Tris(1,3-dihydroxyprop-2-yl) borate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

No data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards with acceptable restrictions. Study conducted on the hydrolysis product of reference substance, boric acid.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1962

Report date:

1962

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: No data

Deviations:

not specified

Principles of method if other than guideline:

Boric acid was administered orally by gavage to six groups of five male and five female albino Sprague-Dawley rats. The test material was administered as a 50 % w/v suspension in 0.5 % aqueous methyl cellulose at dosage levels of 2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw. Rats were fasted for a period of 3 to 4 h prior to dosage. Animals were observed for mortality and toxic effects at 1, 2, 4, and 24 h and once daily after for a total of 14 days. At teh end of the observation period the surviving animals were weighed sacrificed and autopsies were performed.

GLP compliance:

no

Remarks:

Study pre-dates GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Boric acid

EC Number:

233-139-2

EC Name:

Boric acid

Cas Number:

10043-35-3

Molecular formula:

BH3O3

IUPAC Name:

Boric acid

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material: Boric acid
- Substance type: Solid
- Physical state: Fine soft white powder
- Analytical purity: > 99 %

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: Males: 267 - 302 g; Females: 214 - 248 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 0.5 % aqueous methyl cellulose

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 % w/v

MAXIMUM DOSE VOLUME APPLIED: 3450 - 4080 mg/kg bw

Doses:

2.0; 2.5; 3.16; 3.98; 5.01 and 6.31 g/kg bw.

No. of animals per sex per dose:

Five animals/group; no further data

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs

Statistics:

Litchfield and Wilcoxon

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

3 450 mg/kg bw

Based on:

test mat.

95% CL:

2 950 - 4 040

Remarks on result:

other: mg boric acid/kg

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

4 080 mg/kg bw

Based on:

test mat.

95% CL:

3 640 - 4 560

Remarks on result:

other: mg boric acid/kg bw

Mortality:

No data

Clinical signs:

other: Symptoms include sings of CNS depression, ataxia, convulsions, laboured breathing or rapid respiration; blood crust around nose, marked diarrhoea and ptosis.

Gross pathology:

Autopsies indicated congestion of lungs, kidneys and adrenals; inflammation of the pyloric portion of stomach and small intestine.

Other findings:

No data

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information no data Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of boric acid for male albino rats was 3450 (2950 - 4040) mg boric acid/kg, equivalent to 604 mg B/kg bw. In female albino rats the acute oral LD50 of boric acid was 4080 (3640 - 4560) mg boric acid/kg, equivalent to 714 mg B/kg bw.