Registration Dossier
Registration Dossier
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EC number: 229-102-5 | CAS number: 6410-32-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
PR022
A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with the test item administered by oral gavage in Sprague Dawley rats (12/sex/dose) was performed according to OECD TG 422. The dose levels for this study were 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females).
There were no effects on reproduction or development; therefore, the NOAEL for the reproductive/developmental toxicity was considered to be 1000 mg/kg/day in both parental animals and offspring.
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
Effects on developmental toxicity
Description of key information
PR022
A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with the test item administered by oral gavage in Sprague Dawley rats (12/sex/dose) was performed according to OECD TG 422. The dose levels for this study were 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females).
There were no effects on reproduction or development; therefore, the NOAEL for the reproductive/developmental toxicity was considered to be 1000 mg/kg/day in both parental animals and offspring.
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
Justification for classification or non-classification
No Classification, as no adverse effects were observed.
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.
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