Registration Dossier
Registration Dossier
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EC number: 206-114-9 | CAS number: 302-01-2
Immunotoxicity
Administrative data
- Endpoint:
- immunotoxicity
- Remarks:
- other: popliteal lymphnode assay
- Type of information:
- experimental study
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- publication
- Title:
- The popliteal lymph node assay: results of a preliminary interlaboratory validation study
- Author:
- Vial T, Legrain B, Verdier F, Descotes J
- Year:
- 1 997
- Bibliographic source:
- Toxicology 122, 213-218
Materials and methods
- Principles of method if other than guideline:
- see additional information on materials and methods
- GLP compliance:
- not specified
- Limit test:
- 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:
- hydrazine (no further information)
Constituent 1
Test animals
- Species:
- other: rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 8 week old
- Weight at study initiation: 240-300 g
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
in each laboratory rats were housed under standard conditions
Administration / exposure
- Route of administration:
- other:
- Vehicle:
- physiological saline
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- see section any other information on material and method
- Frequency of treatment:
- see section any other information on material and method
Doses / concentrations
- Remarks:
- Doses / Concentrations:
10, 30, 100 mg/ml
Basis:
- No. of animals per sex per dose:
- see section any other information on material and method
Results and discussion
Any other information on results incl. tables
Hydrazine was identified in all 3 laboratories as positive
All 3 laboratories noted a dose-related increase in popliteal lymph node weight and cellularity
The negative control was functional
Applicant's summary and conclusion
- Executive summary:
In a priliminary interlaboratory validation study using the popliteal lymph node (PLN) assay
hydrazine yielded a positive result(Vial 1997).
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