Registration Dossier
Registration Dossier
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EC number: 200-252-3 | CAS number: 56-04-2
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:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Methylthiouracil
- EC Number:
- 200-252-3
- EC Name:
- Methylthiouracil
- Cas Number:
- 56-04-2
- Molecular formula:
- C5H6N2OS
- IUPAC Name:
- methylthiouracil
- Test material form:
- solid: crystalline
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- EpiSkin from SkinEthic Laboratories France.
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 20 mg
- Duration of treatment / exposure:
- 3, 60 and 240 minutes
- Duration of post-treatment incubation (if applicable):
- 3 hour incubation with MTT
- Number of replicates:
- Two
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 90.83
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 96.64
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 min exposure
- Value:
- 92.23
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- he absolute mean OD570 of the negative control tissues was 0.9712, 0.8067 and 0.9037 for the 3 -minute, 60 -minute and 240 -minute exposures, respectively.
Any other information on results incl. tables
Mean OD values of individual epidermis units.
3 -minutes exposure
| Adsorption (OD570) | ||
| R1 | R2 | |
| Negative control | 1,0449 | 0,9851 |
Test item |
0,9804 |
0,8715 |
60 -minutes exposure
| Adsorption (OD570) | ||
| R1 | R2 | |
| Negative control | 0,8406 | 0,8605 |
| Test item | 0,8172 | 0,8297 |
240 -minute exposure
| Adsorption (OD570) | ||
| Negative control | 0,9423 | 0,8527 |
| Positive control | 0,0840 | 0,0788 |
| Test item | 0,8786 | 0,8759 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- After 240 -minute exposure in the Reconstructed Human Epidermis model the test item showed tissue viability 92.23%. Taken together, methylthiouracil is non-corrosive in the in vitro skin corrosion test performed according to OECD 431 guideline.
- Executive summary:
The test item, methylthiouracil, was tested for its possible skin corrosion potential using a three dimensional Reconstructed Human Epidermis model, EpiSkin, through topical application. The study was perfomed according to OECD 431 guideline. The absolute mean OD570 of the negative control tissues was 0.9712, 0.8067 and 0.9037 for the 3 -minute, 60 -minute and 240 -minute exposures, respectively. The positive control has a mean cell viability of 4.16 % after 240 -minute exposure. Thus, the results of the controls indicate that the test system functioned properly.
After 240 -minute exposure the test item showed tissue viability 92.23%. Taken together, the test item methylthiouracil is non-corrosive in the in vitro skin corrosion test.
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