Registration Dossier
Registration Dossier
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EC number: 206-114-9 | CAS number: 302-01-2
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: test performed with human volunteers
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The identification of contact allergens by Human Assay. III The Maximization test: A Procedure for screening and rating Contact Sensitizers
- Author:
- Kligman AM
- Year:
- 1 966
- Bibliographic source:
- J Invest Dermatol 47, 393-409
- Reference Type:
- review article or handbook
- Title:
- Chemikalien und Kontaktallergie - eine besertende Zusammenstellung (Komplettfassung vollständig überarbeitet)
- Author:
- Bundesinstitut für gesundheitlichen Verbraucherschutz und Veterinärmedizin: Kayser D, Schlede E (eds)
- Bibliographic source:
- Medizin& Wissen, Urban und Vogel, Münschen, ISBN 3-86092-1631
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- RM-Freetext: method: pretreatment (no data if this was necessary for the TS because of the suspected irritation) with 5% sodium lauryl sulfate for 24 h (inflammatory reaction promote sensitization); occlusive allergen patches for induction with 5% TS solution for 48 h; repetition of both four times; challenge patch for 48 h; challenge concentration 0.5%; evaluation 0 and 48 h after removing the patch.
- GLP compliance:
- no
Test material
- Reference substance name:
- Hydrazine
- EC Number:
- 206-114-9
- EC Name:
- Hydrazine
- Cas Number:
- 302-01-2
- Molecular formula:
- H4N2
- IUPAC Name:
- hydrazine
- Details on test material:
- no further details
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- 23 volunteers :18-50 years old negroes
- Clinical history:
- no clinical history
- Controls:
- no data
- Route of administration:
- dermal
- Details on study design:
- RM-Freetext: method: pretreatment (no data if this was necessary for the TS because of the suspected irritation) with 5% sodium lauryl sulfate for 24 h (inflammatory reaction promote sensitization); occlusive allergen patches for induction with 5% TS solution for 48 h; repetition of both four times; challenge patch for 48 h; challenge concentration 0.5%; evaluation 0 and 48 h after removing the patch.
Results and discussion
- Results of examinations:
- 23/23 volunteers developed senitizational skin effects (grade 5) which was evaluated by the author as extreme
Applicant's summary and conclusion
- Executive summary:
In this maximization test, 23/23 volunteers developed senitizational skin effects (grade 5) which was evaluated by the author as extreme (Kligman 1966).
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.
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