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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 / corrosion
other: in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well performed guideline study according to GLP.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
other: EU Method B.46 (Skin Irritation)
according to guideline
other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
GLP compliance:
yes (incl. QA statement)

Test material

Test animals

other: EpiSkin reconstructed human epidermis model (SkinEthic Laboratories)
Details on test animals or test system and environmental conditions:
organotypic reconstructed three-dimensional model of the human epidermis

Test system

Type of coverage:
other: direct application
other: three tissues for negative control (10µL PBS) and positive control (10µL 5% SDS)
Amount / concentration applied:
10 mg + 5 µL aqua dest
Duration of treatment / exposure:
15 minutes
Observation period:
42 +/- 1 h
Number of animals:
three replicate tissues per dose group
Details on study design:
3 replicate tissues are dosed with the test item, the negative control (PBS) and the positive control (5% SDS), respectively. After 15 minutes treatment period at room temperature the test item and the controls are rinsed off with PBS and the tissues are post-incubated for 42 +/- 1 h. Then the tissues are stained via MTT for 3 hours. Isopropanol extracts are measured photometrically at 550 nm.

Results and discussion

In vivo

Irritation parameter:
other: mean relative tissue viability
other: mean tissue viability of the negative control tissues
Time point:
other: 15 min treatment 42 h post-incubation
Max. score:
Remarks on result:
other: non-irritant; EU CLP and UN GHS: No Category
Irritant / corrosive response data:
If mean tissue viability is > 50% relative to the mean negative control, the test item is classified as non-irritant (EU CLP and UN GHS: No Category).
If mean tissue viability is <= 50% relative to the mean negative control, the test item is classified as irritant (EU CLP and UN GHS: Category 2).
In the in vitro skin irritation test using the EpiSkin human epidermis model 10 mg test item + 5 µL A. dest. were applied topically for 15 minutes. After 42 h post-incubation cytotoxic effects were determined via MTT reduction assay.
The mean relative tissue viability (% negative control) was > 50%.
The test item is therefore classified as "non-irritant" (EU CLP and UN GHS: No Category).
Other effects:
The test item showed no direct MTT reducing capability and no colouring potential.

Applicant's summary and conclusion

Interpretation of results:
not classified
Migrated information non irritant Criteria used for interpretation of results: EU
The substance is classified as "non-irritant" (No Category).
Executive summary:

The potential of the substance to induce skin irritation was analysed by using the three-dimensional human skin model EPISKIN-SM. In this study under the given conditions the substance showed no irritant effects. The substance is therefore classified as "non-irritant" in accordance with UN GHS and EU CLP "No Category".