Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

In a dermal sensitization study (Manciaux, 1999) with Esterol C (batch No. 99.06.501) in corn oil, Hartley guinea-pigs were tested using the method of Guinea pig maximisation test. No clinical signs and no deaths were noted during the study. No cutaneous reactions were observed after the challenge application. Under the experimental conditions of the study, Esterol C does not induce delayed contact hypersensitivity in guinea pig.

Many other studies on different members of the category are reported in secondary literature and they are all negative. It can be concluded that no concern is raised for sensitisation of fatty acid C16 -C18 and C18 insatd. methyl esters.


Migrated from Short description of key information:
Not sensitizing

Justification for classification or non-classification

There is no human or animal evidence on this endpoint therefore no classification is warranted under 67/548/EEC or Regulation 1272/2008.