Registration Dossier
Registration Dossier
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EC number: 807-112-6 | CAS number: 1393708-17-2
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Harlan Cytotest Cell Research GmbH (Harlan CCR), In den Leppsteinswiesen 19, 64380 Rossdorf Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium
- EC Number:
- 807-112-6
- Cas Number:
- 1393708-17-2
- Molecular formula:
- C13H20N2O4S
- IUPAC Name:
- 3-(diethylcarbamoyl)-1-(3-sulfonatopropyl)pyridin-1-ium
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PYRIDINIUMSULFONATE
- Substance type: white powder with lumps
- Analytical purity: 99.8 % (HPLC)
- Lot/batch No.: CHZT000001
- Expiration date of the lot/batch: Feb. 2016
- Storage condition of test material: at room temperature
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/water (7+3, v/v)
- Concentration:
- 10, 25, and 50% (w/w)
- No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: In this study Stimulation Indices (S.I.) of 1.17, 1.46, and 1.27 were determined with the test item at concentrations of 10, 25, and 50% (w/w) in ethanol/water (7+3, v/v), respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: In this study DPM of 3819, 4728, and 4141 were determined with the test item at concentrations of 10, 25, and 50% (w/w) in ethanol/water (7+3, v/v), respectively.
Any other information on results incl. tables
The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. greater than the threshold value of 3.
The animals did not show any signs of systemic toxicity or local skin irritation during the course of the study and no cases of mortality were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test item PYRIDINIUMSULFONATE was not a skin sensitiser under the test conditions of this study.
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