Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
December 6, 1976

Data source

Referenceopen allclose all

Reference Type:
other company data
Title:
Unnamed
Year:
1976
Report Date:
1976
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: Kligman, A.M., «The identification of contact allergens by human assay. III. The maximization test : a procedure for screening and rating contact sensitizers.» Journal of Investigative Dermatology. Vol. 47, no. 5, p. 393-409. (1966).
Deviations:
not applicable
Principles of method if other than guideline:
Human maximisation test: test item is applied under occlusion on the volar forearms or backs of volunteers for five alternate-day 48 hours periods. If irritation was not observed in a pre-test with the test item, the test site was pre-treated with 2.5% aqueous Sodium Lauryl Sulfate (SLS) for 24 hours under occlusion to maximise the reactions. Following a ten day rest period, a challenge patch of the test material was applied to a different site for a 48 hour period under occlusive conditions. SLS at 5 to 10% was appied to test site for one hour before application of the test material. Observations were made immediately after removal of the challenge patch and 24 hours thereafter.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
None

Method

Type of population:
not specified
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 25
- Sex: women
- Age: 18-38 years old
- Race: 20 Caucasian 5 African
- Demographic information: no data
- Other: healthy volunteers
Clinical history:
No data available. Healthy volunteers.
Controls:
No
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: Maximisation patch test (epicutaneous test)

ADMINISTRATION
- Type of application: occlusive
- Description of patch: no data available
- Vehicle / solvent: petrolatum
- Concentrations: 30%
- Volume applied: no data available
- Testing/scoring schedule: Test material was applied on the volar forearm or back of all subjects for 5 alternate-day 48 hour periods. The patch site was pretreated for 24 hours with 2.5% aqueous SLS under occlusion. Following a 10 day rest period, a challenge patch of the test material was applied to a different site for a 48-hour period under occlusion. Prior to challenge, 5 to 10% SLS was applied to test site for one hour before application of test material. The challenge site was read at patch removal and 24 hours thereafter.
- Removal of test substance: No

EXAMINATIONS
- Grading/Scoring system: no data available
- Statistical analysis: none

Results and discussion

Results of examinations:
SYMPTOMS
No reactions were observed

NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 25
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0

Applicant's summary and conclusion

Conclusions:
Under the test conditions, the test material is not a contact-sensitiser when tested at 30% in petrolatum on 25 volunteers in a maximisation study.
Executive summary:

A human maximization test was conducted on the volar forearm or back of 25 healthy female volunteers aged 18-38 years old. Test material at 30% in petrolatum was applied on the volar forearm or back of all subjects for 5 alternate-day 48 hour periods. The patch site was pretreated for 24 hours with 2.5% aqueous sodium lauryl sulfate (SLS) under occlusion. Following a 10 day rest period, a challenge patch of the test material was applied to a different site for a 48-hour period under occlusion. Prior to challenge, 5 to 10% SLS was applied to test site for one hour before application of test material. The challenge site was read at patch removal and 24 hours thereafter.

No reactions were observed in any of the volunteers.

Under the test conditions, the test material is not a contact-sensitiser when tested at 30% in petrolatum on 25 volunteers.