Registration Dossier
Registration Dossier
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EC number: 400-920-6 | CAS number: 89857-06-7
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL = 200 mg/kg bw/day
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subacute
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
This study was designed to investigate the effects of continuous administration of test item on male and female reproductive performance, such as gonadal function, estrous cycle, mating behavior, conception, parturition, lactation and weaning.
Test item was administered orally by gavage, once daily to parent males for a 70-day pre-pairing period, during the pairing period and after-pairing period until one day before the scheduled sacrifice. Parent females received the test item during a 14-day pre-pairing period and also during the pairing, gestation and lactation periods until one day before the
scheduled necropsy. The following dose levels were utilized: 10, 40, and 200 mg/kg body weight.
At 200 and 40 mg/kg/day, mean body weight gain was slightly reduced only during the prepairing period, which was considered to be an adaptive reaction to treatment with the test item.
Based on these data, the No-Observable-Adverse-Effect Level (NOAEL) was established at the high dose of 200 mg/kg body weight.
There was no effect on male or female reproductive performance. Therefore, the No-Observable-Effect Level (NOEL) for reproductive effects was established at the high dose of 200 mg/kg body weight.
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance to the CLP Regulation (EC) No.1272/2008 classification of this substance is not required for reproductive toxicity occurring at maternally toxic doses.
Additional information
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