SAT Report

PMN Number: P-12-0404

SAT Date: 

Print Date: 4/1/2014

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 2

 Persistence Bioaccum Toxicity Comments

3 12

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: DEVEL, THYMUS, LIVER, LUNG, IRR, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-12-0404

FATE: 

log Koc = 2.23 (E)

log Fish BCF = 1.39 (E)

log Fish BAF = 1.57 (E) 
POTW removal (%) = 90 via unknown biodeg; All Analogs: Substance C: 

OPPTS835.3200/835.3210: Inherently Biodegradable; Substance B: OECD301B(Mod Sturm 

CO2 ev): 6-11%/28d NRB. 

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = low

PBT Potential: P3B1

*CEB FATE: Migration to ground water = rapid

 Health:

 Health Summary: Absorption is nil through the skin as the neat material, 

moderate through the skin when in solution, and good through the lungs and GI tract based on 

physical/chemical properties. There is concern for lung effects if inhaled and irritation based on 

the properties of the PMN material. There is concern for liver and thymus effects and 

developmental toxicity based on the submitted study for an analog 

 with a paternal NOEL = 10 mg/kg and a 

developmental NOEL = 50 mg/kg. Moderate concern. 

 Test Data: Substance B 

negative in Salmonella and E coli with and without activation

oral absorption/metabolism study in rats - serum half-life is approximately 6 hours (males only)

corrosive to the rabbit eye

mild skin irritant in rabbits

not a dermal sensitizer in guinea pigs, Magnusson and Kligman

acute oral study in rats - 2 of 6 died at 2000 mg/kg, lethargy, ventro-lateral recumbency, hunched 

posture, uncoordinated movements, flat gait, shallow respiration, piloerection, salivation

negative for induction of chromosome aberrations in cultured human lymphocytes with and

without activation

oral combined repeated dose toxicity study with reproduction/developmental screening toxicity 

test in rats (10, 50, 250 mg/kg) - salivation, perioral substance and urine-stained abdominal fur at 

250 mg/kg; reduced body weight gain and feed consumption at 50 and 250 mg/kg, microscopic 

changes in liver at 50 and 250 mg/kg; microscopic changes in thymus at 250 mg/kg; no effects 

on FOB and motor activity; no reproductive effects; reduced number of liveborn pups and 

increase in stillborn pups at 250 mg/kg; reduced viability of pups and reduced pup weights at 

250 mg/kg; paternal NOEL = 10 mg/kg; developmental NOEL = 50 mg/kg

oral absorption/metabolism study in rats (males and females only) - analytic phase of study not 

completed due to problems with the animals

no skin irritation in rabbits

oral absorption/metabolism study in rats (male and female) - halflife in serum = 17 hours

slight eye irritant in rabbits

not a dermal sensitizer in guinea pigs, Magnusson and Kligman

acute oral study in rats - no deaths at 2000 mg/kg, lethargy, uncoordinated movements, hunched 

posture, chromodacryorrhea
28-day oral study in rats (15, 30 mg/kg) - hunched posture, slight increase in severity of 

haemopoiesis of the spleen, haemolytic serum samples at 30 mg/kg

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 28

daphnid 48-h LC50 34

green algal 96-h EC50 2.3

fish _ chronic value 0.21

daphnid _ chronic 

value

4.4

algal _ chronic 

value

0.48

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for amides; SAR chemical class = 

amide; MW 343; pH7; 

effective concentrations based on 100% active ingredients and mean measured concentrations; 

hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

21

SARs amides

SAR Class amide

Ecotox Category None

Ecotox Factors Comments: 

 SAT Chair: Becky Jones