Registration Dossier
Registration Dossier
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EC number: 701-388-0 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In a reproductive and developmental toxicity screening study (OECD 421) the substance was administered to rats (12/sex/dose) by oral gavage at dose levels of 0, 30, 300 or 1000 mg/kg bw/day. No adverse effects were reported on reproductive parameters and the NOEL is 1000 mg/kg bw/day, this being the highest dose tested.
There are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues or reveal other concerns in relation with reproductive toxicity. Therefore the conduct of an EOGRTS is not justified.
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
- Quality of whole database:
- Sufficient to address requirements.
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Effects on developmental toxicity
Description of key information
In a reproductive and developmental toxicity screening study (OECD 421) the substance was administered to rats (12/sex/dose) by oral gavage at dose levels of 0, 30, 300 or 1000 mg/kg bw/day. No adverse effects were reported on developmental parameters and the NOEL is 1000 mg/kg bw/day, this being the highest dose tested. Since the supply volume has now exceeded 100tpa, a testing proposal has been submitted to ECHA for a new developmental toxicity study in the rat (OECD 414).
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
- Quality of whole database:
- Sufficient to address requirements.
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the findings of a reliable reproductive and developmental toxicity screening study (OECD 421), classification of the substance is not justified.
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.
