A mixture of cis- and trans-cyclohexadec-8-en-1-one

Toxicity to reproduction

Administrative data

Endpoint:

extended one-generation reproductive toxicity - basic test design (Cohorts 1A, and 1B without extension)

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the extended one-generation reproductive toxicity study does not need to be conducted because there are no results from available repeated dose toxicity studies that indicate adverse effects on reproductive organs or tissues, or reveal other concerns in relation with reproductive toxicity

Justification for type of information:

According to Regulation (EC) No. 1907/2006, Annex IX, 8.7.3. column 1, an extended-one-generation study for assessment of reproductive toxicity is not required if no adverse effects on reproductive organs were reported in either a 28-day or 90-day repeated dose toxicity study. A repeated dose study according to OECD 407 and in compliance with GLP is available for cyclohexadec-8-en-1-one (CAS 3100-36-5). There were no adverse effects on reproductive organs (ovaries and testes) up to the highest dose tested (1190.5 and 1198.75 mg/kg bw/day in males and females, respectively). Furthermore, a 90-day repeated dose toxicity study (rat, oral route) is proposed and will yield further information on toxicity to reproductive organs and thyroid hormones. For this reason, and due to animal welfare reasons, results from this subchronic study should be first taken into account. If the results of this study are available, the further need of a reproductive toxicity study will be evaluated again. However, for the time being, based on the OECD 407 study, and considering the scope of REACH to minimise the use of animals, the extended one-generation reproductive toxicity study is waived.