Registration Dossier
Registration Dossier
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EC number: 203-957-4 | CAS number: 112-31-2
Endpoint summary
Administrative data
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
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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