Registration Dossier

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
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 2,6-dimethylhept-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.


Short description of key information:
One generation studies were performed using analogue substances 2,6-dimethylhept-5-enal and Heptanoic acid. The NOAEL was 300 mg/kg bw/day and 200 mg/kg bw/day respectively.

Justification for selection of Effect on fertility via oral route:
The 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

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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

According to Directive 67/548/EEC and Regulation (EC) 1272/2008, no classification is warranted.