Registration Dossier
Registration Dossier
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EC number: 216-509-8 | CAS number: 1604-34-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- EpiDerm-Corrosivity-Test
- GLP compliance:
- no
Test material
- Reference substance name:
- 6,10-dimethylundecan-2-one
- EC Number:
- 216-509-8
- EC Name:
- 6,10-dimethylundecan-2-one
- Cas Number:
- 1604-34-8
- Molecular formula:
- C13H26O
- IUPAC Name:
- 6,10-dimethylundecan-2-one
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Tetrahydrogeranylaceton
- Substance No.: 01/0275-1
- Batch-Nr.: B 633
- Purity: 97.5 area% (GC)
- Date of production: 17 Oct 2000
- Substance type: Liquid / colourless - clear
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: BASF, Batch No. B 633
In vitro test system
- Test system:
- human skin model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Concentration (if solution): 100 %
NEGATIVE CONTROL
- Concentration (if solution): 100 %
POSITIVE CONTROL
- Concentration (if solution): 100 % - Duration of treatment / exposure:
- 3 min and 1 h exposure
- Number of replicates:
- 2 tissues
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min exposure
- Run / experiment:
- mean of two tissues
- Value:
- 103
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not corrosive
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 1h
- Run / experiment:
- mean of two tissues
- Value:
- 104
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not corrosive
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Direct-MTT reduction: No
Any other information on results incl. tables
Results:
| Exposure: 3 min | ||||
| Tissue 1 (570 nm) | Tissue 2 (570 nm) | Mean OD (570 nm) | viability (% of negative control) | |
| Negative control | 1.884 | 1.864 | 1.874 | 100 |
| Test substance | 1.909 | 1.942 | 1.925 | 103 |
| Positive control | 0.149 | 0.166 | 0.157 | 8 |
| Exposure: 1 h | ||||
| Tissue 1 (570 nm) | Tissue 2 (570 nm) | Mean OD (570 nm) | viability (% of negative control) | |
| Negative control | 2.241 | 2.11 | 2.176 | 100 |
| Test substance | 2.259 | 2.284 | 2.72 | 104 |
| Positive control | 0.123 | 0.195 | 0.159 | 8 |
The test substance was not able to directly reduce MTT. Viability of the test substance treated tissues determined after an exposure period of 3 minutes and 1 hour was 103% and 104%, respectively.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Procedure only excludes potential for skin corrosion
- Conclusions:
- Based on these results it was concluded that Tetrahydrogeranylaceton does not have a corrosive potential in the EpiDerm skin corrosivity test under the chosen conditions.
- Executive summary:
Two EpiDerm tissue samples were incubated with the test substance for 3 minutes and 1 hour, respectively. Tissue destruction was determined by measuring the metabolic activity of the tissue after exposure using a colorimetric test. The reduction of mitochondrial dehydrogenase activity, measured by reduced formazan production after incubation with a tetrazolium salt (MTT) was chosen as suitable endpoint. The formazan production of the test substance treated epidermal tissues is compared to that of negative control tissues. The quotient of both values indicates the relative tissue viability.
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