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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: report in brief of different application routes

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Objective of study:
toxicokinetics
Principles of method if other than guideline:
Administration of test substance via gavage, drinking water, oral undefined, subcutan, intratracheal and dermal without and with collar and availabiltiy in blood and excretion rate were determined.
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
10217-52-4
Cas Number:
10217-52-4
IUPAC Name:
10217-52-4
Constituent 2
Reference substance name:
hydrazine hydrate
IUPAC Name:
hydrazine hydrate
Details on test material:
hydrazine hydrate (99 %)
Radiolabelling:
no

Test animals

Species:
rat
Strain:
other: CPB-SPF
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 180-220 g
- metabolism cages: yes, only animals that were nominated for urinalysis

Administration / exposure

Route of administration:
other: (1) oral gavage, (2) drinking water, (3) oral undefined, (4) subcutan, (5) intratracheal, (6) dermal
Vehicle:
water
Details on exposure:
see section additional information on material and methods
Duration and frequency of treatment / exposure:
see section additional information on material and method
Doses / concentrations
Remarks:
Doses / Concentrations:
see section additional information on material and method
No. of animals per sex per dose / concentration:
see section additional information on material and method
Control animals:
yes
Positive control reference chemical:
no
Details on study design:
determination of hydrazine in blood:
Reaction of hydrazine with p-dimethylaminobenzaldehyd result in
Dimethylaminobenzalazin (DMABA) which is yellow and
can be extracted with chloroform and measured fluorimetrically
urinary analysis
by HPLC combined with UV-detection
Details on dosing and sampling:
see secton addional information on material and methods
Statistics:
no data

Results and discussion

Preliminary studies:
no data

Toxicokinetic / pharmacokinetic studies

Details on absorption:
see section remarks on result
Details on distribution in tissues:
no data
Transfer into organs
Transfer type:
other: not determened
Observation:
other: no data
Details on excretion:
see section remarks on result
Toxicokinetic parameters
Toxicokinetic parameters:
other: see section remarks on results

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
no data

Any other information on results incl. tables

Trial (1) blood examination: rapid absorption from the gastrointestinal tract; highest concentration 15 min post application: 234 ng/ml and 441 ng/ml, respectively half live in blood: 35 min and 90 min., respectively urinalysis within 24 hours 13.1 and 16.9 % of the dose as unchanged hydrazine trial(2) blood examination 10 ppm: 13.6 ng/ml 50 ppm: 48 ng/ml urinalysis 10 ppm: 216 µmol 50 ppm: 715 µmol trial(3)-(6) (3) oral unspecified: 23.4-27.5 % of the dose (4) subcutan: 37.2-50.9 % of the dose (5) intratracheal: 28.3 % of the dose (6a) dermal (without collar) 21.1 % of the dose (6b) dermal (with collar) 14.7-7.5 % of the dose.

Applicant's summary and conclusion