Registration Dossier
Registration Dossier
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EC number: - | CAS number: 85338-42-7
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment Adopted according to OECD SIDS or other official EU regulation procedures (public available peer reviewed source).
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- A sensitive mouse lymph node assay with two application phases for detection of contact allergens.
- Author:
- Ikarashi, Y. et al.
- Year:
- 1 993
- Bibliographic source:
- Arch Toxicol 67, 629 - 636
- Reference Type:
- secondary source
- Title:
- SIDS Category of Alkyl sulfates, Alkane sulfonates and Alpha-olefin sulfonates
- Author:
- OECD
- Year:
- 2 007
- Bibliographic source:
- UNEP Publications
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- e.g. limited data on test substance available, only 3 insead of 4 animals per group
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Sodium dodecyl sulphate
- EC Number:
- 205-788-1
- EC Name:
- Sodium dodecyl sulphate
- Cas Number:
- 151-21-3
- Molecular formula:
- C12H26O4S.Na
- IUPAC Name:
- sodium dodecyl sulfate
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
Study design: in vivo (LLNA)
- No. of animals per dose:
- 3
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- daily topical application of 25 µL of a 5% solution in water on 3 consecutive days
- Parameter:
- SI
- Value:
- 1.61
- Test group / Remarks:
- daily topical application of 25 µL of a 10% solution in water on 3 consecutive days
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- daily topical application of 25 µL of a 25% solution in water on 3 consecutive days
- Parameter:
- SI
- Value:
- 1.58
- Test group / Remarks:
- intradermal injection of 50 µL of a 0.05% solution in saline; after 5 days daily topical application of 25 µL of a 5% solution in 50% DMSO on 3 consecutive days
- Parameter:
- SI
- Value:
- 1.93
- Test group / Remarks:
- intradermal injection of 50 µL of a 0.5% solution in saline; after 5 days daily topical application of 25 µL of a 5% solution in 50% DMSO on 3 consecutive days
- Parameter:
- SI
- Value:
- 1.48
- Test group / Remarks:
- intradermal injection of 50 µL of a 5% solution in saline; after 5 days daily topical application of 25 µL of a 5% solution in 50% DMSO on 3 consecutive days
Any other information on results incl. tables
Stimulation indices: a.) 0.73, 1.61 and 1.13; b.) 1.58, 1.93 or 1.48
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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