Registration Dossier
Registration Dossier
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EC number: 822-765-7 | CAS number: 1817777-04-0
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- October 2016 to February 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-Chloro-8-((S)-1-cyclopropyl-ethyl)-5,8-dihydro-pteridine-6,7-dione
- EC Number:
- 822-765-7
- Cas Number:
- 1817777-04-0
- Molecular formula:
- C11H11ClN4O2
- IUPAC Name:
- 2-Chloro-8-((S)-1-cyclopropyl-ethyl)-5,8-dihydro-pteridine-6,7-dione
- Test material form:
- solid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Vehicle:
- other: water and isopropanol
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- 25 mg of the test article was added to 0.3 mL deionised water and 0.3 mL isopropanol
- Duration of treatment / exposure:
- 60 minutes
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 105.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article, BI 759368, was not considered to be irritant in the in vitro skin model EpiDermTM SIT (EPI-200).
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