Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards, well documented and reliable for assessment

Data source

Reference
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The toxicity of ethyl cyanoacetate is studied upon single i.p. injection into mice
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
Reference substance 001
Details on test material:
- Name of test material (as cited in study report): Cyanoessigsäure
- Physical state: liquid
-

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 20-30 g (male) 20-28 g (female)
- Fasting period before study: 15-20 h
- Diet (e.g. ad libitum): Mrh-Haltungsdiät

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5 % aqueous preparation
Details on exposure:
- The applied volume was constant at 10 ml/kg
Doses:
50; 200; 700; 2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of weighing and observations: multiple times on the day of application and daily therafter (except weekends). animals were weighed on day 2-4, day 7 and 13
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 700 - < 2 000 mg/kg bw
Mortality:
700 mg/kg bw: 0/10 animals died
2000 mg/kg bw: 9/10 animals died
Clinical signs:
50 mg/kg bw: stretching
200 mg/kg bw: redness of skin, stretching
700 mg/kg bw: staggering, stretching
2000 mg/kg bw: dyspnoe, apathy, staggering, convulsions, anaemic paleness, dyspnoe
Body weight:
mean weights:
50 mg/kg bw: body weights developed within the normal range
200 mg/kg bw: day 0: body weights developed within the normal range.
700 mg/kg bw: day 0: 28 g (male) and 26 g (female); day 13: 34.0 g (male) and 25.4 g (female)
Gross pathology:
No treatment related abnormalities were observed.

Applicant's summary and conclusion