Registration Dossier
Registration Dossier
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EC number: 276-431-5 | CAS number: 72162-23-3 The high-boiling fraction separated by distillation from the products obtained from the reaction of nitric acid with cyclododecanol and cyclododecanone. Composed primarily of dodecanedioic acid, undecanedioic acid, and sebacic acid.
Endpoint summary
Administrative data
Description of key information
A key read-across study with dodecanedioic acid (CAS# 693-23-2) demonstrated that Corfree® M1 (CASRN: 72162-23-2) is not expected to show any adverse effects after repeated dose.
A 90-day oral gavage repeated dose study in rats showed no adverse effects up to dose levels of 1800 mg/kg bw/d.
A 14-day oral gavage repeated dose study in rats showed no adverse effects up to dose levels of 2400 mg/kg bw/d.
A 50-day oral combined repeated dose and reproductive toxicity study in rats showed no adverse effects up to dose levels of 1000 mg/kg bw/d.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 800 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
A repeated dose oral 13 week study was conducted in rats with the test substance dodecanedioic acid. No changes of toxicological importance were seen at any of the dose levels tested and, therefore, the NOAEL was 1800 mg/kg bw/day.
Justification for classification or non-classification
No adverse effects were noted, classification is not required.
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