Registration Dossier

Administrative data

Description of key information

Not to mildly irritating to skin and eyes; no significant respiratory exposure. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Justification for classification or non-classification

Eye and/or skin irritation studies are available on hydrogenated castor oil, ‘fatty acids, castor oil hydrogenated’ and stearic acid. These studies suggest that 12-hydroxystearic acid is likely to be not or only minimally irritating to skin and eyes.

 

Exposure to 12-hydroxystearic acid via the inhalation route and consequent respiratory irritation is not expected given it low vapour pressure and solid form (flakes). Appropriate risk management measures are implemented wherever necessary (e.g. dustproof masks). Moreover, the absence of any significant skin or eye irritation does not suggest 12-hydroxystearic acid to be a respiratory irritant.

Based on the available data, this substance does not require to be classified for eye or skin irritation properties according to Directive 67/548/EEC or Regulation EC (No) 1272/2008.