Registration Dossier
Registration Dossier
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EC number: 200-834-7 | CAS number: 75-04-7
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Acceptable publication but only limited data is given.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 954
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 991
- Reference Type:
- publication
- Title:
- The Toxicity of Allylamines
- Author:
- Hine C. et al.
- Year:
- 1 960
- Bibliographic source:
- Arch. Env. Health Vol. 1, 1960, 343-352
- Reference Type:
- review article or handbook
- Title:
- Aliphatic and Alicyclic Amines
- Author:
- Benya T.J. et al.
- Year:
- 1 994
- Bibliographic source:
- Patty's Industrial Hygiene and Toxicology, Vol. 2, Part B, Chapter 17
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Principle of test:
Single oral dose toxicity is estimated by the gastric intubation of groups of five non-fasted Carworth-Wistar rats, weighing 90 to 120 grams and maintained from time of weaning on Rockland rat diet, complete. The most probable LD50 value and its fiducial range were estimated by the method of Thompson. - GLP compliance:
- no
- Remarks:
- predating GLP
- Limit test:
- no
Test material
- Reference substance name:
- Ethylamine
- EC Number:
- 200-834-7
- EC Name:
- Ethylamine
- Cas Number:
- 75-04-7
- Molecular formula:
- C2H5NH2
- IUPAC Name:
- ethanamine
- Details on test material:
- - Name of test material (as cited in study report): Ethylamine
- Analytical purity: no data
Constituent 1
- Specific details on test material used for the study:
- FORM AS APPLIED IN THE TEST: Aqueous solution
Test animals
- Species:
- rat
- Strain:
- other: Carworth-Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 90 to 120 grams
- Diet: Rockland rat diet
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 1 to 10 mL
- Doses:
- No data; dosages were in a logartitmic series
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 400 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no data
- Clinical signs:
- no data
- Body weight:
- no data
- Gross pathology:
- no data
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The mean lethal dose of the test substance after single oral administration was found to be 400 mg/kg bw in rats.
- Executive summary:
The test article was administered to a group of 5 non-fasted Carworth-Wistar rats by intubation of dosages in a logartithmic series. After 14 days of observation the single dose oral toxicity was calculated to be 400 mg/kg bw.
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