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Registration Dossier
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EC number: 203-463-9 | CAS number: 107-11-9
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Old study, not to GLP, but similar to current guidelines
Data source
Reference
- Reference Type:
- publication
- Title:
- The Toxicity of Allylamines
- Author:
- Hine, CH, et al
- Year:
- 1 960
- Bibliographic source:
- Archives of Environmental Health, Volume 1, Pages 343-352
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Only 3 animals per dose
- GLP compliance:
- no
- Remarks:
- Old study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Allylamine
- EC Number:
- 203-463-9
- EC Name:
- Allylamine
- Cas Number:
- 107-11-9
- Molecular formula:
- C3H7N
- IUPAC Name:
- prop-2-en-1-amine
- Test material form:
- other: liquid
- Details on test material:
- Molecular weight: 57.09
Boiling point: 52.9 deg C
Melting point: -88.2 deg C
Flash point, tag open cup: -20 deg F
Specific Gravity, 20/4 C: 0.7627
Solubility in water, 20 deg C, %W: complete
pH of 0.1M aqueous solution: 11.2
ppm in 1 mg/mL: 429
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Animals weighed 2.0-2.8 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back/flanks
- % coverage: Not stated
- Type of wrap if used: rubber
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped dry
- Time after start of exposure: several hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): neat material, as required
- Concentration (if solution): N/A - Duration of exposure:
- Several hours
- Doses:
- 13, 25, 50 and 100 mg/kg
- No. of animals per sex per dose:
- 3 males
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 10 days
- Frequency of observations and weighing:
- Necropsy of survivors performed: yes, where possible - Statistics:
- LD50 calculated by method of Weil, 1952.
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 35 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 13 mg/kg: 0/3
25 mg/kg: 0/3
50 mg/kg: 3/3 (4-24 hours)
100 mg/kg: (3-4 hours) - Clinical signs:
- other: Considerable local erythema and oedema, progressing to eschar formation Deaths occurred with no preliminary sign but head drop
- Gross pathology:
- Premature decedents usually had fluid in the pleural cavity and dilation of the gastroenteric veins. Microscopically all had severely congested lungs.
Applicant's summary and conclusion
- Interpretation of results:
- Toxicity Category I
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 was 35 mg/kg
- Executive summary:
Mortality in male rabbits was:
13 mg/kg: 0/3
25 mg/kg: 0/3
50 mg/kg: 3/3 (4-24 hours)
100 mg/kg: (3-4 hours)
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