Registration Dossier
Registration Dossier
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EC number: 233-118-8 | CAS number: 10039-54-0
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication (with a short method description) which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Development and Validation of an Alternative Dermal Sensitization Test: The Mouse Ear Swelling Test (MEST)
- Author:
- Gad, S.C., Dunn, B.J., Dobbs, D.W., Reilly, C., Walsh, R.D.
- Year:
- 1 986
- Bibliographic source:
- Toxicology and Applied Pharmacology, 84, 93-114
- Reference Type:
- publication
- Title:
- A Scheme for the Prediction and Ranking of Relative Potencies of Dermal Sensitizers Based on Data from Several Systems.
- Author:
- Gad, S.C.
- Year:
- 1 988
- Bibliographic source:
- Journal of Applied Toxicology, 8(5), 361-368
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- not applicable
- Remarks:
- (due to missing details in the method description)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed prior to existence of LLNA guideline.
Test material
- Reference substance name:
- Bis(hydroxylammonium) sulphate
- EC Number:
- 233-118-8
- EC Name:
- Bis(hydroxylammonium) sulphate
- Cas Number:
- 10039-54-0
- Molecular formula:
- H3NO.1/2H2O4S
- IUPAC Name:
- bis(hydroxyammonium) sulfate
- Details on test material:
- - Name of test material (as cited in study report): hydroxylamine sulfate
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Acclimation period: 14 days
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - intradermal injection: 5%; - topical induction: 25%
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - challenge: 10%
- No. of animals per dose:
- 15 (test group), 6 (control group)
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 48 h
- Site: intradermal injected skin site
B. CHALLENGE EXPOSURE
- Exposure period: 24 h
- Site: naive skin site
Results and discussion
In vivo (non-LLNA)
Results
- Group:
- test chemical
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Remarks on result:
- positive indication of skin sensitisation
Any other information on results incl. tables
100% of the treated guinea pigs showed a positive reaction. Based on a self-made ranking and classification system (Gad,1988), hydroxylamine sulfate has to be classified in class III (moderate sensitizer).
Applicant's summary and conclusion
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