1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

September 12, 1990 - October 18, 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

other: HRIPT test

Principles of method if other than guideline:

A Human Repeated Insult Patch Test (HRIPT) was conducted to assess the sensitising properties of Cashmeran in humans.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one

EC Number:

251-649-3

EC Name:

1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one

Cas Number:

33704-61-9

Molecular formula:

C14H22O

IUPAC Name:

1,1,2,3,3-pentamethyl-2,3,4,5,6,7-hexahydro-1H-inden-4-one

Method

Type of population:

general

Ethical approval:

confirmed and informed consent free of coercion received

Subjects:

- Number of subjects exposed: 53
- Sex: 9 males and 44 females
- Age: ranging from 19 to 65 years
- Race: no data
- Demographic information: no data
- Other: subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article

Route of administration:

dermal

Details on study design:

TYPE OF TEST(S) USED: the 9 repeated insult (occlusive) patch test (9 RIPT)

ADMINISTRATION: INDUCTION PHASE
- Type of application: occlusive patch
- Description of patch: Parke-Davis Readi-Bandage
- Vehicle / solvent: test substance 4.0% in Alcohol SD 39C, volatilized at least 30 minutes on the patch prior to application.
- Concentrations: 4.0%
- Volume applied: 0.2 ml
- Testing/scoring schedule: rest period after removal: on Tuesday and Thursday: 24h, on Saturday: 48h, on Monday and Wednesday: 24h, on Friday: 48h.
Test site was scored by a trained examiner just prior to the next patch application. This procedure was repeated until nine application of the test article had been made.
- Removal of test substance: 24 hours after application
- Other: if a subject developed a positive reaction of a 2-level erythema or greater during the induction phase or if the skin response warranted a change in site, the patch would be applied to a previously unpatched, adjacent site for the next application. If a 2-level reaction (or greater) occurred at the new site, no further applications would be made.

ADMINISTRATION: CHALLENGE PHASE
- Rest period after induction: 10 to 21 days
- Type of application: previously unpatched test site (occlusive)
- Testing/scoring schedule: test site was scored 24 and 48h after application

EXAMINATIONS
- Grading/Scoring system: according to a 6-point scale:
0 = no evidence of any effect
1 = barely perceptible
2 = moderate
3 = marked
4 = severe
accompanying oedema was recorded with an "e"
- Statistical analysis: no data

Results and discussion

Results of examinations:

SYMPTOMS
- Frequency, level, duration of symptoms observed: a single, transient, barely perceptible non-specific patch test response was observed on 1/48 subjects during the induction phase of the study.

Any other information on results incl. tables

A total of 48 subjects completed the study. A single, transient, barely perceptible non-specific response was observed in one of the subjects. None of the other subject showed any response.

Applicant's summary and conclusion

Conclusions:

In a Human Repeated Insult Patch Test (HRIPT), Cashmeran did not induce irritant or allergic contact dermatitis in human subject under the conditions of this test. According to the criteria outlined in Annex VI of 1272/2008/EC, Cashmeran does not have to be classified as sensitizing to the skin.

Executive summary:

To determine the irritation and/or sensitization potential of Cashmeran, a repeated insult (occlusive) patch test was performed in 53 healthy volunteers. 4.0% of test substance in Alcohol SD 39C was applied to the back of each subject. After a rest period of 10 to 21 days, the challenge patch was applied to a previously unpatched site and scored 24 and 48 hours after application. A total of 48 volunteers completed the study. A single, barely perceptible non-specific response was observed on 1/48 subjects. No other effects were observed.