Registration Dossier
Registration Dossier
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EC number: 261-448-2 | CAS number: 58798-47-3
Endpoint summary
Administrative data
Description of key information
The toxicity of the test item, following daily oral administration by gavage for four consecutive weeks and recovery from any treatment related effects during a period of two weeks, was investigated in a study according to OECD 407. The NOAEL of 95 mg/kg bw/day based on the effects on mortality, body weight, food consumption, certain clinical chemistry parameters and organ weights seen in the high dose group.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 95 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The toxicity of the test item (94.3 % purity) in rats, following daily oral administration by gavage for four consecutive weeks and recovery from any treatment related effects during a period of two weeks, was investigated in a study in accordance to OECD guideline 407. The dose levels orally administered were 0, 30, 95 and 300 mg/kg bw/day. Due to severe toxicity and related mortality observed in the high dose group, the dose in this group was reduced to 200 mg/kg bw, beginning with day 10 after starting the treatment. The NOAEL was 95 mg/kg bw/day based on the effects on mortality, body weight, food consumption, certain clinical chemistry parameters and organ weights seen in the high dose group (300/200 mg/kg bw/day). No treatment-related effects were observed at the histopathological evaluation in any dose group. No changes, which could be considered to be adverse, were observed in male and female rats following dosing with the test item when administered by oral gavage for four consecutive weeks at the dosages of 30 and 95 mg/kg body weight/day.
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
GLP guideline study
Justification for classification or non-classification
Based on the available data, the target substance does not need to be classified in accordance to the CLP regulation.
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