Dimethylcyclohex-3-ene-1-carbaldehyde

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

24-10-2001 to 30-11-2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

not a guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Principles of method if other than guideline:

- Principle of test: 9 Repeated Insult (occlusive) Patch Test (9-RIPT)
- Short description of test conditions: During the induction phase a sufficient amount of test article was placed to the back of each subject, every Monday, Wednesday and Friday till 9 applications had been made. The patch was removed after 24 hours. During the challenge phase (after a rest period of 2 weeks), the challenge patch was applied to a previously unpatched test site.
- Parameters analyzed / observed: During the induction phase positive reactions of a level 2 erythema or greater results in a change of application site. After the challenge, the site was scored after 24, 48 and 72 hours for erythema. All subjects were instructed to report any delayed skin reactivity.

GLP compliance:

no

Remarks:

according to GCP regulations

Test material

Test material information

Constituent 1

Reference substance name:

Dimethylcyclohex-3-ene-1-carbaldehyde

EC Number:

248-742-6

EC Name:

Dimethylcyclohex-3-ene-1-carbaldehyde

Cas Number:

27939-60-2

Molecular formula:

C9H14O

IUPAC Name:

(1R,6R)-3,6-dimethylcyclohex-3-ene-1-carbaldehyde; (1R,6R)-4,6-dimethylcyclohex-3-ene-1-carbaldehyde

Test material form:

liquid

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 110
- Sex: 18 (M)/ 92 (F)
- Age: 21-69

Clinical history:

The subjects did no exhibit any physical or dermatological condition that would have precluded application of the test article or determination of potential effects of the test article.

Route of administration:

dermal

Details on study design:

ADMINISTRATION
- Type of application: occlusive
- Description of patch: Park-Davis Readi-Bandage
- Vehicle / solvent: not specified
- Concentrations: 1% (v/v)
- Volume applied: 0.2 mL
- Testing schedule:
During the induction phase a sufficient amount of test article was placed to the back of each subject, every Monday, Wednesday and Friday till 9 applications had been made. 2 weeks after the final application a challenge patch was applied to a previously unpatched test site.
-Scoring schedule:
The site was scored 24, 48 and 72 hours after application. The subjects were instructed to report any delayed skin reactivity.
- Removal of test substance: The subjects removed the bandage 24 hours after application
EXAMINATIONS
- Grading/Scoring system: 0= No evidence of any effect: += Barely perceptible (minimal, faint, uniform or spotty erythema): 1= Mild (Pink, uniform erythema covering most of the contact site): 2= Moderate (Pink-red erythema uniform in the entire contact site): 3= Marked (Bright red erythema with/ without petechiae
RECHALLENGE
- One subject returned approximately 6 weeks after the study for a rechallenge with the substance under previously unpatched test sites under occlusive (back patch), semi-occlusive (back patch) and open (forearm) application. is not associated with an allergic dermatitis response.

Results and discussion

Results of examinations:

SYMPTOMS
- At 1% which was used in this study, no responses were noted on any subject during the induction phase. During the challenge phase 1 (1/106) mild (level 1) response was observed at the 48 hour evaluation. At the 72 hour evaluation the response decreased to a barely perceptible (+) and no response was noted at the 96 hour evaluation. Due to the transient nature, the responses were not considered to be evidence for sensitisation.

OTHER RESULTS:
- 4 subjects (4/110) discontinued for personal reasons unrelated to the conduct of the study
- One subject, who showed a mild and transient response, was re-challenged (approximately 6 weeks after the end of the study). The results indicated that the substance is not associated with an allergic dermatitis response.

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test 1% test substance was not sensitising.

Executive summary:

An HRIPT test was performed with 1% test substance. 106 volunteers finished the study and they were exposed to 0.2 mL solution mainly under occlusive conditions. The subjects removed the bandages 24 hours after application. The basic schedule was kept in the induction phase every Monday, Wednesday and Friday till 9 applications had been made. The test patch was applied to the same site each time, unless reaction to sample rendered this inadvisable, in which case the test patch was applied to a distant site. After two weeks a challenge patch was applied to a site not previously exposed and removed after 24 hours. Reactions to the challenge were assessed after 24, 72 and 96 hours. None of the 106 subjects tested was sensitized by the sample. In addition, for one subject who showed a mild and transient response, a re-challenge was performed 6 weeks after the study. From occlusive, semi-occlusive and open application it was concluded that under the conditions of the test 1% test substance is not sensitizing.