Registration Dossier
Registration Dossier
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EC number: 814-072-3 | CAS number: 77614-79-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 - 27 Sep 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2016
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- Version / remarks:
- adopted in 2019
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Behörde für Gesundheit und Verbraucherschutz, Hamburg, Germany
Test material
- Reference substance name:
- 3,5-bis(difluoromethyl)-1H-pyrazole
- EC Number:
- 814-072-3
- Cas Number:
- 77614-79-0
- Molecular formula:
- C5H4F4N2
- IUPAC Name:
- 3,5-bis(difluoromethyl)-1H-pyrazole
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: MatTek In Vitro Life Science Laboratories, Bratislava, Slovakia
- Source strain:
- other: EpiDerm™ Skin Model (EPI-200-SCT)
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount applied: 25 mg, skin was moistened with 25 µL sterile deionised water
POSITIVE CONTROL
- Amount applied: 50 μL
- Concentration: 8 N
NEGATIVE CONTROL
- Amount applied: 50 μL - Duration of treatment / exposure:
- 3 min and 60 min
- Duration of post-treatment incubation (if applicable):
- Not applicable.
- Number of replicates:
- Duplicates for each treatment and control group.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 3 min exposure
- Value:
- 74.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- mean value of 2 tissues
- Run / experiment:
- 60 min exposure
- Value:
- 10.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- other: Skin Corr. 1, H314 according to Regulation (EC) No. 1272/2008.
- Conclusions:
- In this in vitro skin corrosion test with EpiDerm™ tissue conducted according to OECD guideline 431, the mean cell viability compared to the negative control was 74.5% after 3 min exposure and 10.8% after 60 min exposure with the test substance. All validity criteria were within acceptable limits. Under the conditions of the test, the test item is considered corrosive and requires classification as Skin Corr. 1 (H314) according to CLP/EU GHS criteria.
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