Registration Dossier
Registration Dossier
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EC number: 204-640-3 | CAS number: 123-66-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
In the key combined repeated dose with the reproduction/developmental toxicity screening test in rats (OECD 422), there were no effects of the test item on fertility; therefore, a No Observed Adverse Effect Level (NOAEL) for the test item was 1000 mg/kg bw/day (top dose).
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:
- The key study was a good quality study, conducted using OECD Guideline 422 and complies with GLP and was therefore assigned 1 (reliable without restrictions).
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 key combined repeated dose with the reproduction/developmental toxicity screening test in rats with the test item, no toxicologically-relevant parental reproductive effects were observed. All findings recorded were within the range of normal background alterations.
Effects on developmental toxicity
Description of key information
In the key combined repeated dose with the reproduction/developmental toxicity screening test in rats (OECD 422), there were no effects of the test item on pup development; therefore, a No Observed Adverse Effect Level (NOAEL) for the test item was 1000 mg/kg bw/day (top dose).
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:
- The key study was a good quality study, conducted using OECD Guideline 422 and complies with GLP and was therefore assigned 1 (reliable without restrictions).
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 key combined repeated dose with the reproduction/developmental toxicity screening test in rats with the test item, no toxicologically-relevant developmental effects were observed. All findings recorded were within the range of normal background alterations.
Justification for classification or non-classification
Based on the results of a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in rats, the test substance does not requite classification for reproductive toxicity according to CLP (Regulation EC No 1272/2008).
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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