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Toxicological information

Endpoint summary

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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
12-hydroxystearic acid is not expected to be a skin sensitizer.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

12-hydroxystearic acid was tested for sensitization potential in a local lymph node assay (LLNA) in the mouse and two guinea-pig maximization tests (GPMT) according to the Magnusson and Kligman protocol. The LLNA study produced a positive response.However, as seen in the case of other fatty acids, the response may have been a false positive so that follow up GPMT testing was conducted. In a first GPMT study,a too high concentration was used for the challenge application and it was therefore not possible to conclude clearly on the skin sensitization potential. A second study was therefore conducted under optimised conditions. 12-hydroxystearic acid in this case did not induce delayed contact hypersensitivity in guinea pigs and was not considered as sensitizing.

Given the limitations of the LLNA study for substances with fatty acid structures and based on the results of the optimised GPMT study as well as the absence of structural alerts, 12-hydroxystearic acid is not considered to be a skin sensitizer.


Migrated from Short description of key information:
12-hydroxystearic acid is not expected to be a respiratory sensitizer.

Justification for classification or non-classification

12-hydroxystearic acid is not expected to be a skin sensitiser based on available animal and human data. Therefore no classification is required for sensitisation according to Directive 67/548/EEC or Regulation (EC) No. 1272/2008.