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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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 levelsopen allclose all
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
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:
Symptoms include sings of CNS depression, ataxia, convulsions, laboured breathing or rapid respiration; blood crust around nose, marked diarrhoea and ptosis.
Body weight:
No data
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.

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