Registration Dossier
Registration Dossier
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EC number: 947-816-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: 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
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- previous identifier no longer suitable
- EC Number:
- 947-816-1
- Cas Number:
- 00-00-0
- Molecular formula:
- previous identifier no longer suitable
- IUPAC Name:
- previous identifier no longer suitable
- Test material form:
- liquid
Constituent 1
In vitro test system
- Test system:
- human skin model
- Source species:
- other: n.a. skin model
- Cell type:
- other: n.a. skin model
- Cell source:
- other: n.a. skin model
- Source strain:
- other: n.a. skin model
- Vehicle:
- unchanged (no vehicle)
- Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean
- Value:
- 115.4
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test article, Reaction mass of sodium methyl sulphate and 1-methylpyridinio-3-
carboxylate, was considered not to be irritant in the in vitro skin model EpiDerm™
SIT (EPI-200).
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