Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent

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:
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.

Lacrimation and gasping (hard breathing) were observed in
all animals.

2 males died within 3 hours after application.

The third one did not consume a feed. Erected hair, anaemic
cutis, anaemic mucous membrane, ataxia, hunched posture and
diarrhoea were observed in this one male.


Dose 300 mg/kg - males and females

No animal was died. No changes in behavoir were observed.
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