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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Basic toxicokinetics

Currently viewing:

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
Chemical structure
Reference substance name:
hydrazine hydrate
Cas Number:
10217-52-4
Molecular formula:
H4N2*xH2O
IUPAC Name:
hydrazine hydrate
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