Registration Dossier
Registration Dossier
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EC number: 932-349-8 | CAS number: 8006-64-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
Preliminary Extended One Generation Reproductive Toxicity Study: on-going
Extended One Generation Reproductive Toxicity Study: planned
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Experimental exposure time per week (hours/week):
- 168
- 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
OECD 414 study in rats (Klimisch 1, Key study); NOAEL = 60 mg/kg bw/day
OECD 414 study in rabbits (Klimisch 1, Key study); NOAEL = 250 mg/kg bw/day
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 60 mg/kg bw/day
- Study duration:
- subacute
- Experimental exposure time per week (hours/week):
- 168
- 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 adverse effects on reproductive function and on pre-natal development have been identified in the on-going preliminary extended one generation toxicity study and in two pre-natal developmental toxicity studies in rats and rabbits. Therefore, the registered substance does not need to be currently classified for reproductive toxicity according to CLP regulation.
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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