Registration Dossier

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.