Registration Dossier
Registration Dossier
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EC number: 500-129-7 | CAS number: 55552-95-9
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:
- 2 017
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Formaldehyde, oligomeric reaction products with diethylenetriamine and phenol
- EC Number:
- 500-129-7
- EC Name:
- Formaldehyde, oligomeric reaction products with diethylenetriamine and phenol
- Cas Number:
- 55552-95-9
- Molecular formula:
- (C6H6O.C4H13N3.CH2O)x
- IUPAC Name:
- Formaldehyde, oligomeric reaction products with diethylenetriamine and phenol
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Details on animal used as source of test system:
- EpiDerm™ Reconstructed Human Epidermis Model Kit
Supplier : MatTek
Date received : 14 June 2016
EpiDermTM Tissues (0.63cm2) lot number : 23341
Assay Medium lot number : 060916ZSA
Upon receipt of the EpidermTM tissues, the sealed 24-well plate was stored in a refrigerator until use. - Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 50 uL
- Duration of treatment / exposure:
- 3 minute
60 minute - Duration of post-treatment incubation (if applicable):
- 3 hours
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minute
- Value:
- 39.8
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute
- Value:
- 12.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Exposure Period |
Percentage Viability |
||
| Negative Control | Positive Control | Test Item | |
| 3 minute | 100* | 6.2 | 39.8 |
| 60 minute | 100* | 5.6 | 12.9 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item was considered to be corrosive to the skin. EU CLP/UN GHS: H314/Category 1A. UN packing group I.
- Executive summary:
Introduction
The purpose of this test is to evaluate the corrosivity potential of the test item using the EpiDerm™ Human Skin Model after treatment periods of 3 and 60 minutes. Corrosion is directly related to cytotoxicity in the EpiDerm™ tissue. Cytotoxicity is determined by the reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to formazan by viable cells in the test item treated tissues relative to the corresponding negative control. The results are used to make a prediction of the corrosivity potential of the test item.
Methods
Duplicate tissues were treated with the test item for exposure periods of 3 and 60 minutes. Negative and positive control groups were treated for each exposure period. The test item was found to directly reduce MTT and therefore additional non-viable tissues were incorporated into the testing for correction purposes. At the end of the exposure period the test item was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.
At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 μL samples were transferred to the appropriate wells of a pre-labeled 96-well plate. The optical density (OD) was measured at 562 nm (OD562).
Data are presented in the form of percentage viability (MTT reduction in the test item treated tissues relative to negative control tissues).
Results
Quality criteria: The quality criteria required for acceptance of results in the test were satisfied.
Conclusion
The test item was considered to be corrosive to the skin. EU CLP/UN GHS: H314/Category 1A. UN packing group I.
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