Pyrrolo[3,4-c]pyrrole-1,4-dione, 2,5-dihydro-3,6-diphenyl-

Endpoint summary

Description of key information

28 day oral repeated dose toxicity: NOAEL > 1000 mg/kg bw ; OECD 407, RCC 1987 

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Dose descriptor:

NOAEL

1 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Additional information

An oral subacute toxicity study (28 d) was conducted, according to OECD guideline 407 (RCC 1987). Groups of 5 male and 5 female Wistar rats were dosed orally via gavage cannula over 4 weeks with the test substance at dose levels of 0, 100, 300 and 1000 mg/kg bw/day. Clinical signs and mortality were observed twice daily in all animals. Blood and urine samples were taken for laboratory investigations 24 hours after last application. On completion of 4 weeks of dosing all animals were killed and necropsied and given a detailed post mortem examination with organs being weighed and a list of tissues placed in fixative.

The results of the study can be summarised as follows:

- Analysis of Dosing Solutions: All formulations were prepared to an acceptable degree of accuracy.

- Mortality: There were no deaths as a result of treatment with the test substance.

- Clinical Signs: No signs of toxicity which could be related to test article treatment were observed.

- Body Weights: No significant differences in body weight gain was observed between the animals of the test article and control groups during the experiment.

- Food Consumption: No significant differences in food consumption was observed between the animals of the test article and control groups during the experiment.

- Ophtalmoscopic Examination: No treatment-related findings were noted.

-Laboratory Investigations:

* Haematology: The assessment of hematology data indicated no changes of toxicological significance at termination of the treatment.

* Clinical Chemistry: The assessment of clinical biochemistry data indicated no changes of toxicological significance at termination of the treatment.

* Urinalysis: The assessment of urinanalysis data indicated no changes of toxicological significance at termination of the treatment.

- Terminal Studies

* Organ Weights: No significant differences were observed in absolute and relative organ weights between the animals of the control and test article-treated group.

* Necropsy Findings: All pathologic findings recorded were of a spontaneous nature common to rats of this age and strain. There was no evidence of abnormal histopathological findings, resulting from treatment with the test substance.

Based upon the results obtained in this study the "no observed adverse effect level" and the "no observed effect level" were greater than 1000 mg/kg bw/d for male and female rats when administered orally by gavage.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for repeated oral 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 oral toxicity under Regulation (EC) No. 1272/2008.