Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Exposure related observations in humans: other data

Administrative data

Endpoint:
exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
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
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

Constituent 1
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

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.