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Key value for chemical safety assessment

Effects on fertility

Description of key information

In accordance with Column 1 of REACH Annex IX the extended one-generation reproductive toxicity study (EOGRTS required in Section 8.7.3) does not need to be conducted since no adverse effects on reproductive organs and tissues were observed in a 90-day repeated dose toxicity study.

One generation studies were performed using analogue substances 2,6-demethylhept-5-enal and Heptanoic acid. The NOAEL was 300 mg/kg bw/day and 200 mg/kg bw/day respectively.

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

The test substance was assessed for toxicity to reproduction using a one-generation study in rats using the analogue substances 2,6 -dimethylhept-5-enal and Heptanoic acid. The results showed that under the conditions of the test, dose levels of 300 mg/kg bw/day of 2,5,diemthylhept-5 -enal, and dose levels of 200 mg/kg bw/day of Heptanoic acid had no adverse effects on the reproductive performance of female Sprague Dawley rats or the growth or development of their offspring.



Justification for selection of Effect on fertility via oral route:
The Observed No Observed Adverse Effect Level (NOAEL) for adult toxicity, reproduction and offspring survival, growth and development was considered to be 200 mg/kg bw/day.

Effects on developmental toxicity

Description of key information

In order to fulfil the standard information requirements, a GLP-compliant prenatal developmental toxicity study in rats via the oral route following OECD TG 414 is proposed according to Annex IX, Column 1, Section 8.7.2.

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available (further information necessary)
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

No study to address developmental toxicity is available, yet.

Additional information