Registration Dossier
Registration Dossier
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EC number: 224-338-5 | CAS number: 4316-73-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 10, 2007 - July 15, 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sarcosine
- EC Number:
- 203-538-6
- EC Name:
- Sarcosine
- Cas Number:
- 107-97-1
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- N-methylglycine
- Details on test material:
- - Name of test material (as cited in study report): PRODUIT ATOX 150B
- Physical state: solid
- Analytical purity: >98%
- Lot/batch No.: 2CAC1339
- Expiration date of the lot/batch: May 31, 2008
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- other: Ethanol:deionised w ater 3+7
- Concentration:
- 5, 10, 25%
25% technically maximum achievable concentration - No. of animals per dose:
- 4
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Control group - 1 5% - 1.73 10% - 1.10 25% - 413.9
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: DPM of the pooled lymph nodes of one test group Control group - 377.8 5% - 655.0 10% - 745.1 25% - 413.9
Any other information on results incl. tables
None of the tested concentrations exceeded the cut-off stimulation index of 3.0
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
