Registration Dossier
Registration Dossier
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EC number: 272-574-2 | CAS number: 68890-66-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Octopirox was tested in a segment III study concerning peri- / postnatal effects. In doses as high as 500 mg/kg body weight administered
subcutaneously to rats no treatment related abnormalities were noticed with regard to various parameters examined at birth, as well as with regard to general differentiation, functions, open field behaviour and learning ability.
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
Effect on fertility: via dermal route
- Dose descriptor:
- NOAEL
- 100 mg/kg bw/day
Additional information
Fertility studies in rats have revealed no significant effects of Octopirox on reproductive parameters either by the oral or dermal route of exposure. The NOAELs in these studies were consistently at or above 100 mg/kg body weight per day.
Short description of key information:
Octopirox was tested for reproductive toxicity in different species using different routes of exposure. Fertility was not influenced in studies with rats either when administerd via gavage or subcutaneously.
Effects on developmental toxicity
Description of key information
Octopirox was tested for developmental toxicity in rats and in rabbits using the oral and dermal route of exposure. In doses as high as 2000 mg/kg body weight. In all of these studies, Octopirox was devoid of embryo- or fetotoxic effects and no teratogenic potential was revealed.
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
Effect on developmental toxicity: via dermal route
- Dose descriptor:
- NOAEL
- 2 000 mg/kg bw/day
Additional information
Octopirox was tested for developmental toxicity in rats and rabbits. Administration in doses as high as 2000 mg/kg body weight per day by the oral route as well as by the dermal route of exposure during the sensitive phase of organogenesis revealed no indications of embryo- and/or fetotoxicity and no teratogenic potential of Octopirox.
Toxicity to reproduction: other studies
Additional information
Octopirox was tested for peri- / postnatal development in the rat. After dermal administration no significant effects on reproductive parameters were observed.
Justification for classification or non-classification
Octopirox was investigated extensively for potential reproductive toxicity in different species using different routes of exposure. In all of the available tests Octopirox was devoid of embryo- and/or fetotoxicity and did not cause any developmental / teratogenic effects. Fertility studies have not revealed any indications that Octopirox is significantly affecting reproductive performance. Based hereupon Octopirox is not subject for labelling and classification requirements.
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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