Registration Dossier
Registration Dossier
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EC number: 232-259-2 | CAS number: 7803-49-8
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given, method comparable to todays standard.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 977
- 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
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- A patch test (according to Shelanski/Shelanski (1953) [see Griffith (1969)]) was performed with humans to determine the sensitising potental of the test substance.
- GLP compliance:
- no
Test material
- Reference substance name:
- Automatically generated during migration to IUCLID 6, no data available
- IUPAC Name:
- Automatically generated during migration to IUCLID 6, no data available
- Details on test material:
- - Name of test material (as cited in study report): hydroxylamine sulfate
Constituent 1
Method
- Type of population:
- not specified
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: cotton felt patches
- Vehicle / solvent: detergent solution
- Concentrations: 0.05%
- Testing/scoring schedule: The patches were left on the dorsal skin of the upper arm for 24 h and were applied 3 days per week (monday, wednesday, and friday) for 3 weeks. Following this induction series, there is a 2 week period during which no patches are applied. At the beginning of the 6th week, each subject is challenged with the test material at the same sites as used for induction and at fresh sites on the opposite arm. The challenge patches are removed at 24 h and any responses are graded immediately and at 48 and 96 h. Reactions suggestive of sensitization are confirmed by a second challenge 2 months after the first challenge.
Results and discussion
Any other information on results incl. tables
Hydroxylamine sulfate sensitized 3 of 76 (= 4%) human subjects at 0.05%. Based on a self-made ranking and classification system (Gad,1988), hydroxylamine sulfate has to be classified in class I (severe sensitizer).
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.
