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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:
supporting study
Study period:
1955
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit interpretation of study results
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1955
Report Date:
1955
Reference Type:
publication
Title:
Unnamed
Year:
1962

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Range finding study.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Methyl borate
- Molecular formula (if other than submission substance): C3H9BO3
- Molecular weight (if other than submission substance): 103.9
- Physical state: Liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: In-House
- Age at study initiation: 4 to 5 weeks
- Weight at study initiation: 90 to 120 grams

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Single oral dose toxicity estimation by gastric intubation.
Doses:
Not available.
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Single dose oral toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, 4 to 5 weeks of age and weighing 90 to 120 grams. Animals were maintained on Rockland rat diet since weaning. The dosages were arranged in a logarithmic series differingby a factor of two.
Statistics:
Based upon mortalities during a 14 -day observation period, the most probable LD50 value and its fiducial range were estimated by the method of Thompson using the Tables of Weil.

Results and discussion

Preliminary study:
No data available.
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
5 551 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Data mentioned in the report is 6.1 ml/kg; which is converted to mg/kg (5551 mg/Kg).
Mortality:
No data available.
Clinical signs:
No data available.
Body weight:
No data available.
Gross pathology:
No data available.
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 value considered is 5551 mg/kg body weight and its fiducial range is 4550 - 7280 mg/kg body weight.
Executive summary:

Single dose oral toxicity was estimated by the gastric intubation of groups of five non-fasted, Carworth-Wistar male rats, 4 to 5 weeks of age and weighing 90 to 120 grams. Animals were maintained on Rockland rat diet since weaning.

The dosages were arranged in a logarithmic series differing by a factor of two. Based upon mortalities during a 14 -day observation period, the LD50 value and its fiducial range were estimated by the method of Thompson using the Tables of Weil.

Based upon mortalities during a 14 -day observation period, the LD50 value considered is 5551 mg/kg body weight and its fiducial range is 4550 - 7280 mg/kg body weight.