### Page 2 of 47 Acute oral toxicity studies were perfor med using C12-ADAA and C16-ADAA. ADAA has moderate to low acute toxicity vi a the oral and dermal routes of exposure. Low acute toxicity is generally associated with C16-ADAA while modera te acute toxicity is associated with C12- ADAA. In acute dermal and eye irritation studies, C12-ADAA was se verely irritating to the skin and eyes. A mixture of C12- C16 ADAA was used in a local lymph node assay (LLNA) to evaluate the potential to cause skin sensitiz ation, C12-C16 ADAA was fo und to be a sensitizer; however, it gave a negative res ponse for skin sensitization in in vivo guinea pigs as determined by Magnusson-Kligman test.

Two developmental studies were available; an oral toxicity study in the rat and a screening level developmental dermal toxicity study in the rabbit. In the developm ental toxicity study in the rat, maternal toxicity was manifested as reduced body weight gain, staine d and matted haircoats, respiratory rates at 50 mg/kg/day and above. Offspring toxicity was manifested as reduced or absent ossification of the skull, sternebrae #5 and/or #6, and other sternebrae at 250 mg/kg/day. The no observed adverse effect level (NOAEL) for developmental toxicity in rats was 150 mg/kg/day. In the screening le vel developmental dermal toxic ity study in rabbits, maternal toxicity manifested as skin irritation, inhibition of body weight gain, decreased food consumption and resorptions at doses of 100 mg/ kg/day and above while o ffspring toxicity was manifested as increased incidence of resorp tions and decreased average litter size at ≥ 100 mg/kg/day. The NOAEL for systemic and developmen t toxicity in rabbits via dermal route was 40 mg/kg/day.

A dose range-finding and a main study of Combin ed Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Te st according to the OPPTS Harmonized Test Guideline 870.3650 study were av ailable in the rat. In the range-finding study, at > 100 mg/kg/day, a reduction was observed in mean food consumption, body wei ght, and body weight gain during the pre-pairing peri od in all animals. Also, anim als pushed their heads through the bedding throughout the treatme nt period at doses > 100 mg/kg/day. At 1000 mg/kg/d, mortality was observed in all animals within 24 hours. In the main OPPTS Harmonized Test Guideline 870.3650 study, parental toxicity was manifested as microscopic lesions (squamous hyperplasia, hyperkeratosis, submucosal inflammation and edema) in the forestomach at the lowest dose tested (50 mg/kg/day). Reproductive and developm ental toxicity was manifested as increased implantation losses, decreased birth and viabi lity indices, and decreased pup weight at 300 mg/kg/day (highest dose tested). The NOAEL fo r reproductive/developmental toxicity was 150 mg/kg/day.

Several mutagenicity studies (two Ames assays and chromosome aberration assay) were available for review. The results for these studi es were negative. No animal carcinogenicity studies are available in the data base. Based on structure activity relationship (SAR) analysis, no structural alerts for carci nogenicity were identified.

Two in vitro dermal absorption studies were available in hairless mice. The dermal absorption factor of C12-ADAA and C16-ADAA was estimated to be <1%.

There are no residual concerns fo r susceptibility to the offspring since fetal toxicity was observed at doses that were higher than the dose that cau sed maternal toxicity. In addition, there was a

### Page 3 of 47 clear NOAEL for reproductive and developmental toxi city seen in the rat offspring, and the point of departure is based on these endpoints. Theref ore, EPA has determined that the safety of infants and children would be adequately protected if the FQPA safety factor was reduced to 1X.

The Agency notes the surfactants are surface-acti ve materials that can damage the structural integrity of cellular membranes at high dose leve ls. Thus, surfactants are often corrosive and irritating in concentrated solutions. It is possibl e that some of the observed toxicity seen in the repeated dose studies, such as microscopic stom ach lesions or decrease d body weight gain, can be attributed to the co rrosive and irritating natu re of these surfactants.

There are no published or unpublished ADA A metabolism studies. However, ADAA are expected to metabolized via three potential me tabolic pathways: 1) omega oxidation followed by beta oxidation of the carbon chain, 2) conjugation of ADAA at the carboxylic acid portion of the molecule by any of a number of amino acids, or 3) glucuronidation at the same site on ADAA, followed by elimination.

There was no hazard attributable to a single exposu re seen in the toxicity database for ADAA. Therefore, ADAA is not expect ed to pose an acute risk.

A chronic aggregate risk assessment takes into a ccount exposure estimates from chronic dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for chronic exposure and the use limitation of not more than 20% by weight in pesticide formulations, the chronic dietary exposure fr om food and water to ADAA is 19.5% of the cPAD for the U.S. population and 62.9% of the cPAD fo r children 1-2 years old, the most highly exposed population subgroup. A more complete list of results can be found in Appendix A.

Short-term aggregate exposure takes into accoun t short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level)

. ADAA are used as inert ingredients in pesticide products that are curre ntly registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term re sidential exposures to ADAA

. Using the exposure assumptions described in this unit, EPA has concluded that the combined shortterm aggregated food, water, and residential expo sures result in aggregate MOEs of 110 for adult males and adult females. Adult residential e xposure combines high end dermal and inhalation handler exposure from indoor hard surface wipi ng with a high end post application dermal exposure from contact with treated lawns. EPA has concluded the combined short-term aggregated food, water, and residential exposu res result in an aggr egate MOE of 130 for children. Children’s residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). As the level of con cern is for MOEs that are lower than 100, these MO Es are not of concern.

Intermediate-term aggregate exposure takes into account intermediate-ter m residential exposure plus chronic exposure to food and water (consid ered to be a backgr ound exposure level). ADAA

are currently registered for uses that could result in intermediate -term residential exposure and the Agency has determined that it is appropriate to aggregate ch ronic exposure through food and water with intermediate-term residential exposures to ADAA. Using the exposure assumptions

### Page 4 of 47 described in this unit, EPA has concluded that the combined intermedia te-term aggregated food, water, and residential exposures result in aggregate MOEs of 450 for adult males and adult females. Adult residential exposure includes hi gh end post application dermal exposure from contact with treated lawns. EPA has conclude d the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 150 for children. Children’s residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). As the level of c oncern is for MOEs that are lower than 100, this MOE is not of concern.

The EPI Suite TM 

### estimated values for the physical and chemical properties of ADAA indicate that it will have minimal impact on the envir onment. The results indicate that ADAA is not likely to bioconcentrate and is readily biodegradab le. It is also not likely to volatilize from surface water. ADAA is expected to partition prim arily to soil, but the small amounts that enter the water will readily degrade.

The ecotoxicity of ADAA was estimated using EC OSAR, which is a program that estimates a chemical’s acute and chronic toxicity to aquatic organisms by using Structure Activity Relationships (SARs). The estimated values for ADAA indicate that th e ecotoxicity of ADAA ranges from practically nontoxi c to slightly toxic.

Potential areas of environmental ju stice concerns, to the extent possi ble, were considered in this human health risk assessment, in accordance w ith U.S. Executive Order 12898, “Federal Actions to Address Environmental Just ice in Minority Populations an d Low-Income Populations”, http://www.eh.doe.gove/oepa/ guidance/justice/eo12898.pdf . This assessment does not rely in part on data from studies in which adult hum an subjects were inten tionally exposed to a pesticide.

Taking into consideration all available inform ation on ADAA, EPA concl udes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to ADAA. Therefore, the establishment of an exemption from the requirement of a for residues of ADAA when used as an inert ingredient (surfactant) in pesticide formulations at a maximum of 20% in formul ation when applied pre-harvest under 40 CFR 180.920 and when applied to animals under 40 CFR 180.930 can be considered safe under section 408 of the FFDCA.

I. Background

Rhodia, Inc. submitted a petition dated April 9, 2009 proposing to establish specific exemptions from the requirement of a tolerance unde r 40 CFR §180.920 (pre-harvest only) and 40 CFR §180.930 (applied to animals) with a limit of up to 20% of pesticide formulations for the following descriptor:

Alkyl (C12-C16) dimethyl ammonio acetate (ADAA)

### Page 5 of 47 The proposed use of ADAA is as an inert ingredient (surfactant) in pesticide formulations. EPA published the Notice of Filing for this petition in the Federal Re gister of August 19, 2009 (74 FR 41895, FRL-8429-9). No comments were received in response to this notice.

This document provides an assessment of ADAA fo r the requested tolerance exemptions, and is based on information and data submitted by the petitioner and information found in the public literature.

II. Use Information

A. Pesticide Uses

Currently, two of the CAS Reg. Nos. (CAS Reg. Nos. 2601-33-4 and 693-33-4) for which Rhodia is requesting tolerance exemptions, are on the list for Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products.

B. Other Uses

The components of ADAA are used in personal ca re products including liquid hand soaps, facial cleansers, shampoos and shower gels. Thes e components function as foam boosters and typically used in these products at concentrations up to 5%. (Mintel GNPD Database, 2009; Wong, 1997)

### Page 6 of 47 III. Structural Information

IV. Physical and Chemical Properties

The physical and chemical properties of ADAA ar e listed in Table 2. These properties were estimated using EPI Suite TM 

### (EPA Estimation Programs Interface). EPI Suite TM 

### is a Windows ®



### - based suite of physical/chemical property and environmental fate estimation programs developed by the EPA’s Office of Pollution Prevention a nd Toxic Substances (OPPTS) and Syracuse Research Corporation (SRC). . Table 1: Structural Information Structure References

C12-ADAA (CAS Reg. No. 683-10-3)

C14-ADAA (CAS Reg. No. 2601-33-4)

C16-ADAA (CAS Reg. No. 693-33-4) ChemIDplus Lite

### Page 7 of 47 Table 2: Physical and Chemical Properties
C12-ADAA C14-ADAA C16-ADAA References Molecular Formula C 16 H 33 NO 2 C 18 H 37 NO 2 C 20 H 41 NO 2

CAS # 683-10-3 2601-33-4 693-33-4 Scientific Name 1-Dodecanaminium, N-(carboxymethyl), N, Ndimethyl, inner salt 1-Tetradecanaminium, N-(carboxymethyl), N, N-dimethyl, inner salt 1-Hexadecanaminium, N-(carboxymethyl), N, N-dimethyl, inner salt ChemIDplus Lite

Molecular Weight 272.5 301.52 329.57

Log Kow 0.47 3.46 4.44 Boiling Point (oC) 520 543 566

Melting Point (oC) 222 233 243

Vapor Pressure (mmHg at 25 oC) 6.88 E-14 1.3 E-15 2.74 E-15

Water Solubility (mg/L) 1.73 E+4 a 0.2866 b 33.35 a 0.0267 b 3.301 a 0.00247 b

Henry’s LawConstant atmm3/mole at 25 oC (Bond) 1.4 E-14 1.55 E-15 2.74 E-15

Log Koc 2.804 c 0.329 d 3.325 c 1.982 d 3.846 c 2.524 d Probability of Rapid Biodegradation (BIOWIN) 0.7990 e 0.8357 f 3.26 days-weeks g 0.6677 h
0.7794 i 0.7851 e 0.7710 f 3.1958 weeks g 0.6801 h
0.7828 i 0.7718 e 0.6933 f 3.1338 weeks g 0.6955 h
0.7910 iBCF (L/kg wetwt) 70.79 70.79 70.79

Atmospheric Oxidation Half Life (hr) 6.9 E+10 j
7.53 E+11 k 6.55 E+11 j
7.16 E+12 k 3.88 E+11 j
4.23 E+12 k

Fugacity Model Compartment/ Mass Amount (%) Air: 6.14 E-5 Water: 18.5 Soil: 81.2 Sediment: 0.321 Air: 1.64 E-5 Water: 15.9 Soil: 83.0 Sediment: 1.1 Air: 0.000119 Water: 15.3 Soil: 81.4 Sediment: 3.25 Fugacity Model Compartment/ Half Life (hr) Air: 7.49 Water: 208 Soil: 416 Sediment: 1.87 E+3 Air: 6.92 Water: 360 Soil: 720 Sediment: 3.24 E+3 Air: 6.43 Water: 360 Soil: 720 Sediment: 3.24 E+3 ADAA EPI Suite TM Estimates as cited in US EPA Petition #9E7557

a WSKOW result; not appropriate for estimation of water f Biowin2 (non-linear model) solubility of dispersible compounds, including surfactants g Biowin3 (Ultimate survey model)
b Fragment Result h Biowin5 (MITI linear model)

c MCI method result i Biowin (MITI non-linear model)
d Kow method result j Model River

e Biowin1 (linear model) k Model Lake

### Page 8 of 47

V. Human Health Assessment

Toxicological Discussion

Table 3. Summary of Acute Toxicity Data for ADAA Parameter Toxicity Value Reference Oral LD 50, 

### rat (C12-ADAA) 71 mg/kg Ridout et al., 1991

Oral LD 50, 

### rat (C16-ADAA) 1620 mg/kg Ridout et al., 1991

Oral LD 50, 

### rat (C12-ADAA) >5000 mg/kg in males Maynard, 1963

Dermal LD 50, 

### rat, (C12-ADAA) >1300 mg/kg Ridout et al., 1991

Dermal LD 50, 

### rat (C16-ADAA) >16,000 mg/kg Ridout et al., 1991
Eye Irritation, rabbit (C12- ADAA) Severe irritant Maynard, 1963

Skin Irritation, guinea pig(C12- ADAA) Severe irritant (10%) Maynard, 1963

Skin Sensitizationguinea pig (Magnusson - Kligman) Not a sensitizer Pelcot, 2006

Skin Sensitizationmouse (LLNA) Sensitizer Wang-Fan, 2005

Developmental Toxicity Study in the rat

In a developmental toxicity study F1803 (ADAA) wa s administered by gavage to CD rats at doses of 0, 50, 150 or 250 mg/kg/da y on days 6-15 of gestation.

Respiratory rates and stained and matter haircoat s were observed at all doses. Also, a dose dependent reduction in body weight gain was observed during the overall gestation (days 0-20) and treatment intervals in all dose groups. Th e maternal systemic toxicity LOAEL was 50 mg/kg/day.

There was an increased incidence of litters w ith reduced ossification and unossification of the skull, sternabrae #5 and/or 6 and other ster nabrae at 250 mg/kg/day. The NOAEL for the developmental toxicity was 150 mg/kg/day.

### Page 9 of 47

Developmental Dermal Toxicity Screening Study in the rabbit

In a developmental dermal toxicity study in ra bbits with B0612-02 (ADAA), the test material in vehicle, 5% isopropanol (B0644-01) was administered topically to New Zealand white female rabbits (8/dose) at doses of 0, 10, 20, 40,100 or 200 mg/kg/day on da ys 6-18 of gestation. The treatment of the 100 and 200 mg/kg/day dose groups was terminated on days 8 and 6, respectively, due to mortality and severe topical effects. Since a no eff ect level could not be established with the tested doses a 2 mg/kg/day and another contro l group (8/dose) were added to the study. These rabbits were not inseminate d and were treated for 13 consecutive days.

The only effects observed at 2 mg/kg/day were erythema and desquamation. Uncoordinated movement and partial paralysis were observed on four consecutive days in 1/8 rabbits at 40 mg/kg/day. The effects were considered second ary to the local skin and stomach irritations caused by treatment with ADAA. In addition, thes e signs were not observed in a new conducted Combined Repeated Dose Toxicity Study w ith the Reproduction/Developmental Toxicity Screening Test (MRID 47731301) at a dose of 50 mg/kg/day (oral dosing). A slight reduction (3-4%) in body weight gain and food consump tion occurred at all doses. Skin irritation (erythema, desquamation, atonia, and fissure) were observed at ≥ 40 mg/kg/day. The effects ranged from slight with recove ry at 2 mg/kg/day to marked and persistent at 100 and 200 mg/kg/day. The maternal systemic toxicity NOAEL was 40 mg/kg/day based on mortality seen at 100 mg/kg/day and above.

An increased incidence of resorptions occurred at ≥ 100 mg/kg/day. A decrease in average litter size (live fetuses) was observed at ≥ 100 mg/kg/day. The developm ental toxicity NOAEL is 40 mg/kg/day. The results of this study may not be used for ri sk assessment purposes since the effect of vehicle used in dermal application of the test material could not be assessed and sever skin irritation at all doses was reported.

Range-finding Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test

In a dose range-finding study for a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Sc reening Test (MRID 47731302), Ag-RHO FKC 1000 (Batch # W17C078716) in Milli-Q water was admini stered by gavage to groups of three male and three female Han Wistar rats at doses of 0, 33, 100, 300, or 1000 mg/kg bw/day for 14 days before mating. The males remained on trea tment throughout mating, and post-mating up to a total treatment time of 28 days. Females re mained on treatment throughout mating and up to post coital day 13. Males and females in the same dose group were paired until evidence of mating was observed (copulatory plug or sperm in vaginal smear); the day of mating was designated as post coital (gestation day) 0. All animals were observed twice daily for mortality and once daily for clinical signs. Food consump tion was measured at 3 or 4 day intervals for males throughout and for females during the pre-ma ting period and at weekly intervals during gestation. Body weights were measured daily in all animals. Males were s acrificed at the end of treatment on day 28, and surviving females were sacrificed on gestation day 14. In males, abnormal organs were excised and fixed; in fe males, the uterus was evaluated for fertility,

### Page 10 of 47 number and distribution of impl antation sites, live or dead embryos, and early and late embryonic deaths. The number of corpora lu tea was counted; abnormal organs were fixed.

All animals in the 1000-mg/kg/day group died wi thin 24 hours of receiving the first dose; no clinical signs were observed. The remain ing animals survived until termination.

At 300 mg/kg/day, clinical sign in cluded pushing head through the bedding after the daily dosing and sedation in males and females and hunched back in females. These clinical signs were indicative of local irritation. Food consumpti on was reduced by 20% in males and 29% in females, and weight gain during the pre-mati ng period was decreased by 45% in males and 63% in females. Males gained 38% more weight than controls during mating, and 19% more during the post-mating period. No effect was obser ved on body weight gain of females during gestation. The only other abnormality observed was reduced size of testes and epididymides in one male rat.

At 100 mg/kg/day, the only clinical sign observed in male and female rats was pushing the head through the bedding after th e daily dosing which was considered as secondary effects due to local irritation. Food consumption was reduced by 10% in males and was similar to that of controls in females. Weight gain was decrea sed by 27% in males and was unaffected in females during the pre-mating period; wei ght gain was reduced by 14% during mating and was similar to that of controls during the post- mating period in males. Gestati onal weight gain was slightly increased in females compared w ith that of controls. The NOAEL for parental systemic toxicity in the range finding st udy was 33 mg/kg/day.

At 300 mg/kg/day, no effect was observed on the mating index. One female did not become pregnant, thus reducing the fertili ty and conception indices to 67% . There was a small, but not significant reduction in the mean number of cor pora lutea and the mean number of live embryos; no dead embryos were found. The mean number of implantation sites was not affected by treatment. Post-implantation losses we re observed (1.5/dam vs 0 in controls).

At 33 and 100 mg/kg/day, no treatment-related re productive or developmental effects were observed. The mean number of post-implantation losses was 2.0 and 1.3 at 33 and 100 mg/kg/day, respectively. The lack of a dose-respon se relationship indicates that this finding is not treatment related. The NOA EL for reproductive and developm ental toxicity in the range finding study was 100 mg/kg/day.

Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (Main Study)

In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (MRID 47731301), Ag-RHO FK C 1000 (Batch # W17C078716) in Milli-Q water was administered by gavage to groups of 10 male and 10 fema le Han Wistar rats at doses of 0, 50, 150, or 300 mg/kg bw/day for 14 days before mating. Males remained on treatment during mating and after mating for a total of 28 days. Females remained on treatment during mating, gestation, and up to post partum day 4. A neurobehavioral assessment (functional observational battery (FOB) and locomotor assessm ent) was conducted prior to sacrifice at study

### Page 11 of 47 termination. Male rats were sacrificed at th e end of treatment on day 28, surviving offspring on post partum day 5, and females on post partum day 5 or post coital day 25 if the animals were not pregnant.

No parental animals died during treatment. Treatment-related c linical signs were observed in both sexes in the mid-dose (pushing head through th e bedding after daily treatments with the test material) and high-dose groups (ruffled fur, dia rrhea, sedation, and saliva tion) throughout most of the study. General poor c ondition was noted in males in th e high-dose group from pre-mating days 5-11. Ruffled fur, diarrhea, and sedati on were observed in both sexes and general poor condition in males in the high- dose group during the detailed week ly clinical examination. These clinical signs were considered due to local irritation at 150 and 300 mg/kg/day.

During the first 8 days of the pre-mating peri od, males and females in the high-dose group lost weight (-21 g and -11 g, resp ectively) and controls gained weight (22 g and 11 g, respectively), and the high-dose group gained 88% (males) and 32% (females) less weight than controls overall during the pre-mating peri od and the males gained 28% less weight than controls during the mating period. The weight loss and decreased weight gain resulted in significantly decreased absolute body weight in males in the high-dose group throughout the study ranging from 8-13% less than that of controls for most of the study. Mid-dose group males gained 24% less weight than controls over the entire pre-mating period. Females in the highdose group weighed significantly less (5-10%) th an control during pre-mating days 3-11 only. Food consumption was reduced in both sexes in the high-dose group during the pre-mating period, particularly during the first 8 days.

No treatment-related hematological changes in e ither sex or clinical chemistry changes in females were observed in this study. The only tr eatment-related clinical chemistry change in male rats was elevated serum urea in the mi d- and high-dose groups without collaborating histological findings at the mid dose. The post-mortem assess ment showed an increase (13%) in relative kidney weight in males at the high dose only. There were no changes in organ weights considered treatment related and toxicological ly significant at the remaining doses. Gross findings included thickened stomach in both sexe s at the high-dose leve l and retractions in females at the mid- and high-dose levels. Micros copic examination showed that the stomach and kidneys and urinary bladder are the primary target s affected by the test substance. Treatmentrelated kidney lesions in males and female s in the high-dose group included urothelial hyperplasia, collecting duct hyperp lasia, tubular basophilia, gr anular casts, and mononuclear infiltrates in the kidneys and ur othelial hyperplasia in the urinary. Granular casts were observed in one male at the mid-dose level. Treatment -related forestomach lesions were observed at all dose levels in females and in the mid- and high-do se level in males. Treatment-related lesions in both sexes at the high-dose level included ulcerations/erosion, squamous hyperplasia, hyperkeratosis, parakeratosis, pustules, submucos al inflammation, and submucosal edema. The same microscopic lesions were observed in the fo restomach of male and female rats in the middose group and in female rats in the low-dose group. Submucosal edema was observed in one male in the low-dose group. No treatment-rela ted microscopic lesions were observed in the glandular stomach of males, bu t submucosal inflammation and submucosal edema were observed in females at the high-dose level and submucos al edema at the mid-dose level. The remaining treatment-related microscopic le sions, which were considered secondary to treatment and

### Page 12 of 47 indicative of the irritative proper ties of the test substance, incl uded increased granulopoiesis in males at the mid- and high-dose levels and in fe males at all dose levels and extramedullary hematopoiesis in the adrenal glands in females at the high-dose level.

The lowest-observed-adverse-eff ect level (LOAEL) for Ag RHO FK C 1000 for parental toxicity in rats is 50 mg/kg bw/day based on microscopi c lesions in the forestomach. The no-observedadverse-effect level (NOAEL) could not be dete rmined. Since the forestomach local irritation effects are not considered relevant for risk asse ssment, the NOAEL for systemic toxicity was 150 mg/kg/day based on body weight changes, increa sed in blood urea, increased in kidney/body weight ratio, and microscopic changes in the kidneys at 300 mg/kg/day (LOAEL).

Body weight and body weight gain of females in the high-dos e group during gestation days 14- 21 was significantly decreased compar ed with that of controls. Th e decrease may be due in part to the increase in post-implantation losses resulti ng in decreased number of offspring and to a reduction in food consumption. No treatment-re lated effect was observed on the spermatogenic cycle in male rats. No treatment-related effect s were observed on the precoital interval, gestation interval, or the mating, conception, fertility or ge station indices. The mean numbers of corpora lutea and implantation sites were reduced in the high-dose group but not significantly; the total (30 vs 2 in controls) and mean number of impl antation losses (3.0 vs 0.3 for controls), mean number of live pups delivered (9.2 vs 14.5 for cont rols) were significantly decreased in the highdose group. The number of litters at the high-dos e level with implantation losses was also increased (8 vs 2 for controls). Treatment-rela ted offspring effects were observed at the highdose level; these included increased number of post-natal deaths (9 vs 0 in controls), decreased mean litter size on day 4 (8.3 vs 14.5 for controls), decreased birth index (75.4% vs 98.3% for controls), decreased vi ability index (90.2% vs 100% for controls), and decreased pup body weight. No treatment-related re productive or developmental effect s were observed in the low- or mid-dose groups.

The LOAEL for reproductive/developmental toxi city in rats is 300 mg/kg bw/day based on increases in implantation losses, decreased birth and viability indices, and decreased pup weight. The NOAEL is 150 mg/kg bw/day.

Mutagenicity studies

In two Ames assays, S. typhimurium strains TA 98 and TA100 were exposed to ADAA in the presence and absence of metabolic activation. Th ere was no increased incidence of revertants. No significant increase in chromo somal aberrations was observed in in vitro cytogenetics studies.

Carcinogenicity

No animal carcinogenicity studies are available in the database. Based on SAR analysis, no structural alerts for carci nogenicity were identified.

### Page 13 of 47 Metabolism

There are no published or unpublished ADA A metabolism studies. However, ADAA are expected to metabolized via three potential me tabolic pathways: 1) omega oxidation followed by beta oxidation of the carbon chain, 2) conjugation of ADAA at the carboxylic acid portion of the molecule by any of a number of amino acids, or 3) glucuronidation at the same site on ADAA, followed by elimination.

For the purpose of this risk assessment, a protective overall NOAEL of 40 mg/kg/day was selected for all exposure scen arios based on weight-o f-evidence from three studies in which systemic toxicity was observed at doses of 100 mg/kg/day or above. The different NOAELs observed in these studies are due to the dose se lection process. For example, a NOAEL of 33 mg/kg/day and LOAEL of 100 mg /kg/day (based on pushing head through bedding, decreased food consumption and weight ga in) were established in a range finding study for a combined reproduction/ developmental toxicity screeni ng test. In the main study, Organization for Economic Cooperation and Development (OECD) co mbined repeated dose toxicity study with the reproduction/developmental toxicity screen ing test, the LOAEL wa s established at 50 mg/kg/day (lowest dose tested). However, the LOAEL was based on irritation in the forestomach of rats due to the physical/chemical properties of ADAA, wh ich was not considered relevant for human risk assessments. Also, the NOAEL of 40 mg/kg/day is considered to be protective of marginal decreases in body weights seen at the LOA EL of 50 mg/kg/day in the oral development toxicity study in rats because body weight effects were not observed in the OECD 422 study (main study) at a dose level of 150 mg /kg/day. Additionally, this NOAEL is supported by the developmental dermal toxicity study in the rabbit. In this study, a NOAEL of 40 was established based on the effect s (uncoordinated movement, part ial paralysis and increased incidence of resorptions) observe d at 100 mg/kg/day in the pres ence of sever skin irritation.

### Page 14 of 47 Table 4:Toxicology Profile for ADAA Study Mg/kg/day NOAEL/LOAEL 870.3650 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (Range finding study) 0, 33, 100, 300, 1000 Parental NOAEL= 33 mg/kg/day Parental LOAEL=100 mg/kg/day based on decreased body weight gains Reproductive and Offspring NOAEL=100 mg/kg/day Reproductive and Offspring =300 mg/kg/day based on post implantation loss 870.3650 Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (Main Study) 0, 50, 150, or 300 mg/kg bw/day Parental systemic toxicity NOAEL= 150 mg/kg/day Parental LOAEL= 300 mg/kg/day based on body weight changes, increased in blood urea, increased in kidney/body weight ratio, and microscopic changes in the kidneys. Reproductive and Offspring toxicity NOAEL=150 mg/kg/day Reproductive and Offspring toxicity LOAEL=300 mg/kg/day based on increases in implantation losses, decreased birth and viability indices, and decreased pup weight 870.3700

Oral Developmental toxicity study- rats 0, 50, 150 or 250 mg/kg/day Parental systemic toxicity NOAEL = not established Parental systemic toxicity LOAEL= 50 mg/kg/day based on body weight changes Developmental toxicity NOAEL=150 mg/kg/day Developmental toxicity LOAEL=250 mg/kg/day increased incidence of litters with reduced ossification and unossification of the skull, sternabrae #5 and/or 6 and other sternabrae 870.3700

Dermal Developmental toxicity study- rabbits 0, 2, 10, 20, 40,100 or 200 mg/kg/day Parental systemic toxicity NOAEL = 40 mg/kg/day Parental LOAEL= 100 mg/kg/day based on mortality Developmental toxicity NOAEL=40 mg/kg/day Developmental Toxicity LOAEL=100 mg/kg/day based on resorption and decrease in litter size

### Page 15 of 47 Toxicity Endpoint Selection Table 5: Summary of Toxicological Doses and Endpoints for AADA for Use in Human Health Risk Assessment Exposure/Scenario Point of Departure and Uncertainty/Safety Factors RfD, PAD, LOC for Risk Assessment Study and Toxicological Effects

Acute dietary (General population including infants and children) The Agency notes that surfactants ar e surface active materials that can damage the structural integrity of cellular membranes at high dose levels. Moderate acute toxicity is associated with c12-ADAA. However, these effects are consider ed local irritations rather than systemic toxicity. Therefore, this endpoint is not appr opriate for risk assessment. In addition, no endpoint of concern attributed to a single dose was identified in the database. Chronic dietary (All populations) NOAEL= [40 ] mg/kg/day UF A 

### = [10 ] x UF H 

### = [10 ] x FQPA SF = [11x Chronic RfD = [0.4 ] mg/kg/day

cPAD = [0.4 ] mg/kg/day Overall NOAEL based on three studies OECD 422 range finding and main study Developmental toxicity study in rabbits via dermal route, Oral developmental toxicity study in rats Incidental oral short-and intermediate term (1 to 30 days) (1 to 6 months) NOAEL= [40 ] mg/kg/day UF A 

### = [10 ] x UF H 

### = [10 ] x FQPA SF = [11x LOC for MOE

= [100 ] Overall NOAEL based on three studies OECD 422 range finding and main study Developmental toxicity study in rabbits via dermal route, Oral developmental toxicity study in rats Dermal short- and intermediate term (1 to 30 days) (1 to 6 months) NOAEL= [40 ] mg/kg/day UF A 

### = [10 ] x UF H 

### = [10 ] x FQPA SF = [11x

10% dermal absorption factor LOC for MOE

= [100 ] Overall NOAEL based on three studies OECD 422 range finding and main study Developmental toxicity study in rabbits via dermal route, Oral developmental toxicity study in rats

### Page 16 of 47Inhalation shortand intermediate term (1 to 30 days) (1 to 6 months) 100% inhalation absorption LOC for MOE

= [100] Overall NOAEL based on three studies OECD 422 range finding and main study Developmental toxicity study in rabbits via dermal route, Oral developmental toxicity study in rats

Cancer (Oral, dermal, inhalation) Not necessary. No cancer concerns were identified.

UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). UF L = use of a LOAEL to extrapolate a NOAEL. UF S = use of a short-term study for long-term risk assessment. UF DB = to account for the absence of data or other data deficiency. FQPA SF = Food Quality Protection Act Safety Factor. PAD = popul ation adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.



### VI. Special Considerations for Infants and Children

Section 408(b)(2)(c) of FFDCA provides that EP A shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effect s to account for prenatal and postnatal toxicity and the completeness of th e database on toxicity and exposure unless EPA determines, based on reliable data, that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act (FQPA) safety f actor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliabl e data is available to EPA to support the choice of a different factor. EPA concluded that th e FQPA safety factor should be reduced to 1 X for ADAA.

There was no evidence of increased susceptibil ity of infants and children in the available developmental toxicity studies via dermal and oral routes of exposure. In these studies, developmental toxicity was observe d in the presence of maternal t oxicity and/or at one dose level higher. There was no evidence of increased susc eptibility of infants and children in the OPPTS 870.3650 study (OECD 422) study. In th is study, the maternal toxicity was manifested as body weight changes and microscopic ch anges, while the fetal toxicity was manifested as increased implantation losses and decreased pup weight. The maternal and developmental NOAEL was 150 mg/kg/day.

EPA has determined that reliable data show th at the safety of infants and children would be adequately protected if the FQ PA SF were reduced to 1X. That decision is based on the following findings:

i.The database is considered adequate for FQPA assessment. The following acceptable studies are available:

### Page 17 of 47

Developmental toxicity study in rats (1) Developmental dermal toxicity study in rabbits Combined development/reproduction re peated dose toxicity study (1)

ii. Fetal susceptibility was not observed in the oral developmental toxi city study in the rat, the developmental dermal toxicity study in the rabbit or in the OPPTS Harmonized Test Guideline 870.3650 study. In these studies, fetal toxicity was observed at doses that were higher than the dose that caused maternal toxicity. Therefore, there are low concerns or residual uncertainties concerning pr e- and postnatal toxicity.

iii. Clinical signs of neurotoxicity (uncoordi nated movement, partial paralysis) were observed in the developmental dermal study in the rabbit. However, no effects on Functional Observation Battery (FOB) parame ters were observed at doses up to and including 300 mg/kg/day in the OPPTS 870.3650 (OECD 422 study). Therefore, EPA concluded that the developmental neurotoxicity study is not required.

iv. No evidence of immunotoxicity was observed in the database.

v. No chronic toxicity or carci nogenicity studies are available in the database, however the Agency notes that surfactants are surface-activ e materials that can damage the structural integrity of cellular membranes at high dose le vels. Thus, surfactants are often corrosive and irritating in concentrated solutions. The observed toxicity seen in the repeated dose studies, such as microscopic lesions or decr eased body weigh gain, are attributed to the corrosive and irritating nature of these surfactants. The Agency has considerable toxicity information on surfactants, which indicates that the effects do not progressively increase in severity over time. In addition, use of the full 10X interspecies factor will actually provide an additional margin of safety because it is not expected that humans' response to local irritation/corrosiveness effects would be marked ly different from animals. The database on ADAA indicates that the target organ toxic ity is occurring at re latively high doses. Based on the above consideration, the Agency concluded that an additional FQPA safety factor for the lack of a ch ronic study is not necessary.

vi. The dietary food exposure assessment utiliz es highly conservative default assumptions and would not underestimate the dietary risk to all populations. For the purpose of the screening level dietary risk assessment to s upport this request for an exemption from the requirement of a tolerance for ADAA, a value of 100 ppb based on screening level modeling was used for the chronic dietary risk assessment. The value of 100 ppb is considered to be a high end, conservative assu mption that is not likely to underestimate drinking water risks.

Taking into consideration the available inform ation, EPA concludes the additional 10X FQPA safety factor can be reduced to 1X.

### Page 18 of 47 VII. Endocrine Disruption

EPA is required under the Federal Food, Drug a nd Cosmetic Act (FFDCA), as amended by FQPA, to develop a screening program to determ ine whether certain substances (including all pesticide active and other ingredient s) “may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” Following recommendations of its Endocrine Disruptor and Testing Advisory Committee (EDSTAC), EPA determined that there was a scientific basis for including, as part of the program, the androgen and thyroid hormone sy stems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommenda tion that the Program include evaluations of potential effects in wildlife. For pesticide chem icals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluati ons. As the science de velops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP).

When additional appropriate scre ening and/or testing protocol s being considered under the Agency’s EDSP have been developed, ADAA may be subjected to further screening and/or testing to better charact erize effects related to endocrine disruption.

VIII. Exposure Assessment

A. Dietary Exposure

In evaluating dietary exposure to ADAA, EPA considered exposure und er the petitioned for exemptions from the requirement of a toleran ce. EPA assessed dietar y exposure from ADAA in food as follows:

*Residues of Concern

Sufficient data were provided on the chemical identity of ADAA, how ever, limited data are available on the metabolism and environmental degradation of these compounds. The Agency relied collectively on information provided on th e representative chemical structures, the submitted physicochemical EPI Suite TM 

### data, structure activity rela tionship information, as well as information on other surfactants and chemicals of similar size and functionality to determine the residues of concern for these inert ingredients. The residues of concern for risk assessment purposes are the parent compounds only.

*Quantification of Dietary Risk

* Acute The Agency notes the surfactants are surface-acti ve materials that can damage the structural integrity of cellular membranes at high dose levels. Moderate acute toxicity is associated with C12-ADAA. However, these effects are consider ed local irritations rather than systemic toxicity. Therefore, this endpoint is not appropria te for risk assessment. In addition, no endpoint of concern attributed to a single dos e was identified in the database.

### Page 19 of 47

* Chronic In conducting the chronic dietary exposure asse ssment, EPA used food consumption information from the United States Department of Ag riculture (USDA) [19 94–1996 and 1998] Nationwide Continuing Surveys of Food Intake by Individu als (CSFII). As to residue levels in food, no residue data were submitted for ADAA. In the absence of specific residue data, EPA has developed an approach, which uses surroga te information to derive upper bound exposure estimates for the subject inert ingredient. Upper bound exposure estimates are based on the highest tolerance for a given commodity from a list of high-use insecticides, herbicides, and fungicides. A complete descripti on of the general approach taken to assess inert ingredient risks in the absence of residue data is contai ned in the memorandum entitled “Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chroni c Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments for the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

In the dietary exposure assessment, the Agency assumed that the residue level of the inert ingredient would be no higher than the highest tolerance for a give n commodity. Implicit in this assumption is that there would be similar rates of degradation (if any) between the active and inert ingredient and that the con centration of inert ingredient in the scenarios leading to these highest of tolerances would be no higher than the concentration of the active ingredient.

The Agency believes the assumptions used to esti mate dietary exposures lead to an extremely conservative assessment of dietary risk due to a series of compounded conservatisms. First, assuming that the level of residue for an inert ingredient is equal to the level of residue for the active ingredient will overstate e xposure. The concentrations of active ingredient in agricultural products is generally at least 50 percent of the product and often can be much higher. Further, pesticide products rarely have a single inert ingred ient; rather there is generally a combination of different inert ingredients used which additionall y reduces the concentration of any single inert ingredient in the pesticide produc t in relation to that of the active ingredie nt. In the case of ADAA, EPA made a specific adjustment to the di etary exposure assessment to account for the use limitations of the amount of ADAA that may be in formulations (no more than 20% by weight in pesticide formulations) and a ssumed that ADAA are present at the maximum limitation rather than at equal quantities with the active ingredient. This remains a very conservative assumption because surfactants are generally used at levels far below this percentage.

Second, the conservatism of this methodology is compounded by EPA’s decision to assume that, for each commodity, the active ingredient which w ill serve as a guide to the potential level of inert ingredient residues is the active ingredie nt with the highest tolerance level. This assumption overstates residue values because it would be highly unlikely, given the high number of inert ingredients, that a single inert ingredient or class of ingredients would be present at the level of the active ingredient in the highest tolerance for every commodity. Finally, a third compounding conservatism is EPA’s assumption that all foods contain the in ert ingredient at the highest tolerance level. In other words, EPA assumed 100 percent of all foods are treated with the inert ingredient at the rate and manner n ecessary to produce the hi ghest residue legally possible for an active ingredient. In summ ary, EPA chose a very conservative method for

### Page 20 of 47 estimating what level of inert residue could be on food, then used this methodology to choose the highest possible residue that co uld be found on food and assumed that all food contained this residue. No consideration was given to potenti al degradation between harvest and consumption even though monitoring data shows that tolerance level residues are typica lly one to two orders of magnitude higher than actual residues in food when distributed in commerce.

Accordingly, although sufficient information to qua ntify actual residue levels in food is not available, the compounding of these conserva tive assumptions will lead to a significant exaggeration of actual exposures. EPA does not believe that this approach underestimates exposure in the absence of residue data.

* Cancer ADAA is not expected to be carcinogenic since there was no evidence of carcinogenicity in the available studies. Since the Agency has not iden tified any concerns for carcinogenicity relating to ADAA, a cancer dietary exposure assessment was not conducted.

*Drinking Water Residue Profile For the purpose of the screening level dietary risk assessment to suppor t this request for an exemption from the requirement of a toleran ce for ADAA, a conserva tive drinking water concentration value of 100 ppb, based on screen ing level modeling, was used to assess the contribution to drinking water for the chronic dietary risk assessments for parent compound. These values were directly entere d into the dietary exposure model.

B. Non-Dietary Exposure

The term “residential exposure” is used in this document to refer to non-occupational, nondietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). ADAA may be used as inert ingredie nts in pesticide products that are registered for specific uses that may resu lt in both indoor and outdoor residential exposures. A screening level residential exposure and risk assessment was completed for products containing ADAA as inert ingredients. The ADAA inerts ar e used in pesticide formulations that may be used around the home in pesticide formul ations used on lawn, turf, or gardens. In addition, these inerts may be present in pers onal care products. The Agency selected representative scenarios and conducted an a ssessment to represent worst-case residential exposure by assessing ADAA in pesticide formul ations (outdoor s cenarios) and ADAA in disinfectant-type uses (indoor scenarios). Based on informati on contained in the petition, ADAA can be present in personal care products (maxim um concentration 5%). Therefore, the Agency assessed the personal care products containing ADAA using exposure scenarios used by OPP’s Antimicrobials Division to repres ent worst-case resi dential handler exposure. The Agency conducted an assessment to represent worst- case residential exposure by assessing post application exposures and risks from ADAA in pesticide formula tions (Outdoor Scenarios) and ADAA in disinfectant-type uses (Indoor Scenarios). All estimated MOEs were below the level of concern for RD. Further details of this resi dential exposure and risk analysis can be found at http://www.regulations.gov in the memorandum entitled JITF Inert Ingredients. Residential and Occupational Exposure Assessment Algorith ms and Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exem ption from the Requirement of a Tolerance

### Page 21 of 47 When Used as Inert Ingredients in Pesticide Formulations ” (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.

IX. Cumulative Exposure Section 408(b)(2)(D)(v) of FFFDC A requires that, when consid ering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide’s re sidues and “other substances that have a common mechanism of toxicity.”

Unlike other pesticide ingredients for which EP A has followed as cumulative risk approach based on a common mechanism of to xicity, EPA has not made a co mmon mechanism of toxicity finding as to ADAA acetate and any other subs tances and, ADAA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that ADAA has 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 th e cumulative effects of such chemicals, see the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and proc edures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pest icides/cumulative/

.

X. Occupational Exposure Occupational handler risks are not of concern fo r all scenarios except for workers using a low pressure hand wand to apply pesticides containi ng ADAA to ornamentals in greenhouse settings. Since MOEs for workers applying pesticides to ornamentals in greenhouses do not exceed an MOE of 100, the Agency has provided additional exposure and risk estimat es reflecting reduced amounts of ADAA in all pesticide formulations. The Agency does not believe that it is routine for workers to wear gloves for these scenario s. MOEs exceed 100 at a concentration of 20% ADAA as an inert ingredient is pesticide formula tions. A more complete list of results can be found in Appendix C.

The Agency notes that that the occupational handler assessment assumes that mixer/loader/applicators who are handling pe sticides containing ADAA for aerial and ground application on high acreage crops or turf will we ar chemical resistant gloves. The Agency believes this is a reasonable assumption given the volume of pesticide handled for these applications.

Occupational post application hand ler risks exceed and MOE of 100 on the day of application for all scenarios except for postappl ication activities invol ving herbicides, insecticide and fungicides on corn, specifically the hand-harv esting/detassling scenario. Thos e scenarios results an MOE of 44, 46 and 92 respectively on the day of application (Day 0). The Agency notes that it is not expected to be typical agricultu ral practice to apply herbicides, insecticides or fungicides on the same day workers would be conducting hand harvesting and detassling activities.

### Page 22 of 47 XI. Environmental Justice Statement Potential areas of environmental ju stice concerns, to the extent possi ble, were considered in this human health risk assessment, in accordance w ith U.S. Executive Order 12898, “Federal Actions to Address Environmental Just ice in Minority Populations an d Low-Income Populations,” http://www.eh.doe.gov/oepa/ guidance/justice/eo12898.pdf

..

XII. Environmental Fate and Drinking Water Consideration

The estimated physical and chemical properties fo r ADAA listed in Table 2 provide the basis for the environmental fate consideration of this chemical in regards to its use as an inert ingredient in pesticide products. All the values in the table were estimated using EPI Suite TM



### . The octanol-water partition coefficient (log Kow) indicates whether a ch emical is hydrophilic or lipophilic in an aquatic environment. The es timated log Kow values range from 0.47 to 4.44, indicating that ADAA has a similar affinity for wate r and lipids to a slight ly higher affinity for lipids than water and is not likel y to bioconcentrate. Water so lubility was estimated at 0.29 - 0.0025 mg/l, indicating that the subj ect chemical is slightly sol uble. However, due to model constraints it is believed that EPI Suite TM 

### underestimates the water solubility of this chemical. The estimated values for melting point (222-243 oC) and boiling point (520-566 oC) are high. These two factors, in combina tion with the predicted vapor pressure (6.88E-11-2.42E-12 mmHg at 25 oC) indicate that the subject chemical exis ts primarily as a solid. The low Henry’s Law Constant (1.4E-14-2.74-E-15 atm-m3/mole at 25 oC ) also indicates that ADAA is not likely to volatilize from surface water.

The Organic Carbon Absorption Coefficient (Log Ko c) values demonstrate the likelihood of a chemical to partition to soil or se diment from water. The estimated log Koc values (2.8 to 3.8) of ADAA suggest sorption to soils and sedime nts may occur and are not likely to enter groundwater.

The probability of rapid biodegradation was esti mated using methods and modules within EPI Suite TM 

### . In general, values greater than 0.5 indicate rapid biodegradation or th at the test material is readily degradable, while valu es less than 0.5 indicate “not ra pid biodegradation” or that the test material is not readily biodegradable. (EPA , 2005) The estimated values for probability of rapid biodegradation are listed in Table 2 and all indicate that ADAA is likely to undergo rapid biodegradation and that it is readily degradable.

The potential for ADAA to bioconcentrate in aq uatic organisms was determined by EPI Suite TM



### . The bioconcentration factor (BCF) is the ratio (in L/kg) of a ch emical’s concentration in the tissue of an aquatic organism to it concentration in ambient water, when exposure of the organism is to waterborne chemicals only, not including dietary intake. (EPA, 2005) Measured values that are greater than or equal to 5000 are considered to have high bioconcentration potential, 1000-5000 are moderate, and less than 1000 are considered low. Since the estimated value for ADAA is 70.78, this indicates that ADAA is not expected to bioconcentrate in aquatic organisms.

### Page 23 of 47 The fugacity model within EPI Suite TM 

### provides screening level pred ictions of environmental partitioning (percent in each me dia) of chemicals between air, soil, sediment, and water under steady state conditions for a default model “envi ronment”. This information is useful in determining where a chemical is most likely to reside once it has b een released to the environment. (EPA, 2005) The estimated values for ADAA indicate that once the chemical is released to the environment, 81.2-83.0% woul d reside in soil, 0.321-3.25% would reside in sediment and 1.64 E-5 to .0000119% would be in the air.

The EPI Suite TM 

### estimated values for the physical and chemical properties of ADAA indicate that it will have minimal impact on the envir onment. The results indicate that ADAA is not likely to bioconcentrate and is readily biodegradab le. It is also not likely to volatilize from surface water. ADAA is expected to partition prim arily to soil, but the small amounts that enter the water will readily degrade.

XIII. Ecological Assessment

The ecotoxicity of ADAA was estimated using Ecological Structure Ac tivity Relationships (ECOSAR). ECOSAR is a computerized predictive system that estimates th e aquatic toxicity of industrial chemicals. The program estimates a chemical's acute (short-term) toxicity and chronic (long-term or delayed) toxicity to aquatic orga nisms such as fish, aquatic invertebrates, and aquatic plants by using Structur e Activity Relationships (SARs). ( http://www.epa.gov/oppt/newchems/tools/21ecosar.htm )

The estimated ecotoxicity values for C 12-ADAA, C14-ADAA and C16-ADAA are listed in Tables 6, 7, and 8. The results indicate that the ecotoxicity of ADAA ranges from practically nontoxic to slightly toxic. Table 6: ECOSAR Predicted Calculations for C12-ADAA (CAS Reg. No. 683-10-3) Organism Duration End Point Predicted mg/L (ppm)

Fish 96-hr LC50 805.746* Fish 14-day LC50 820.957* Daphnid 48-hr LC50 487.380* Green Algae 96-hr EC50 284.300 Fish 30-day ChV 86.658* Daphnid ChV 60.914 Green Algae ChV 117.581 Fish (SW) 96-hr LC50 1080.529* Mysid Shrimp 96-hr LC50 572.753* Fish (SW) ChV 154.155 Mysid Shrimp (SW) ChV 43.012 Earthworm 14-day LC50 4245.049* * Asterisk designates: Chemical may not be soluble enough to measure this predicted effect

### Page 24 of 47

Table 7: ECOSAR Predicted Calculations for C14-ADAA (CAS Reg. No. 2601-33-4) Organism Duration End Point Predicted mg/L (ppm)

Fish 96-hr LC50 121.443* Fish 14-day LC50 125.710* Daphnid 48-hr LC50 84.938* Green Algae 96-hr EC50 75.902* Fish 30-day ChV 13.950 Daphnid ChV 12.403 Green Algae ChV 39.976* Fish (SW) 96-hr LC50 151.147* Mysid Shrimp 96-hr LC50 42.841* Fish (SW) ChV 40.859* Mysid Shrimp (SW) ChV 2.405 Earthworm 14-day LC50 3702.048* * Asterisk designates: Chemical may not be soluble enough to measure this predicted effect



### Table 8: ECOSAR Predicted Calculations for C16-ADAA (CAS Reg. No. 693-33-4) Organism Duration End Point Predicted mg/L (ppm)

Fish 96-hr LC50 18.146* Fish 14-day LC50 19.083* Daphnid 48-hr LC50 14.674* Green Algae 96-hr EC50 20.089* Fish 30-day ChV 2.226 Daphnid ChV 2.504 Green Algae ChV 11.528* Fish (SW) 96-hr LC50 20.960* Mysid Shrimp 96-hr LC50 3.177 Fish (SW) ChV 10.736* Mysid Shrimp (SW) ChV 0.133 Earthworm 14-day LC50 3200.555* * Asterisk designates: Chemical may not be soluble enough to measure this predicted effect



### XIV. Risk Characterization Rhodia Inc. submitted a petition (#9E7557) propos ing to establish an exemption from the requirement of a tolerance under 40 CFR 180.920 (pre-harvest) and 40 CFR 180.930 (animal application) for residues of ADAA wh en used as a pesticide inert i ngredient, with a limit of up to 20% in pesticide formulations.

### Page 25 of 47 Currently, two of the CAS Reg. Nos. (CAS Reg. Nos. 2601-33-4 and 693-33-4) for which Rhodia is requesting tolerance exemptions, are on the list for Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products. The compon ents of ADAA are used in personal care products including liquid hand soap s, facial cleansers, shampoos and shower gels. These components function as foam boosters and typically used in these products at concentrations up to 5%. (Mintel GNPD Database, 2009; Wong, 1997)

Acute oral toxicity studies were perfor med using C12-ADAA and C16-ADAA. ADAA has moderate to low acute toxicity vi a the oral and dermal routes of exposure. Low acute toxicity is generally associated with C16-ADAA while modera te acute toxicity is associated with C12- ADAA. In acute dermal and eye irritation studies, C12-ADAA was se verely irritating to the skin and eyes. A mixture of C12- C16 ADAA was used in a local lymph node assay (LLNA) to evaluate the potential to cause skin sensitiz ation, C12-C16 ADAA was fo und to be a sensitizer; however, it gave a negative res ponse for skin sensitization in in vivo guinea pigs as determined by Magnusson-Kligman test.

Two developmental studies were available; an oral toxicity study in the rat and a screening level developmental dermal toxicity study in the rabbit. In the developm ental toxicity study in the rat, maternal toxicity was manifested as reduced body weight gain, staine d and matted haircoats, respiratory rates at 50 mg/kg/day and above. Offs pring toxicity was manifested as reduced or absent ossification of the skull, sternebrae #5 and/or #6, and other sternebrae at 250 mg/kg/day. The NOAEL for developmental toxicity was 150 mg/kg/day. In the screening level developmental dermal toxicity study in rabbits, ma ternal toxicity manifested as skin irritation, inhibition of body weight gain and decreased f ood consumption at doses of 100 mg/kg/day and above while offspring toxicity was manifested as increased incidence of resorptions and decreased average litter size at ≥ 100 mg/kg/day.

A dose range-finding and a main study of Combin ed Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Te st according to the OPPTS Harmonized Test Guideline 870.3650 study were av ailable in the rat. In the range-finding study, at > 100 mg/kg/day , a reduction was observed in mean food consumption, body wei ght, and body weight gain during the pre-pairing peri od in all animals. Also, anim als pushed their heads through the bedding throughout the treatme nt period at doses > 100 mg/kg/day. At 1000 mg/kg/d, mortality was observed in all animals within 24 hours. In the main OPPTS Harmonized Test Guideline 870.3650 study, parental toxicity was manifested as microscopic lesions (squamous hyperplasia, hyperkeratosis, submucosal inflammation and edema) in the forestomach at the lowest dose tested (50 mg/kg/day). Reproductive and developm ental toxicity was manifested as increased implantation losses, decreased birth and viabi lity indices, and decreased pup weight at 300 mg/kg/day (highest dose tested). The NOAEL fo r reproductive/developmental toxicity was 150 mg/kg/day.

Several mutagenicity studies (two Ames assays and chromosome aberration assay) were available for review. The results for these studi es were negative. No animal carcinogenicity studies are available in the database. Base d on SAR analysis, no structural alerts for carcinogenicity were identified.

### Page 26 of 47 Two in vitro dermal absorption studies were available in hairless mice. The dermal absorption factor of C12-ADAA and C16-ADAA was estimated to be <1%.

There are no published or unpublished ADA A metabolism studies. However, ADAA are expected to metabolized via three potential me tabolic pathways: 1) omega oxidation followed by beta oxidation of the carbon chain, 2) conjugation of ADAA at the carboxylic acid portion of the molecule by any of a number of amino acids, or 3) glucuronidation at the same site on ADAA, followed by elimination.

EPA determines whether acute a nd chronic pesticide exposures ar e safe by comparing aggregate exposure estimates to the aPAD and cPAD. Th e aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA cal culates the aPAD and cPAD by dividing the POD by all applicable UFs. For lin ear cancer risks, EPA calculates the probability of additional cancer cases given the estimated ag gregate exposure. Shor t-, intermediate-, and chronic-term risks are evalua ted by comparing the estimate d aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

There was no hazard attributable to a single exposu re seen in the toxicity database for ADAA. Therefore ADAA is not expected to pose an acute risk.

A chronic aggregate risk assessment takes into a ccount exposure estimates from chronic dietary consumption of food and drinking water. Using the exposure assumptions discussed in this unit for chronic exposure and the use limitation of not more than 20% by weight in pesticide formulations, the chronic dietary exposure fr om food and water to ADAA is 19.5% of the cPAD for the U.S. population and 62.9% of the cPAD fo r children 1-2 years old, the most highly exposed population subgroup. A more complete list of results can be found in Appendix A.

The Agency has not identified any concer ns for carcinogenicity relating to ADAA.

Short-term aggregate exposure takes into accoun t short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level)

. ADAA are used as inert ingredients in pesticide products that are curre ntly registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term re sidential exposures to ADAA

. Using the exposure assumptions described in this unit, EPA has concluded that the combined shortterm aggregated food, water, and residential expo sures result in aggregate MOEs of 110 for adult males and adult females. Adult residential e xposure combines high end dermal and inhalation handler exposure from indoor hard surface wipi ng with a high end post application dermal exposure from contact with treated lawns. EPA has concluded the combined short-term aggregated food, water, and residential exposu res result in an aggr egate MOE of 130 for children. Children’s residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). As the level of con cern is for MOEs that are lower than 100, these MO Es are not of concern.

### Page 27 of 47 Intermediate-term aggregate exposure takes into account intermediate-ter m residential exposure plus chronic exposure to food and water (consid ered to be a backgr ound exposure level). ADAA

are currently registered for uses that could result in intermediate -term residential exposure and the Agency has determined that it is appropriate to aggregate ch ronic exposure through food and water with intermediate-term residential exposures to ADAA. Using the exposure assumptions described in this unit, EPA has concluded that the combined intermedia te-term aggregated food, water, and residential exposures result in aggregate MOEs of 450 for adult males and adult females. Adult residential exposure includes hi gh end post application dermal exposure from contact with treated lawns. EPA has conclude d the combined intermediate-term aggregated food, water, and residential exposures result in an aggregate MOE of 150 for children. Children’s residential exposure includes total exposures associated with contact with treated lawns (dermal and hand-to-mouth exposures). As the level of c oncern is for MOEs that are lower than 100, this MOE is not of concern.

A more complete list of results for aggregat e exposure to ADAA can be found in Appendix B.

Taking into consideration all available inform ation on ADAA, EPA concl udes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to ADAA. Therefore, the establishment of an exemption from the requirement of a for residues of ADAA when used as an inert ingredient (surfactant) in pesticide formulations at a maximum of 20% in formul ation when applied pre-harvest under 40 CFR 180.920 and when applied to animals under 40 CFR 180.930 can be considered safe under section 408 of the FFDCA.

### Page 28 of 47 References

ChemIDplus Lite. Search date: August 10, 2009. http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp

Maynard, C.W. 1963. Haskell Laboratory. Report 3385. Sponsored by E.I. DuPont de Nemours & Co. June 13, 1963. EPA TSCA No. 8EHQ-1092-12353.

Mintel GNPD Databa se Search, 2009. http://www.gnpd.com/ Subscription service database contains persona l car product names, brands and ingredients. Search date: April 2, 2009. (As cited in PP#9E7557)

Pelcot, C. 2006. CIT Safety and Health Rese arch Laboratories. July 26, 2006. Lab study no. 31597 TSG.

Ridout, G., Hinz, R.S., Hostynek, JJ., Reddy, A.K., Wiersema, R.J., Hodson, C.D., Lorence, C.R. Guy, R.H. 1991. Fundam.Appl. Toxicol. 16:41-50.

Simon, G. (2009) Copies of Studies Cited in "Petition Proposing an Exemption from the Requirement of a Tolerance for Residues of (Inert Ingredient) under 40 CFR 180.920 and 180.930. Project Number: 040809. Unpublished study pr epared by Rhodia, Inc. 480 p. (MRID 47731303)

Technology Sciences Group, Inc. (on behalf of Rhodia, Inc.) 2009. Petition Proposing an Exemption from the Requirement of a Tolerance for Residues of “Alkyl (C12-C16) Dimethyl Ammonio Acetate (ADAA)” under 40 CF R 180.920 and 180.930. (US EPA Petition #9E7557)

US EPA. 2009. Estimation Programs Interface Suite TM 

### for Microsoft Windows, v 4.00. United States Environmental Protection Agency, Washington, DC, USA. http://www.epa.gov/oppt/expos ure/pubs/episuite.htm

US EPA. 2009. Ecological St ructure Activity Relationshi ps (ECOSAR) Class Program http://www.epa.gov/oppt/newchems/tools/21ecosar.htm

US EPA. 2009. Inert Ingredients Permitted for Use in Nonfood Use Pesticide Products Last Updated January 27, 2009. http://www.epa.gov/opprd001/inerts/inert_nonfooduse.pdf

US EPA. 2005. OPPTS Pollution Prev ention P2 Framework, 748-B-04-001-2005. http://www.epa.gov/oppt/sf/pubs/p2frame-june05a2.pdf

Wang-Fan, W. 2005. RCC Ltd., Study no. 859355. August 30, 2005.

Whitlow, S.; Flade, D.; Thio, T. (2009) Ag-R HO FKC 1000: Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxici ty Screening Test in the Han Wistar Rat: Final Report. Project Number: B62774. Unpublishe d study prepared by Harlan Laboratories, Ltd. 579 p. (MRID 47731301)

### Page 29 of 47

Whitlow, S.; Flade, D. (2008) Ag-RHO FKC 100 0: Dose Range-Finding Study for a Combined Repeated Dose Toxicity Study w ith the Reproduction/Developmenta l Toxicity Screening Test in the Han Wistar Rat. Project Number: B62763. Unpublished study prepared by RCC, Ltd. 212 p. (MRID 47731302)

Wong, M. 1997. “Cleansing of Hair .” In Hair and Hair Care. E. Dale H. Johnson. Marcel Dekker, Inc.: 1997. PP. 48. 49, 52-54.

“Alkyl Amines Polyalkoxylates (Cluster 4): Acute and Chr onic Aggregate (Food and Drinking Water) Dietary Exposure and Risk Assessments fo r the Inerts.” (D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.

JITF Inert Ingredients. Re sidential and Occupa tional Exposure Assessment Algorithms and Assumptions Appendix for the Human Health Risk Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations” (D364751, 5/7/09, Lloyd/LaMay in docket ID number EPA-HQ-OPP-2008-0710.

### Page 30 of 47 

# Appendices

### Page 31 of 47 Appendix A:

U.S. Environmental Protection Agency Ver. 2.00 DEEM-FCID Chronic analysis for ADAA DEEM (1994-98 data) Residue file name: C:\DEEMFCID\ADAA (20 percent limit) DEEM.R98

Adjustment factor #2 used. Analysis Date 09-14-2009/14:07:00 Residue file dated: 09-14-2009/13:55:06/8 Reference dose (RfD, Chronic) = .4 mg/kg bw/day NOEL (Chronic) = 40 mg/kg bw/day COMMENT 1: Inert 57 active ingredients + drinking water (100ppb) for ADAA (limit 20% in formulation)

=============================================================================== Total exposure by population subgroup

-------------------------------------------------------------------------------

Total Exposure

----------------------------------- Population mg/kg Margin of Percent Subgroup body wt/day Exposure 1/ of RfD

-------------------------------------- ------------- ---------- --------- U.S. Population (total) 0.077868 514 19.5%

U.S. Population (spring season) 0.079459 503 19.9% U.S. Population (summer season) 0.078852 507 19.7% U.S. Population (autumn season) 0.076480 523 19.1% U.S. Population (winter season) 0.076718 521 19.2%

Northeast region 0.084453 474 21.1% Midwest region 0.077463 516 19.4% Southern region 0.069793 573 17.4% Western region 0.085214 469 21.3%

Hispanics 0.082115 487 20.5% Non-hispanic whites 0.076323 524 19.1% Non-hispanic blacks 0.075316 531 18.8% Non-hisp/non-white/non-black 0.100337 399 25.1%

All infants (< 1 year) 0.162979 245 40.7% Nursing infants 0.086622 462 21.7% Non-nursing infants 0.191967 208 48.0% Children 1-6 yrs 0.200100 200 50.0% Children 7-12 yrs 0.097084 412 24.3%

Females 13-19 (not preg or nursing) 0.056466 708 14.1% Females 20+ (not preg or nursing) 0.060979 656 15.2% Females 13-50 yrs 0.063033 635 15.8% Females 13+ (preg/not nursing) 0.066766 599 16.7% Females 13+ (nursing) 0.078789 508 19.7%

Males 13-19 yrs 0.060208 664 15.1% Males 20+ yrs 0.058790 680 14.7% Seniors 55+ 0.062214 643 15.6%

**Children 1-2 yrs 0.251480 159 62.9%** Children 3-5 yrs 0.186542 214 46.6% Children 6-12 yrs 0.103337 387 25.8% Youth 13-19 yrs 0.058563 683 14.6% Adults 20-49 yrs 0.058941 679 14.7% Adults 50+ yrs 0.062073 644 15.5% Females 13-49 yrs 0.059332 674 14.8%

----------------------------------------------------------------------

### Page 32 of 47

Appendix B:

Table 1. Short-term Exposure and Risks for ADAA Residential Handlers
Exposure Scenario (Formulation/ Application) Application Rate 1 (lb

inert/ gallon) Quantity Handled/ Treated per day 2 Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure (mg/ lb inert) 3 Dermal Dose (mg/kg /day) 4 Inhalation Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8

Outdoor Products Liquids/ Low Pressure Handwand (ST) (ORETF data) 0.18 lb/gal 5 gallons 38 0.003 0.049 3.86E-5 820 1000000 820

Liquids/ Hose End Sprayer, Lawn (ST) (ORETF data) 0.18 lb/gal 5 gallons 11 0.017 0.014 0.00022 2800 180000 2800

Liquids/ Trigger Sprayer/ Home Garden (ST) (ORETF data) 0.18 lb/gal 5 gallons 54 0.0019 0.069 2.44E-5 580 1600000 580

Indoor Products
Indoor hard surface, Mopping (ST) (CMA data) 0.0065 lb/gal 1 gallon 71.6 2.38 0.00067 0.00022 60,000 180,000 45,000

Indoor hard surface, Wiping (ST) (CMA data) 0.417 lb/gal 0.13 gallons 2870 67.3 0.2223 0.05212 180 770 150

Indoor hard surface, Aerosol spray (ST) (PHED data) 0.417 lb/gal 0.094 gallons (12 oz) 220 2.4 0.0123 0.0013 3,200 30,000 2,900

1 Application rates are based on maximum application rates of products cont aining ADAA inerts multiplied by 20% for outdoor products and 5% for indoor products to convert from product application rate to inert application rate.
2 Quantity treated daily values for indoor products are assumed to be used at 1 gallon of solution for the mopping scenario, 0.5 L of solution for the wiping scenario, and a 12 oz can of spray for the aerosol spray/air deodorization scenario.
3 Unit Exposure data sources are identified in the exposure scenario column. All e xposure scenarios assess exposure reflecting applicators wearing short-sleeved shirts an d shorts and no respiratory protection.
4 Daily Dermal Dose = (Dermal Un it Exposure (mg inert /lb inert) * Application Ra te (lb /gal) * Quantity handled (gallons/day))/ Body Weight (70 kg) *Dermal Absorption factor (10%)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (mg inert / lb inert) * Appli cation Rate (lb /gal) * Quantity handled (gallons/day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/ day)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total MOE = 1/ [(1/ Dermal MOE) + (1/ inhalation MOE)]

### Page 33 of 47

Table 2. Residential Postapplication Short- and Intermediate-term Exposures and Risks for ADAAs Exposure Scenario Application Rate 1 

### Exposed Population &

Exposure Duration 2 

### Daily Dose (mg/kg/day) 3 

### MOE 4



### Outdoor Products Adult ST 0.021 

### 1900 Adult IT 0.011 

### 3800 Child ST 0.035 

### 1100 Dermal Exposure to Treated Lawns
Child IT 0.0175 

### 2300 Child ST 0.013 

### 3000 Hand-to-Mouth from Treated Lawn Child IT 0.0064 

### 6300 Child ST 

### 12000 Object-to-Mouth from Treated Lawn Child IT 0.0034

Child ST Soil Ingestion Child IT 4.51E-5 

### 890,000

Child ST 0.048 

### 830 Total Lawn Combined Exposures* 0.9 lb/day

Child IT 0.024 

### 1700


### Indoor Cleaning Product
Child ST Dermal Exposure to Treated Indoor Surface Child IT 0.00349 11000

Child ST 0.00425 9400 Hand-to-Mouth from Treated Indoor Surface Child IT 0.00202 20000

Child ST 0.00774 5200 Total Surface Combined Exposures* 6.5E-6 lb/ft 2

Child IT 0.00551 7300

1 Application rates for outdoor products assume 5 gallons used her day, wi th 1/10 dilution. Applic ation rates indoor products a re determined by assuming 0.5 gallons of solution used per day, 1 gallon used to treat 1,000 ft 2 of hard surface (0.5 gallons used treats 500 ft 2 ), a dilution rate of 2 ounces product per gallon of water in solution, solution is assumed to have a density of 8.34 lbs per gallon (density of water), and 5% in ert is assumed to be in product.
2 ST and IT indicate short- or in termediate-term exposure durations
3 Daily Dose = Daily Dose algorithms for various residential postapplication scenarios outlined in “ JITF Inert Ingredients. Residential and Occupa tional Exposure Assessment Algorithms and Assump tions Appendix for the Human Health Risk Assessments to Support Proposed Exemption from the Requirement of a Tolerance When Used as Inert Ingredients in Pesticide Formulations”, D364751, 5/7/09.
4 MOE = PoD (NOAEL of 40 mg/kg/day)/ Daily dose (mg/kg/day)
5 Combined exposures reflect the aggrega tion of dermal exposure to treated areas and HTM exposure from treated areas (for children). Total Combined Exposures = 1/ [(1 / Dermal MOE) + (1/ HTM MOE)]

### Page 34 of 47

Table 3. Short- and Intermediate-Term Re sidential Exposures for the ADAA Aggregate Risk Calculations Population Handler Exposure (mg/kg/day) 1 

### Postapplication Exposure (mg/kg/day) 2 

### Residential Exposure (mg/kg/day) 3


### Short-Term
Adult Male 0.27442 Indoor hard surface, Wiping (ST) 0.021 Dermal Lawn Exposure 0.29542

Adult Female 0.27442 Indoor hard surface, Wiping (ST) 0.021 Dermal Lawn Exposure 0.29542

Child N/A 0.048 Dermal + HTM Lawn Exposure 0.048



### Intermediate-Term

Adult Male N/A 0.011 Dermal Lawn Exposure 0.011

Adult Female N/A 0.011 Dermal Lawn Exposure 0.011

Child N/A 0.024 Dermal + HTM Lawn Exposure 0.024

1 – Handler exposure represents high end inhalation handler exposure, where the exposure duration is appropriate to assess. 2 – Postapplication exposure combines high end dermal and incidental oral exposure to outdoor or indoor products for the relevant exposure duration. 3 - Residential exposure represents handler exposure for short-term with combined post- application dermal a nd incidental oral
exposure.


### Short- and intermediate-term aggregate risk s are summarized in the table below.

Table 4. Short- and Intermediate-Term Aggregate Risk Calculations for ADAAs

Population PoD mg/kg/day LOC 1 Max Allowable Exposure 2 mg/kg/day Average Food & Water Exposure mg/kg/day Residential Exposure 3 mg/kg/day Aggregate dose (food and residential) 4 Aggregate MOE 5

Short-Term

Adult Male 40 100 0.4 0.077868 0.29542 0.373288 110

Adult Female 40 100 0.4 0.077868 0.29542 0.373288 110

Child 40 100 0.4 0.25148 0.048 0.29948 130
Intermediate-Term

Adult Male 40 100 0.4 0.077868 0.011 0.088868 450

Adult Female 40 100 0.4 0.077868 0.011 0.088868 450

Child 40 100 0.4 0.25148 0.024 0.27548 150

1 The LOC (Level of Concern) is base d on the standard inter- and intra-sp ecies uncertainty factors totaling 100.
2 Maximum Allowable Exposure (mg/kg/day) = PoD (Point of Departure)/LOC
3 Residential Exposure = [Oral exposure + Dermal exposure + Inhalation Exposure]. Sources identified above in Table XX
4 Aggregate dose = Avg Food & Water Exposure + Residential Exposure
5 Aggregate MOE = [PoD/ (Avg Food & Wate r Exposure + Residential Exposure)]

### Page 35 of 47

Appendix C.

Table 5. Exposure and Risks for Occupational Handlers of ADAA in Herbicide Products (All Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader Scenarios
Liquids/ Aerial Application/ High Acreage Crops (ST) 2.08 10.34 0.043 4 930 4

Liquids/ Aerial Application/ High Acreage Crops (IT) 0.4 1200 1.99 0.0082 20 4,900 20

Liquids/ Airblast/ Nut Tree (ST) 1.44 0.239 0.00099 170 41,000 170
Liquids/ Airblast/ Nut Tree (IT) 0.64 40 0.106 0.00044 380 91,000 380
Liquids/ Groundboom/ High Acreage Crops (ST) 2.08 1.723 0.00713 23 5,600 23
Liquids/ Groundboom/ High Acreage Crops (IT) 0.4 200 0.331 0.0014 120 29,000 120
Liquids/ Groundboom/ Turf (ST) 2.08 0.345 0.0014 120 28,000 120
Liquids/ Groundboom/ Turf (IT) 0.4 40 0.0663 0.00027 600 150,000 600
Liquids/ Low Pressure Handwand/ Turf (ST) 1.44 0.0298 0.00012 1,300 320,000 1,300
Liquids/ Low Pressure Handwand/ Turf (IT) 1.44 5 2.9 1.2

0.0298 0.00012 1,300 320,000 1,300

Wettable Powder/ Airblast/ Nut Tree (ST) 0.32 0.068 0.0079 590 5,100 530

Wettable Powder/ Airblast/ Nut Tree (IT) 0.32 40 0.068 0.0079 590 5,100 530

Wettable Powder/ Groundboom/ High Acreage Crops (ST) 0.32 0.338 0.039 120 1,000 110

Wettable Powder/ Groundboom/ High Acreage Crops (IT) 0.2 200 0.2114 0.0246 190 1,600 170

Wettable Powder/ Groundboom/ Turf (ST) 0.32 0.0677 0.0079 590 5,100 530

Wettable Powder/ Groundboom/ Turf (IT) 0.2 40 0.0423 0.0049 950 8,100 850
Wettable powder/ Low Pressure Handwand/ Turf (ST) 1.44 0.038 0.0044 1,100 9,000 940

Wettable powder/ Low Pressure Handwand/ Turf (IT) 1.44 5 3.7 43

0.038 0.0044 1,100 9,000 940 

### Applicator Scenarios
Liquid/ Aerial Application/ High Acreage Crops (ST) 9 2.08 0.0196 0.0024 2,000 16,000 1,800

Liquid/ Aerial Application/ High Acreage Crops (IT) 9 0.4 1200 Eng control only: 0.0055 Eng control only: 0.068 0.0038 0.0005 11,000 86,000 9,400

Airblast/ Nut Tree (ST) 0.32 0.0066 0.00082 6,100 49,000 5,400
Airblast/ Nut Tree (IT) 0.32 40 0.36 4.5 0.0066 0.00082 6,100 49,000 5,400

Groundboom/ High Acreage Crops (ST) 2.08 0.0083 0.0044 4,800 9,100 3,100
Groundboom/ High Acreage Crops (IT) 0.4 200 0.0016 0.00085 25,000 47,000 16,000

Groundboom/ Turf (ST) 2.08 0.00166 0.00088 24,000 45,000 16,000

Groundboom/ Turf (IT) 0.4 40 0.014 0.74

0.00032 0.00017 130,000 240,000 82,000 

### Mixer/Loader/Applicator Scenario

Low Pressure Handwand/ 1.44 5 No 6.6 NA 0.00068 NA 59,000 NA

### Page 36 of 47

Table 5. Exposure and Risks for Occupational Handlers of ADAA in Herbicide Products (All Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8

Turf (ORETF data) (ST) 10
Low Pressure Handwand/ Turf (ORETF data) (IT) 10 1.44 Data NA 0.00068 NA 59,000 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (ST) 10 1.44 NA 0.1131 NA 350 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (IT) 10 1.44 NA 0.1131 NA 350 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (LT) 10 1.44 5 No Data 1100

NA 0.1131 NA 350 NA

Liquid/ Low Pressure Handwand/ Ornamentals (ST) 1.44 1.029 0.0031 39 13,000 39

Liquid/ Low Pressure Handwand/ Ornamentals (IT) 1.44 1.029 0.0031 39 13,000 39

Liquid/ Low Pressure Handwand/ Ornamentals (LT) 1.44 5 100 30

1.029 0.0031 39 13,000 39 

### Flagger Scenarios
Liquid/ Flagger/ High Acreage Crops (ST) 2.08 0.039 0.0125 1,000 3,200 770
Liquid/ Flagger/ High Acreage Crops (IT) 0.4 1200 0.011 0.35 0.0075 0.0024 5,300 17,000 4,000

1 Application rates are based on ma ximum application rates of products containi ng inerts in ADAAs multiplied by 20% to convert to application rate of just inert in a product (Pesticide products assumed to contain a maximum of 20% inert ADAA). Application rates for Short-term (ST) expos ure risk estimates are based on maximum a pplication rates. Application rates for Intermediate-term (IT) and long-te rm (LT) exposures are based on average applic ation rates. Baseline Dermal PPE is single layer clothing, no gloves.
2 Area treated daily values are from the EP A HED estimates of acreage tr eated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess inhalation and dermal exposures with engineering controls.
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor (10%)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 ST Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhala tion dose (mg/kg/day)
8 Total Combined MOE = 1/ [(1/ De rmal MOE) + (1/ inhalation MOE)]
9 Aerial applicators do not have baseline exposure: only engineering control e xposure can be assessed. All other exposure scenarios assess baseline dermal (no gl oves) plus baseline inhalation exposure.
10 These scenarios have baseline inhalation unit exposures , but not baseline dermal unit expos ures. The M/L/A scenario assessed has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves derma l
exposure.

### Page 37 of 47

1 Application rates are based on ma ximum application rates of products containi ng inerts in ADAA multiplied by 20% to convert to application rate of just inert in a product (Pesticide produ cts contain a maximum of 20% inert ADAA). Application rates for Short-term (ST) exposure risk estimates ar e based on maximum application rates. App lication rates for Intermediate-term (IT) and long-term (LT) exposures are based on average application ra tes. Scenarios shown are with Baseline Dermal PPE (single layer clothing) plus gloves and Baseline Inhalation PPE (no respirator).
2 Area treated daily values are from the EP A HED estimates of acreage tr eated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess minimum dermal PPE (plus gl oves) plus baseline inhalation exposure.
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor of 10% (0.10)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Dai ly dose dermal + Daily dose inhalation (mg/kg/day)]
9 Exposure scenarios assess minimum derm al PPE (baseline PPE plus gloves) plus baseline inhalation exposure. 

### Table 6. Exposure and Risks for Occupational Handl ers of ADAA in Herbicide Products (All Exposure Durations) with Baseline Dermal PPE (single layer clothing) plus Gloves and Baseline Inhalation PPE (No respirator) for High Acreage Mixer/ Loader Scenarios

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Min PPE Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Min PPE Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader Scenarios
Liquids/ Aerial Application/ High Acreage Crops (ST) 9 

### 2.08 0.082 0.0428 490 930 320

Liquids/ Aerial Application/ High Acreage Crops (IT) 9 

### 0.4 1200 0.0158 0.00823 2,500 4,900 1,700

Liquids/ Groundboom/ High Acreage Crops (ST) 9 

### 2.08 0.01367 0.00713 2,900 5,600 1,900

Liquids/ Groundboom/ High Acreage Crops (IT) 9 

### 0.4 200 0.023 1.2

0.00263 0.00137 15,000 29,000 10,000



### Table 7: Exposure and Risks for Occupational Ha ndlers of ADAA in Herbicide Products Used in Low Pressure Handwand Applications to Ornamentals in Greenhouses (All Exposure Durations) at Baseline Dermal PPE (single layer clothing, no gloves) and Baseline Inhalation PPE (no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader/Applicator for Herbicide Pr oducts with 15% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 1.08 5 100 30 0.7714 0.0023 52 17,000 52



### Mixer/Loader/Applicator for Herbicide Pr oducts with 10% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 0.72 5 100 30 0.5143 0.00154 78 26,000 78



### Mixer/Loader/Applicator for Herbicide Pr oducts with 7% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 0.504 5 100 30 0.36 0.00108 110 37,000 110

### Page 38 of 47

1 Application rates are based on maximum application rates of products containing inerts in the ADAA cluster multiplied by variable % ADAA in formulation to convert to applicatio n rate of just inert in an herbicide product.
2 Area treated daily values are from the EP A HED estimates of acreage treated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess baseline dermal PPE (single layer no gloves) plus baseline inha lation exposure
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor of 10% (0.10)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Dai ly dose dermal + Daily dose inhalation (mg/kg/day)]



### Table 8. Exposure and Risks for Occupational Handlers of ADAA in Insecticide Products (All Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader Scenarios
Liquids/ Aerial Application/ High Acreage Crops (ST) 0.4 1.989 0.0082 20 4,900 20

Liquids/ Aerial Application/ High Acreage Crops (IT) 0.14 1200 0.696 0.00288 57 14,000 57

Liquids/ Airblast/ Nut Tree (ST) 1.8 0.298 0.00123 130 32,000 130
Liquids/ Airblast/ Nut Tree (IT) 0.5 40 0.083 0.00034 480 120,000 480
Liquids/ Groundboom/ High Acreage Crops (ST) 0.4 0.331 0.0014 120 29,000 120
Liquids/ Groundboom/ High Acreage Crops (IT) 0.14 200 0.116 0.00048 340 83,000 340
Liquids/ Groundboom/ Turf (ST) 0.4 0.066 0.00027 600 150,000 600
Liquids/ Groundboom/ Turf (IT) 0.14 40 0.023 0.0001 1,700 420,000 1,700
Liquids/ Low Pressure Handwand/ Turf (ST) 1.44 0.0298 0.00012 1,300 320,000 1,300
Liquids/ Low Pressure Handwand/ Turf (IT) 1.44 5 2.9 1.2

0.0298 0.00012 1,300 320,000 1,300

Wettable Powder/ Airblast/ Nut Tree (ST) 1.2 0.254 0.029 160 1,400 140

Wettable Powder/ Airblast/ Nut Tree (IT) 0.6 40 0.127 0.0147 320 2,700 280

Wettable Powder/ Groundboom/ High Acreage Crops (ST) 0.32 0.338 0.039 120 1,000 110

Wettable Powder/ Groundboom/ High Acreage Crops (IT) 0.14 200 0.148 0.0172 270 2,300 240

Wettable Powder/ Groundboom/ Turf (ST) 0.32 0.0677 0.0079 590 5,100 530

Wettable Powder/ Groundboom/ Turf (IT) 0.14 40 0.0296 0.00344 1,400 12,000 1,200
Wettable powder/ Low Pressure Handwand/ Turf (ST) 1.44 0.038 0.0044 1,100 9,000 940

Wettable powder/ Low Pressure Handwand/ Turf (IT) 1.44 5 3.7 43

0.038 0.0044 1,100 9,000 940 

### Applicator Scenarios

Liquid/ Aerial Application/ High 0.4 1200 Eng control Eng control 0.0038 0.0005 11,000 86,000 9,400

### Page 39 of 47

Table 8. Exposure and Risks for Occupational Handlers of ADAA in Insecticide Products (All Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8

Acreage Crops (ST) 9

Liquid/ Aerial Application/ High Acreage Crops (IT) 9 0.14 only: 0.0055 only: 0.068 0.0013 0.0002 30,000 250,000 27,000

Airblast/ Nut Tree (ST) 1.8 0.037 0.0046 1,100 8,600 960
Airblast/ Nut Tree (IT) 0.5 40 0.36 4.5 0.0103 0.0013 3,900 31,000 3,500

Groundboom/ High Acreage Crops (ST) 0.4 0.0016 0.00085 25,000 47,000 16,000
Groundboom/ High Acreage Crops (IT) 0.14 200 0.00056 0.0003 71,000 140,000 47,000

Groundboom/ Turf (ST) 0.4 0.00032 0.00017 130,000 240,000 82,000

Groundboom/ Turf (IT) 0.14 40 0.014 0.74

0.00011 0.00006 360,000 680,000 230,000 

### Mixer/Loader/Applicator Scenarios

Low Pressure Handwand/ Turf (ORETF data) (ST) 10 1.44 NA 0.00068 NA 59,000 NA

Low Pressure Handwand/ Turf (ORETF data) (IT) 10 1.44 5 No Data 6.6 NA 0.00068 NA 59,000 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (ST) 10 1.44 NA 0.1131 NA 350 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (IT) 10 1.44 NA 0.1131 NA 350 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (LT) 10 1.44 5 No Data 1100

NA 0.1131 NA 350 NA

Liquid/ Low Pressure Handwand/ Ornamentals (ST) 1.44 1.029 0.0031 39 13,000 39

Liquid/ Low Pressure Handwand/ Ornamentals (IT) 1.44 1.029 0.0031 39 13,000 39

Liquid/ Low Pressure Handwand/ Ornamentals (LT) 1.44 5 100 30

1.029 0.0031 39 13,000 39 

### Flagger Scenarios
Liquid/ Flagger/ High Acreage Crops (ST) 0.4 0.0075 0.0024 5,300 17,000 4,000
Liquid/ Flagger/ High Acreage Crops (IT) 0.14 1200 0.011 0.35 0.0026 0.00084 15,000 48,000 11,000

1 Application rates are based on ma ximum application rates of products containi ng inerts in ADAA multiplied by 20% to convert to application rate of just inert in a product (Pesticide products assumed to contain a maximum of 20% inert ADAA). Application rates for Short-term (ST) expos ure risk estimates are based on maximum a pplication rates. Application rates for Intermediate-term (IT) and long-te rm (LT) exposures are based on average applic ation rates. Baseline Dermal PPE is single layer clothing, no gloves.
2 Area treated daily values are from the EP A HED estimates of acreage tr eated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess inhalation and dermal exposures with engineering controls.
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor (10%)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 ST Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhala tion dose (mg/kg/day)
8 Total Combined MOE = 1/ [(1/ De rmal MOE) + (1/ inhalation MOE)]
9 Aerial applicators do not have baseline exposure: only engineering control e xposure can be assessed. All other exposure scenarios assess baseline dermal (no gl oves) plus baseline inhalation exposure.

### Page 40 of 47

10 These scenarios have baseline inhalation unit exposures , but not baseline dermal unit expos ures. The M/L/A scenario assessed has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves derma l
exposure.

1 Application rates are based on maximum application rates of products cont aining inerts in the ADAA multiplied by 20% to convert to application rate of just inert in an insecticide product (Insectic ide products contain maximum of 20% inert ADAA). Application rates for Short-term (ST) expos ure risk estimates are based on maximum a pplication rates. Application rates for Intermediate-term (IT) and long-te rm (LT) exposures are based on average application rates.
2 Area treated daily values are from the EP A HED estimates of acreage tr eated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess minimum dermal PPE (plus gl oves) plus baseline inhalation exposure.
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor of 10% (0.10)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Dai ly dose dermal + Daily dose inhalation (mg/kg/day)]
9 Aerial applicators do not have baseline exposure: only engineering control e xposure can be assessed. All other exposure scenarios assess baseline dermal (no glove s) plus baseline inhalation exposure. 

### Table 9. Exposure and Risks for Occupational Handl ers of ADAA in Insecticide Products (All Exposure Durations) with Baseline Dermal PPE (single layer clothing) plus Gloves and Baseline Inhalation PPE (No respirator) for High Acreage Mixer/ Loader Scenarios

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Min PPE Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Min PPE Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader Scenarios
Liquids/ Aerial Application/ High Acreage Crops (ST) 

### 0.4 0.01577 0.00823 2,500 4,900 1,700

Liquids/ Aerial Application/ High Acreage Crops (IT) 

### 0.14 1200 0.023 1.2 0.00552 0.00288 7,200 14,000 4,800



### Table 10: Exposure and Risks for Occupational Handl ers of ADAA in Insecticide Products Used in Low Pressure Handwand Applications to Ornamentals in Greenhouses (All Exposure Durations) at Baseline Dermal PPE (single layer clothing, no gloves) and Baseline Inhalation PPE (no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader/Applicator for Insecticide Pr oducts with 15% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 1.08 5 100 30 0.7714 0.0023 52 17,000 52



### Mixer/Loader/Applicator for Insecticide Pr oducts with 10% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 0.72 5 100 30 0.5143 0.00154 78 26,000 78



### Mixer/Loader/Applicator for Insecticide Pr oducts with 7% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 0.504 5 100 30 0.36 0.00108 110 37,000 110

### Page 41 of 47

1 Application rates are based on ma ximum application rates of products containi ng inerts in the ADAA multiplied by variable % ADAA in formulation to convert to application rate of just inert in an insecticide product.
2 Area treated daily values are from the EP A HED estimates of acreage treated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess baseline dermal PPE (single layer no gloves) plus baseline inha lation exposure
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor of 10% (0.10)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Dai ly dose dermal + Daily dose inhalation (mg/kg/day)]



### Table 11. Exposure and Risks for Occupational Handlers of ADAA in Fungicide Products (All Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader Scenarios
Liquids/ Aerial Application/ High Acreage Crops (ST) 1 4.97 0.0206 8 1900 8

Liquids/ Aerial Application/ High Acreage Crops (IT) 0.14 1200 0.696 0.00288 57 14000 57

Liquids/ Airblast/ Nut Tree (ST) 2.2 0.365 0.0015 110 27,000 110
Liquids/ Airblast/ Nut Tree (IT) 0.6 40 0.0994 0.0004 400 97,000 400
Liquids/ Groundboom/ High Acreage Crops (ST) 1 0.829 0.0034 48 12,000 48
Liquids/ Groundboom/ High Acreage Crops (IT) 0.14 200 0.116 0.00048 340 83,000 340
Liquids/ Groundboom/ Turf (ST) 1 0.166 0.00069 240 58,000 240
Liquids/ Groundboom/ Turf (IT) 0.14 40 0.023 0.0001 1,700 420,000 1,700
Liquids/ Low Pressure Handwand/ Turf (ST) 1.44 0.0298 0.00012 1,300 320,000 1,300
Liquids/ Low Pressure Handwand/ Turf (IT) 1.44 5 2.9 1.2

0.0298 0.00012 1,300 320,000 1,300

Wettable Powder/ Airblast/ Nut Tree (ST) 1.4 0.296 0.0344 140 1,200 120

Wettable Powder/ Airblast/ Nut Tree (IT) 0.4 40 0.085 0.0098 470 4,100 420

Wettable Powder/ Groundboom/ High Acreage Crops (ST) 0.2 0.211 0.025 190 1,600 170

Wettable Powder/ Groundboom/ High Acreage Crops (IT) 0.12 200 0.127 0.0147 320 2,700 280

Wettable Powder/ Groundboom/ Turf (ST) 0.2 0.0423 0.005 950 8,100 850

Wettable Powder/ Groundboom/ Turf (IT) 0.12 40 0.0254 0.00295 1,600 14,000 1,400
Wettable powder/ Low Pressure Handwand/ Turf (ST) 1.44 0.038 0.0044 1,100 9,000 940

Wettable powder/ Low Pressure Handwand/ Turf (IT) 1.44 5 3.7 43

0.038 0.0044 1,100 9,000 940 

### Applicator Scenarios

Liquid/ Aerial Application/ High 1 1200 Eng control Eng control 0.0094 0.0012 4,200 34,000 3,800

### Page 42 of 47

Table 11. Exposure and Risks for Occupational Handlers of ADAA in Fungicide Products (All Exposure Durations) at Baseline PPE (single layer clothing, no gloves, no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8

Acreage Crops (ST) 9

Liquid/ Aerial Application/ High Acreage Crops (IT) 9 0.14 only: 0.0055 only: 0.068 0.0013 0.00016 30,000 250,000 27,000

Airblast/ Nut Tree (ST) 1.4 0.0289 0.0036 1,400 11,000 1,200
Airblast/ Nut Tree (IT) 0.6 40 0.36 4.5 0.0123 0.0015 3,200 26,000 2,900

Groundboom/ High Acreage Crops (ST) 1 0.004 0.002 10,000 19,000 6,500
Groundboom/ High Acreage Crops (IT) 0.14 200 0.00056 0.0003 71,000 140,000 47,000

Groundboom/ Turf (ST) 1 0.0008 0.00042 50,000 95,000 33,000

Groundboom/ Turf (IT) 0.14 40 0.014 0.74

0.00011 0.00006 360,000 680,000 230,000 

### Mixer/Loader/Applicator Scenarios

Low Pressure Handwand/ Turf (ORETF data) (ST) 10 1.44 NA 0.00068 NA 5,900 NA

Low Pressure Handwand/ Turf (ORETF data) (IT) 10 1.44 5 No Data 6.6 NA 0.00068 NA 5,900 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (ST) 10 1.44 NA 0.113 NA 350 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (IT) 10 1.44 NA 0.113 NA 350 NA

Wettable Powder/ Low Pressure Handwand/ Ornamentals (LT) 10 1.44 5 No Data 1100

NA 0.113 NA 350 NA

Liquid/ Low Pressure Handwand/ Ornamentals (ST) 1.44 1.029 0.0031 39 13,000 39

Liquid/ Low Pressure Handwand/ Ornamentals (IT) 1.44 1.029 0.0031 39 13,000 39

Liquid/ Low Pressure Handwand/ Ornamentals (LT) 1.44 5 100 30

1.029 0.0031 39 13,000 39 

### Flagger Scenarios
Liquid/ Flagger/ High Acreage Crops (ST) 1 0.0189 0.006 2,100 6,700 1,600
Liquid/ Flagger/ High Acreage Crops (IT) 0.14 1200 0.011 0.35 0.0026 0.0008 15,000 48,000 11,000

1 Application rates are based on ma ximum application rates of products containi ng inerts in ADAA multiplied by 20% to convert to application rate of just inert in a product (Pesticide products assumed to contain a maximum of 20% inert ADAA). Application rates for Short-term (ST) expos ure risk estimates are based on maximum a pplication rates. Application rates for Intermediate-term (IT) and long-te rm (LT) exposures are based on average applic ation rates. Baseline Dermal PPE is single layer clothing, no gloves.
2 Area treated daily values are from the EP A HED estimates of acreage tr eated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess baseline dermal PPE plus baseline inhalation exposure except for aerial applicator scenarios, which assess inhalation and dermal exposures with engineering controls.
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor (10%)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 ST Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhala tion dose (mg/kg/day)
8 Total Combined MOE = 1/ [(1/ De rmal MOE) + (1/ inhalation MOE)]
9 Aerial applicators do not have baseline exposure: only engineering control e xposure can be assessed. All other exposure scenarios assess baseline dermal (no gl oves) plus baseline inhalation exposure.

### Page 43 of 47

10 These scenarios have baseline inhalation unit exposures , but not baseline dermal unit expos ures. The M/L/A scenario assessed has a higher unit exposure at baseline dermal exposure than either of the two scenarios shown at baseline PPE plus gloves derma l
exposure.


### Table 12. Exposure and Risks for Occupational Handl ers of ADAA in Fungicide Products (All Exposure Durations) with Baseline Dermal PPE (single layer clothing) plus Gloves and Baseline Inhalation PPE (No respirator) for High Acreage Mixer/ Loader Scenarios

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Min PPE Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Min PPE Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader Scenarios
Liquids/ Aerial Application/ High Acreage Crops (ST) 

### 1 0.0394 0.02057 1,000 1,900 670

Liquids/ Aerial Application/ High Acreage Crops (IT) 

### 0.14 1200 0.023 1.2 0.00552 0.00288 7,200 14,000 4,800

1 Application rates are based on maximum application rates of products cont aining inerts in the ADAA multiplied by 20% to convert to application rate of just inert in an fungicide product (Fungicide products contai n maximum of 20% inert ADAA). Application rates for Short-term (ST) expos ure risk estimates are based on maximum a pplication rates. Application rates for Intermediate-term (IT) exposures are based on average application rates.
2 Area treated daily values are from the EP A HED estimates of acreage tr eated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess minimum dermal PPE (plus gl oves) plus baseline inhalation exposure .
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor of 10% (0.10)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Dai ly dose dermal + Daily dose inhalation (mg/kg/day)]

1 Application rates are based on ma ximum application rates of products containi ng inerts in the ADAA multiplied by variable % ADAA in formulation to convert to application rate of just inert in a fungicides product. 

### Table 13: Exposure and Risks for Occupational Handl ers of ADAA in Fungicide Products Used in Low Pressure Handwand Applications to Ornamentals in Greenhouses (All Exposure Durations) at Baseline Dermal PPE (single layer clothi ng, no gloves) and Baseline Inhalation PPE (no respirator)

Exposure Scenario

(Formulation/ Application/ Crop) Application Rate 1 (lb inert/ A) Area Treated Daily 2 (acres) Dermal Unit Exposure

(mg/lb inert) 3 Inhalation Unit Exposure

(ug/ lb inert) 3 Baseline Dermal Dose (mg/kg /day) 4 Baseline Inhalation

Dose (mg/kg/

day) 5 Baseline Dermal MOE 6 Baseline Inhalation

MOE 7 Total MOE 8



### Mixer/Loader/Applicator for Fungicide Pr oducts with 15% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 1.08 5 100 30 0.7714 0.0023 52 17,000 52



### Mixer/Loader/Applicator for Fungicide Pr oducts with 10% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 0.72 5 100 30 0.5143 0.00154 78 26,000 78



### Mixer/Loader/Applicator for Fungicide Pr oducts with 7% ADAA in formulation

Liquids/ Low Pressure Handwand/ Ornamentals (IT) 

### 0.504 5 100 30 0.36 0.00108 110 37,000 110

### Page 44 of 47

2 Area treated daily values are from the EP A HED estimates of acreage treated in a single day for each exposure scenario of

concern. 3 Unit Exposure values are reported in PHED Surrogate Exposur e Guide dated August 1998 or fro m ORETF data. All exposure scenarios assess baseline dermal PPE (single layer no gloves) plus baseline inhalation exposure
4 Daily Dermal Dose = (Dermal Unit Exposure (mg inert /lb inert) * Application Rate (lb inert /A) * Area Treated (A /day))/ Body Weight (70 kg) * Dermal Absorption Factor of 10% (0.10)
5 Daily Inhalation Dose = (Inhalation Unit Exposure (μg inert / lb inert) * Conversion Factor (1 mg /1000 μg) * Application Rate (lb inert /A) * Area Treated (A /day)) / Body Weight (70 kg)
6 Dermal MOE = PoD (NOAEL of 40 mg/kg/da y)/ Daily dermal dose (mg/kg/day)
7 Inhalation MOE = PoD (NOAEL of 40 mg/kg/ day) / Daily inhalation dose (mg/kg/day)
8 Total Combined MOE = (NOAEL of 40 mg/kg/day)/ [Dai ly dose dermal + Daily dose inhalation (mg/kg/day)]



### Table 14. Short- and Intermediate-Term Occupati onal Postapplication Dermal Exposures and Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & Exposure Duration Application Rate (lb inert /A) Work Activity Transfer Coefficient 1

(cm 2 /hr) Day after Treatment 2 DFR t (μg/cm 2 ) 3 Daily Dose (mg/kg/day) 4 MOE 5 

### Herbicide Products Scout, weed low foliage 100 0 0.0053 7,500
Scout, weed high foliage 400 0 0.0213 1,900
Scout, irrigate,

weed high

foliage 1,000 0 0.0533 750 Corn (ST) 2.08

Harvesting/ detassling 17,000 0 4.667

0.9067 44
Days after Treatment when MOE > LOC of 100 8

Scout, weed low foliage 100 0 0.0006 65,000
Scout, weed high foliage 400 0 0.0025 16,000
Scout, irrigate,

weed high

foliage 1,000 0 0.0062 6,500 Corn (IT) 0.24

Harvesting/ detassling 17,000 0 0.539

0.1046 380
Hedge, irrigate,

weed, scout,

train, tie 500 0 0.0123 3,200

Scout, train, tie 1,000 0 0.0246 1,600 Harvest, pull,

thin, prune,

train, tie 5,000 0 0.1231 320 Grapes (Table) (ST) 0.96

Cane turning, girdle 10,000 0 2.154

0.2462 160
Hedge, irrigate,

weed, scout,

train, tie 500 0 0.0072 5,600

Scout, train, tie 1,000 0 0.0144 2,800 Harvest, pull,

thin, prune,

train, tie 5,000 0 0.0718 560 Grapes (Table)

(IT) 0.56

Cane turning, 10,000 0 1.257

0.1436 280

### Page 45 of 47

Table 14. Short- and Intermediate-Term Occupati onal Postapplication Dermal Exposures and Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & Exposure Duration Application Rate (lb inert /A) Work Activity Transfer Coefficient 1

(cm 2 /hr) Day after Treatment 2 DFR t (μg/cm 2 ) 3 Daily Dose (mg/kg/day) 4 MOE 5 girdle Mowing 500 0 0.007 6,000 Turf/ sod

(ST) 2.08 Transplant, weed, harvest 6,800 0 1.167 0.091 440
Mowing 500 0 0.001 52,000 Turf/ Sod (IT) 0.24 Transplant, weed, harvest 6,800 0 0.135 0.01 3,800


### Insecticide Products Scout, weed low foliage 100 0 0.0051 7,800
Scout, weed high foliage 400 0 0.0205 1,900
Scout, irrigate,

weed high

foliage 1,000 0 0.0513 780 Corn (ST) 2

Harvesting/ detassling 17,000 0 4.488

0.8719 46
Days after Treatment when MOE > LOC of 100 8

Scout, weed low foliage 100 0 0.0005 78,000
Scout, weed high foliage 400 0 0.0021 19,000
Scout, irrigate,

weed high

foliage 1,000 0 0.0051 7,800 Corn (IT) 0.2

Harvesting/ detassling 17,000 0 0.449

0.0872 460
Hedge, irrigate,

weed, scout,

train, tie 500 0 0.018 2,200

Scout, train, tie 1,000 0 0.0359 1,100 Harvest, pull,

thin, prune,

train, tie 5,000 0 0.1795 220 Grapes (Table) (ST) 1.4

Cane turning, girdle 10,000 0 3.141

0.359 110
Hedge, irrigate,

weed, scout,

train, tie 500 0 0.0077 5,200

Scout, train, tie 1,000 0 0.0154 2,600 Harvest, pull,

thin, prune,

train, tie 5,000 0 0.0769 520 Grapes (Table)

(IT) 0.6

Cane turning, girdle 10,000 0 1.356

0.1539 260
Mowing 500 0 0.006 6,200 Turf/ sod

(ST) 2 Transplant, weed, harvest 6,800 0 1.122 0.087 460

### Page 46 of 47

Table 14. Short- and Intermediate-Term Occupati onal Postapplication Dermal Exposures and Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & Exposure Duration Application Rate (lb inert /A) Work Activity Transfer Coefficient 1

(cm 2 /hr) Day after Treatment 2 DFR t (μg/cm 2 ) 3 Daily Dose (mg/kg/day) 4 MOE 5 Mowing 500 0 0.001 62,000 Turf/ Sod (IT) 0.2 Transplant, weed, harvest 6,800 0 0.112 0.009 4,600 

### Fungicide Products Scout, weed low foliage 100 0 0.0026 16,000
Scout, weed high foliage 400 0 0.0103 3,900
Scout, irrigate,

weed high

foliage 1,000 0 0.0256 1,600 Corn (ST) 1

Harvesting/ detassling 17,000 0 2.244

0.4359 92
Day after Treatment when MOE > LOC of 100 1

Scout, weed low foliage 100 0 0.0005 78,000
Scout, weed high foliage 400 0 0.0021 19,000
Scout, irrigate,

weed high

foliage 1,000 0 0.0051 7,800 Corn (IT) 0.2

Harvesting/ detassling 17,000 0 0.449

0.0872 460
Hedge, irrigate,

weed, scout,

train, tie 500 0 0.0128 3,100

Scout, train, tie 1,000 0 0.0256 1,600 Harvest, pull,

thin, prune,

train, tie 5,000 0 0.1282 310 Grapes (Table) (ST) 1

Cane turning, girdle 10,000 0 2.244

0.2564 160
Hedge, irrigate,

weed, scout,

train, tie 500 0 0.0051 7,800

Scout, train, tie 1,000 0 0.0103 3,900 Harvest, pull,

thin, prune,

train, tie 5,000 0 0.0513 780 Grapes (Table)

(IT) 0.4

Cane turning, girdle 10,000 0 0.898

0.1026 390
Mowing 500 0 0.003 12,000 Turf/ sod

(ST) 1 Transplant, weed, harvest 6,800 0 0.561 0.044 920
Mowing 500 0 0.001 62,000 Turf/ Sod (IT) 0.2 Transplant, 6,800 0 0.112 0.009 4,600

### Page 47 of 47

Table 14. Short- and Intermediate-Term Occupati onal Postapplication Dermal Exposures and Risks for ADAAs at Baseline Dermal PPE (single layer clothing, no gloves)

Crop & Exposure Duration Application Rate (lb inert /A) Work Activity Transfer Coefficient 1

(cm 2 /hr) Day after Treatment 2 DFR t (μg/cm 2 ) 3 Daily Dose (mg/kg/day) 4 MOE 5 weed, harvest

1 Transfer coefficient from Science Advisory Council for Exposure: Policy Memo #003 “Agricultural Transfer Coefficients” 05/07/98. 2 DAT = Day After Treatment
3 DFR = Application rate (lbs inert/acre) * fraction of active ingredient that remains on foliage (0.2 for crop, 0.05 for turf)* (1-D(10% dissipation)) (t= 0) * 4.54 μg/lb * 24.7 x10-9 acre/cm 2

4 Daily Dose = DFR (μg/cm 2 ) * Tc (cm 2 /hr) * (1 mg/1000 μg) * ET (8 hrs/day) / body weight (70 kg) * Dermal Absorption Factor (10%)
5 MOE = Dermal PoD (NOAEL of 40 mg/kg/day) / Daily Dose (mg/kg/day)