Registration Dossier
Registration Dossier
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EC number: 226-798-2 | CAS number: 5470-11-1
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 scientific publication which meets basic scientific principles. A short method description is enclosed.
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. et al.
- 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 specified
- Remarks:
- missing details
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
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
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- - Acclimation period: 14 days
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- - intradermal injection: 5%
- topical induction: 25%
- challenge: 10%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- - intradermal injection: 5%
- topical induction: 25%
- challenge: 10%
- No. of animals per dose:
- test group: 15
control group: 6 - 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 - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- intradermal induction 5%, challenge 10%
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Group:
- negative control
- Remarks on result:
- other: not specified
- Group:
- positive control
- Remarks on result:
- other: not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- CLP: Skin Sens. 1, H317 (corresponding to the harmonized classification according to Annex VI of CLP Regulation)
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).
Based on the test results, the test substance is considered to be skin sensitising category 1. The available data are not sufficient for a decision on the appropriate subcategory according to the criteria of the CLP Regulation.
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