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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 204-640-3 | CAS number: 123-66-0
Endpoint summary
Administrative data
Description of key information
In the key Combined Repeated Dose Toxicity 28-day / Reproduction/Developmental Toxicity Screening Test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for the test item was 1000 mg/kg bw/day (top dose). These data were supported by the dose range finder study conducted in rats.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- The key study was a good quality study, conducted according to OECD Guideline 422 (complies with GLP) and was therefore assigned 1 (reliable without restrictions).
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the key study, a test item-related increase in throid hormone (T4) was observed in adult males and pups at 1000 mg/kg. However, it was not considered to have toxicological relevance since there were no correlated changes in other parameters including microscopic findings of thyroids (with parathyroids). At the top dose an increase in prothrombin time (both sexes) and increased kidney weight (females) were observed; however, these effects were not considered to have toxicologically relevance as no correlated microscopic findings were observed. Additionally, decreased gamma glutamyl transpeptidase was identified in males in all test item-treated groups; however, it was not considered to have toxicological relevance since there were no correlated microscopic findings.
Justification for classification or non-classification
No adverse effects were observed in the key combined repeated dose with the reproduction/developmental toxicity screening test in rats (OECD 422) in rats or in the dose range finder study; therefore, the test substance is not classificable as STOT RE according to CLP (Regulation EC No 1272/2008).
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.
