SAT Report

PMN Number: P-13-0773

SAT Date: 8/9/2013

Print Date: 8/30/2013

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 3

 Persistence Bioaccum Toxicity Comments

1 12

Exposure Based Review:

Health:

Ecotox: Yes

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: MUTA; ONCO; DEVEL; AQUATOX

Summary of Assessment:
 Fate:

Fate Summary: P-13-0773

FATE: Solid with MP = 180-181 C (M)log Kow = 0.08 (E) S = 7.82 g/L at 25 C (E)VP = 1.7E-4 torr at 25 C (E)BP = 276 C (E)H < 1.00E-8 (E)log Koc = 1.00 (E)log Fish BCF = 0.50 (E)log Fish BAF = -0.02 (E) POTW removal (%) = 50-90 via biodeg; OECD NS: 1.0(low), 10.0 (high)/24h & 7d NRB.Time for complete ultimate aerobic biodeg = wkSorption to soils/sediments = lowPBT Potential: P1B1*CEB FATE: Migration to ground water = negl - slow

 Health: Health Summary: Not absorbed through the skin as the neat material, moderate absorption t

solution; moderate absorption from the GI tract and good absorption from the lung (pchem). Concern for mutage

submitted test data and oncogenicity and developmental toxicity based on aromatic amines.

 Test Data: (-) Salmonella with and without activation; (-) E. coli with and without ac

lymphoma assay without activation; rat oral LD0 = 2000 mg/kg; rat dermal LD0 = 2000 mg/kg; no eye irritation irritation in rabbits; (-) for skin sensitization in a mouse local lymph node assay up to 75% ai

 Ecotox:

Test Organism Test Type Test End Point Predicted Measured C

fish 96-h LC50 480 > 133 

NOEC = 133 

a

daphnid 48-h LC50 1.2 no d
green algal 96-h EC50 5.1 > 121 mg/L

NOEC = 121 mg/L 

a

fish 

_

chronic value 2.8

daphnid _ chronic value 0.069

algal _ chronic value 7.6

Sewage Sludge 3-h EC50 _Sewage Sludge _ Chronic Value _

Ecotox Values Comments: Predictions are based on SARs for unhindered anilines; SAR chemical class = an

MW 155; log Kow = 0.08 (EPI); solid with mp = 181 C (M); S = 7.66 g/L at 20 C (P); pH7; effective concentra

active ingredients and mean measured concentrations; DWhardness <150.0 mg/L as CaCO3; and DWTOC <2.0 Ecotoxicity Data Review for: P-13-0773Chemical Name: 2,5 Dimethoxy-4-PyrimidinamineTest Material Name: 4-Amino-2,5-dimethoxypyrimidineCASRN: 6960-17-4Trade Name: 4-ADMP, Dimethoxy Aminopyrimidine 20th, August 2013Two ecotoxicity studies were submitted with the PMN P13-0773 from 

 a 96-hour acute fish toxi

algae growth inhibition test. The studies were conducted in 2013 and the substance was described as a solid with value of 0.08, an estimated water solubility of 7.66 g/L, and purity = 99.5%. The studies were performed under Gsigned quality assurance statement and certificate of analysis also provided. Both tests followed OECD and OPPTesting of Chemicals (203 and 201; 850.1075and 850.4500 for 1) water quality parameters; 2) species, age, size, For the fish test, to prepare the test solutions, the test substance was directly added to laboratory dilution water. 1800 mg of the test substance were dispensed into approximately 15 L of dilution water to achieve a target (nomconcentration of 120 mg/L. Test solutions were stirred on a magnetic stir plate utilizing a Teflon coated stir bar tsolutions were allowed to equilibrate to test temperature prior to exposure initiation. For the algal test, to prepare 

primary stock solution was prepared at the highest test concentration of 120 mg/L. The test material (0.2400 g) wtared scintillation vial. The vial was then filled approximately halfway with AAP, capped, shaken vigorously to to a 2-L volumetric flask. This was repeated until no visible test material remained in the vial. The flask was brAAP and stirred on a magnetic stir plate using a Teflon lined magnetic stir bar for approximately 2 hours. The pwas clear and colorless. The primary stock was then diluted to achieve the remaining nominal concentrations. T
stoppered and shaken vigorously until the solution appeared homogenous. 

96-hour Acute Fish Toxicity TestA 96-hour fish toxicity test in rainbow trout (Oncorhynchus mykiss) was conducted under static conditions. Follrange-finding test, three replicates of ten O. mykiss were exposed to laboratory dilution water (control) or the tesnominal concentration of 120 mg/L in a limit test at a light intensity of 675-844 lux with a photoperiod of 16:8 liCorresponding mean measured concentrations of < LOQ (water control) and 133 mg/L were determined via LC/0.00119 mg/L). Each test vessel was loosely covered to reduce evaporation. Measured concentrations of test su109 to 115% of nominal on day 0 and 107 to 116 % of nominal on day 4. Over the course of the study, temperat= 6.7 to 7.5, DO = 6.4 to 9.5 mg/L, and water hardness = 60 to 62 mg CaCO3/L. A loading rate of 0.907 g fish/L mean length was 5.3 cm. Fish were observed at 0, 24, 48, 72, and 96 hours after test initiation. During the studysub-lethal effects were observed at any concentration tested, including the control. 96-hour LC50 > 133 mg/LNOEC = 133 mg/L

96-hour Algae Toxicity TestA 96-hour growth inhibition test with freshwater green alga (Pseudokirchneriella subcapitata) was conducted un

Following a preliminary range-finding test, five replicates of P. subcapitata (1 x 104 cells/mL) were exposed to tnominal concentrations of 0, 3.75, 7.5, 15, 30, 60 and 120 mg/L. Corresponding mean, measured concentrations 14.6, 29.5, 60.2, and 121 mg/L, respectively and were determined via HPLC/MS analysis (LLQ = 0.00119 mg/Lreplicates of P. subcapitata (1 x 104 cells/mL) were concurrently exposed to AAP medium (control). The additiotest and control level was not inoculated with algae to serve as a counting blank. These blanks were used to correfor the interference of the test material and to monitor pH without the algal biomass. The algae were illuminated hour photoperiod and a light intensity of 4430-5950 lux with constant shaking (100 rpm). Test vessels were sealstoppers. Over the course of the study, temperature = 22-23oC and pH = 6.8-8.7. The 72-hour mean cell density cultures increased by a factor of 247. The testing facility listed the IC50 value (the concentration which inhibits to the control) which is the same as the LC50. 96-hour IC50 (cell yield, growth inhibition and area under the curve) > 121 mg/L96-hour NOEC = 121 mg/L ConclusionBoth the fish and algal studies are considered acceptable. The preparation methods are reasonable and attempts tthe measured PMN material in solution are done so with a precise and sensitive technique. However, without the 
daphnid test, ECOSAR (v. 1.10) predictions will be used to determine the concern concentrations due to the daph

predicted as the most sensitive. The acute concern concentration is based on the 48-hour EC50 value for daphnia value is divided by an assessment factor of 5 to yield 0.240 mg/L or 240 μg/L. The chronic concern concentratioon the chronic value for daphnia of 0.069 mg/L. This value is divided by an assessment factor of 10 to yield 0.00Acute CC = 240 ppb Chronic CC = 7 ppb

Reviewer: S. Pollack

Factors Values Comments

Assessment Factor 10

Concentration of Concern (ppb) 7

SARs unhindered anilines

SAR Class aniline-unhindered

Ecotox Category Anilines

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916