### SAT Report PMN Number: P-11-0226 SAT Date: 3/15/2011 Print Date: 3/4/2014

Related cases :

Concern levels : Type of Concern: Health Eco Comments Level of Concern: 2-3 1

Persistence Bioaccum Toxicity Comments 1 12

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: N o releases to water Fate: ; Keywords : Keywords: IRR-E,L,MM N EURO MUTA ONCO DEVEL DEVEL- N EURO MALE REPRO KIDNEY SENS-S,L IMMUNO
Summary of Assessment :Fate : Fate Summary: P-11-0226 FATE:

POTW removal (%) = 90 via biodeg Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = low PBT Potential: P1B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is good all routes based on analogs. Expect Michael addition to the There is concern for irritation to the eye, lung, and mucous membranes, based on analog test data. There are also concerns for kidney and developmental toxicities, immunotoxicity. neurotoxicity, developmental neurotoxicity, and male reproductive toxicity based on There are also concerns for mutagenicity, based on , as well as for oncogenicity based on and positive genotox data. There is also concern for dermal and respiratory sensitization based on the Michael addition. Test Data: Submitted with the PMN:
Salmonella assay negative with and without activation; E. coli reverse mutation assay negative with and without activation; Rat acute oral (gavage) LD50 > 2.0 g/kg; Rat subchronic (28D) oral (gavage) N OAEL 50 mg/kg, with neurotoxic and male reproductive system effects; Rat acute dermal LD50 > 2000 mg/kg; Minimal eye irritant in male rabbits at 99% ai; N ot a dermal irritation in male rabbits at 99% ai; N ot a dermal sensitizer (with slight irritation at application site) in female mice at 10% ai

Submitted with
Rat acute oral LD0 2.0 g/kg; Rabbit acute dermal LD0 400 mg/kg; Mild and transient (1 d) eye irritation in rabbits at 40% ai; N o skin irritation in rabbits at 40% aiSubmitted with
Severe eye irritation.

Submitted with
Mouse lymphoma assay positive; Chromosome aberrations in CHO cells positive; Rat 13-wk dermal NOEL 10 mg/kg, LOEL 75 mg/kg, with renal toxicity; renal toxicity also at 250 mg/kg; Developmental and developmental-neurotoxic effects LOEL 5-10 mg/kg

Submitted with
Ames assay positive

Ecotox :
Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 340 >98 mg/L daphnid 48-h LC50 340 >96.4 mg/L green algal 96-h EC50 340 121 mg/L 72-hr EC50 fish

_ chronic value 15 daphnid

_ chronic value 37

algal

_ chronic value 15

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = MW 115; p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;
Ecotoxicity Test Data Results for P-11-0226:

Three acute ecotoxicity studies were conducted on this PMN (P-11-0226) in with fish, daphnia, and algae . The PMN is at room temperature with a purity of >99%, measuredThe testing laboratory performed limit tests for the fish and the daphnid tests according to OECD guidelines 202 and 203. The algal test included 5 test concentrations (OECD 201). Even though nominal concentrations were reported, the testing laboratory measured the PMN in the test medium at test initiation and at test termination using a HPLC-MS (limit of quantification = 2 mg/L). For the fish test, a 96-hour static-renewal exposure regime was employed. The daphnia and algal tests were static. In the fish test and the daphnid test, no adverse effects were observed. Adverse effects were observed in the algal test. All studies complied with OECD guidelines for: 1) O2, p H, temperature, water hardness values and other water quality parameters; 2) species, age, number of organisms per replicate, and biomass loading rates; and, 3) replicate and overall variability.
Rainbow trout (Oncorhynchus mykiss) (10 fish/concentration of the test material) were exposed to the PMN in a limit test (0 and 100 mg/L (nominal)) under 96-hour renewal semi-static conditions. The analytically determined measured concentrations of the PMN ranged between 92 and 101% of the nominal concentrations. Over the course of the study, water temperature ranged from 14.7-15.3°C; p H ranged fro m 7.8

–8.3; O2 levels ranged from 86

–103 % of the air saturated value and water hardness was 184-190 mg CaCO3/L. The measured 96-hour LC50 for fish is > 98 mg/L. The measured 96-hour NOEC for mortality is 98 mg/L.
In a 48-hour immobilization test, water fleas (Daphnia magna) (5 daphnia/replicate x 4 replicates) were exposed to the PMN in a limit test (0 and 100 mg/L (nominal)) under static conditions for a total of 48 hours. The analytically determined measured concentrations of the PMN ranged between 94 and 100% of the nominal concentrations. Over the course of the study, water temperature was 21°C; p H ranged fro m 7.8

–8.1; O2 levels ranged from 93-95 % of the air saturated value and water hardness was 258 mg CaCO3/L. The nominal 48-hour EC50 for D. magna is > 96.4 mg/L. The nominal NOEC for mortality is 96.4 mg/L.
In a 72-hour test for algal growth rate and area under the curve, an initial cell concentration of 1E+4 cells/ml (6 replicates/control and 3 replicates/test concentration) of green algae (Pseudokirchneriella subcapitata) were exposed to nominal concentrations of 4.27, 9.3 9, 20.7, 45.5, and 100 mg/l (and a control) of the PMN under static conditions. The analytically determined measured concentrations of the PMN ranged between 93 and 100% of the nominal concentrations. The measured concentrations were 4.17, 9.24, 20.7, 43.9 and 96.6 mg/L (and a control). The test occurred with continuous light (6550 lux) and continuous agitation. The temperature ranged from 22.6-23.7°C. The pH ranged from 7.6

–9.8. Cell growth was measured microscopically using a particle counter. The measured 72-hour EC50 for algae is > 96.6 mg/L. The reported measured 72-hour LOEC and NOEC for mortality were 43.9 and 20.7 mg/L, respectively. An algal chronic value (ChV) is defined as the geometric mean of the N OEC and the LOEC. The algal ChV for is 30.14 mg/L. The chronic concern concentration is defined by the lowest ChV divided by an uncertainty factor of 10. As a result, the chronic concern concentration for PMN is 3.014 mg/L or 3,014 p pb. To derive an acute concern concentration from a chronic toxicity estimate (for example, a ChV), multiply the chronic toxicity estimate by the acute to chronic ratio (ACR) value (derived from experimental data sets) for the corresponding test species of interest. In other words, the estimated (by EPA) 72-hr algal EC50 is 30.14 mg/L (algal ChV) times the algal ACR value of 4, yielding 120.56mg/L or 121,000 p pb.
All three acute ecotoxicity studies are considered valid. N o adverse effects were observed in the fish and daphnid tests. The measured chronic concern concentration for algae, based on the algal ChV, is 3,014 p pb, although the greatest chronic toxicity threshold value is 1,000 p pb. The estimated 72-hr algal EC50 is 121,000 p pb, although the greatest acute toxicity threshold value is 20,000 p pb. For comparative purposes, chronic concern concentration for is 1,000 p pb based on the ECOSA R -based predictions. As a result of the valid test data, the updated chronic and acute concern concentrations are 1,000 p pb an d 20,000 p pb, respectively.

Ecotox Study Reviewer: J. Gallagher QA/QC: A. Kennedy 16 March 2011

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1000

SARs SAR Class Ecotox Category

Ecotox Factors Comments:

SAT Chair: J. Kwiat