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Registration Dossier
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EC number: 219-552-0 | CAS number: 2460-77-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Aug 2017- 21 Nov 21 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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 (incl. QA statement)
Test material
- Reference substance name:
- 2,5-di-tert-butyl-p-benzoquinone
- EC Number:
- 219-552-0
- EC Name:
- 2,5-di-tert-butyl-p-benzoquinone
- Cas Number:
- 2460-77-7
- Molecular formula:
- C14H20O2
- IUPAC Name:
- 2,5-di-tert-butyl-1,4-benzoquinone
- Test material form:
- solid: bulk
Constituent 1
- Specific details on test material used for the study:
- EpiSkin kit from SkinEthic Laboratories, France.
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:
- Source of the test system: 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 min
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min exposure
- Value:
- 153.15
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min exposure
- Value:
- 105.75
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 240 minute exposure
- Value:
- 94.701
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1. OD values of individual epidermis units, 3 min exposure
Absorption, OD570 |
||
| R1 | R2 | |
| Negative control | 0,49600 | 0,49125 |
| Test item | 0,75120 | 0,76080 |
| Negative control (color) | 0,00460 | - |
| Non-specific color control | 0,00480 | |
able 2. OD values of individual epidermis units, 60 min exposure
Absorption, OD570 |
||
| R1 | R2 | |
| Negative control | 0,61720 | 0,61470 |
| Test item | 0,65080 | 0,65190 |
| Negative control (color) | 0,00585 | 0,00550 |
| Non-specific color control | 0,00565 | 0,00640 |
able 3. OD values of individual epidermis units, 240 min exposure
Absorption, OD570 |
||
| R1 | R2 | |
| Negative control | 0,54845 | 0,5480 |
| Positive control | 0,02695 | 0,02180 |
| Test item | 0,52150 | 0,51685 |
| Negative control (color) | 0,00225 | 0,00190 |
| Non-specific color control | 0,00205 | 0,00350 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 2,5-di tertiary butyl 1,4-benzoquinone is non-corrosive in the EpiSkin in vitro skin corrosion model.
- Executive summary:
The test item was tested for its possible skin corrosion potential using a three-dimesional Reconstructed Human Epidermis model, EpiSkin, through topical application. After 3 min, 60 min and 240 min exposures with the test item, the observed cell viability was 153% and 106% and 95%, respectively.
The positive control had a mean cell viability of 4.44% after 240 -minutes exposure. The absolute mean OD570 of the negative control tissue was 0.493625, 0.61595 and 0.548225 for the 3 -minute, 60 -minutes and 240 -minutes exposures, respectively. The results of the controls indicate that the test system functioned properly.
The study indicate that the test item 2,5 -di tertiary butyl 1,4 -benzoquinone is non-corrosive in this in vitro skin corrosion test using reconstructed human epidermis under the conditions of testing employed.
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