Registration Dossier
Registration Dossier
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EC number: 203-366-1 | CAS number: 106-14-9
Endpoint summary
Administrative data
Description of key information
Oral NOAEL for risk assessment purposes: 10% in feed, equivalent to an estimated 5,000 mg/kg bw/day.
Dermal NOAEL for risk assessment purpose: >200 mg/kg bw/day
No significant respiratory exposure.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 5 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
Justification for classification or non-classification
While there is no specific data on 12-hydroxystearic acid, its repeated dose toxicity can be assessed based on information for hydrogenated castor oil, which contains glycerides that are metabolizedin vivoto glycerol and 12-hydroxystearic acid, or structurally analogous longer chain fatty acids such as stearic, oleic or palmitic acid.
In animal feeding trials, no adverse effects were noted up to dose levels of 5,000 mg/kg bw/day. At higher doses, effects may occasionally be observed but these are related to changes associated with increased lipid absorption and subsequent metabolic activity rather than a true toxic effect. In this context it is also of important that the longer chain fatty acids and castor oil are exempted under Annex IV or V of the REACH regulation due to absence of hazardous properties.
Exposure via the inhalation route is not expected given the physical state (solid) and low vapour pressure of 12-hydroxystearic acid. Wherever necessary, the use of appropriate risk management measure (e.g. dustproof mask) is recommended at the workplace.
No dermal toxicity was observed in various animal studies at doses up to and including 200 mg/kg bw/day.
Based on the above information, the substance does not qualify for repeated dose toxicity classification according to Directive 67/548/EC or Regulation 1272/2008/EC.
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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