Registration Dossier
Registration Dossier
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EC number: 500-607-5 | CAS number: 161278-17-7
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 4,4'-isopropylidenediphenol and m-phenylenebis (methylamine)
- EC Number:
- 500-607-5
- EC Name:
- Formaldehyde, oligomeric reaction products with 4,4'-isopropylidenediphenol and m-phenylenebis (methylamine)
- Cas Number:
- 161278-17-7
- Molecular formula:
- unspecified
- IUPAC Name:
- 1-[3-(aminomethyl)phenyl]methanamine; 2-[({[3-(aminomethyl)phenyl]methyl}amino)methyl]-4-(2-{3-[({[3-(aminomethyl)phenyl]methyl}amino)methyl]-4-hydroxyphenyl}propan-2-yl)phenol; 2-[({[3-(aminomethyl)phenyl]methyl}amino)methyl]-4-[2-(3-{[({3-[({[5-(2-{3-[({[3-(aminomethyl)phenyl]methyl}amino)methyl]-4-hydroxyphenyl}propan-2-yl)-2-hydroxyphenyl]methyl}amino)methyl]phenyl}methyl)amino]methyl}-4-hydroxyphenyl)propan-2-yl]phenol; 2-[({[3-(aminomethyl)phenyl]methyl}amino)methyl]-4-[2-(4-hydroxyphenyl)propan-2-yl]phenol; 4-[2-(4-hydroxyphenyl)propan-2-yl]phenol
- Test material form:
- liquid
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:
- 23.9
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minute
- Value:
- 6.7
- 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* | 12.2 | 23.9 |
| 60 minute | 100* | 2.2 | 6.7 |
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:
The aim of this study is to evaluate the skin corrosion potential of the test item, EK195.
The test item was applied for three minutes and one hour to the EpiDerm™ three-dimensional human skin model. The model consisted of normal, human-derived epidermal keratinocytes, which had been cultured on 0.6 cm2 inserts to form a multilayered, highly differentiated model of the human epidermis with a functional multilayered stratum corneum. The cell viability of the multi layers was determined by mitochondrial dehydrogenase activity assessed by the reduction of MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) to a soluble, coloured, formazan product. The formazan produced was quantified by spectrophotometric measurement. The prediction model uses the percentage viability values (compared to negative control viability) at three minute and one hour exposure times to identify corrosive and non-corrosive items.
The test item, EK195, elicited a mean tissue viability of 23.9% for three minute contact and 6.7% for one hour contact and was predicted as corrosive in the EpiDerm™ skin corrosivity test.
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