Related cases: 

Health related cases: 

Ecotox related cases: 

Conce1·n levels: 

Type of Concern: 

Level of Concern: 

Health 

2 

Persistence 

2 

Exposure Based Review: 

SAT Report 

PMN Number: P-15-0326 

SAT Date: 3/12/2015 

Print Date: 717/2015 

Eco Comments 

2 

es 

Bioaccum 

1 

Toxicity 

2 

Comments 

Health: No Exposure based testing (health): The equivalent of the base set has aheady been 

submitted 

Ecotox: Yes 

Routes of exposure: 

Keywords: 

Health: Inhalation 

Ecotox: All releases to water 

Fate: ; 

Keywords: NEURO UNCERT-CARDIAC SENS AQUATOX-A,C 

Summary of Assessment: 

Fate: 

Fate Summary: P-15-0326 

FATE: 

S = 778.9 mg/L at 25 oc (M) 

VP = 1459 ton at 25 oc (M) 

BP = 6.5 oc (NOMOS) 

H = 2.11E-1 (E) 

log Koc = 2.79 (E) 
log Fish BCF = 1.60 (E) 

log Fish BAF = 1.92 (E) 

POTW removal (%) = 90 via sorption and stripping 

Time for complete ultimate aerobic biodeg = mo 

S01ption to soils/sediments = moderate 

Volatilization half-life from a standard river = 1 hrs 

Volatilization half-life from a standard lake = 5 da 

Atmospheric Oxidation Half-life = 3.9 hr via OH radical 

Atmospheric Oxidation Half-life = 160 hr via ozone 

PBT Potential: P2B 1 

*CEB FATE: Migration to ground water = moderate 

Health: 

Health Sum~ through the skin and GI u·act under 

ordinaty conditions because the-expect good abs01ption via the lungs 

(pchem). Based on the submitted studies, there is concem for neurotoxicity and uncettain 

concem for cardiac sensitization. There is also concem for analogy to 

activation 

Negative for chromosome abenations in human peripheral blood lymphocytes with and without 

activation, in viu·o 

Negative in a micronucleus assay, 28-day inhalation study in rats 

Acute inhalation study in rats, 1-hr (33,000 ppm)- no deaths, decreased activity levels after 5 

minutes of exposure; u·emors, muscle spasms and convulsions after 10 minutes of exposure; 

study tenninated after 10 minutes of exposure 

Acute inhalation study in rats, 4-hr (17,000, 25,000 ppm)- high dose group terminated after 

having muscle spasms at 5 minutes and violent convulsions after 8 minutes; decreased activity in 

the low dose group 

Acute inhalation study in rats, 4-hr nose-only - deaths at 24,000 ppm and greater; dose groups at 

50,000 ppm and greater were tenninated within the first few minutes due to humane reasons; no 

deaths or clinical signs of toxicity at 15,000 ppm 

Acute inhalation study in rats, 1-hr no deaths at 24,000 ppm 

Cardiac sensitization study in dogs (70,000, 80,000, 90,000 ppm) -NOEL= 70,000 ppm; 

convulsions in all dose groups; early tennination of study at 80,000 and 90,000 ppm (terminated 

before challenge dose) 

28-day inhalation study in rats (1000, 10,000, 20,000/15,000 ppm)- 4 of 10 males died in the 

high dose group, NOAEC = 10,000 ppm 
Ecotox: 

Test Test Test End Predicted Measured Comments 

Organism Type Point 

fish 96-h LC50 20 76.1 

daphnid 48-h LC50 12 22.5 

green algal 96-h EC50 13 >23.7 

fish chronic 2.2 - value 

daphnid - chronic 1.5 2.25 

value 

algal - chronic 4.1 6.9 

value 

ewag~ 3-h EC50 - ludg~ 

ewag~ - Chronic - lud ~ Value 

Ecotox Values Comments: Predictions are based on SARs for 

SAR chemical class = MWIIlog Kow = 

with mp = -90.5 C at 5 C (P); pH7; effective concentrations based on 

100% active ingredients and nominal concenu·ations; hardness <150.0 mg/L as CaC03; and 

TOC <2.0 mg/L; 

was statement provided. 

The study was conducted in Jlme 2011 according to the OECD Guidelines for Testing of 

Chemicals no. 203 "Fish Acute Toxicity Test (1992). 
Medaka (01yzias latipes) were exposed to the PMN material for 96 hours under semi-static 

conditions with the test material replenished eve1y 24 hours. Ten fish per concentration were 

exposed to the PMN material with 99.976% purity under a 16-hour light: 8-hom· dark cycle. An 

initial range fmding test was perf01med with 0, 10, 100 and 500 mg/L test concentrations. 

Measured concentrations were much lower than nominal due to volatility of the test material (VP 

= 453 mm Hg). A second range-fmding test was perf01med using 0, 50, and 250 mg/L test 

concentrations but the measured concentrations were equally low to those from the first 

range-fmding study. 

For the defmitive test, the temperature ranged from 23.7 - 24.1 °C, DO= 6.6 - 8.2 mg/L, pH= 

7.2 - 7.6. The mean, measured test concentrations were 0, 13.1, 20.5, 34.4, 55.2, and 105 mg/L 

all of which were 21 - 78% of nominal (0, 25, 44, 79, 140, and 250 mg/L). Test concentrations 

were sampled at two renewal times resulting in a set of four samples taken during the 96-hour 

exposure period. Due to the volatility of the test material, test concentrations were dete1mined at 

higher than the upper limit concentration that the guideline suggests (> 100 mg/L). 

Analysis of the test material was perfonned at the beginning and end of each renewal period. 

Each test group was collected and analyzed by GC/MS with a detection limit (LOD) = 0.00005 

mg/L. 

No mortality was observed in the control group. In the 13.1, 20.5, 34.4, 55.2, and 105 mg/L test 

concentrations, mortality was 0, 20, 0, 0, and 100 %, respectively. Abn01mal swimming behavior 

and difficulty swimming was observed in the 79 and 140 mg/L test concentrations, respectively. 

96-hourLC50 = 76.1 mg/L (95% C.I. = 13.1-105 mg/L) 

Acute Daphnid Immobilisation Test 

A 48-hour acute · immobilisation test was conducted 

was statement 

provided. The study was conducted in Jlme 2011 according to the OECD Guidelines for 

Testing ofCheinicals no. 202 Daphnia sp., Acute Immobilisation Test (1992). 

Daphnia magna were exposed to the PMN material for 48 hours under semi-static conditions 

with the test material replenished eve1y 24 hours. Twenty daphnids per concentration (1 0 

daphnids I vessel; 2 replicates I test group) were exposed to the PMN material with 99.976% 

purity lmder a 16-hour light: 8-hour dark cycle. An initial range finding test was perf01med with 

0, 0.10, 1.0, 10 and 100 mg/L test concentrations. 

For the defmitive test, the temperature ranged from 19.7 - 20.0 °C, DO= 8.4 - 8.8 mg/L, pH= 

8.0 - 8.3. The nominal test concentrations were 0, 5, 11, 22, 47, and 100 mg/L. The measured 

concentrations were 0, 1.57, 4.27, 7.88, 16.8, and 51.3 mg/L all of which were 27 - 75% of 

nominal. The reduction of the test concentrations is thought to be due to the volatility of the test 

material. Due to the volatility of the test material, test concentrations were poured into each of 

the five test vessels per group and immediately plugged with a ground-in stopper to prevent 
volatilization of the test substance. 

Analysis of the test material was perfonned at the beginning and end of each renewal period. 

Test concenu·ations were sampled at two renewal sets of four during the 48-hour exposure 

period. Each test group was collected and analyzed by GC/MS with a detection limit (LOD) = 

0.00005 mg/L. 

No mortality was observed in the conu·ol group. In the 1.57, 4.27, 7.88, 16.8, and 51.3 mg/L test 

concenu·ations, mortality was 0, 0, 0, 30, and 95 %, respectively. 

48-hour EC50 = 22.5 mg/L (95% C.I. = 17.9 - 29.6 mg/L) 

Algal Toxicity Test 

A 72-hour 

study 

was statement provided. 

The study was conducted in Jlme 2011 according to the OECD Guidelines for Testing of 

Chemicals no. 201 Freshwater Alga and Cyanobacteria, Growth Inhibition Test (2006). 

Green algae (Pseudo.kirchneriella subcapitata) were exposed to the PMN material (99.976% 

purity) for 72 hours static conditions. The initial cell density was 5 X 103 cells/mL in each of 6 

vessels for the conu·ol and 3 vessels for each test concentration. The test vessels were in a closed 

system and were shaken continuously at 100 1pm. Test vessels were exposed to continuous light 

at 61-64 iE/m2/s. An initial range finding test was perfonned with 0, 50, and 500 mg/L test 

concenu·ations. For the definitive test, the nominal test concenu·ations were 0, 50, 89, 160, 280, 

and 500 mg/L. The measured concentrations were 0, 1.88, 3.00, 6.92, 13.4, and 23.7 mg/L all of 

which were 1- 35% of nominal. The low agreement between nominal and measured values for 

the test concentrations is most likely due to the volatility of the test material. To compensate for 

the expected loss and the volatility of the test material, test concenu·ations were detennined 

above the maximum upper limit concenu·ation than what is suggested in the guideline (> 100 

mg/L). 

For the defmitive test, the temperature ranged from 21.0- 22.5 °C, pH= 7.5 - 10.1. Analysis of 

the test material was perfonned at the beginning and end of each renewal period. Test 

concenu·ations were sampled at two renewal sets of four during the 72-hour exposure period. 

Each test group was collected and analyzed by GC/MS with a detection limit (LOD) = 0.00005 

mg/L. 

72-hour ErC50 = > 23.7 mg/L 

NOErC = 6.92 mg/L 

All three tests are considered valid. Despite the nature of the PMN test material, the 

studies were conducted in a manner to account and mean, measured 

concenu·ations were rep01ted. The measured values '"'"'"u-.. .... .., .... well with ECOSAR (v. 1.1) 

predicted values and are within the same order of magnitude. 

FactorsiValues I Comments 
Assessment F 

Ecotox Factors Comments: 

SATChair:-

Fate assessor: Ecotox assessor: Health assessor: