2-hydroxy-1,2,3-

propanetricarboxylate), 1-(coco alky) ethers, sodium salts (CAS No. 151911-51-2); Dglucopyranose, 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). The results 

of these studies are outlined in Table 4. 

Table 4: Ecotoxicity Test Results for AGEs Surrogate Chemicals 

Test Test 

Material 

 (CAS No.)

Species Duration Results MRID 

Acute Toxicity 

to Fish 

151911-53-4 Oncorhynchus 

mykiss 

96 hours LC50=15.0 mg/l 48179206 

Acute Toxicity 

to invertebrates 

151911-51-2 Artemia salina 24 hours LC0=5 mg/l 

LC50= 19.7 mg/l 

48179217 

151911-53-4 

Daphnia magna 48 hours EC50= 46.0 mg/l 

NOEC= 35.2 

mg/l 

48179208 

Artemia salina 24 hours LC50=14.4 mg/l 48179216 

151911-52-3 Artemia salina 24 hours LC0= 1 mg/l 

LC50= 10.2 mg/l 

48179217 

Acute Toxicity 

to Plants 

151911-53-4 Selenastrum 

capricornutum 

96 hours EC50=8.4 mg/l 

(biomass) 

EC50=16.9 mg/l 

(growth) 

NOEC= 6.5 mg/l 

48179209 

IX. Risk Characterization 
Page 18 of 22

 

 AGEs have low acute toxicity via the oral route. There is no available regarding acute exposure 

via the dermal, eye or inhalation routes. 

 A combined repeated dose toxicity study with the reproduction/developmental toxicity 

screening test was available for a surrogate chemical in rats. There were no treatment related 

effects observed in parents or offspring at doses up to 1000 mg/kg/day. 

 

Neurotoxicity studies with AGEs were not available for review. However, neurotoxicity was not 

observed in the dietary studies at concentrations as high as 1,000 mg/kg/day (limit dose). 

Mutagenicity studies (Ames) for surrogate chemicals were available for review. The results for 

these studies were negative. 

Metabolism studies were not available. However, studies on the metabolism of orally 

administered β -glucosides in mice show that rapid hydrolytic acetal cleavage takes place 

principally in the stomach and intestine of the mice. The cleavage products pass into the fatty acid 

and carbohydrate metabolic pathways. That assumption is also confirmed by another study on 

alkylglycosides where 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. 

Residues of concern are not anticipated for dietary (food and drinking water) or for residential 

exposure from the use of AGEs for the proposed use pattern as an inert ingredient in pesticide 

products. As discussed above, EPA expects aggregate exposure to the AGEs to pose no 

appreciable dietary risk, given that the data on the AGEs show a lack of systemic toxicity at doses 

up to 1000 mg/kg/day. 

Taking into consideration all available information on AGEs, EPA has determined that there is a 

reasonable certainty that no harm to any population subgroup will result from aggregate exposure 

to AGE when used as an inert ingredient in pesticide formulations applied during pre-and postharvest when considering dietary exposure and all other nonoccupational sources of pesticide 

exposure for which there is reliable information. Therefore, the establishment of an exemption 

from tolerance under 40 CFR 180.910 for residues of AGEs (CAS Reg.Nos. 1079993-97-7, 

1079993-92-2, 1079993-94-4) when used as inert ingredients in pre- and post-harvest applications 

in pesticide formulations, can be considered assessed as safe under section 408(q) of the FFDCA. 

REFERENCES 

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(NLM), United States. CHEM-BANKTM =, Lactic Acid; HSDB. 2009. Hazardous Substances 
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MRID 47867200 Lamberti USA, Inc. (2009) Submission of Product Chemistry and Toxicity 

Data in Support of the Amended Registration of Inert Ingredients. Transmittal of 18 Studies. 

MRID 47867205 Curone, D. (2001) Freezing Point of (Inert Ingredient). Project Number: 

V0085, V0058, 08/02/2001. Unpublished study prepared by Cesalpinia Chemicals SpA. 3 p. 

MRID 47867206 Curone, D. (2001) Freezing Point of (Inert Ingredient). Project Number: 

08/02/2001, V0058. Unpublished study prepared by Cesalpinia Chemicals SpA. 3 p. 

MRID 47867207 Curone, D. (2001) Freezing Point of (Inert Ingredient). Project Number: 

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MRID 47867208 Curone, D. (2001) Water Solubility of (Inert Ingredient). Project Number: 

08/11/2001. Unpublished study prepared by Cesalpinia Chemicals SpA. 5 p. 

 

MRID 47867209 Curone, D. (2001) Water Solubility of (Inert Ingredient). Project Number: 

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MRID 47867225 Leming, D. (2009) EPIWIN Calculation on (Inert Ingredient). Unpublished 

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MRID 47867226 Leming, D. (2009) EPIWIN Calculation on (Inert Ingredient). Unpublished 

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MRID 47867228 Leming, D. (2009) EPIWIN Calculation on (Inert Ingredient). Unpublished 

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Page 20 of 22

MRID 47867229 Leming, D. (2009) EPIWIN Calculation on (Inert Ingredient). Unpublished 

study prepared by Lamberti, S.p.A. 5 p. 

MRID 47867230 Leming, D. (2009) EPIWIN Calculation on (Inert Ingredient). Unpublished 

study prepared by Lamberti S.p.A. 5 p. 

MRID 47867231 Leming, D. (1966) Toxicological Evaluation of Some Antimicrobials, 

Antioxidants, Emulsifiers, Stabilizers, Flour-Treatment Agents, Acids and Bases: 050. (Inert 

Ingredient). Published Study Prepared by Joint FAO/WHO Expert Committee on Food Additives; 

Dec 13-20, 1965, Rome & Oct 11-18, 1966, Geneva. 5 p. 

MRID 47867235 Leming, D. (1973) Seventeenth Report of the Joint FAO/WHO Expert 

Committee on Food Additives, Wld Hlth Org. Techn. Rep. Ser., 1974, No. 539; FAO Nutrition 

Meetings Report Series, 1974, No.53.: 293. (Inert Ingredient). Published Study Prepared by Joint 

FAO/WHO Expert Committee on Food Additives; Jun-Jul 25-4, 1973, Geneva. 5 p. 

MRID 47867236 Leming, D. (1973) Seventeenth Report of the Joint FAO/WHO Expert 

Committee on Food Additives, Wld Hlth Org. Techn. Rep. Ser., 1974, No. 539; FAO Nutrition 

Meetings Report Series, 1974, No.53.: 298. (Inert Ingredient). Published Study Prepared by Joint 

FAO/WHO Expert Committee on Food Additives; Jun-Jul 25-4, 1973, Geneva. 5 p. 

MRID 48179200 Lamberti USA, Inc. (2010) Submission of Product Chemistry, Toxicity, Fate 

and Environmental Fate Data in Support of the Petition for Tolerance of (Inert Ingredient). 

Transmittal of 19 Studies. 

MRID 48179201 Costantini, G. (2001) Determination of Physical-Chemical Properties of 

(Inert Ingredient). Project Number: 01/2874. Unpublished study prepared by Biolab S.p.A. 93 p. 

MRID 48179202 Biffi, E. (1993) Acute Oral Toxicity in Rats (Inert Ingredient). Project 

Number: 93/06632; 93/409.A1. Unpublished study prepared by Biolab SGS srl. 11 p. 

MRID 48179203 Biffi, E. (1993) Acute Oral Toxicity in Rats (Inert Ingredient). Project 

Number: 93/06633. Unpublished study prepared by Biolab SGS srl. 11 p. 

MRID 48179204 Biffi, E. (1993) Acute Oral Toxicity in Rats (Inert Ingredient). Project 

Number: 93/06634; 93/409/C1. Unpublished study prepared by Biolab SGS srl. 11 p. 

MRID 48179205 Curone, D. (2001) Water Solubility of (Inert Ingredient). Unpublished study 

prepared by Cesalpinia Chemicals SpA. 6 p. 

MRID 48179206 Jenkins, C. (2000) (Inert Ingredient): Acute Toxicity to Rainbow Trout. 

Project Number: RTS/018, RTS/018/002978. Unpublished study prepared by Huntingdon Life 

Sciences, Ltd. 64 p. 
Page 21 of 22

MRID 48179207 Todd, M. (2001) (Inert Ingredient), Validation of Analytical Methodology 

for the Determination in Aqueous Media. Project Number: RTS/021, RTS/021/003153. 

Unpublished study prepared by Huntingdon Life Sciences, Ltd. 46 p. 

MRID 48179208 Jenkins, C. (2000) (Inert Ingredient), Acute Toxicity to Daphnia magna. 

Project Number: RTS/017, RTS/017/002978. Unpublished study prepared by Huntingdon Life 

Sciences, Ltd. 62 p. 

MRID 48179209 Jenkins, C. (2000) (Inert Ingredient), Algal Growth Inhibition Assay. Project 

Number: RTS/019, RTS/019/002978. Unpublished study prepared by Huntingdon Life Sciences, 

Ltd. 68 p. 

MRID 48179210 Golzio, L. (1996) (Inert Ingredient) Ames Test. Project Number: 950771. 

Unpublished study prepared by Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A. 40 p.

 

MRID 48179211 Golzio, L. (1996) (Inert Ingredient) Ames Test. Project Number: 950770. 

Unpublished study prepared by Istituto di Ricerche Biomediche Antoine Marxer RBM S.p.A. 40 p.

 

MRID 48179212 Tonti, A. (1995) Zahn-Wellens Test of (Inert Ingredient). Project Number: 

021/1995/AT. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48179213 Tonti, A. (1995) Zahn-Wellens Test of (Inert Ingredient). Project Number: 

021B/1995/AT. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48179214 Tonti, A. (1995) Zahn-Wellens Test of (Inert Ingredient). Project Number: 

021C/1995/AT. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48179215 Tonti, A. (1997) Closed Bottle Test of (Inert Ingredient). Project Number: 

061/1997/AT. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48179216 Lezzeni, B. (2001) Acute Toxicity Test at 24 H Using Artemia salina (Inert 

Ingredient). Project Number: 001/1998/BL. Unpublished study prepared by Lamberti S.p.A. 4 p. 

MRID 48179217 Lezzeni, B. (2001) Acute Toxicity Test at 24 H Using Artemia salina (Inert 

Ingredient). Project Number: 004/1998/BL. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48179218 Tonti, A. (2001) Closed Bottle Test of (Inert Ingredient). Project Number: 

016A/1998/AT. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48179219 Tonti, A. (1998) Closed Bottle Test of (Inert Ingredient). Project Number: 

016B/1998/AT. Unpublished study prepared by Lamberti S.p.A. 5 p. 

MRID 48368200 Lamberti-USA, Inc. (2011) Submission of Toxicity, Environmental Fate, 

Residue, and Exposure and Risk Data in Support of the Petition for Tolerance of (Inert 

Ingredients) for Use on All Agricultural Commodities. Transmittal of 1 Study. 
Page 22 of 22

MRID 48368201 D.H. Dawe & Associates, LLC (2011) Inert Ingredient Tolerance 

Exemption Petition: (Inert Ingredients): Revision and Consolidation Additional Information to 

Support Petition # 9E7621. Unpublished study prepared by Lamberti-USA, Inc. 630 p. 

49275100 Kill Fleas Dead, LLC (2013) Submission of Exposure/Risk and Toxicity Data in 

Support of the Petition for Tolerance of a New Food Use Inert Ingredient. Transmittal of 3 Studies.

 

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October 2013, ppl-7 with Changes and Additions Highlighted in YELLOW. Unpublished study 

prepared by Lamberti S.p.A.. 7p. 

MRID 49275102 Unknown (2013) Inert Assessments: Three Exemptions for the Requirement 

of a Tolerance: 29 October 2013, pp 1-27 with Changes and Additions Highlighted in YELLOW. 

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MRID 49275103 Schleh, C. (2013) Combined Repeated Dose Oral Toxicity Study with the 

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