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 

period if inhalation criteria are

Ecotox: Yes

Routes of exposure: Health: Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: LUNG, NEURO, 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)

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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 - NOAEL = 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, possible 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 - parental NOAEL = 100 mg/kg, 2 males 

died at 350 mg/kg, hunched posture, piloerection, reduced body weight gain; reproductive 

NOAEL = 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 0.050

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fish _ 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 = phosphate salt-60.2% PO4; MW 158; solid; S = 2.8 mg/L at 25 C (M); pH7; 

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 

(ppb)

2

SARs inorganic phosphates

SAR Class inorganic phosphate new chemicals category: phosphates, 

inorganic

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

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