Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Principles of method if other than guideline:
Single administration of seven concentrations with an application volume of 20 ml/kg to fasted rats (5 males and 5 females) via stomach tube with an observation period of 14 days
GLP compliance:
no
Test type:
other: acute oral toxicity, rat
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
3-Aminocrotonsäuremethylester, solid, content and identity not certified

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Lutrol (PEG 400)
Doses:
1.3, 1.5, 1.8, 1.9, 2.0, 2.5 and 3.1 g/kg with an application volume of 20 ml/kg
No. of animals per sex per dose:
5
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
1 760 mg/kg bw
Based on:
test mat.
95% CL:
1 610 - 1 910

Any other information on results incl. tables

No symptoms in males and females at doses of 1.3 g/kg

Symptoms at doses of 1.5 g/kg and above: reduced general condition, cyanosis, ventral or lateral position, narcosis, dyspnea

Onset / Duration of symptoms: clinical signs occurred after 5 to 10 min after administration, on day 3 all (surviving) animals were free of symptoms

All death occurred on the first day after administration

Dissection of dead animals: bleedings in the mucous membrane of the stomach

No abnormal findings were seen at final necropsy

Applicant's summary and conclusion

Executive summary:

The acute oral toxicity of methyl 3 -aminocrotonate was determined in fasted male and female rats after single administration of seven concentrations with an application volume of 20 ml/kg via stomach tube with an observation period of 14 d.

The acute oral LD50was 1760 mg/kg.