222 OP

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion

Remarks:

other: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well performed guideline study according to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: EU Method B.46 (Skin Irritation)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Test animals

Species:

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

Controls:

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

Results

Irritation parameter:

other: mean relative tissue viability

Basis:

other: mean tissue viability of the negative control tissues

Time point:

other: 15 min treatment 42 h post-incubation

Score:

102

Max. score:

100

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

Remarks:

Migrated information non irritant Criteria used for interpretation of results: EU

Conclusions:

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".