Registration Dossier
Registration Dossier
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EC number: 228-726-5 | CAS number: 6337-43-5
Endpoint summary
Administrative data
Description of key information
Oral:
Relevant NOAEL (equivalent to OECD 407, gavage, rat): 1000 mg/kg bw/d
A 28 -day repeated oral dose toxicity study of the test item followed by a 14 -day recovery study was performed in groups of five male and five female Crl:CD (SD) rats at 5 weeks of age. The high dose was set at 1000 mg/kg/day, and altogether 3 doses including 150 and 25 mg/kg/day were employed. Recovery groups were also set for the 1000 mg/kg and vehicle control groups.
No death occurred and no abnormalities were noted in all examinations.
No abnormalities were noted in the recovery test.
Based on these results, the NOEL and NOAEL of the test item in rats under the present study conditions were estimated to be 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:
- reliable without restrictions
Additional information
see above
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
Guideline conform GLP study
Justification for classification or non-classification
Due to the NOAEL of 1000 mg/kg bw/day in a 28 day oral toxicity study (OECD 407) in rats the test substance does not have to be classified regarding systemic and target organ toxicity after repeated exposure according to the criteria laid down in in the EU Classification Labelling and Packaging Regulation (1272/2008/EC).
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