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Toxicological information

Sensitisation data (human)

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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:
1966
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

Constituent 1
Chemical structure
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

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).