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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:
key study
Study period:
1962
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data are given

Data source

Reference
Reference Type:
publication
Title:
Range-finding toxicity Data List VI
Author:
Smyth, H.F. et al.
Year:
1962
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 23, 95-107

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material: 1,3-Propanediamaine

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 4 - 5 weeks
- Weight at study initiation: 90 - 120 grams
- Fasting period before study: no
- Rockland rat diet

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
The dosages were arranged in a logarithmic series differing by a factor of two.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
14-day post observation period
Statistics:
Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson* using the tables of Weil**.

*Thompson, W. R.: Use of Moving Averages and Interpolation to Estimate Median Effective Dose. Bacteriol. Rev. 11: 115 (June 1947).

**Weil, C. S.: Tables for Convenient Calculation of median-Effective Dose (LD50 or ED50) and Instruction in Their Use. Biometrics 8: 249 (Sep 1952)

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
311 mg/kg bw
Based on:
test mat.
95% CL:
>= 196 - <= 507
Mortality:
Only LD 50 value of 0.35 mL/kg bw (corr. to 311 mg/kg bw) was reported
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

Details of toxic effects not reported other than lethal dose value. Result in publication is given as 0.35 mL/kg. Density used by the registrant for conversion: 0.89 g/mL

Applicant's summary and conclusion