### SAT Report PMN Number: P-12-0017 SAT Date: 11/1/2011 Print Date: 7/2/2014

Related cases :

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

Persistence Bioaccum Toxicity Comments 3 12

Exposure Based Review : Health: Yes Exposure based testing (health): results of base set studies may be available (currently EU summary only) may also need a 90-day inhalation study with 60 day holding p eriod if inhalation criteria are Ecotox: Yes

Routes of exposure : Health: Drinking Water Inhalation Ecotox: All releases to water Fate: ;
Keywords : Keywords: LUNG, N EURO, DEVEL, UNCERT-IMMUNO, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-12-0017 FATE: Solid S = 2.8 mg/L at 25 C (M) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E)POTW removal (%) = 90 via sorption Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong PBT Potential: P3B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil through the skin and poor through the lungs and GI tract based on physical/chemical properties. There is concern for lung effects from lung overload associated with poorly soluble respirable particulates if inhaled. Particle size information in the submission indicates about . There is also concern for neurotoxicity and developmental toxicity and uncertain concern for immunotoxicity for lithium (about 5% of the molecular weight). Low moderate concern. Test Data: acute oral study in rats - LD50 > 2000 mg/kg, no signs of toxicity acute inhalation study in rats - 4 hr LC50 > 3.2 mg/L, no signs of toxicity not a skin irritant in rabbits not an eye irritant in rabbits negative for dermal sensitization in the mouse local lymph node assay 28-day oral study in rats - N OAEL = 150 mg/kg; all animals were sacrificed during the first week of treatment due to poor condition at 650 mg/kg (emaciated appearance, severe body weight loss, reduced organ weights, atrophic changes in various organs, p ossible effects on the kidneys); no histopatholgical changes at 350 mg/kg, clinical chemistry changes in the blood negative in Salmonella and E coli negative in the mouse lymphoma assay negative for chromosome aberrations in human lymphocytes developmental/reproductive screening study in rats - p arental NOAEL = 100 mg/kg, 2 males died at 350 mg/kg, hunched posture, p iloerection, reduced body weight gain; reproductive N OAEL = 350 mg/kg (highest dose tested); developmental NOAEL = 100 mg/kg; decreased number of living pups, increase in postnatal loss, decrease in viability index at 350 mg/kg

Studies submitted with : negative in Salmonella and E coli negative for chromosome aberrations in CHO cells acute oral study in rats - no deaths at 2000 mg/kg slight eye irritation in rabbits no skin irritation in rabbits no skin sensitization in guinea pigs using the Magnusson-Kligman assay

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

fish 96-h LC50 >100 daphnid 48-h LC50 >100 green algal 96-h EC50 0.050fish

_ chronic value >10 daphnid

_ chronic value >10

algal

_ chronic value 0.017

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for inorganic phosphate; SAR chemical class = p hosphate salt-60.2% PO4; MW 158; solid; S = 2.8 mg/L at 25 C (M); p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 2

SARs inorganic phosphates SAR Class inorganic phosphate new chemicals category: p hosphates, inorganic Ecotox Category

Ecotox Factors Comments:

SAT Chair: Becky Jones