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Toxicological information

Sensitisation data (human)

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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

Constituent 1
Chemical structure
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:
2-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]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.