Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | CAS number: -
Endpoint summary
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:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
