Hydrazinium, 2-(3-methoxy-3-oxopropyl)-1,1,1-trimethyl-, bromide (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

10.01. - 26.01.2005.

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

GLP compliance:

yes

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

463-070-5

EC Name:

-

Cas Number:

106966-25-0

Molecular formula:

C7H17N2O2Br

IUPAC Name:

2-(3-methoxy-3-oxopropyl)-1,1,1-trimethylhydrazinium bromide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Water for injections

Doses:

2000 and 300 mg/kg body weight

No. of animals per sex per dose:

6 (six) male and 3 (three) female, in all 9 (nine) animals.
The dosing was performed sequentially to three male animals (first step) using a starting dose of 2000 mg/kg body weight, to three male animals
(second step) using a dose of 300 mg/kg body weight and to three female animals (third step) using a dose of 300 mg/kg body weight. The dose
wolume of administered solution did not exceed 2 ml/ 100 g body weight of animals.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were weighed before application, on the 8th day of study and before euthanasia (15th day) of
animals.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, increment weights

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 mg/kg bw

Mortality:

Male: 2000 mg/kg bw; Number of animals: 3; Number of deaths: 2
Male: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0
Female: 300 mg/kg bw; Number of animals: 3; Number of deaths: 0

Clinical signs:

other: Signs of toxicity related to dose levels: Dose 2000 mg/kg - males The test substance caused death of two males (from 3). 30 min. after aplication all animals laied on belly and anaemic cutis and anaemic mucous membrane were observed. Lacrimatio

Gross pathology:

Effects on organs:
Dose 2000 mg/kg - males

Necroscopy findins in two died males:

diarrhoea, serous discharge out of nose, congested
hypodermis, oedema of lung, acute catarrhal inflammation of
stomach, small intestine - flatulence and liquid volume,
congested vessels of small intestine.


Dose 300 mg/kg - males

Necroscopy findings

In two animals was observed marked structure in kidney.


Dose 300 mg/kg - females

Necroscopy findings

In two animals was observed slightly granular surface in
spleen.

Applicant's summary and conclusion

Interpretation of results:

harmful

Remarks:

Migrated information Criteria used for interpretation of results: EU