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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: Acceptable publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VI
Author:
Smyth HF, Carpenter CP, Weil CS 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)
Deviations:
not specified
Principles of method if other than guideline:
Method: other: Smyth/Carpenter
GLP compliance:
no
Remarks:
prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Colony of the Mellon Institute of Industrial Research (Pittsburgh, Pennsylvania, USA) (in-house breeding)
- Age at study initiation: 4-5 weeks old
- Weight at study initiation: 90 to 120 g
- Fasting period before study: no
- Diet: Rockland rat diet complete

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: water, corn oil or 1 % Tergitol Penetrant 7
Details on oral exposure:
(Dose volume: 1 to 10 mL/rat, oral gavage)
Doses:
Logarithmic series of dose levels
No. of animals per sex per dose:
5 animals
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
The most probable LD50 was estimated by the methods of Thompson (1947) and Weil (1952).

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
600 mg/kg bw
Remarks on result:
other: reported as 0.60 mL/kg bw
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 0.43 - <= 0.84 mL/kg bw
Mortality:
Death occurred within 14 days, no detailed information provided.
Clinical signs:
No information provided
Body weight:
No information provided
Gross pathology:
No information provided

Any other information on results incl. tables

single oral gavage, deaths within 14 days. Limits of +/- 1.96 standard deviation using the method of Thompson: 430 - 840 mg/kg bw. Original LD50 given as 0.6 mL/kg bw.

Applicant's summary and conclusion