Registration Dossier
Registration Dossier
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EC number: 295-371-0 | CAS number: 92044-91-2
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- (Lack of data on test substance and the first reading was performed 6 h after patch removal instead of 1 h)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
- Endpoint addressed:
- skin irritation / corrosion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Guidelines for the Assessment of Skin Tolerance of Potentially Irritant Cosmetic Ingredients (COLIPA, 1997)
- Deviations:
- yes
- Remarks:
- first reading time point after 6 h instead of 1 h, lack of data on test substance
- GLP compliance:
- yes
- Remarks:
- according to GCP
Test material
- Reference substance name:
- 63705-03-3
- EC Number:
- 613-333-7
- Cas Number:
- 63705-03-3
- IUPAC Name:
- 63705-03-3
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: no data
Constituent 1
Method
- Ethical approval:
- confirmed and informed consent free of coercion received
- Details on study design:
- 24 h Patch Test according to COLIPA-standard. The test substance was applied occlusive on the backs of the volunteers for 24 h. The reading time points were 6, 24, 48 and 72 h after removal of the test substance.
Grading/Scoring system: according to Frosch and Kligman, 1979 - Details on exposure:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn Chamber on Scanpor, 12 mm
- Vehicle / solvent: presumably cosmetic alcohol
- Volume applied: 70 µL
- Dose: 20% active substance (AS)
- Testing/scoring schedule: The test substance was applied on the backs of the volunteers for 24 h. The reading time points were 6, 24, 48 and 72 h after removal of the test substance.
REFERENCE SUBSTANCES
1% Texapon N25, 0.5% sodium dodecylsulfate (SDS), distilled water, physiological saline and cosmetic alcohol
Results and discussion
- Results:
- Exposure to the test substance (20% AS) leads to slight erythema in 3/20 volunteers and slight scaling in 2/20 volunteers. The mean scores after 6, 24, 48 and 72 h were 0.15 for erythema and 0.25 for erythema, edema, scaling and fissure. The skin compatibility of the test substance in comparison to 1% Texapon N25 and 0.5% SDS was good.
Applicant's summary and conclusion
- Conclusions:
- After 24 h exposure, the test substance (20% AS) was not irritating to human skin.
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