EPA REGISTRATION DIVISION COMPANY NOTICE OF FILING FOR 

PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER 

EPA Registration Division contact: [Janet Whitehurst 703 305-6129]

[Ecolab, Inc.]

[1E7933]

EPA has received a pesticide petition ([1E7933]) from [Ecolab, Inc. (Ecolab, EPA 

Company Number 1677)], [370 N. Wabasha Street, St. Paul, Minnesota, 55102]

requesting, 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 to establish an exemption from 

the requirement of a tolerance for [Aluminum Sulfate (CAS # 10043-01-3) under 40 CFR 

180.940(a) for use as an inert ingredient as a defoamer in antimicrobial pesticide 

formulations applied to food-contact surfaces in public eating places, dairy-processing 

equipment, and food-processing equipment and utensils] at [50] parts per million (ppm). 

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. [Not applicable/Not required for the establishment of a 

tolerance exemption for inert ingredients.]

B. Toxicological Profile

1. Acute toxicity. [The acute toxicity data indicate that aluminum sulfate has 

a low hazard potential. The International Uniform Chemical Information Database 

(IUCLID) references a GLP study conducted according to OECD 401 guidelines in 1990 

that concluded that the oral LD50 for aluminum sulfate is >5000 mg/kg. No studies have 

been found to address dermal or inhalation toxicity. Aluminum sulfate is completely 

soluble in water therefore dermal toxicity should be of negligible concern. Since the 

product will be used in closed loop cleaning systems and not sprayed or misted inhalation 

toxicity is of negligible concern. IUCLID references two GLP dermal irritation studies 

conducted in rabbits according to OECD 404 guidelines that concluded aluminum sulfate 

is not a dermal irritant at up to a 27% solution (IUCLID 2000). EPA’s TSCATS V2.01 

concludes that ocular irritation is of medium concern.]
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2. Genotoxicty. [Aluminum sulfate has been assessed for mutagenic/genotoxic 

potential in a variety of in vitro assays, specifically: IUCLID 2000 references two in vitro 

studies (Bacillus subtilis recombination assay and SOS Chromotest) conducted for 

genotoxicity that were negative. The Rec-assay with B. subtilis H17 rec+ and M45 recstains showed no mutagenic activity for aluminum sulfate and showed no sign of 

morphological transformations of Syrian hamster embryo cells (Nishioka, 1975; 

Lippman, 1992). ]

3. Reproductive and developmental toxicity. [An OECD 416 guideline twogeneration reproductive toxicity study (Hirata-Koizumi M, et al. 2011) was conducted 

using concentrations of 0, 120, 600, and 3000 ppm aluminum sulfate (98.5% purity) in 

drinking water. The NOAEL was found to be 600 ppm for parental systemic toxicity and 

reproductive/ development toxicity. No developmental effects or maternal toxicity were 

observed. Aluminum sulfate is not considered to be a developmental toxicant. ]

4. Subchronic toxicity. [A 21-day oral toxicity study was performed in two month 

old male albino rats (Rattus norvegicus) (Roy, et al., 1991). Doses were selected based on 

an unreferenced LD50 of 10,600 mg/kg body weight. A NOAEL was not established, as 

dose dependent effects were observed in the liver at the lowest dose tested, 212 mg/kg 

body weight/day. ]

5. Chronic toxicity. [A 10-month repeat dose oral study (Stacchiotti, A., et al., 

2008) was conducted on male adult C57BL/6 mice. Eight adult male mice of an 

unspecified age were treated with 2.5% aluminum sulfate dissolved in tap water 

administered orally. No adverse effects were reported. ]

6. Animal metabolism. [There are no adsorption, distribution or metabolism and 

elimination studies for aluminum sulfate. However, based on available physicochemical 

properties and available toxicological information no metabolites of toxicological 

concern are expected.]

7. Metabolite toxicology. [No metabolites of toxicological concern are expected.]

8. Endocrine disruption. [Aluminum sulfate does not belong to a class of 

chemicals known or suspected of having adverse effects on the estrogen receptor or 

endocrine system.]

C. Aggregate Exposure

1. Dietary exposure. [Based on the literature search conducted for aluminum 

sulfate, there is no study available that provides relevant acute effects for the 

determination of an acute reference dose. Additionally, the dietary intake assessment 

does not differentiate between acute and chronic exposures. Therefore, no separate acute 

reference dose has been determined. Based on the results of the developmental toxicity

study in rats, there was no increased sensitivity to infants and children from aluminum 

sulfate in the absence of parental toxicity and therefore no need for an additional 10X 

FQPA safety factor when determining the chronic reference dose. The chronic reference 
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dose (cRfD) and the chronic population adjusted dose (cPAD) were calculated using the 

NOAEL of 8.06 mg Al/kg bw/day and the standard 10X uncertainty factors for each of 

intra- and inter- species variability. Based on this information, the chronic reference dose 

(cRfD) and chronic population adjusted dose (cPAD) are equal and are calculated to be 

0.0806 mg/kg/day.

i. Food. [Low residues, based on an evaluation of potential residues of aluminum 

sulfate from the dairy and beverage production scenarios show that 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. [Aluminum sulfate is readily biodegradable according to 

OECD criteria; exposures to residues above toxicity levels of concern are not 

anticipated.]

2. Non-dietary exposure. [In aggregating exposure, FFDCA section 408 directs 

EPA to consider available reliable information concerning exposures from pesticide 

residues in food and all other non-occupational exposures, including drinking water from 

groundwater or surface water and exposures through pesticide use in gardens, lawns, or 

buildings (residential and other indoor uses).

Given the low estimate of dietary exposure, there is ample room in the overall aggregate 

MOE to conservatively account for non-dietary uses of aluminum sulfate.]

D. Cumulative Effects

[Based on information provided in the ATSDR Aluminum review, “No specific 

molecular mechanisms have been elucidated for human toxicity to aluminum.” 

Furthermore, there is no information in the public literature to suggest that aluminum 

sulfate would have a common mechanism of toxicity with other substances. For the 

purpose of the tolerance exemption action cited herein, Ecolab has assumed that 

aluminum sulfate will not have a common mechanism of toxicity with other substances.]

E. Safety Determination

1. U.S. population. [Based on the conservative exposure estimates, there is a 

reasonable certainty that no harm will result to the U.S. population from the aggregate 

exposure to aluminum sulfate.]

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 factor may be reduced or removed. 
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Based on available information for aluminum sulfate, Ecolab supports reducing the 

FQPA safety factor to 1X. An OECD guideline two-generation reproduction study in rats 

indicated that there was no evidence of developmental or reproductive toxicity nor was 

there evidence of increased susceptibility of developing offspring in the absence of 

parental toxicity. Ecolab requests that the additional tenfold safety factor for the 

protection of infants and children be removed for the purposes of this tolerance 

exemption. For the reasons described above, the default 10X FQPA safety factor may be 

reduced to 1X, and the cRfD is therefore equivalent to the chronic population adjusted 

dose (cPAD) for aluminum sulfate. ]

F. International Tolerances

[There are no known international tolerances for aluminum sulfate specified in 

this petition.]