Registration Dossier
Registration Dossier
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EC number: 947-816-1 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vitro
- 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 442E
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- other: human Cell Line Activation Test (h-CLAT)
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
Results and discussion
In vitro / in chemico
Resultsopen allclose all
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Viability IgG
- Value:
- 98.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Viability CD86
- Value:
- 97.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Viability CD54
- Value:
- 97.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: Viability IgG
- Value:
- 98.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 1
- Parameter:
- other: Viability CD86
- Value:
- 98.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Run / experiment:
- other: 2
- Parameter:
- other: Viability CD54
- Value:
- 98
- Vehicle controls validity:
- valid
- 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 to be negative in the human Cell Line Activation Test.
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