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EC number: 807-621-3 | CAS number: 1428450-95-6
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- Version / remarks:
- adopted in 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.40 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test (TER))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
Test material
- Reference substance name:
- N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide
- EC Number:
- 807-621-3
- Cas Number:
- 1428450-95-6
- Molecular formula:
- C13H14N2O3S
- IUPAC Name:
- N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide
- Test material form:
- solid: particulate/powder
Constituent 1
In vitro test system
- Test system:
- human skin model
- Remarks:
- EpiDerm™; reconstructed three-dimensional human epidermis (EPI-200)
- Cell type:
- other: Human-derived epidermal keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Vehicle:
- water
- Details on test system:
- REMOVAL OF TEST SUBSTANCE
- Washing: The test substance was washed from the skin surface with phosphate buffered saline.
- Time after start of exposure: 3 and 60 min
CELL VIABILITY MEASUREMENTS
For determining alterations in cell viability, MTT reduction assays were performed. Therefore, tissues were incubated with 300 µL prewarmed MTT solution for 3 h at 37 ± 1°C, 5 ± 1 % CO2 and 80-95 % RH. After aspiration of the MTT solution, tissues were washed several times in phosphate buffered saline followed by tissue drying. Extraction of the formazan product was carried out in 2 mL isopropanol. The optical density was measured at 570 nm wave length in a plate spectrophotometer. - Control samples:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 25 mg ± 2.5 mg moistened with 25 µL demineralized water
POSITIVE CONTROL SUBSTANCE:
- Positive control substance: 8 M KOH - Duration of treatment / exposure:
- 3 min at room temperature and 60 min at 37 °C in an incubator
- Duration of post-treatment incubation (if applicable):
- not applicable
- Number of replicates:
- 2
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min
- Value:
- ca. 86.6
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of corrosion
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 h
- Value:
- ca. 105.3
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: no indication of corrosion
Any other information on results incl. tables
Table 1: MTT assay after 3 minutes exposure
|
OD Tissue 1 |
OD Tissue 2 |
OD Mean |
SD |
Viability % |
RSD % |
Negative Control |
1.856 1.840 1.819 |
1.817 1.802 1.812 |
1.824 |
0.02 |
100 |
--- |
Test Substance |
1.501 1.645 1.580 |
1.588 1.588 1.578 |
1.580 |
0.05 |
86.6 |
0.4 |
Positive Control |
0.409 0.424 0.438 |
0.431 0.404 0.400 |
0.418 |
0.02 |
22.9 |
2.0 |
Table 2: MTT assay after 60 minutes exposure
|
OD Tissue 1 |
OD Tissue 2 |
OD Mean |
SD |
Viability % |
RSD % |
Negative Control |
1.515 1.659 1.584 |
1.867 1.865 1.847 |
1.723
|
0.16 |
100 |
--- |
Test Substance |
1.871 1.894 1.867 |
1.754 1.757 1.747 |
1.815 |
0.07 |
105.3 |
4.9 |
Positive Control |
0.141 0.141 0.141 |
0.163 0.161 0.161 |
0.151
|
0.01 |
8.8 |
9.7 |
Table 3: Historical Control Data
Parameter |
OD Negative Control |
OD Negative Control |
Viability % |
Viability % Positive Control |
Incubation Time |
3 min |
60 min |
3 min |
60 min |
Mean |
1.936 |
1.920 |
27.2 |
14.1 |
SD |
0.157 |
0.168 |
5.6 |
4.4 |
Range |
1.614 – 2.355 |
1.598 – 2.326 |
20.2 – 43.6 |
8.5 – 24.2 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There is regulatory acceptance in the EU that a substance can be considered corrosive (Skin Corrosive Cat. 1A) based on a positive result in the human epidermis model test. Negative in vitro corrosivity responses are not conclusive with respect to non-classification or classification as irritant and shall therefore be subject to further evaluation.
- Executive summary:
One valid experiment was performed.
Two tissues of the human skin model EpiDerm TM were treated with N-[4-(2,4-dihydroxyphenyl)
thiazol-2-yl]isobutyramide for three minutes and one hour, respectively. In average,
24. 7 mg of the solid test item were applied to each tissue and spread to match the tissue
size.
Demineralised water was used as negative Qontrol, 8 M KOH was used as positive control.
After treatment, the respective substance was rinsed from the tissue; then, cell viability of
the tissues was evaluated by addition of MTT which can be reduced to a blue formazan.
Formazan production was measured by measuring the optical density (OD) of the resulting
solution.
After treatment with the negative control, the absorbance values were within the required
acceptability criterion of mean OD ~ 0.8 and !5 2.8 for both treatment intervals thus showing
the quality of the tissues. The positive control showed clear corrosive effects for both
treatment intervals.
After three minutes treatment with the test item, the relative absorbance values were reduced
to 86.6 %. This value is well above the threshold for corrosion potential (50 %). After
one hour treatment, relative absorbance values were increased to 105.3 %. This value,
too, is well above the threshold for corrosion potential (15 %). In the guideline, values
greater or equal to the threshold are considered as ''non-corrosive to skin".
Therefore, N-[4-(2,4-dihydroxyphenyl)thiazol-2-yl]isobutyramide is considered as
not corrosive in the Human Skin Model Test.
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