Registration Dossier
Registration Dossier
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EC number: 215-385-2 | CAS number: 1324-76-1
Endpoint summary
Administrative data
Description of key information
NOAEL for all effects: > 1000 mg/kg/day
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- guideline test with GLP
Additional information
In the subacute toxicity study following OECD guideline No. 422 with GLP regulations, the potential toxic effects of test article was investigated 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 substanceat0, 50, 250 and 1000 mg/kg/day.Males were exposed for 30 days. Females were exposed for 41 to 45 days.No treatment-related toxicoiogically significant changes were noted in any of the parameters investigated in this study.
In addition, according to Regulation (EC) 1907/2006, repeated dose toxicity test only need to be performed via the most likely exposure route for human. Since the most likely route is considered to be via oral, the repeated toxicity test via inhalation/dermaldon’t need to be conducted.
From the results presented in the 28 -day study, the systemic No Observed Adverse Effect Level (NOAEL) for test substance of at least 1000 mg/kg/day was established.
Justification for classification or non-classification
Based on the available data, no adverse effect was observed during the test period. Therefore, test article cannot be classified according to CLP (Regulation No. 1272/2008).
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