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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 260-906-9 | CAS number: 57693-14-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
NOAEL = 1000 mg/kg bw/day
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a study according to OECD guideline 422, no adverse effects were observed in parental as well as in offspring animals. The NOAEL regarding fertility was 1000 mg/kg/day.
Effects on developmental toxicity
Description of key information
NOAEL = 1000 mg/kg bw/day
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
In a study according to OECD guideline 422 no adverse effects at all were observed in parental as well as in offspring animals. The NOAEL for developmental toxicity was 1000 mg/kg bw/day.
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), adverse effects on reproduction seen only at very high dose levels in animal studies (for example doses that induce prostration, severe inappetence, excessive mortality) would not normally lead to classification, unless other information is available, e.g. toxicokinetics information indicating that humans may be more susceptible than animals, to suggest that classification is appropriate.
However, specification of the actual ‘limit dose’ depends upon the test method that has been employed to provide the test results, e.g. in the OECD guideline for repeated dose toxicity studies by the oral route, an upper dose of 1000 mg/kg is recommended as a limit dose, unless expected human response indicates the need for a higher dose level.
In a study according to OECD guideline 422, no adverse effects at all were observed in parental as well as in offspring animals up to the highest tested dose of 1000 mg/kg bw/day. The NOAEL was identified as 1000 mg/kg bw/day and no classification was applied.
Additional information
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.
