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EC number: 401-540-3 | CAS number: 84632-65-5
Endpoint summary
Administrative data
Description of key information
28 d, rat, gavage: NOAEL males / females > 1000 mg/kg body weight (GLP, OECD 407, RCC AG 1986)
No substance-specific organotoxicity was observed after repeated administration of high oral doses to animals. Experimental data on repeated dermal or inhalation exposure is not available.
Key value for chemical safety assessment
Additional information
Oral
In a subacute toxicity study performed according to GLP and OECD 407(RCC 1986) the test substance (CAS No. 84632-65-5, purity unknown) was administered daily by oral gavage to Wistar rats (5 animals/sex/dose) at dose levels of 0, 100, 300 and 1000 mg/kg body weight/day for 28 days.
Two female animals, one of the control group and one of the mid dose group died spontaneously on day 17 respectively 20 of the test, due to a possible intubation error.
In the high-dose group (1000 mg/kg) red discolored extremities were observed in the animals starting with day 21 until termination of treatment. In addition the same animals showed red discolored feces, starting with day 18 until termination.
No other symptoms related to test article treatment were observed. No significant differences in food consumption and body weight gain as well as no ophthalmoscopic differences were observed between the animals of the treatment groups and the control group during the experiment.
The assessment of hematology, clinical biochemistry and urinalysis data indicated no changes of toxicological significance at termination of the treatment. No significant differences were observed in absolute and relative organ weights between the animals of the control and test article-treated groups. Additionally, all pathology findings recorded were of a spontaneous nature common in rats of this age and strain. There was no evidence of abnormal histopathological findings resulting after treatment with the test compound.
Based upon the results obtained in the study, the NOAEL for the 28-day repeated dose oral toxicity test of 3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione was considered to be higher than 1000 mg/kg/day for male and female rats when administered orally by gavage. The red discolored extremities and feces observed in animals of the high dose group were related to the color of the test compound.
Dermal
There are no data for repeated dermal exposure.
Inhalation
There are no data for repeated inhalation exposure.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for repeated dose toxicity under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008.
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