6-isopropyl-3-methylcyclohex-2-enone

Skin sensitisation

Administrative data

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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

6-isopropyl-3-methylcyclohex-2-enone

EC Number:

201-942-7

EC Name:

6-isopropyl-3-methylcyclohex-2-enone

Cas Number:

89-81-6

Molecular formula:

C10H16O

IUPAC Name:

6-isopropyl-3-methylcyclohex-2-enone

Test material form:

not specified

Details on test material:

Name: Piperitone

In vivo test system

Test animals

Species:

human

Strain:

other: Not applicable

Sex:

not specified

Details on test animals and environmental conditions:

No data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, occlusive

Vehicle:

no data

Induction 2

Concentration / amount:

No data

Challenge

Challenge 1

Route:

epicutaneous, occlusive

Vehicle:

no data

Challenge 2

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

Results and discussion

Any other information on results incl. tables

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

Applicant's summary and conclusion

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.