Registration Dossier
Registration Dossier
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EC number: 224-338-5 | CAS number: 4316-73-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD test guideline 431
- Principles of method if other than guideline:
- The present test is based on the experience that corrosive chemicals produce cytotoxicity in human reconstructed epidermis after a short term topical exposure. The test is designed to predict skin corrosion potential of a chemical by using the three dimensional human epidermis model EpiDermTM. After application of the test material to the stratum corneum surface of the EpiDermTM tissue for 3 minutes and 1 hour the induced cytotoxicity (=loss of viability) is measured by a colorimetric assay. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5- dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol extraction of the formazan from the tissue the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of test substance treated tissues is compared to negative control values from tissue treated with doubly distilled water and expressed as relative tissue viability.
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium sarcosinate
- EC Number:
- 224-338-5
- EC Name:
- Sodium sarcosinate
- Cas Number:
- 4316-73-8
- Molecular formula:
- C3H7NO2.Na
- IUPAC Name:
- sodium (methylamino)acetate
Constituent 1
Test animals
- Species:
- other: EpiDerm Corrosivity-Test in vitro
Test system
- Amount / concentration applied:
- undiluted
- Duration of treatment / exposure:
- 3 min, 1 h
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- ca. 71
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- ca. 16
Any other information on results incl. tables
| Exposure: 3 min | ||||||
| Test-Article | OD570 tissue 1 | OD570 Tissue 2 | OD570 Killed tissue control | mean OD570 | mean OD570 killed tissue control corrected | Viability [% of negative control] |
| Negative Control | 1.877 | 2.001 | 0.219 | 1.939 | - | 100 |
| Sarcosine-Na solution | 1.741 | 0.996 | 0.233 | 1.369 | - | 71 |
| Positive Control | 0.463 | 0.397 | 0.430 | - | 22 | |
| Exposure: 1 h | ||||||
| Test-Article | OD570 tissue 1 | OD570 Tissue 2 | OD570 Killed tissue control | mean OD570 | mean OD570 killed tissue control corrected | Viability [% of negative control] |
| Negative Control | 1.879 | 1.895 | 0.221 | 1.887 | - | 100 |
| Sarkosine-Na solution | 0.285 | 0.306 | 0.266 | 0.296 | - | 16 |
| Positive Control | 0.143 | 0.341 | - | 0.242 | - | 13 |
Applicant's summary and conclusion
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