Registration Dossier
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EC number: 203-996-7 | CAS number: 112-67-4
Endpoint summary
Administrative data
Description of key information
NOAEL oral (rat) ≥ 1000 mg/kg bw/d (OECD 422, tested with docosanoic acid CAS 112-85-6)
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
No further details.
Additional information
No data are available for palmitoyl chloride (CAS 112-67-4), but for the read-across substance docodanoic acid (CAS 112-85-6).
The repeated dose toxicity of docosanoic acid (CAS 112-85-6) 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/d of docosanoic acid by gavage, respectively. 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 a result of this treatment, neither mortality nor abnormalities in general condition were observed. In addition, no changes in body weight, body weight gain and food consumption were found. The observed minor changes in the corpuscular haemoglobin concentration, glucose, chloride, calcium and alkaline phosphate levels were regarded as incidental which also holds true for the observed changes in liver weights in male and kidney weights in females, respectively. All histopathological findings noted in all dose groups were also detected in the control groups, so that all findings could be regarded as not treatment-related. Overall, no treatment-related adverse effect was apparent, so that the highest dose of 1000 mg/kg bw/day is regarded as the NOAEL for docosanoic acid (Nagao, 2002).
Justification for classification or non-classification
No classification suggested for repeated dose toxicity as criteria of regulation 1272/2008/EC are not met.
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