Registration Dossier
Registration Dossier
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EC number: 457-320-2 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
EC#457-320-2 has been tested in reproduction and developmental toxicity screening study in rats, conducted in accordance with GLP and OECD TG 421. Doses used were 0, 100, 300 and 1000 mg/kg bw/day. Some parental animals in the top dose group showed signs of behavioural/CNS effects, such as intermittent tremors, repetitive movements of mouth and jaws, and excessive pawing and licking of the cage. The female top dose group also had an increase mean liver weight compared to the control group. The NOAEL for general parental toxicity was therefore concluded to be 300 mg/kg bw/day. However, there were no effects on reproductive indices, and the NOAEL for reproduction toxicity was concluded to be 1,000 mg/kg bw/day.
Short description of key information:
The NOAEL for reproduction toxicity is 1000 mg/kg bw/day
Effects on developmental toxicity
Description of key information
The NOAEL for developmental toxicity is 1000 mg/kg bw/day
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
EC#457-320-2 has been tested in reproduction and developmental toxicity screening study in rats, conducted in accordance with GLP and OECD TG 421. Doses used were 0, 100, 300 and 1000 mg/kg bw/day. Some parental animals in the top dose group showed signs of behavioural/CNS effects, such as intermittent tremors, repetitive movements of mouth and jaws, and excessive pawing and licking of the cage. The female top dose group also had an increase mean liver weight compared to the control group. The NOAEL for general parental toxicity was therefore concluded to be 300 mg/kg bw/day. However, there were no effects on any neonatal parameters assessed, and the NOAEL for developmental toxicity was concluded to be 1,000 mg/kg bw/day.
Justification for classification or non-classification
EC#457-320-2 has been tested in reproduction and developmental toxicity screening study in rats, conducted in accordance with GLP and OECD TG 421. Doses used were 0, 100, 300 and 1000 mg/kg bw/day. Some parental animals in the top dose group showed signs of behavioural/CNS effects, such as intermittent tremors, repetitive movements of mouth and jaws, and excessive pawing and licking of the cage. The female top dose group also had an increase mean liver weight compared to the control group. The NOAEL for general parental toxicity was therefore concluded to be 300 mg/kg bw/day. However, there were no effects on any reproductive or neonatal parameters assessed, and the NOAEL both for reproduction toxicity and developmental toxicity were concluded to be 1,000 mg/kg bw/day. Therefore, no classification is required.
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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