Heptadecanol, branched and linear

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Heptadecanol N was tested for its sensitizing effect on the skin of the guinea pig in the BUEHLER Test based on the method of BUEHLER, E.V. (1965) and OECD 406 guideline (BASF, 2007). The test-substance concentrations for the main test were selected based on the results of the pretest and the 1st challenge. All inductions were performed with the undiluted test substance. For the 1st challenge a 25% (w/w) test-substance preparation in acetone was chosen. Due to skin reactions in control group animals at this concentration a 2nd challenge was performed using a 10% (w/w) test-substance preparation in acetone. Acetone was used as the vehicle based on solubility of the test substance. The study was performed using 1 control group and 1 test group. The inductions were performed on days 0, 7 and 14. Two challenges were carried out 14 and 21 days after the last induction. The test substance caused discrete or patchy to moderate and confluent erythema and swelling in the test group animals after the induction treatments. After the 1st challenge discrete or patchy to moderate and confluent erythema were observed at the application sites of the test-substance preparation in animals of the control group and of the test group. The 2nd challenge caused discrete or patchy erythema at the application site of the testsubstance preparation in one test-group animal 24 hours after removal of the patch. No skin reactions were observed in the control group animals. No skin reactions were observed at the application sites of the vehicle acetone in all control and test group animals after both challenges.

After the 1st challenge skin reactions were noticed in both, animals of the test and the control group, although this had not been observed in the pretest, probably due to the low number of animals and the differences in source of the animals between the pretest and animals in the main study. In addition, the reaction in the test group showed a tendency for recovery. Therefore these skin reactions are attributed to skin irritation, the 25% concentration of the test substance is considered to be too high and a 2nd challenge with a 10% test-substance concentration was performed. After this challenge only a slight skin reaction was noted in one animal of the test group. Based on the evaluation criteria, the results of the second challenge do not indicate a sensitizing effect of the test substance. Taking into account that acetone may enhance the penetration of the test substance, the reaction pattern observed in this study supports the conclusion, that the skin reactions observed are due to primary skin irritation by the test substance preparation and that a certain shift of the irritation threshold towards a lower concentration occurred in the test group. Based on the considerations given above, it is concluded that Heptadecanol N does not have a sensitizing effect on the skin of the guinea pig in the BUEHLER Test under the test conditions chosen.

Migrated from Short description of key information:
Buehler-Test: not sensitising (BASF, 2007)

Justification for classification or non-classification

The test substance was not a skin sensitiser in a Buehler-Test according to OECD 406 guideline. Therefore, the test substance has not to be classified according to EU (67/548/EEC)- and CLP (1272/2008/EC) requirements for this endpoint.