Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 March 1974 to 18 April 1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report date:
1975

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Five groups of 5 male fasted animals was given a single oral dose of test material as a solution in Corn Oil at dose levels of 2.0 mL/kg, 4.0 mL/kg, 8 mL/kg, 16.0 mL/kg and 32.0 mL/kg The animals were observed for fourteen days after the day of dosing.
GLP compliance:
no
Remarks:
Prior to GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Test material form:
not specified

Test animals

Species:
rat
Strain:
other: Sherman-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
Test Animals
- Weight at study initiation - 200 to 250g
- Fasting period before study - 24 hours prior to dosing
- Diet - With the exception of an 24 hour fast prior to dosing, free access to food and water was allowed through the study

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25% w/v suspension

MAXIMUM DOSE VOLUME APPLIED: 32ml/kg

:
Doses:
2.0 ml/kg
4.0 ml/kg
8.0 ml/kg
16.0 ml/kg
32.0 ml/kg
No. of animals per sex per dose:
5 males
Control animals:
no
Details on study design:
The animals were observed for signs of toxicity and mortality daily for 14 days.
Statistics:
No statistical analysis was performed.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 32 mL/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the course of the study
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: Section 1500.3 - Hazardous Substances and Articles, Administraton and Enforcement Regulations, Federal Register, Vol. 38 No 187 P.27014, 27 September 1973, Section (c) (2) (1)
Conclusions:
The Acute Oral LD50 in the male Sherman-Wistar rat was found to be greater than 32 mL/kg (equivalent to 8 g/kg)
Executive summary:

Guideline

A study was performed to assess the acute oral toxicity of the test material in the Sherman-Wistar strain rat.

Method

Five groups of 5 male fasted animals was given a single oral dose of test material as a solution in Corn Oil at dose levels of 2.0 mL/kg, 4.0 mL/kg, 8.0 mL/kg, 16.0 mL/kg and 32.0 mL/kg The animals were observed for fourteen days after the day of dosing.

Results

There were no deaths. The acute oral median lethal dose (LD50) of the test material in the Sherman-Wistar strain rat was found to be greater than 32 mL/kg bodyweight.

Conclusion

The Acute Oral LD50 in the male Sherman-Wistar rat was found to be greater than 32 mL/kg (equivalent to 8 g/kg).