Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study - approved in vitro method

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: OECD 431 "In vitro skin corrosion: Human Skin Model Test"
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
Batch No. S-122009-311853
Purity: 100%

Test animals

Species:
human
Strain:
other: not appplicable
Details on test animals or test system and environmental conditions:
Human skin samples were obtained from Skinthetic Laboratories, Nice, France

Test system

Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
physiological saline
Controls:
other: not applicable
Amount / concentration applied:
not applicable - see details on in vtro method
Duration of treatment / exposure:
not applicable - see details on in vtro method
Observation period:
not applicable - see details on in vtro method
Number of animals:
not applicable - see details on in vtro method
Details on study design:
Test material is applied topically to the stratum corneum surface, at the air interface, so that undiluted and/or end use dilutions can be tested directly. The test is based on the experience that corrosive chemicals are cytotoxic after a short term exposure to the EPISKIN model. Corrosive chemicals are able to penetrate the stratum corneum and are sufficiently cytotoxic to cause cell death in the underlying cell layers. Toxicity is determined by the metabolic conversion of the vital dye MTT to formazan by viable cells in the test material treated cultures relative to the negative control.

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: % viability of treated tissues
Value:
121
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 4 hours. Reversibility: other: not applicable. Remarks: score is % mean viability relative to controls. (migrated information)

Applicant's summary and conclusion

Interpretation of results:
other: not corrosive
Remarks:
Criteria used for interpretation of results: EU