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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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".