Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April - May 1961
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No indication of guideline followed or GLP compliance.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1961
Report Date:
1961

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Rats were administered a single dose of test material via stomach intubation and were observed for 14 days to determine the toxicity of the test substance when administered orally.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Trimethylolpropane Monoallyl Ether was a viscous, clear, colourless liquid.

Test animals

Species:
rat
Strain:
other: Albino
Sex:
male
Details on test animals and environmental conditions:
Five male albino rats weer used. The rats were non-fasted.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: mazola
Details on oral exposure:
The chemical was diluted with mazola and the concentration of the aliquots to be used for dosing the various concentration levels was adjusted so that no less than on milliliter or more than 10 milliliters was given to each animal.
Doses:
The rats were administered at four consecutive dosage levels differing by a factor of 2, specifically: 2, 3.98, 7.95 and 15.8 g/kg.
No. of animals per sex per dose:
5 male rats per dose.
Control animals:
no
Details on study design:
Doses were administered by stomach intubation to groups of five male albino rats who were non-fasted. Each rat received between 1 and 10 ml of test material. The rats were observed for 14 days at which time mortality due to chemcial exposure was considered complete. All fatalities were subjected to autopsies to include extraneous causes of death. Survivors were sacrificed and examined for the existence of gross lesions.
Statistics:
he single oral dose LD50 based on mortality during the 14-day observation period was estimated by Thompson's method of moving averages employin tables of Weil.

Results and discussion

Preliminary study:
Not applicable.
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
4.93 other: g/kg
Based on:
test mat.
95% CL:
3.73 - 5.16
Mortality:
1 rat died 1 day after dosing at the 3.98 g/kg dose level.
All 5 rats died at the 7.95 g/kg dose level, with 4 rats dead 4 hours after dosing and 1 rat dead 1 day after dosing.
All 5 rats died less than 1 hour after dosing at the 15.8 g/kg dose level.
Clinical signs:
At the higher concentrations tested, trimethylolpropane monoallyl ether resulted in a slight narcotic effect on rats.
Body weight:
For the surviving rats in the 2.00 and 3.98 g/kg dose groups, an increase in body weight was recorded.
Gross pathology:
The survivors of the 14-day observation period showed no gross lesions upon examinaiton following sacrifice.
Other findings:
The growth of the surviving rats was normal and they were in good condition.

Any other information on results incl. tables

The Acute Oral Toxicity for Rats of Trimethylolpropane Monoallyl Ether.

Average Weight (kg)

 

 

Dosage g/kg

Initial

Change 14 days

Number Died / Number Dosed

Days after dosing on which death occurred.

2.00

115

+66

0/5

-

3.98

124

+80

1/5

1 (1)

7.95

128

-

5/5

4 hrs (4), 1 (1)

15.8

120

-

5/5

1hr (3), 2 (1), 3 (1)

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 of trimethylolpropane monoallyl ether was determined to be 4.93 g/kg, when tested on male rats.
Executive summary:

The acute oral toxicity of Trimethylolpropane monoallyl ether was determined in male albino rats. Groups of five male albino rats were administered a single dose of Trimethylolpropane monoallyl ether at dose levels of 2, 3.98, 7.95 and 15.8 g/kg via stomach intubation. The rats were observed for 14 days and an oral LD50 based on mortality was determined to be 4.93 g/kg. 1 mortality was observed in the 3.98 g/kg dose group the day after dosing. In the 7.95 and 15.8 g/kg dose groups, all 5 rats in each group died within 1 day of dosing. All surviving rats had an increase in body weight followig the 14 day observation period.