Trimethyl borate

Acute Toxicity: dermal

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-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1955

Report date:

1955

Reference 2

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

Test material information

Constituent 1

Reference substance name:

Trimethyl borate

EC Number:

204-468-9

EC Name:

Trimethyl borate

Cas Number:

121-43-7

Molecular formula:

C3H9BO3

IUPAC Name:

trimethyl borate

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 or test system 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:

other: 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.