Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Skin irritation / corrosion
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:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes
Test material
- Test material form:
- other: liquid
Constituent 1
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: other: mean relative tissue viability
- 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: other: relative mean tissue viability
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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