Registration Dossier
Registration Dossier
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EC number: 233-139-2 | CAS number: 10043-35-3
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards with acceptable restrictions.
Data source
Reference
- Reference Type:
- publication
- Title:
- Acute intravenous and intraperitoneal toxicity studies on sodium pentaborate decahydrate and sodium tetraborate decahydrate.
- Author:
- Easterday OD & Hamel H
- Year:
- 1 963
- Bibliographic source:
- Arch. Int. Pharmacodyn. 143 (1-2)144 – 164.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The toxicity observations in mice of varying borate-glucose molar ratios and relative potencies was reported following intravenous and intraperitoneal administration. Also presented were data showing the effect of age on tetraborate toxicity. Swiss mice were administered with reagent grade sodium tetraborate decahydrate and intravenous 50 % d-glucose dissolved in sterile water or saline. The doses were injected as mg of the parent drug/g body weight per 0.01 or 0.02 mL. By maintaining a constant borate dose and varying the amount of d-glucose in the injected preparation the effect of different borate-glucose molar ratios on toxicity was determined. The observation period was 24 h after intravenous administration and after intraperitoneal administration 5 to 12 days. The acute toxicity data were statistically analysed by probit transformation, maximum likelihood solution and relative potency techniques.
- GLP compliance:
- no
- Remarks:
- Studypre-dates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Sodium pentaborate decahydrate and sodium tetraborate decahydrate
- IUPAC Name:
- Sodium pentaborate decahydrate and sodium tetraborate decahydrate
- Details on test material:
- - Name of test material: Sodium pentaborate decahydrate; Sodium tetraborate decahydrate
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- Swiss
- Sex:
- male/female
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- other: Water or saline
- Doses:
- Sodium pentaborate decahydrate: 2175 and 2300 mg/kg
Sodium tetraborate decahydrate: 2700, 2750, 2800 and 2884 mg/kg - No. of animals per sex per dose:
- Sodium pentaborate decahydrate: Between 14 and 42 males; and between 1 and 26 females
Sodium tetraborate decahydrate: Between 7 and 30 males; and between 9 and 34 females - Control animals:
- yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 737 mg/kg bw
- Based on:
- other: Borate
- Remarks on result:
- other: Tetraborate : distilled water; 2737 ± 479
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 792 mg/kg bw
- Based on:
- other: Borate
- Remarks on result:
- other: Tetraborate : saline; 2792 ± 420
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 3 037 mg/kg bw
- Based on:
- other: Borate
- Remarks on result:
- other: Tetraborate : d-glucose; 3037 ± 620.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 817 mg/kg bw
- Based on:
- other: Borate
- Remarks on result:
- other: Tetraborate : d-glucose; 2817 ± 243.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 375 mg/kg bw
- Based on:
- other: Borate
- Remarks on result:
- other: Pentaborate : d-glucose; 2375 ± 118.
Applicant's summary and conclusion
- Conclusions:
- Toxic responses of intraperitoneally administered sodium pentaborate decahydrate and sodium tetraborate decahydrate were convulsions which generally occurred during the first 3 h. Trunk muscular contractions and opisthotonic responses occassionally occurred. General motor activity and the respiration rate were markedly depressed and usually existed for several hours. Frequently observable motor activity depression continuing through the second day after administration was observed. Most of the deaths occurred during the first 3 days.
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