SAT ReportPMN Number:P-11-0526SAT Date:7/29/2011Print Date:8/30/2013Related cases:Health related cases:Ecotox related cases:Concern levels:Type of Concern:HealthEcoCommentsLevel of Concern:1-22Health:PMN substance; Eco:intact material23Health:; Eco:toxicity of incomplete incineration products to terrestrialorganismsPersistenceBioaccumToxicityComments121PMN3 3 2 Incin Pdt.Exposure Based Review:Ecotox:YesRoutes of exposure:Health:Dermal Inhalation DW and Inh forprdtEcotox:All releases to waterFate:;Keywords:Keywords:PMN: LUNG; IRR-E,S,MM; SENS-S (UNCERT); AQUATOXLIVER; BLOOD; MALE REPRO; IMMUNOTOX; ONCO;Summary of Assessment:Fate:Fate Summary:P-11-0526FATE:S = Dispersible (E)H < 1.00E-8 (E)POTW removal (%) = 50-90 via sorption and biodegTime for complete ultimate aerobic biodeg > moSorption to soils/sediments = moderatePBT Potential: PMN P1B2; Incin Pdt P3B3*CEB FATE: Migration to ground water = moderateHealth:Health Summary:Not absorbed through the skin as the neat material poor absorption through the skin if insolution (pchem);poor absorption from the GI tract and moderate absorption from the lung (analog). Concern for effects onthe lung; irritation to eye, skin (chronic), mucous membranes and lung based on properties of the compound and thereportedUncertain concern for dermal sensitization based on the. For the potential incompleteincineration product, based on test data forconcerns are liver toxicity, blood toxicity, and male reproductivetoxicity [rat 28-day oral NOAEL = 50 mg/kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral LOAEL = 10 mg/kg based ondecreased body weight in males at all doses and liver toxicity and anemia at 200 mg/kg; there were toxic effects on the testes in 2males in the 90-day oral study that were judged by the reviewer to be indicative of the potential for male reproductive toxicity. Thereis also concern for immunosuppression and oncogenicity based on data for.Test Data:The following studies were listed in the PMN as on-going: skin irritation; local lymph nodeassay; eye irritation; oral LD-50; bacterial reverse mutation; acute inhalation (TBD); cytogenicity study in mammalian cells; dermalALD; subchronic oral w/repro & devel screen (TBD); 48-hr Daphnia EC50; 21-d Daphnia chronic; 96-hr trout LC50; 72-hr algaegrowth inhibition; activated sludge respiration inhibition; ready biodegradation; adsorption/desorption (TBD); abiotic hydrolysis as afunction of pH (TBD); 7-day oral toxicity range-finding and toxicokinetic behaviorEcotox:Test OrganismTest TypeTest End PointPredictedMeasuredCommentsfish96-hLC50>86daphnid48-hLC50>61green algal96-hEC50>17fish_chronic value>13daphnid_chronic value>9.4algal_chronic value>4.2Sewage Sludge3-hEC50_Sewage Sludge_Chronic Value_Ecotox Values Comments:Predictions are based on SARs forSAR chemical class =with mp unknown; Seffective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC<2.0 mg/L;high concern for toxicity of incomplete incineration products to terrestrial organismsThree acute ecotoxicity studies were conducted on this PMN (P-11-0526) in 2011 by,with fish, daphnia, and algae. The PMN consisted of amber liquidat room temperature with a purity of 30% and an estimated vapor pressure of 1E-6 mmHg at 25°C. This PMN is estimated to bedispersible. The sorption to sediments and soils from P-11-0526 is moderate. For the toxicity studies, the testing laboratoriesprovided nominal test concentrations.Rainbow trout (Oncorhynchus mykiss) (7 fish/concentration of the test material) were exposed to P-11-0526 under 96-hour staticconditions. The nominal test concentrations were 0.12, 1.2, 12, and 120 mg a.i./L (plus a dilution water control). Throughout thecourse of the study, water temperature ranged from 12.0–12.2°C,pH ranged from7.2 - 8.0, and the O2 concentrations ranged 7.6–10.8 mg/L. The 96-hour LC50 for fish with P-11-0526 is > 120 mg a.i./L.In a 48-hour immobilization test, water fleas (Daphnia magna) (10 daphnia/test concentration) were exposed to P-11-0526 under staticconditions. The nominal test concentrations were 0.12, 1.2, 12, and 120 mg a.i./L (plus a dilution water control). Throughout thecourse of the study, water temperature ranged from 19.5—21.2°C,, and the O2 concentrations ranged 8.5–8.8 mg/L. The48-hour EC50 for water fleas with P-11-0526 is > 120 mg a.i./L.In a 72/96-hour acute toxicity test for algal biomass, yield, and growth rate, an initial cell concentration of 1E+4 cells/ml (3replicates/control and 2 replicates/test concentration) of green algae (Pseudokirchneriella subcapitata) were exposed to P-11-0526under static conditions. The nominal test concentrations were 0.012, 0.12, 1.2, 12, and 120 mg a.i./L (plus a dilution water control).Throughout the course of the study, water temperature was 23°C and the pH rThe test occurred with continuouslight(5730 to 7080 lux) and continuous agitation (100 rpm). In the 96-hour algal test, cell density (biomass) results were reported attest termination (96-hours). Algal yield and growth rate were reported at 72-hours even though it was a 96-hour test. The 96-houralgal EC50 for biomass, yield (72-hour), and growth rate (72-hour) are all > 120 mg a.i./L. The 96-hour algal NOEC and LOEC forboth biomass and yield (72-hour) are 120 and > 120 mg a.i./L, respectively. The 72-hour algal NOEC and LOEC for growth rate are12 and 120 mg a.i./L, respectively. The 96-hour algal EC50 (cell density) for green algae with P-11-0526 is 8.2 mg a.i./L. The algalchronic value for P-11-0526, based on the geometric mean of the NOEC and LOEC (growth rate), is 37.9 mg a.i./L.The three submitted aquatic ecotoxicity studies are considered invalid for several reasons. According tofor fish, an acute fish toxicity test should have a minimum of 5 test concentrations and a minimum of 7fish per test concentration. The submitted fish test had 7 fish per test concentration, but only had 4 test concentrations. According toandminimum of 20 organisms per test concentration and have at a minimum 5 test concentrations. The submitted D. magna test used 10organisms per test concentration and only had a total of four test concentrations. Furthermore, according tofor algae, a minimum of 3 replicates of algae per test concentration is required and 6 replicates isrecommended for the controls. The submitted algal toxicity test only used 2 algal replicates per test concentration and 3 replicates forthe control. As a result, the chronic and acute concern concentrations for P-11-0526 will be based on ECOSAR (v. 1.00a)predictions.The chronic and acute concern concentrations arerespectively.Ecotox Study Reviewer: J. Gallagher3 August 2011FactorsValuesCommentsAssessment Factor10Concentration of Concern (ppb)420SARsSAR Classnew chemicals category: noneEcotox CategoryEcotox Factors Comments:SAT Chair:L Keifer 564-8916