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

EPA Registration Division contact: W. Cutchin 703

- 30 5

- 7990

TEMPLATE:

Huntsman Corp.

I N

- 10565

EPA has received a pesticide petition IN

- 10565 from Huntsman Corp., 8600 Gosling Rd., The Woodlands, TX 77381 request ing, 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

, t o establish an exemption from the requirement of a tolerance for

cu menesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium and zinc salts with no limits used as surfactants, related adjuvants of surfactants on 40 CFR 180.920 and 180.930 including the following wi th Chemical Abstracts Se rvice Registry Numbers (CASRNs) : b enzenesulfonic acid, 4

- (1

- methylethyl)

- , sodium salt ( 15763

- 76

- 5 ); b enzenesulfonic acid, 4

- (1

- methylethyl)

- ( 16066

- 35

- 6 ); b enzenesulfonic acid, 4

- (1

- methylethyl)

- , potassium salt ( 164524

- 02

- 1 ); b enz enesulfonic acid, (1

- methylethyl)

- , potassium salt ( 28085

- 69

- 0 ); b enzenesulfonic acid, (1

- methylethyl)

- , sodium salt (1:1) ( 28348

- 53

- 0 ); b enzenesulfonic acid, 2(or 4)

- (1

- methylethyl)

- ( 28631

- 63

- 2 ); b enzene, (1

- methylethyl)

- , monosulfo deriv., sodium salt ( 1:1) ( 32073

- 22

- 6 ); b enzenesulfonic acid, (1

- methylethyl)

- , ammonium salt (1:1) ( 37475

- 88

- 0 ); b enzenesulfonic acid, (1

- methylethyl)

- ( 37953

- 05

- 2 ); b enzenesulfonic acid, (1

- methylethyl)

- , magnesium salt ( 90959

- 88

- 9 ) in or on all the raw agricultural commodit ies

. Prior to the submission of this petition to add cumenesulfonate CASRNs, the EPA reapproved toluenesulfonate and xylenesulfonate hydrotropes in Decision Documents dated 9/14/2006 and 6/30/2006

. The combined documents are available at http://www.epa.g ov/opprd001/inerts/xylenesulfonic.pdf

. Huntsman is relying on the information in that combined Decision Document to support this petition which includes a chemistry that was also in the Screening Information Data Set ( SIDS ) Initial Assessment Report for H ydrotropes

. The SIDS Hydrotropes category included toluenesulfonates, xylenesulfonates and cumenesulfonates. In fact, cumenesulfonate data was used to support the reassessment of the toluenesulfonate s and xylenesulfonate s in the EPA Decision Document. H untsman does not expect the addition of these cumenesulfonate CASRNs to result in additional exposure or risk , and no new data is being submitted with this petition

.
EPA has determined that the petition contains data or information regarding the elemen ts set forth in section 408 (d)(2) of F F DCA; however, EPA has not fully2

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. NA

2. Analytical method. NA

3. Magnitude of residues. NA

B. Toxicological Profile

1. Acute toxicity. Toxicity results are consistent across the toluene, xylene, and cumene sulfonates and their various salts. A cute Oral LD 50 values in animals ranged from 1044 mg/kg bw (calcium xylene sulfonate) to 6500 mg/kg bw (sodium xylene sulfonate). The dermal LD 50 in rabbits was >624 mg/kg bw (calcium xylene sulfonate), and the inhalation LC 50 in rats was >557 mg / L (557 g / m 3 sodium toluene sulfonate). In a series of rabbit skin and eye irritation studies, sodium xylene sulfonate, calcium xylene sulfonate, and sodium cumene sulfonate were not skin irritants and both calcium xylene sulfonate and sodium cumene sulfonate caus ed slight but reversible eye irritation. There was no skin sensitization observed in animal studies.

2. Genotoxicty. The hydrotropes category was assessed for mutagenic/genotoxic potential in a variety of assays including the mouse micronucleus, Ames, m ouse l y mphoma, sister chromatid exchange, and chromosome aberration assays. No positive results were seen in vitro or in vivo in any of the studies. For both mice and rats dermally exposed for two years, there was no evidence of a carcinogenic potential.

3. Reproductive and developmental toxicity. There are no reproductive toxicity studies noted for this category of chemicals, however, after examination of the sex organs (such as the prostate, testes, and ovaries) from the animals in the 91

- and 90

- day oral feeding studies and 90

- day and two year dermal studies yielded no evidence to suggest that these chemicals would have an adverse effect on the reproductive
organs. In a developmental toxicity study in rats, calcium xylene sulfonate (31% a.i.) was adm inistered via gavage to female rats at 0, 150, 1500, or 3000 mg / kg bw/day in water days 6

- 15 of gestation. No treatment related effects were observed and there was no evidence of d evelopmental toxicity. The NOAEL for maternal and fetal toxicity was 3000 mg / kg bw/day, corresponding to 936 mg a.i./kg bw/day (the highest dose tested).

4. Subchronic toxicity. Thirteen oral and dermal repeat

- dose (subchronic and chronic) studies were conducted in rats or mice. Doses ranged from 6 to 2000 mg/kg bw/day dermal ly and from 1.1 up to 4092 mg/kg bw/day orally. Test durations ranged from 17 days to two years. No significant systemic toxicity was noted in the3

dermal studies with local effects (NOAEL 400 mg/kg bw/day, LOAEL 1300 mg/kg bw/day ( epidermal hyperplasia ) ) noted in one of the six studies. In regard to the results of the oral studies, it was determined that the most appropriate NOAEL for systemic toxicity was 763 mg/kg bw/day based on a reduction in relative spleen weight in female rats.

5. Chronic toxici ty. Included with Subchronic in B4 above

.

6. Animal metabolism. The hydrotrope chemicals do not appear to produce toxic metabolites produced by other substances.

7. Metabolite toxicology

. The hydrotrope chemicals do not appear to produce toxic metaboli tes produced by other substances.

8. Endocrine disruption

. FQPA requires EPA to develop a screening program
to determine whether certain substances, including all pesticide chemicals (both inert and active ingredients), "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect..." EPA has been working with interested stakeholders to develop a screening and testing program as well as a priority setting scheme. As the Agency procee ds with implementation of this program, further testing of products containing hydrotrope chemicals for endocrine effects may be required

.
C. Aggregate Exposure

1. Dietary exposure. In examining aggregate exposure, the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticid e use in gardens, lawns, or buildings (residential and other indoor uses). For these chemicals, a qualitative assessment for all pathways of human exposure (food, drinking water, and residential) is appropriate given the use limitations and lack of human health concerns associated with exposure to these substances when used as inert ingredients in pesticide formulations.

i. Food. Dietary (food and drinking water) and residential (dermal and inhalation) exposures are possible from the use of these chemica ls as inert ingredients in pesticide products. Based on the SIDS conclusions for the hydrotropes category; cumenesulfonic acid and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts (as defined above ) are also predicted to be readily biode gradable according to OECD criteria, which will reduce the likelihood of residues on food.

ii. Drinking water. For the same reason, significant contributions to drinking water are not anticipated from the use of these chemicals as inert ingredients in
p esticide products applied to growing crops only or animals. These chemicals have4

low toxicity, and exposure to residues above toxicity levels of concern is not anticipated.

2. Non

- dietary exposure

. These chemicals have low toxicity, and exposure to

res idues above toxicity levels of concern is not anticipated.

D. Cumulative Effects

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity findi ng as to the chemistries in the SIDS Hydrotrope category and any other substances. T he hydrotrope chemicals do not appear to produce toxic metabolites produced by other substances. For the purposes of th e hydrotrope decision document tolerance action, th erefore, EPA has not assumed that these chemicals have a common mechanism of toxicity with other substances

.
E. Safety Determination

1. U.S. population. Taking into consideration available toxicity and exposure information, the Agency determined in the decision document that there is a reasonable certainty that no harm to any population subgroup will result from aggregate exposure (dietary and non

- occupational sources of exposure) to any of the hydrotrope chemistries including cumene sulfonic acid and its ammonium, calcium, magnesium, potassium, sodium, and zinc salts (as defined above ) when used as inert ingredients in pesticide formulations applied to growing crops only or to animals

.

2. Infants and children

. As covered in the hydrotrope decision docum ent and SIDS Assessment, n o treatment related effects were observed and there was no evidence of developmental toxicity. In a developmental toxicity study in rats, calcium xylene sulfonate (31% a.i.) was administered via gavage to female rats at 0, 150, 1 500, or 3000 mg/kg bw/day in water days 6

- 15 of gestation. The NOAEL for maternal and fetal toxicity was 3000 mg/kg bw/day, corresponding to 936 mg a.i./kg bw/day (the highest dose tested). Based on this information, there is no concern, at this time, fo r increased sensitivity to infants and children to any of the hydrotrope chemistries including cum enesulfonic acid and its ammonium, calcium, magnesium,
po tassium, sodium, and zinc salts when used as inert ingredients applied to growing
crops only or to an imals

.

F. International Tolerances

There are no known international tolerances for Cumenesulfonic acid or its salts

.