(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Sensitisation data (human)

Administrative data

Endpoint:

sensitisation data (humans)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

11 September 1978 to 12 October 1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Type of sensitisation studied:

skin

Study type:

study with volunteers

Test guideline

Qualifier:

according to guideline

Guideline:

other: Maximization Test, 'Updating the Maximization Test for Identifying Contact Allergens' Contact Dermatitis 1975 1: 231-239

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

EC Number:

224-815-8

EC Name:

(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Cas Number:

4501-58-0

Molecular formula:

C10H16O

IUPAC Name:

(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde

Details on test material:

- Name of test material: Campholenic aldehyde

Method

Type of population:

general

Ethical approval:

not specified

Subjects:

- Number of subjects exposed: 25
- Sex: male and female
- Age: 19 to 50 years old
- Race: white, black and oriental
- Demographic information: no further data

Clinical history:

All volunteers were reported to be healthy

Route of administration:

dermal

Details on study design:

PRE-TESTING
The test substance was pre-tested on twenty-five subjects to determine whether sodium lauryl sulfate pre-treatment was required. A patch of material was applied to a normal site on the volar forearm for 48 hours under occlusion. The material was found to be not irritating.

INDUCTION
0.3 g of test substance was applied under an occlusive dressing to the same site on the forearm for five 48 hour periods. Since the test substance was found to be non-irritating, it was decided to use 2.5% sodium lauryl sulfate during this period.

CHALLENGE
Following a ten day rest period, a challenge patch of the test substance was applied to a different site (opposite upper arm) for a 48 hour period under occlusion. The challenge site was pre-treated for one hour with 10% aqueous solution of sodium lauryl sulfate. Observations were made immediately after removal of the challenge patch and 24 hours thereafter based on the following scale:
0 - not sensitised
1 - mild sensitisation (mainly erythema and a little oedema)
2 - moderate sensitisation (erythema with infiltration, raised, spreading beyond the borders with or without vesiculation)
3 - strong sensitisation (large, vesiculo-bullous, vividly red, infiltrated plaques)

Results and discussion

Results of examinations:

There was one instance of contact-sensitisation from this material on the maximisation study.

Any other information on results incl. tables

Table 1: Results

	Induction Application					Challenge
Subject number	1	2	3	4	5	48 h	72 h
1	0	0	0	0	0	0	0
2	0	0	2	*	*	*	*
3	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0
5	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0
7	0	0	0	0	0	0	0
8	0	0	0	0	0	0	0
9	0	0	0	0	0	0	0
10	0	0	0	0	0	0	0
11	0	0	0	0	0	0	0
12	0	0	0	0	0	0	0
13	0	0	0	0	0	0	0
14	0	0	0	0	0	0	0
15	0	0	0	0	0	0	0
16	0	0	0	0	0	0	0
17	0	0	0	0	0	0	0
18	0	0	0	0	0	0	0
19	0	0	0	0	0	0	0
20	0	0	0	0	0	0	0
21	0	0	0	0	0	0	0
22	0	0	0	0	0	0	0
23	0	0	0	0	0	0	0
24	0	0	0	0	0	0	0
25	0	0	0	0	0	0	0

* indicates subject stopped on study due to allergic reaction. The subject refused to have challenge done because of allergic reaction which appeared during induction

Applicant's summary and conclusion

Conclusions:

Under the conditions of the test, there was one instance of contact-sensitisation with the test substance. The test substance should be considered to be a weak sensitiser.

Executive summary:

In a human sensitisation study conducted in line with Contact Dermatitis (1975) 1: 231-239, the test substance was considered to be a weak sensitiser in human volunteers.