6-isopropyl-3-methylcyclohex-2-enone

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

The study was conducted in 1975.

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Documentation insufficient for assessment.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Thirty one healthy inmate volunteers were screened and twenty seven completed the experiment.
The materials were pre-tested on all subjects in order to determine whether sodium lauryl sulphate pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No evidence of irritation was observed and all subjects were pre-tested with 5 % SLS.
The materials were applied under occlusion to the same site on the volar aspects of the forearm of all subjects for five alternate day 48 hours periods. Patch sites were pre-treated for 24 hours with 5 % aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of the test material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2 % aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labelled site 5.

GLP compliance:

no

Remarks:

Pre-dates GLP.

Type of study:

other: Modified maximisation test

Species:

human

Strain:

other: Not applicable

Sex:

not specified

Details on test animals and environmental conditions:

No data

Route:

epicutaneous, occlusive

Vehicle:

no data

Concentration / amount:

No data

Route:

epicutaneous, occlusive

Vehicle:

no data

Concentration / amount:

No data

No. of animals per dose:

Twenty seven completed the experiment.

Details on study design:

Thirty one healthy inmate volunteers were screened and twenty seven completed the experiment.
The materials were pre-tested on all subjects in order to determine whether sodium lauryl sulphate pre-treatment was required. A patch of each material was applied to normal sites on the backs for 48 hours under occlusion. No evidence of irritation was observed and all subjects were pre-tested with 5 % SLS.
The materials were applied under occlusion to the same site on the volar aspects of the forearm of all subjects for five alternate day 48 hours periods. Patch sites were pre-treated for 24 hours with 5 % aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of the test material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2 % aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right and labelled site 5.

Positive control substance(s):

not specified

The test substance produced no significant reactions that were considered irritant or allergic in the twenty seven subjects tested.

Interpretation of results:

not sensitising

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance produced no significant reactions that were considered irritant or allergic in the twenty seven subjects tested.

Executive summary:

The test substance was assessed for skin sensitisation potential on twenty seven human volunteers. The test substance produced no significant reactions that were considered irritant or allergic in the twenty seven subjects tested.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Thirty one healthy inmate volunteers were screened and twenty seven completed the modified maximisation experiment. 

The materials were applied under occlusion to the same site on the volar aspects of the forearm of all subjects for five alternate day 48 hours periods. Patch sites were pre-treated for 24 hours with 5 % aqueous SLS under occlusion for the initial patch only. Following a 10-14 day rest period, challenge patches of the test material was applied under occlusion to fresh sites for 48 hours. Challenge applications were preceded by 30 minute applications of 2 % aqueous SLS under occlusion on the left side of the back whereas the test materials were applied without SLS treatment on the right side. Additional SLS controls were placed on the left and petrolatum on the right.

The test substance produced no significant reactions that were considered irritant or allergic in the twenty seven subjects tested.

Migrated from Short description of key information:
The test substance was assessed for skin sensitisation potential on twenty seven human volunteers. The test substance produced no significant reactions that were considered irritant or allergic in the twenty seven subjects tested.

Justification for selection of skin sensitisation endpoint:
The study was conducted on the target substance in human volunteers.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

A skin sensitiser is defined as a substance that will lead to an allergic response following skin contact. Sensitisation includes two phases, the induction of specialised immunological memory in an individual by exposure to an allergen and solicitation were production of cell-mediated or antibody-mediated allergic response by exposure of a sensitised individual to an allergen.

For skin sensitisation, an induction phase is required in which the immune system learns to react; clinical symptoms can arise when subsequent exposure is sufficient to elicit a visible skin reaction (elicitation phase). Lower levels are usually required for elicitation than are required for induction.

Substances are classified as a Category 1 skin sensitiser if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons, or if there are positive results from an appropriate animal test.

No positive skin sensitisation reactions were elicited with human volunteers and the test substance is therefore not classified as a skin sensitiser.