Registration Dossier

Toxicological information

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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. 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:
1997
Report Date:
1997

Materials and methods

Endpoint addressed:
skin irritation / corrosion
Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Analytical purity: no data

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.