### SAT Report PMN Number: P-14-0216 SAT Date: 1/10/2014 Print Date: 7/7/2014

Related cases :

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

Persistence Bioaccum Toxicity Comments 2 13

Exposure Based Review : Health: N o Ecotox: Yes

Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ;
Keywords : Keywords: ENDOCRINE DISRUPTION; DEVEL; REPRO; SENS-ASTHMA; THYMUS; SPLEEN; LYMPH NODES; BONE MARROW; IMMUNO; SYSTEMIC; N EURO; MUTA; AQUATOX
Summary of Assessment :

Fate : Fate Summary: P-14-0216-18 FATE: Liquid with MP < 25 C (E) S < 1 mg/L at 25 C (E) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 90 via sorption; Analog: OECD 301F(Mano Resp): -3%/28d, -3%/35d;Analog: OECD 301F(Mano Resp): 3%/28d, 3%/35d; Analog: OECD 111(Hydrolysis): ( p H4): <10%/5d. Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = v.strong PBT Potential: P2B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption of LMW components will be moderate all routes based on analogs and physical/chemical properties; absorption of HMW components will be poor all routes based on analogs and physical/chemical properties; expected to hydrolyze in the acid of the stomach based on an analogue. Concern for immunotoxicity based on dialkyltins and trialkyl tins with NOAEL = 0.25 mg/kg/d; IRIS RfD = 3E-5 mg/kg/d based on immunotoxicity from ; concern for neurotoxicity based on data for concern for developmental and reproductive toxicity based on data for alkyl tin compounds; rabbits are the most sensitive species, see below, concern for endocrine disruption based on analogs and fact that target organs are either endocrine or endocrine related; concern for systemic toxicity based on data for trialkyltins; with NOEL = 1.0 mg/kg/d; concern for mutagenicity based on data for organoSn analogs; concern for sensitization and asthma based on analogs. Other concerns as identified in the New Chemicals Csategory for organotin compounds: Tested organotins have been shown to be from moderately irritating to corrosive to the skin and eyes. Acute oral and dermal exposures can result in systemic effects, p rimarily neurotoxicity. Concerns for immunotoxicity are based on data on dialkyltins and trialkyltins. During a 13-week oral study in rats using effects to the thymus, spleen, lymph nodes, and bone marrow were observed. A No-Observable-Adverse-Effect-Level ( N OAEL) of 1.6 mg/kg/d was derived from this study. During a 17-month feeding study in rats using , immunoglobulin E (IgE) titers were reduced, as well as the activity of natural killer cells in the spleen, and there was reduced macrophage function. A N OAEL o f 0.025 mg/kg/d was derived from this study. Based on the immunotoxicity end- p oint, an oral reference dose for chronic exposure (RfD) for of 3 x 10-5 mg/kg/d (IRIS 01/01/89) has been derived. Organotins are well known neurotoxins, with the tri- and being more toxic than the mono- and di-substituted compounds. Test Data: : (+) oral mouse micronucleus assay : (-) oral mouse micronucleus assay; rat oral LD50 = 224.5 mg/kg; rat dermal LD0 = 8000 mg/kg; rat inhalation LC50 = 73.0 mg/L in 1 hour; rat inhalation LC50 > 364 ug/L; rat 19-day oral LOEL = 10 mg/kg, all animals died at 25 and 100 mg/kg; rat oral developmental LOEL = 15 mg/kg; rat oral developmental NOEL = 1 mg/kg (maternal), 5 mg/kg (developmental); rabbit oral developmental LOEL = 1 mg/kg (maternal), 5 mg/kg (developmental); rabbit oral developmental NOEL = 0.1 mg/kg (maternal), 1 mg/kg (developmental); rat oral (diet) reproductive NOEL = 0.3 - 0.4 mg/kg (general toxicity), 1.9 mg/kg (M), 1.7 mg/kg (F) (reproductive effects) : rat oral (diet) OECD 422 N OEL = 96 mg/kg (M), 101 mg/kg (F) (general toxicity), 521 mg/kg (M), 433 mg/kg (F) (reproductive effects)

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

fish 96-h LC50 <1 >3 exp. analog data for potential hyd. p dt. daphnid 48-h LC50 <1 0.84 exp. analog data for potential hyd. p dt. green algal 96-h EC50 <1 0.11 exp. analog data for potential hyd. p dt. fish

_ chronic value <0.1 0.634 exp. analog data for potential hyd. p dt. daphnid

_ chronic value <0.1 0.02 exp. analog data for potential hyd. p dt. algal

_ chronic value <0.1 0.012 exp. analog data for potential hyd. p dt. Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions based on SARs-nearest analog analysis for organotins; SAR chemical class = organotin; MW 916; S < 1 mg/L at 20 C (P); p H 7; hardness <150.0 mg/L as CaCO3; effective concentrations based on 100% active ingredients and mean measured concentrations; and TOC <2.0 mg/L;

SIDS data were identified by the submitter as analogous. Based on professional judgement, only were considered analogous and these were thought to be analogous of p otential hydrolysis products only. In addition to the data shown above, an acceptable mussel (Mytilus edulis) study was available with a ChV based on survival of 0.0063 mg/L suggesting greater concern for sediment organisms.

Preliminary review was limited to information provided in the SIDS documents and information compiled by Vince Nabholz (EPA) for the similar case

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1

SARs Organotin SAR Class OrganotinEcotox Category Organotins

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916