2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Procedure and observations

In order to study a possible allergenic potential of the test item three groups of four female mice were each treated at concentrations of 1 %, 2.5 % and 5 % (w/v) in acetone:olive oil, 4:1 (v/v) by topical application to the dorsum of each ear lobe (left and right) on three consecutive days. A control group of four mice was treated with the vehicle (acetone:olive oil, 4:1 (v/v)) only. No test item-related clinical signs were observed in any animals of the control group or Group 2 (1 %). On the second application day, a slight swelling and general erythema were observed at both dosing sites in all mice of Group 3 (2.5 %). The effects lasted for four days. On the second application day, a moderate to slight swelling and slight to moderate erythema were observed at both dosing sites in all mice of group 4 (5 %), persisting for five days. All treated animals survived the scheduled study period.

Stimulation indices (S.I.) of 1.2, 1.2 and 1.2 were determined with the test item at concentrations of 1 %, 2.5 % and 5 % (w/v) in acetone:olive oil, 4:1 (v/v).

Conclusion

A test item is regarded as a sensitizer in the LLNA if the exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than that recorded in control mice, as indicated by the S.I. Based on these criteria, the test item was found to be a non-sensitizer when tested up to 5 % (w/v) in acetone:olive oil, 4:1 (v/v). The substance showed local irritation at 2.5 % and 5 % (w/v).

Migrated from Short description of key information:
In order to study a possible allergenic potential of the test item three groups of four female mice were each treated at concentrations of 1 %, 2.5 % and 5 % (w/v) in acetone:olive oil (OECD guideline 429). The test item was found to be a non-sensitizer when tested up to 5 % (w/v) in acetone:olive oil, 4:1 (v/v). The substance showed local irritation at 2.5 % and 5 % (w/v).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC.

                               

Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008.