Registration Dossier

Administrative data

Description of key information

Acute oral LD50 > 10,000 mg/kg bw/day; acute dermal LD50 > 5,000 mg/kg bw/day; no significant inhalatory exposure

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Dose descriptor:
LD50
10 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

While no direct acute toxicity data were available for 12-hydroxystearic acid, its acute toxicity profile can be assessed on the basis of data for the read-across substances hydrogenated castor oil and stearic acid. These studies indicate acute oral LD50 values of greater than 10,000 mg/kg bw and acute dermal LD50 values greater than 5,000 mg/kg bw, both suggesting low overall acute toxicity. This is supported by the fact that 12-hydroxystearic acid has a long history of safe use in a wide range of cosmetic and industrial applications.

 

Exposure via the inhalation route is not expected given the substance form (i.e. flake) and low vapour pressure of 12-hydroxystearic acid. Wherever necessary, the use of appropriate risk management measure (e.g. dustproof masks) is recommended at the workplace.

Justification for classification or non-classification

The available data indicates a low potential for acute toxicity (oral and dermal LD50of > 10,000 and > 5,000 mg/kg bw, respectively). 12-hydroxystearic acid therefore does not meet the requirements for classification according toDirective 67/548/EEC or Regulation (EC) No. 1272/2008.