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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
yes

Test material

Constituent 1
Test material form:
solid: crystalline

Test animals

Species:
other: EpiSkin reconstructed human epidermis model (SkinEthic Laboratories)

Test system

Type of coverage:
other: direct application
Vehicle:
other: distilled water
Controls:
other: three tissues for negative control (10 µL PBS) and positive control (10 µL 5% SDS)
Amount / concentration applied:
10 mg substance in 90 µL distilled water
Duration of treatment / exposure:
15 minutes
Observation period:
42 +/- 1 h
Number of animals:
three replicate tissues per dose group

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: mean relative tissue viability
Value:
103.5
Remarks on result:
other:
Remarks:
Basis: mean. Time point: after 15 minutes of exposure and 42 h post incubation. Max. score: 100.0. Remarks: non-irritant; EU CLP and UN GHS: No Category. (migrated information)

In vivo

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).

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD 439
Conclusions:
No irritant effects of the substance were observed in this in vitro-study, therefore the test item is classified as "non-irritant" in accordance with UN GHS and EU CLP "No Category".
Executive summary:

The skin irritation potential of the substance was assessed in an in vitro test using the EPISKIN-Standard Model. Under the given test conditions, the substance showed no irritant effects. The relative mean tissue viability after 15 min. of exposure and 42 h post incubation was >= 50 %. The substance is therefore classified as "non-irritant" in accordance with UN GHS and EU-CLP "No Category".