Registration Dossier

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

Constituent 1
Chemical structure
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:
3-methyl-6-(propan-2-yl)cyclohex-2-en-1-one
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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
No data
Challengeopen allclose all
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

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.