Registration Dossier

Administrative data

Description of key information

In a subacute study with rats (Ciba-Geigy, 1986) the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw.

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

Mode of Action Analysis / Human Relevance Framework

Additional information

In a GLP-compliant subacute rat study (OECD 407), a total of 40 RAIf rats (5 males and 5 females per dose group) were dosed by gavage with 0, 40, 200 and 1000 mg/kg body weight daily for 28 days (Ciba-Geigy, 1985). No relevant clinical signs and no mortalities related to administration of the test substance were observed during the treatment or recovery periods. No changes to body weight gain food consumption and water consumption were noted. In hematology, a minor increase in the percentage of segmented neutrophils was found in males and females of the high dosage group (1000 mg/kg bw), but the difference to controls was not reaching a level of statistical significance. Blood chemistry analysis revealed a minor (statistically not significant) increase in aspartate aminotransferase activity in the male group 4, treated with 1000 mg/kg bw, but no changes attributable to the treatment with the test article were found. Besides some incidental findings in organ weight parameters and microscopy investigations, no effects of toxicological significance attributed to treatment were observed. Therefore, the NOAEL was set at 1000 mg/kg/day under the conditions of this study.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for repeated dose oral toxicity is not warranted under Directive 67/548/EEC.

 

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for repeated dose oral toxicity is not warranted under Regulation (EC) No.1272/2008.