Registration Dossier
Registration Dossier
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EC number: 269-124-2 | CAS number: 68187-77-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
Analogue substance 1 has been tested for reproductive toxicity in a combined study on reproducrive toxicity and repeated dose according to OECD 422
No reproduction or developmental toxicity was observed up to the highest dose level tested (1000 mg/kg).
Effects on developmental toxicity
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Justification for classification or non-classification
Reproductive toxicity includes adverse effects on sexual function and fertility in sexually adult males and females animals, as well as developmental toxicity in the offspring. However, developmental toxicity
essentially means all the adverse effects induced during pregnancy that can be manifested at any point of the life span of the animal, which might in turn bring to structural abnormality, altered growth and/or
organs development, functional deficiency, even death.
Table 3.7.1(a) of Annex I of EC Regulation 1272/2008 states that to classify compounds "for category 2 suspected human reproductive toxicant, reproductive effects shall have been observed in the absence
of other toxic effects, or if occurring together with other toxic effects the adverse effect on reproduction is considered not to be a secondary non-specific consequence of the other toxic effects". To this extent the
screening study performed on analogue substance 1 does not provide any indication of direct adverse effect on reproduction. In fact up to the dose of 1000 mg/kg bw/day no effects were observed in both
genders on reproduction, nor parental toxicity was detected. Moreover, no developmental toxic effects in the offspring were observed at all doses.
In conclusion, since no adverse effects on reproduction were observed, classification for reproductive/ developmental toxicity is not warranted under Regulation 1272/2008.
Based on the read across considerations same results apply to analogue substance 1
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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