Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
500 mg/kg bw/day
Additional information

No adverse effects on fertility or reproductive toxicity were noted in a screening test with the C6-analogue cyclic alkene hexene . Furthermore no adverse effects on reproductive organs were observed in repeated dose toxicity studies. Hence further testing regarding toxicity on reproduction (fertility) is not necessary also because of animal welfare reasons. Cis-cyclooctene is used as a transported intermediate and as a monomer only in closed systems, there is no significant and hence negligible worker exposure and no consumer exposure. Therefore a 2-generation study is considered not necessary according to Annex XI.3 of REACH.


Short description of key information:
Following a read-across approach, results from a combined screening test with the C6-analogue, cyclohexene were considered. In a study according to OECD TG 422 in rats no adverse effect were noted on fertility and no adverse developmental effects were noted on the pups at dose levels of up to 500 mg/kg be/d. Furthermore no adverse effects on reproductive organs were noted in repeated dose toxicity studies.

Effects on developmental toxicity

Description of key information
Following a read-across approach, results from a combined screening test with the C6-analogue, cyclohexene were considered. In a study according to OECD TG 422 in rats no adverse effect were noted on fertility and no adverse developmental effects were noted on the pups at dose levels of up to 500 mg/kg bw/d. Furthermore no adverse effects on reproductive organs were noted in repeated dose toxicity studies. 
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
500 mg/kg bw/day
Additional information

Following a read-across approach, results from a combined screening test with the C6-analogue, cyclohexene were considered. In a study according to OECD TG 422 in rats no adverse effect were noted on fertility and no adverse developmental effects were noted on the pups at dose levels of up to 500 mg/kg bw/d. Furthermore no adverse effects on reproductive organs were noted in repeated dose toxicity studies.

Justification for classification or non-classification

Based on the results in experimental studies, no classification according to EU and GHS criteria is required.