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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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Administrative data

skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed to EU guidelines

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
EC 290-476-8
EC 290-476-8
Test material form:
solid: compact
Details on test material:
As the substnace is normally supplied in water as 30 - 40 % solution, material was dried specifically for testing.

Test animals

Details on test animals or test system and environmental conditions:
In vitro study

Test system

Details on study design:
The principle of the assay is based on the measurement of cytotoxicity in reconstructed
human epidermal cultures following topical exposure to the test item by means of the
colourimetric MTT reduction assay. Cell viability is measured by enzymatic reduction of
the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium
bromide) to a blue formazan salt (within the mitochondria of viable cells) in the test item
treated tissues relative to the negative controls.

Results and discussion

In vitro

Irritation / corrosion parameter:
other: other: In-vitro
Remarks on result:
other: in-vitro
Basis: other: In-vitro. Remarks: In-vitro testing. (migrated information)

In vivo

Irritant / corrosive response data:
The relative mean viability of the test item treated tissues was 112.6% after a 15-Minute exposure period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Migrated information Criteria used for interpretation of results: EU
The relative mean viability of the test item treated tissues was 112.6% after a 15-Minute exposure period and is not considered to be irritant to skin accordign to GHS criteria
Executive summary:

In view of the reported results being below thresholds for classification as irritant, it is considered unlikely that the diluted material manufactured and supplied (30 - 40% in water) will be irritating to skin.

It is not considered necessary to perform in-vivo testing on this substance in its concentrated form.