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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
Reference substance name:
Octocrilene
EC Number:
228-250-8
EC Name:
Octocrilene
Cas Number:
6197-30-4
Molecular formula:
C24H27NO2
IUPAC Name:
2-ethylhexyl 2-cyano-3,3-diphenylacrylate
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