### SAT Report PMN Number: P-13-0473 SAT Date: 6/7/2013 Print Date: 9/30/2013

Related cases : Health related cases: Ecotox related cases : Same as ). Analogs:

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

Persistence Bioaccum Toxicity Comments 1 1 2 PMN 1 1 2 Hyd Pdt

Exposure Based Review : Health: N o Ecotox: Yes

Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ;
Keywords : Keywords: MUTA; CORR-E; SENS-S; DEVEL; IMMUNOTOX; ASTHMA; AQUATOX

Summary of Assessment :

Fate : Fate Summary: P-13-0473 FATE: log Kow = 3.34 (E) log Koc = 1.48 (E) log Fish BCF = 0.50 (E) log Fish BAF = 2.17 (E) PMN Substance: Liquid with MP < 25 C (E)S < 0.1 mg/L at 25 C (E)/dissociates ( p Ks = 5.0) (M) VP = 1.0E-6 torr at 25 C (E) BP = Dec. 205 C (M) H < 1.00E-8 (E) POTW removal (%) = PMN 99% via hydrolysis; via sorption and biodeg; OECD 301F(Mano Resp): 87%/28d. Time for complete ultimate aerobic biodeg = Sorption to soils/sediments = PBT Potential: *CEB FATE: Migration to ground water =

Health : Health Summary: Expect poor absorption via all routes ( p che m ). Concern for mutagenicity, eye corrosion, and dermal sensitization based on submitted test data. Concern for immunotoxicity and asthma based on tin and concern for developmental toxicity based on branched acids. Test Data: (-) Salmonella with and without activation [PMN substance was very toxic to Salmonella]; (+) E. coli with and without activation; (-) for chromosome aberrations in a human lymphocyte assay with and without activation; rat oral LD50 >300 and <2000 mg/kg; rat dermal LD0 = 2000 mg/kg; corrosive to rabbit eyes; not irritating to eye using the in vitro HET-CAM assay; not irritating to skin in the in vitro EpiDerm assay; (+) for skin sensitization in a mouse local lymph node assay, >50% ai

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 9.9 96-hour N OEC ≥ 100 unacceptable

daphnid 48-h LC50 65 96-hour N OEC ≥ 100 unacceptable

green algal 96-h EC50 11 (growth rate) = 94.9 (95 % C.I. = ± 75.5

– 149.4 mg/L) (yield) = 44.7 N OEC = 25.0 LOEC = 50.0 unacceptable

fish

_ chronic value 0.27 daphnid

_ chronic value 10

algal

_ chronic value 1.1 35.35 unacceptableSewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for tin salts and with molecular weight adjustment; SAR chemical class = tin compounds with ); (intact material); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

The PMN P-13-0473 submission came with data that were previously reviewed for The review is below:

Ecotoxicity Test Data Results for

Acute fish, acute daphnia, and algae toxicity studies were conducted on the The studies were completed in he PMN is a tin salt and that is considered to react slowly with water (hrs) to produce which will oxidize to . The PMN material is characterized as a liquid with a slightly yellowish appearance and an unreported purity. The molecular weight is 433.17 g/mol. Studies followed the respective guidelines of OECD 201 (Freshwater Alga Growth Inhibition Test), OECD 202 (Daphnia sp., Acute Immobilization Test), and OECD 203 (Fish Acute Toxicity Test) and all studies followed guidance in OECD 23 for testing of difficult substances; study methods concurred with methods specified in the respective guidelines except where specified below.

(1) A 96-hour fish acute toxicity study (Study was conducted with ( p urity not stated) under static testing conditions. Following a non-GLP pretest (exposure concentrations unspecified), ten zebra fish (Danio rerio) p er concentration were exposed to nominal concentrations of 0 (dilution water control) or 100 mg/L Test solution preparations involved 24 hours of stirring followed by filtration (320 mm filter paper). Mean measured concentrations were 106 to 126% of nominal concentrations according to the submitter and were determined by analysis of dissolved organic carbon (DOC) that included additional filtration (0.45 μm membrane filter) of test solutions as part of the analytical technique. Use of filtration is not generally recommended in OPPTS guidelines unless an acceptable method for determining exposure concentration confirms the presence of the PMN substance. Since analytical monitoring of test concentrations excluded analysis of tin concentrations and since tin may have been filtered out of solution, methods were considered unacceptable to characterize tin toxicity which was considered to be the more toxic portion of the PMN when using SAR techniques. Test solutions were clear following filtration. Over the course of the study, p H ranged fro m 7.7 to 8.4, water temperature ranged from 21.4

– 22.7 °C and the dissolved oxygen concentrations ranged from 80 to 90%. Dilution water hardness was 188 mg CaCO3/L. N o effects were seen at the only test concentration. The submitter indicated that a maximum fish loading of 1 g fish/L was met.The nominal 96-hour LC50 is greater than 100 mg/L, but the presence of tin in solution is questionable. The study is considered unacceptable based on the testing of only a single test concentration, the use of filtration, analytical determination of only the organic portion of the PMN, and non-reporting of test substance purity/composition. 96-hr LC50 > 100 mg/L

(2) A 48-hour daphnid acute toxicity study ( ) was conducted with ( p urity not stated) under static testing conditions. Following a non-GLP pretest (exposure concentrations unspecified), five replicates of five Daphnia magna Straus (< 24 hours old) were exposed to nominal concentrations of 0 (dilution water control) or 100 mg/L . Test solution preparations involved 24 hours of stirring followed by filtration (320 mm filter paper). Mean measured concentrations were 100 to 101% of nominal concentrations according to the submitter and were determined by analysis of dissolved organic carbon (DOC) that included additional filtration (0.45 μm membrane filter) of test solutions as part of the analytical technique. Use of filtration is not generally recommended in OPPTS guidelines unless an acceptable method for determining exposure concentration confirms the presence of the PMN. Since analytical monitoring of test concentrations excluded analysis of tin concentrations and since tin may have been filtered out of solution, methods were considered unacceptable to characterize tin toxicity which was considered to be the more toxic portion of the PMN when using SAR techniques. Test solutions were clear following filtration. Over the course of the study, p H ranged fro m 7.8 to 8.3, water temperature ranged from 21.1

– 21.3 °C and the dissolved oxygen concentrations ranged from 5.9 to 6.2 mg/L. Dilution water hardness was 262 mg CaCO3/L, which exceeds both OECD and OPPTS recomendations. Daphnid loading was 167 daphnid/L, which exceeds OPPTS recommendations (40 daphnid/L) and may result in crowding. N o abnormal behavior or appearance was observed in daphnid. The submitter
p rovided nominal 48-hour EC50 was greater than 100 mg/L. The study is considered unacceptable based on the testing of only a single test concentration, the use of filtration, analytical determination of only the organic portion of the PMN, high water hardness, and non-reporting of test substance purity/composition. 48-hr EC50 > 100 mg/L

(3) A 72-hour algal toxicity study ( was conducted with P ( p urity not stated) under static testing conditions. Desmodesmus subspicatus were exposed to nominal concentrations of 0 (dilution water control), 6.25, 12.5, 25, 50, or 100 mg/L under continuous illumination (8000 lux). Test solution preparations involved 24 hours of stirring followed by filtration (320 mm filter paper). Mean measured concentrations were 87 to 119 % of nominal concentrations according to the submitter and were determined by analysis of dissolved organic carbon (DOC) that included additional filtration (0.45 μm membrane filter) of test solutions as part of the analytical technique. Use of filtration is not generally recommended in OPPTS guidelines unless an acceptable method for determining exposure concentration confirms the presence of the PMN. Since analytical monitoring of test concentrations excluded analysis of tin concentrations and since tin may have been filtered out of solution, methods were considered unacceptable to characterize tin toxicity which was considered to be the more toxic portion of the PMN when using SAR techniques. Test solutions were clear following filtration. Over the course of the study, p H ranged fro m 7.6 to 8.3, water temperature ranged from 25.0

– 25.4 °C, and the dissolved oxygen concentrations ranged from 5.9 to 6.2 mg/L. Cell concentrations weredetermined by photometric measurements using a spectrophotometer. N o inhibition was observed at nominal concentrations of 6.25 to 25 mg/L. At nominal concentrations of 50 and 100 mg/L, 70% and 100% yield inhibition and 27% and 51% growth rate inhibition was observed, respectively. The submitter provided EC50 values of 44.7 and 94.9 mg/L for yield inhibition and growth rate inhibition, respectively. The nominal NOEC and LOEC for both yield inhibition and growth rate inhibition were 25 and 50 mg/L, respectively. When a LOEC value exceeds the EC50 value, EPA uses the NOEC (25 mg/L) as the ChV. However, the study is considered unacceptable based on the use of filtration, analytical determination of only the organic portion of the PMN, and non-reporting of test substance purity/composition. 72-hr ErC50 = 94.9 mg/L 72-hr EbC50 = 44.7 mg/L 72-hr GMATC= 25 mg/L

Studies submitted with the PMN were considered unacceptable primarily due to the use of filtration that may have removed the tin component from exposures and the use of analytical monitoring that excluded measurement of tin. QSAR predictions using analogous tins and analogous indicated a fish 96-hour LC50 of 9.9 mg/L (based on tin), a daphnid 48-hour EC50 of 65 mg/L (based on analogous ), an 96-hour algae EC50 of 11 mg/L (based on tin), a fish ChV of 0.27 mg/L (based on tin), a daphnid ChV of 10 mg/L (based on analogous ), and an algae ChV of 1.1 (based on tin). Acute and chronic concentrations of concern (CoC) will continue to be calculated based on predicted effect levels for fish, the most sensitive test species. The acute CoC for is 1980 p pb using an assessment factor of 5. The chronic CoC for is 27 p pb for using an assessment factor of 10.

Acute CoC = 1980 p pb Chronic CoC = 27 p pb

Ecotox Study Reviewer: K. Moran QA/QC: K.Eisenreich 5/18/2012

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 27

SARs tin salts and SAR Class tin salt, Ecotox Category N one

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916