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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1955
Reliability:
2 (reliable with restrictions)
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:
Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize and associates.
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:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg

Administration / exposure

Type of coverage:
occlusive
Vehicle:
not specified
Details on dermal exposure:
The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film.
Duration of exposure:
24 hours
Doses:
Not available.
No. of animals per sex per dose:
4
Control animals:
not specified
Details on study design:
Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize and associates, using groups of 4 male New Zealand albino rabbits weighing 2.5 to 3.5 kg. The fur was removed from the entire trunk by clipping and the dose was retained beneath an impervious plastic film. The animals were immobilized during the 24 hours contact period. The film was removed after that and the rabbits were caged for the subsequent 14-days (Observation period).
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:
1 820 mg/kg bw
Based on:
test mat.
Remarks on result:
other: value mentioned in the report is 2 ml/kg, whch has been converted to mg/kg (1820mg/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:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 value considered is 1820 mg/kg body weight and its fiducial range is 1365 - 2457 mg/kg body weight.
Executive summary:

Penetration of rabbit skin was estimated by a technique closely akin to the one-day cuff method of Draize and associates, using groups of 4 male New Zealand albino rabbits weighing 2.5 to 3.5 kg.

The fur was removed from the entire trunk by clipping and the dose was retained beneath an impervious plastic film. The animals were immobilized during the 24 hours contact period. The film was removed after that and the rabbits were caged for the subsequent 14-days observation period.

Based upon mortalities during a 14 -day observation period, the LD50 value considered is 1820 mg/kg body weight and its fiducial range is 1365 - 2457 mg/kg body weight.