SAT Report

PMN Number: P-11-0226

SAT Date: 3/15/2011

Print Date: 3/4/2014

Related cases:

 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2-3 1

 Persistence Bioaccum Toxicity Comments

1 12

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: 

IRR-E,L,MM

NEURO

MUTA

ONCO

DEVEL

DEVEL-NEURO

MALE REPRO

KIDNEY

SENS-S,L

IMMUNO

Summary of Assessment:

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 Fate:

Fate Summary: P-11-0226

FATE: 

POTW removal (%) = 90 via biodeg

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = low

PBT Potential: P1B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is good all routes based on analogs. Expect 

Michael addition to the There is concern for irritation to the eye, lung, 

and mucous membranes, based on analog test data. There are also concerns for kidney and 

developmental toxicities, immunotoxicity. neurotoxicity, developmental neurotoxicity, and male 

reproductive toxicity based on There are also concerns for mutagenicity, based on 

, as well as for oncogenicity based on 

and positive genotox data. There is also concern for dermal and respiratory sensitization based 

on the Michael addition.

 Test Data: 

Submitted with the PMN:

Salmonella assay negative with and without activation;

 E. coli reverse mutation assay negative with and without activation;

Rat acute oral (gavage) LD50 > 2.0 g/kg;

Rat subchronic (28D) oral (gavage) NOAEL 50 mg/kg, with neurotoxic and male reproductive 

system effects;

Rat acute dermal LD50 > 2000 mg/kg;

Minimal eye irritant in male rabbits at 99% ai;

Not a dermal irritation in male rabbits at 99% ai;

Not a dermal sensitizer (with slight irritation at application site) in female mice at 10% ai

Submitted with

Rat acute oral LD0 2.0 g/kg;

Rabbit acute dermal LD0 400 mg/kg;

Mild and transient (1 d) eye irritation in rabbits at 40% ai;

No skin irritation in rabbits at 40% ai

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Submitted with 

Severe eye irritation. 

Submitted with 

Mouse lymphoma assay positive;

Chromosome aberrations in CHO cells positive;

Rat 13-wk dermal NOEL 10 mg/kg, LOEL 75 mg/kg, with renal toxicity; renal toxicity also at 

250 mg/kg;

Developmental and developmental-neurotoxic effects LOEL 5-10 mg/kg

Submitted with 

 Ames assay positive 

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 340 >98 mg/L

daphnid 48-h LC50 340 >96.4 mg/L

green algal 96-h EC50 340 121 mg/L 72-hr EC50

fish _ chronic value 15

daphnid _ chronic 

value

37

algal _ chronic 

value

15

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

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

class = MW 115; pH7; effective concentrations based on 

100% active ingredients and nominal concentrations; hardness <180.0 mg/L as CaCO3; and 

TOC <2.0 mg/L;

Ecotoxicity Test Data Results for P-11-0226: 

Three acute ecotoxicity studies were conducted on this PMN (P-11-0226) in 

with fish, daphnia, and 

algae. The PMN is at room temperature with a purity of >99%, measured 

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 The testing 

laboratory performed limit tests for the fish and the daphnid tests according to OECD guidelines 

202 and 203. The algal test included 5 test concentrations (OECD 201). Even though nominal 

concentrations were reported, the testing laboratory measured the PMN in the test medium at test 

initiation and at test termination using a HPLC-MS (limit of quantification = 2 mg/L). For the 

fish test, a 96-hour static-renewal exposure regime was employed. The daphnia and algal tests 

were static. In the fish test and the daphnid test, no adverse effects were observed. Adverse 

effects were observed in the algal test. All studies complied with OECD guidelines for: 1) O2, 

pH, temperature, water hardness values and other water quality parameters; 2) species, age, 

number of organisms per replicate, and biomass loading rates; and, 3) replicate and overall 

variability. 

Rainbow trout (Oncorhynchus mykiss) (10 fish/concentration of the test material) were exposed 

to the PMN in a limit test (0 and 100 mg/L (nominal)) under 96-hour renewal semi-static 

conditions. The analytically determined measured concentrations of the PMN ranged between 

92 and 101% of the nominal concentrations. Over the course of the study, water temperature 

ranged from 14.7-15.3°C; pH ranged from 7.8 – 8.3; O2 levels ranged from 86 – 103 % of the air 

saturated value and water hardness was 184-190 mg CaCO3/L. The measured 96-hour LC50 for 

fish is > 98 mg/L. The measured 96-hour NOEC for mortality is 98 mg/L. 

In a 48-hour immobilization test, water fleas (Daphnia magna) (5 daphnia/replicate x 4 

replicates) were exposed to the PMN in a limit test (0 and 100 mg/L (nominal)) under static 

conditions for a total of 48 hours. The analytically determined measured concentrations of the 

PMN ranged between 94 and 100% of the nominal concentrations. Over the course of the study, 

water temperature was 21°C; pH ranged from 7.8 – 8.1; O2 levels ranged from 93-95 % of the 

air saturated value and water hardness was 258 mg CaCO3/L. The nominal 48-hour EC50 for D. 

magna is > 96.4 mg/L. The nominal NOEC for mortality is 96.4 mg/L. 

In a 72-hour test for algal growth rate and area under the curve, an initial cell concentration of 

1E+4 cells/ml (6 replicates/control and 3 replicates/test concentration) of green algae 

(Pseudokirchneriella subcapitata) were exposed to nominal concentrations of 4.27, 9.3 9, 20.7, 

45.5, and 100 mg/l (and a control) of the PMN under static conditions. The analytically 

determined measured concentrations of the PMN ranged between 93 and 100% of the nominal 

concentrations. The measured concentrations were 4.17, 9.24, 20.7, 43.9 and 96.6 mg/L (and a 

control). The test occurred with continuous light (6550 lux) and continuous agitation. The 

temperature ranged from 22.6-23.7°C. The pH ranged from 7.6 – 9.8. Cell growth was 

measured microscopically using a particle counter. The measured 72-hour EC50 for algae is > 

96.6 mg/L. The reported measured 72-hour LOEC and NOEC for mortality were 43.9 and 20.7 

mg/L, respectively. An algal chronic value (ChV) is defined as the geometric mean of the 

NOEC and the LOEC. The algal ChV for is 30.14 mg/L. The chronic concern 

concentration is defined by the lowest ChV divided by an uncertainty factor of 10. As a result, 

the chronic concern concentration for PMN is 3.014 mg/L or 3,014 ppb. To derive an acute 

concern concentration from a chronic toxicity estimate (for example, a ChV), multiply the 

chronic toxicity estimate by the acute to chronic ratio (ACR) value (derived from experimental 

data sets) for the corresponding test species of interest. In other words, the estimated (by EPA) 

72-hr algal EC50 is 30.14 mg/L (algal ChV) times the algal ACR value of 4, yielding 120.56 

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mg/L or 121,000 ppb.

All three acute ecotoxicity studies are considered valid. No adverse effects were observed in the 

fish and daphnid tests. The measured chronic concern concentration for algae, based on the algal 

ChV, is 3,014 ppb, although the greatest chronic toxicity threshold value is 1,000 ppb. The 

estimated 72-hr algal EC50 is 121,000 ppb, although the greatest acute toxicity threshold value is 

20,000 ppb. For comparative purposes, chronic concern concentration for is 1,000 

ppb based on the ECOSAR-based predictions. As a result of the valid test data, the updated 

chronic and acute concern concentrations are 1,000 ppb and 20,000 ppb, respectively.

Ecotox Study Reviewer: J. Gallagher QA/QC: A. Kennedy

16 March 2011

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1000

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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