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: 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

Principles of method if other than guideline:
Following OECD401 guideline, but using intraperitoneal dosing
GLP compliance:
no
Remarks:
Old study
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 13-22 g

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
water
Details on exposure:
VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): Varies with dose level
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

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
49 mg/kg bw
Based on:
test mat.
95% CL:
37 - 65
Mortality:
20 mg/kg: 0/5
40 mg/kg: 1/5 (4 days)
80 mg/kg: 5/5 (3-4 hours)
160 mg/kg: 5/5 (1-2 hours)
Clinical signs:
Decreased activity, but hyper-reaction to touch was observed after about one hour
Gross pathology:
Mice that died had congested lungs, livers and spleens, grossly, but no histologic change.

Applicant's summary and conclusion

Conclusions:
LD50 was 49 mg/kg (37-65)
Executive summary:

Mortality in male mice was:

20 mg/kg: 0/5

40 mg/kg: 1/5 (4 days)

80 mg/kg: 5/5 (3-4 hours)

160 mg/kg: 5/5 (1-2 hours)