Registration Dossier
Registration Dossier
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EC number: 203-996-7 | CAS number: 112-67-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
NOAEL oral (rat, fertility) ≥ 1000 mg/kg bw/day (OECD 422, docosanoic acid CAS 112-85-6)
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data are available for palmitoyl chloride (CAS 112-67-4), but for the read-across substance docosanoid acid (CAS 112-85-6).
The toxicity to reproduction of docosanoic acid was evaluated in a combined repeated dose and reproductive/developmental toxicity screening test performed under GLP according to OECD Guideline 422.Groups of 13 male and 13 female Sprague-Dawley rats received daily doses of 100, 300 and 1000 mg/kg bw of docosanoic acid by gavage. While the males were treated for 42 days, the females received the test substance from 14 days prior to mating until day 3 of lactation. As result, neither mortality nor abnormalities in general condition were observed. Since no difference in number of corpora lutea, implantation rate, number of implantations and all other reproductive parameters was noted in all treated groups compared to the control group, there were no indications of any adverse effects on reproduction. Thus, the NOAEL toxicity to reproduction was found to be ≥ 1000 mg/kg bw/day (Nagano, 2002).
Effects on developmental toxicity
Description of key information
NOAEL oral (rat, tera) ≥ 1000 mg/kg bw/day (OECD 422, docosanoic acid CAS 112-85-6)
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
No data are available for palmitoyl chloride (CAS 112-67-4), but for the read-across substance docosanoid acid (CAS 112-85-6).
The toxicity to reproduction of docosanoic acid was evaluated in a combined repeated dose and reproductive/developmental toxicity screening test performed under GLP according to OECD guideline 422. Groups of 13 male and 13 female Sprague-Dawley rats received daily doses of 100, 300 and 1000 mg/kg bw of docosanoic acid by gavage. While the males were treated for 42 days, the females received the test substance from 14 days prior to mating until day 3 of lactation. Since the viability, the body weights, and the results of pathological examination of the pups did not reveal any differences between the dose groups and the control groups, there was no indication for any adverse effects on development. Thus, the NOAEL for developmental toxicity and teratogenicity was ≥ 1000 mg/kg bw/day based on the absence of treatment-related effects (Nagao, 2002).
Mode of Action Analysis / Human Relevance Framework
No further details.
Justification for classification or non-classification
No classification suggested on toxicity on reproduction as criteria of regulation 1272/2008/EC are not met.
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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