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
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
- Value:
- 10 000 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 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.
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