Registration Dossier
Registration Dossier
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EC number: 215-385-2 | CAS number: 1324-76-1
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
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
Additional information
The screening study was conducted based on OECD guideline No. 422 to investigate the potential of test article to affect male and female reproductive performance when administered to rats for a minimum of 28 days. Four groups of ten male and ten female Wistar Han rats were exposed by oral gavage to the test substance at 0, 50, 250 and 1000 mg/kg/day. Males were exposed for 30 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were exposed for 41 to 45 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during at least 4 days of lactation. No treatment-related toxicoiogically significant changes were noted in any of the parameters investigated in this study (i.e. mortality, clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, microscopic examination, reproduction, breeding and pup development).
Therefore, test article caused non-toxic reproductive effect under the experimental condition.
Short description of key information:
From the available results, the parental, reproduction, breeding and developmental NOAEL for testsubstance of at least 1000 mg/kg/day was established.
Effects on developmental toxicity
Description of key information
Based on the non-toxic reproductive toxicity and the negligible absorption, developmental toxicity study is scientifically not justifiable nor reasonable.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Justification for classification or non-classification
Based on the available data, test article did not cause treatment-related reproductive/developmental effect. Thus, test article cannot be classified according to CLP(Regulation 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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