Registration Dossier
Registration Dossier
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EC number: 228-250-8 | CAS number: 6197-30-4
Sensitisation data (human)
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:
- 1 992
- 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 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%)
Constituent 1
- 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
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