SAT Report

PMN Number: P-12-0437

SAT Date: 7/17/2012

Print Date: 11/7/2012

Related cases: 

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2

 Persistence Bioaccum Toxicity Comments

2 11

Exposure Based Review:

Health: Yes Exposure based testing (health): Inhalation only

Ecotox: Yes

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: LUNG, IRR-S,E, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-12-0437 

FATE: 

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 50-90 via sorption and biodeg

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = strong

PBT Potential: P2B1
*CEB FATE: Migration to ground water = slow

 Health:

 Health Summary: Absorption is nil all routes based on physical/chemical 

properties. This material may be irritating to the skin and eyes. There is concern for lung effects 

if respirable particles are inhaled based on changes in the balance in the lungs and/or 

cationic binding to lung tissues. Low moderate concern. 

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 2.0

daphnid 48-h LC50 2.1

green algal 96-h EC50 2.0

fish _ chronic value 0.11

daphnid _ chronic 

value

0.15

algal _ chronic 

value

0.50

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for ; SAR 

chemical class = MW 2609; 

 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;

Ecotoxicity Test Data Results for P-12-0437:

An acute marine copepod toxicity study was conducted on PMN P-12-0437 

The study 

was completed in 2012 

The PMN is characterized as a 

. The study was conducted according to ‘ISO 14669 (1999) Water 

Quality -Determination of acute lethal toxicity to marine copepods (Copepoda; Crustacea)’; GLP 

compliance was not stated.

A 48-hour marine copepod acute toxicity study was conducted with the PMN under static testing 

conditions. Following a range-finding study, two replicates of ten Acartia tonsa per 

concentration were exposed to nominal concentrations of 0 (dilution water control), 1, 3.2, 10, 

32, or 100 mg/L. Based on statements made in the study report, the definitive test was conducted 

twice since irregular results were observed in the first definitive test; however, detailed results 
were only presented for one of the tests. Methods for preparing test solutions were described as a 

water accommodated fraction (WAFs), which was considered acceptable since the PMN appears 

to be a mixture. However, since the submitter prepared a single stock solution that was 

subsequently diluted to achieve desired nominal test concentrations, the submitter did not follow 

methods for preparing WAFs (OECD guidelines, ASTM guidelines) that require individual 

preparation of each test concentration. Thus, the submitter’s technique for test solution 

preparation was considered unacceptable. In addition, no attempt was made to quantify the 

amount of PMN in solution compared to controls (e.g., TOC analysis). Test organisms were 19 

days old at test initiation. Over the course of the study dissolved oxygen concentrations of 

89-98%, pH levels of 8.05-8.16, and water temperatures of 20.7-21.5 °C were reported. Dilution 

water hardness was not provided. Percentage mortality was 0%, 9%, 0%, 20%, and 90% in the 0, 

1, 3.2, 10, 32, and 100 mg/L exposure groups for the initial definitive test. In the second 

definitive test, 25% and 85% mortality was observed at nominal concentrations of 10 and 18 

mg/L, respectively. The submitter provides a nominal 48-hour LC50 of 21.7 mg/L, which 

appears to be based on the initial definitive test that was considered by the submitter to have 

irregular results. Based on interpolation of the provided results for the follow-up definitive test, 

the 48-hour LC50 would be about 13 mg/L. Since the inadequate method for preparing WAFs 

may have resulted in lower concentrations than what was reported, the LC50 was considered to 

be ≤13 mg/L. The study was considered unacceptable based on the absence of test concentration 

analysis to confirm amount of substance achieved in each test concentration and the inadequate 

approach for preparing test solutions. 

48-hr LC50 ≤ 13 mg/L

The submitted study was considered unacceptable. Predictions based on the 

QSAR will be used to determine risk are also no effects at saturation for all aquatic acute and 

chronic endpoints. The 96-hour fish LC50 was 2 mg/L, the 48-hour daphnid LC50 was 2.1, the 

96-hour algae EC50 was 2 mg/L, the fish ChV was 0.11 mg/L, the daphnid ChV was 0.15 mg/L, 

and the green algae ChV was 0.5 mg/L. An acute CoC of 400 ppb was calculated based on the 

fish 96-hour LC50 (2 mg/L) divided by an assessment factor of 5. A chronic CoC of 11 ppb was 

calculated based on the fish ChV (0.11 mg/L) divided by an assessment factor of 10. 

Acute CoC = 400

Chronic CoC = 11

Ecotox Study Reviewer: K. Moran QA/QC: L. Newsome 7/19/2012

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

11

SARs

SAR Class

Ecotox Category 
Ecotox Factors Comments: 

 SAT Chair: Becky Jones