Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin corrosion: 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:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

Test animals

Species:
other: EpiDerm human epidermis model

Test system

Type of coverage:
other: direct application
Vehicle:
other: none, undiluted
Controls:
other: 2 tissues for neg. control (water) and positive control (8 N KOH)
Duration of treatment / exposure:
3 min, 60 min
Number of animals:
2 replicates
Details on study design:
In vitro Skin Corrosion: Human Skin Model Test

Results and discussion

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other:
Value:
92
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 3 minutes. Max. score: 100.0. Reversibility: no data. Remarks: non corrosive. (migrated information)
Irritation / corrosion parameter:
other:
Value:
14
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 60 minutes. Max. score: 100.0. Reversibility: no data. Remarks: corrosive. (migrated information)

In vivo

Irritant / corrosive response data:
In this study under the given conditions the test item showed corrosive effects. The test item was classified as "non-corrosive" after 3 min. treatment (relative mean tissue viability >= 50 %) but decreased the relative mean tissue viability below 15 % after 60 min. treatment. The test item is therefore classified as "corrosive" after application over 60 min.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: other: OECD 431
Conclusions:
In this in vitro test under the given conditions the substance showed corrosive effects and is therefore classified as "corrosive".
Executive summary:

In the in vitro test, the substance showed corrosive effects. The substance was classified "non-corrosive" after 3 min. treatment (relative mean tissue viability >= 50 %) but decreased the relative mean tissue viability below 15 % after 60 min. treatment. The substance is therefore classified as "corrosive" after application over 60 min.