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Registration Dossier
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EC number: 204-693-2 | CAS number: 124-26-5
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. Reliability was changed from "1" to "2" according to the ECHA guidance document "Practical guide 6: How to report read-across and categories".
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Principles of method if other than guideline:
- EPISKIN reconstituted human epidermis model: 15 min treatment followed by 42 hours post-exposure incubation period.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Amides, C16-C18 (even numbered)
- Molecular formula:
- not available, UVCB
- IUPAC Name:
- Amides, C16-C18 (even numbered)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Crodamide SR
- Physical state: off white powder (1.0 Gardner)
- Analytical purity: 98.21%
- Composition of test material, percentage of components: 0.05% moisture
- Purity test date: 19 January 2010
- Lot/batch No.: BIN#01
- Expiration date of the lot/batch: 19 January 2011
- Storage condition of test material: room temperature in the dark
- Other: Date of manufacture 07 December 2001
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: reconstituted human epidermis
- Cell source:
- other: adult human-derived epidermal keratinocytes
- Source strain:
- other: not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 15 min
SCORING SYSTEM: not applicable, measurement of cytotoxicity by colourimetric MTT reduction assay - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 10 ± 2 mg - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours post-exposure incubation period
- Number of replicates:
- triplicate tissues
Test system
- Vehicle:
- unchanged (no vehicle)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Test substance
- Run / experiment:
- mean of 3 runs
- Value:
- 117.4
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Negative control
- Run / experiment:
- mean of 3 runs
- Value:
- 100
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- Positive control
- Run / experiment:
- mean of 3 runs
- Value:
- 7.3
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Other effects / acceptance of results:
- The test material was considered to be Non-Irritant (NI).
Any other information on results incl. tables
The test material did not directly reduce MTT.
Mean OD540 values and percentage viabilities for the negative control material, positive control material and test material:
Material |
OD540of tissues |
Mean OD540if triplicate tissues |
± SD of OD540 |
Relative individual tissue viability (%) |
Relative mean viability (%) |
± SD of Relative mean viability (%) |
Negative control |
0.784 |
0.834 |
0.045 |
94.0 |
100* |
5.4 |
0.847 |
101.6 |
|||||
0.871 |
104.4 |
|||||
Positive control |
0.069 |
0.061 |
0.016 |
8.3 |
7.3 |
1.9 |
0.071 |
8.5 |
|||||
0.043 |
5.2 |
|||||
Test material |
1.079 |
0.979 |
0.087 |
129.4 |
117.4 |
10.4 |
0.925 |
110.9 |
|||||
0.933 |
111.9 |
* The mean viability of the negative control tissues is set at 100%
The relative mean viability of the test material treated tissues was 119.2% after a 15 -minute exposure, the test material treated tissues appeared blue which was considered indicative of viable tissue.
The relative mean tissue viability for the positive control treated tissues was ≤ 40% relativ to the negative control, and the standard deviation value of the percentage viability was ≤20%. The positive control acceptance criterion was therefore satisfied.
The mean OD540 for the negative control treated tissues was ≥0.6 and the SD value of the percentage viability was ≤20%. The negative control acceptance criterion was therefore satisfied.
Conclusion:
The test material was considered to be Non-Irritant (NI).
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- CLP: not classified
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