Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Summary of repeated dose toxicity data

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Dose descriptor:
1 000 mg/kg bw/day
Study duration:

Additional information

In a combined repeated dose toxicity study with reproductive/developmental toxicity screening test, Reactive Orange F08-0314 administered daily at dose levels of 62.5, 250, or 1000 mg/kg bw/day by oral gavage to Wistar rats did not result in any test item related mortality or clinical adverse effects, ophthalmological changes, or changes in the body weight, food consumption, haematology, coagulation, clinical chemistry, or urinalysis parameters during either the treatment period or after a 14-Day Recovery period. In conclusion, under the conditions of this study, the no observed adverse effect level (NOAEL) for Reactive Orange F08-0314 for parental effects is considered to be 1000 mg/kg bw/day. 

Justification for classification or non-classification

The above study has been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the study was conducted to GLP and in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds. 

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for prolonged effects is therefore required.