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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
1960
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:
1960
Bibliographic source:
Archives of Environmental Health, Volume 1, Pages 343-352

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Old study
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
mouse
Strain:
other: Princeton
Sex:
male
Details on test animals and environmental conditions:
Animals weighed 13-22g

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): Varies with dose level
- Justification for choice of vehicle: Not stated
- Lot/batch no. (if required):
- Purity:
Doses:
20, 40, 80 and 160 mg/kg.
No. of animals per sex per dose:
5 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:
57 mg/kg bw
Based on:
test mat.
Mortality:
20 mg/kg: 0/5
40 mg/kg: 0/5
80 mg/kg: 5/5 (4-8 hours)
160 mg/kg: 5/5 (2-4 hours)
Clinical signs:
None seen
Gross pathology:
Mice that died had congestion of the gastroenteric tract, discoloured livers, pale spleens, and hyperemic lungs, but histologically all tissues were within normal limits. No findings among survivors.

Applicant's summary and conclusion

Interpretation of results:
Toxicity Category III
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 was 57 mg/kg
Executive summary:

Mortality in male mice was:

20 mg/kg: 0/5

40 mg/kg: 0/5

80 mg/kg: 5/5 (4-8 hours)

160 mg/kg: 5/5 (2-4 hours)