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Description of key information

The key skin sensitisation study for the category (Morris et al, 1997, HTR report number: 96-1104-70A,B; EC 701 -251 -5) was chosen as the study was conducted in humans which are the most relevant species. There is no recognised guideline for this type of test however a well documented study with good scientific principles was undertaken at a certified GLP laboratory which followed a protocol.

A standard Repeated Insult Patch Test was preceded by a Pilot Phase to select a proper concentration of the test material. The test material was tested undiluted and diluted to 50% in Mineral Oil. The negative control was Mineral Oil. The testing was conducted under semi-occluded patch conditions. A total of 24 subjects was tested; one half to undiluted test material and one half to 50% test material in mineral oil. Only minimal reactions were noted during the inductions and challenge so that undiluted test material was selected for testing in the Main Phase. A total of 104 additional subjects completed the Main Phase. The test material was tested undiluted. The negative control was Mineral Oil. The testing was conducted under occluded patch conditions. Only mild to moderate responses were noted during the main phase of the study, and it is concluded that the test material is non-irritating and non-sensitizing under the condition of this test.

A reliability rating of 1 according to the criteria of Klimisch, 1997.

 

The lack of skin sensitization in the human study is consistent with the negative results in multiple animal studies, including guinea pig Maximisation and Buehler studies on analog substances (EC 701 -251 -5; EC 701 -249 -4; EC 272 -388 -1).

Key value for chemical safety assessment

Skin sensitisation

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

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No classification for skin sensitisation is warranted based on a negative HRIPT and multiple negative guinea pig studies for the alkyl phenate sulfide category.

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