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Toxicological information

Skin irritation / corrosion

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: EU Method B.46 (Skin Irritation)
Deviations:
no
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

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".