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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: clinical quotation
Deviations:
no
Principles of method if other than guideline:
The clinical quotation is made 30 minutes after the patch removal and takes in account the erythema, the papules, the vesicles and the blisters. According to their intensity, the quotation is spread out from 0 to 3. The total sum of the scores, divided by the number of volunteers, defines the mean irritation index (M.I.I.), which allows to classify arbitrarily the test item into “non irritant, slightly irritant, moderately irritant, very irritant and severely irritant"
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
Batch no : 13L508D
Test item type : cometic ingredient
Expiry date : nov 2016

Test animals

Species:
human
Details on test animals or test system and environmental conditions:
Normal skin without any dermatological lesion on the experiental area

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
Single application of 5 mg of the studied test item pure on the external face of the arm
Duration of treatment / exposure:
48h in contact with the skin, with the help of a semi-occlusive patch
Observation period:
Clinical quotation made 30 minutes after the patch removal
Number of animals:
20 volunteers of the female or male sex from 18 to 65 years old

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: mean irritation index (M.I.I)
Value:
0
Remarks on result:
other:
Remarks:
Basis: other: human. Time point: 48 hours. Reversibility: no data. (migrated information)
Other effects / acceptance of results:
The mean irritation index (MII) of the test item is 0. The test item can be considered as non-irritant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment