Registration Dossier

Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1992-04-27 to 1992-06-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles. Testing of a cosmetic preparation containing several active ingredients.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
Human Repeat Insult Patch Test, Shelanski modification.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test formulation (H03-146) is lotion vehicle containing a combination of:
- octocrylene (10%)
- avobenzone (4%)
- oxybenzone (5%)
- octyl salicylate (5%)

Specific details on test material used for the study:
Applied as lotion containing different UV filters including Octocrilene

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
- Number of subjects exposed: 217 enrolled, 205 completed the study
- Sex: 20 male (10%), 185 female (90%)
- Age: 18 to 64 years
No further data.
Clinical history:
no data
Route of administration:
dermal
Details on study design:
TYPE OF TEST(S) USED: HRIPT

ADMINISTRATION
- Type of application: occlusive patch
- Vehicle / solvent: lotion
- Concentrations: 10 % (octocrylene) + 3 other UV filters
- Volume applied: 0.2 ml per test product


EXAMINATIONS
- Grading/Scoring system:
0 = Negative; no reaction.
1 = Macular, faint erythema involving at least 25% of the test area.
2 = Moderately intense erythema, with or without infiltration and involving at least 25% of the test area.
3 = Strong, infiltrated erythema and accompanying vesicles or superficial erosions involving at least 25% of the test area.
4 = Bullae or extensive erosions involving at least 50% of the test area.

Results and discussion

Results of examinations:
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
Induction: Scores of 1 were observed in 0, 1, 1, 1, 2, 1, 2, 5 and 4 individuals after 1-9 induction applications respectively.
Callenge: Scores of 1 were observed in 1 and 0 individuals after the 1st and 2nd challenge application, respectively.
The test product did not invoked any scores above 1 in any of the individuals.

Applicant's summary and conclusion