### SAT Report PMN Number: P-12-0451 SAT Date: 7/17/2012 Print Date: 4/27/2015

Related cases : Yes Health related cases: Ecotox related cases:

Concern levels :

Type of Concern: Health Eco Comments Level of Concern: 2 2 Health: PMN ; Eco: intact material 2 3 Health: Incineration/Degradation Product ; Eco: incomplete incineration p

Persistence Bioaccum Toxicity Comments 2 2 2 PMN 3 2 2 Deg Pdt

Exposure Based Review : Health: Yes Ecotox: Yes

Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ; PMN;

Keywords : Keywords: IRR, LIVER, KIDNEY, THYROID, DEVEL, REPRO, ONCO, IMMUNO, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-12-0450-51 FATE: Solid S = Dispersible (E) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E)POTW removal (%) = 0; OECD 301B (Mod Sturm CO2 ev): 29.9%/28d. Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = low PBT Potential: PMN P2B2; Deg Pdt P3B2 *CEB FATE: Migration to ground water = rapid

Health : Health Summary: Absorption is nil through the skin as the neat material, poor through the skin when in solution, poor through the GI tract, and moderate through the lungs based on physical/chemical properties and analogs . There is concern for irritation to all exposed tissues based on the surfactant properties of the PMN material . There is also concern for effects on the liver, kidney, and thyroid based on the 28-day study submitted for a similar compound . The NOEL for this study is 25 mg/kg. There is also concern for developmental and reproductive effects, oncogenicity, and immunotoxicity by analogy to PFOS and PFOA. Moderate concern.

For the potential incomplete incineration product, based on test data for the analogue perfluorohexanoic acid concerns are liver toxicity, blood toxicity, and male reproductive toxicity [rat 28-day oral NOAEL = 50 mg /kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral LOAEL = 10 mg/kg based on decreased body weight in males at all doses and liver toxicity and anemia at 200 mg/kg; there were toxic effects on the testes in 2 males in the 90-day oral study that were judged by the reviewer to be indicative of the potential for male reproductive toxicity

. There is also concern for immunosuppression and oncogenicity based on data for PFOA and PFOS. Test Data: acute oral study in rats - no deaths or signs of toxicity at 5000 mg/kg acute inhalation study in rats, 4-hr - no deaths at 97 mg/m3; 3 of 6 died during the recovery p eriod at 1200 mg/m3, red discoloration of lungs Epiderm skin model - not predicted to be a skin irritant negative in the mouse local lymph node assay at 25, 50, and 100% concentration negative in Salmonella and E coli p redicted to be a mild eye irritant in the Bovine corneal opacity and permeability assay

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 1.9 > 110 daphnid 48-h LC50 5.1 > 102 green algal 96-h EC50 3.1 fish

_ chronic value 0.29 daphnid

_ chronic value 0.78

algal

_ chronic 1.8value Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for anionic surfactants; SAR chemical class = surfactant-anionic-PO4-C11; MW 590; S = dispersible in water at 20 C (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg /L as CaCO3; and TOC <2.0 mg/L;

high concern for the perFC6-COOH stable degradation product;

Ecotoxicity Test data Results for P-12-0450: L-Lysine, compds. with phosphorus oxide (P2O5)-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluororo-1-octanol reaction products (CASRN: N one). Trade name:

Two acute aquatic tests were conducted on P-12-0450 with fish and Daphnia . All testing was conducted between 2011 and 2012 by The PMN is estimated to be a solid at room temperature and is used as a fluorosurfactant, wetting and leveling aid for waxes, floor finishes, strippers and cleaners for industrial and commercial use (32%) and as a fluorosurfactant, antiblocking, defoaming, wetting and leveling aid, and oil repellant for architectural and industrial water-based coatings for consumer, industrial and commercial use (68%). The estimated vapor pressure of P-12-0450 is 1 E -6 mmHg at 25°C. The testing laboratory analyzed the tested concentration of the PMN material during the ecotoxicity studies (fish and aquatic invertebrates) using LC-MS/MS analysis (limit of quantification (LOQ) = 0.100 mg total solids/L). The purity of the PMN was 22.8% (77.2% water). A certificate of analysis was provided for the fish and aquatic invertebrate tests. The PMN was supplied to the testing laboratory as an off-white liquid. The testing laboratory performed toxicity tests on the fish and aquatic invertebrate tests according to OECD guidelines 203 and 202, respectively. The 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) were exposed to P-12-0450 in a 96-hour semi-static test with nominal concentrations of 0 (dilution water control), 7.5, 15, 30, 60, and 120 mg a.i./L total solids with one renewal after 48 hours. The test concentrations were based on a range-finding test. The nominal test concentrations ranged from 79 to 92% of analytically determined concentrations. The mean-measured tested concentrations of P-12-0450 were non-detect (dilution water control), 6.45, 12.8, 27.6, 47.1, and 110 mg/L total solids. The test solutions were prepared by dissolving the PMN material in dilution water and mixing for 2 hours. All test solutions had a surface film and un-dissolved PMN precipitate at the bottom of the test vessels. The test solutions were slightly cloudy to cloudy with exception of the dilution water control and the lowest test concentration (6.45 mg/L total solids). At 96 hours, no fish mortality was observed at any of the test concentrations. No sub-lethal effects were observed throughout the test. Over the course of the study, water temperature ranged from 12.2 to 12.9oC, pH ranged from 7.9-8.4, and percent dissolved oxygen ranged from 8.6-10.5 mg/L. Thehardness of the dilution water at test initiation was 124 mg/L as CaCO3. The mean-measured 96-hour LC50 for O. mykiss to P-12-0450 is greater than 110 mg/L. The test is acceptable. 96-hour LC50 > 110 mg/L

In a 48-hour immobilization static test, aquatic invertebrates (Daphnia magna) were exposed to nominal concentrations of 0 (dilution water control), 7.5, 15, 30, 60, and 120 mg a.i./L total solids with P-12-0450. These nominal test concentrations were based on results from a range-finding test that exposed D. magna to test concentrations of 0 (dilution water control), 0.12, 1.2, 12, and 120 mg a.i./L total solids. The test concentrations were not analytically determined in the range-finding test. In the range finding test, no immobilization or sub-lethal effects were observed. In the definitive test, the nominal test concentrations ranged from 56 to 85% of analytically determined concentrations. The mean-measured test concentrations of P-12-0450 were non-detect (dilution water control), 4.92, 9.85, 16.4, 42.6, and 102 mg/L total solids, which resulted in 0, 5, 15, 20, 10, and 5% immobility, respectively, at the end of 48 hours. The test solutions were prepared by dissolving the PMN material in dilution water and mixing for 2 hours. All test solutions had a surface film and un -dissolved PMN precipitate at the bottom of the test vessels. The test solutions were slightly cloudy to cloudy with exception of the dilution water control and the lowest two test concentrations (4.92 and 9.85 mg/L total solids). There were twenty D. magna per test concentration with four replicates of 5 D. magna / replicate. Lethargy was observed from 5 to 15% of two test concentrations (16.4 and 42.6 mg/L total solids, respectively). Over the course of the study, water temperature ranged from 20.7-21.0oC, pH ranged from 8.2 to 8.4, and dissolved oxygen ranged from 8.6 to 8.8. The hardness of the dilution water at test initiation was 162 mg /L as CaCO3. The mean-measured 48-hour EC50 for D. magna to P-12-0450 is greater than 102 mg/L. The test is acceptable. 48-hour EC50 > 102 mg/L

The submitted O. mykiss and D. magna test results are adequate. Since the complete aquatic base set (fish, Daphnia, and algae) was not included with the initial PMN submission (an algal test was absent), the acute concentration of concern (CoC) will be based on the algal EC50 (3.1 mg/L) derived from ECOSAR (v. 1.1) p redictions. The acute CoC (algal EC50 / uncertainty factor of 4) is 0.775 mg/L or 775 ppb for P-12-0450. The chronic CoC is derived by dividing the lowest ECOSAR-p redicted chronic value (fish) by an uncertainty factor of 10. The chronic CoC for P-12-0450 is 0.029 mg/L or 29 p pb (p redicted fish ChV of 0.29 mg/L / 10).

The acute CoC = 775 ppb The chronic CoC = 29 ppb N ote: This data will be used for P-12-0450 and P-12-0451.





Factors Values Comments Assessment Factor 10 Concentration of Concern (ppb) 29

SARs anionic surfactantsSAR Class surfactant-anionic-PO4-C11 Ecotox Category Anionic Surfactants

Ecotox Factors Comments:

SAT Chair: