Registration Dossier
Registration Dossier
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EC number: 213-983-8 | CAS number: 1070-89-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- Lithiumbis(trimethylsilyl)amide
- EC Number:
- 223-725-6
- EC Name:
- Lithiumbis(trimethylsilyl)amide
- Cas Number:
- 4039-32-1
- Molecular formula:
- C6H19NSi2.Li
- IUPAC Name:
- Lithium-hexamethyldisilazan
- Test material form:
- liquid
- Details on test material:
- - State of aggregation: translucent brown liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Lot # 0013711245 MFG
In vitro test system
- Test system:
- artificial membrane barrier model
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 500 µl
- Number of replicates:
- 4
Test system
- Controls:
- yes
- Details on study design:
- In order to determine if the sample is compatible with the Corrositex kit, the sample (100 mg for solids and 150 µl for liquids) is added to a solution and, if a change in color or texture appears in the solution, the sample "qualifies" as a compatible material.
If the sample qualifies, the sample (100 mg for solids and 150 µl for liquids) is added to each of two different solutions and the color changes observed are compared to a color chart that places the sample into one of two different categories. The category that the sample belongs in determines the length of time required for the test.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Value:
- 19.54
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Trail |
Breakthrough time (min/sec) |
1 |
19.23 Minutes |
2 |
19.67 Minutes |
3 |
19.64 Minutes |
4 |
19.62 Minutes |
Average |
19.54 Minutes |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Conclusions:
- Based on the observed results and applying the evaluation criteria it was concluded, that Li-Hexamethyldisilazane shows a corrosive potential in the Corrositex® - Skin Corrosion Test under the test conditions chosen. The mean breakthrough time determined in the in vitro membrane barrier test was 19.54 minitues.
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