Barium diboron tetraoxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 January - 31 January, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Conducted prior to GLP, and the availabilty of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature and humidity) but adequate for the purposes of hazard classification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

BUSAN 11-M1

IUPAC Name:

BUSAN 11-M1

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sprague Dawley, Madison, WI
- Age at study initiation: No data
- Weight at study initiation: 221 - 261 g (males) 208 - 215 g (females)
- Fasting period before study: No data
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: 26 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 19/12/1978 To: 31/1/1979

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

not specified

Details on oral exposure:

VEHICLE
- Concentration in vehicle: No data
- Amount of vehicle (if gavage): No data
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data

MAXIMUM DOSE VOLUME APPLIED: No data

DOSAGE PREPARATION (if unusual): No data

Doses:

0.34, 0.50, 0.73, 1.07, 2.31, 5.0 g/kg

No. of animals per sex per dose:

8 rats/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Weight was measured at study initiation, day 7 and study termination
Pharmacotoxic signs were observed at hours 1, 2, 5 and daily thereafter.
- Necropsy of survivors performed: yes

Statistics:

No further data

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

850 mg/kg bw

Based on:

test mat.

95% CL:

700 - 1 130

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

530 mg/kg bw

Based on:

test mat.

95% CL:

380 - 660

Mortality:

No animals died in the 0.34 dosage group
1 male and 6 females died in the 0.5 dosage group
3 males and 6 females died in the 0.73 dosage group
6 males and all females died in the 1.07 dosage group
All animals died in the 2.31 dosage group
All animals died in the 5.0 dosage group

Clinical signs:

other: 0.34 dosage group: all animals appeared normal with no clinical signs 0.5 dosage group - 5.0 dosage group: Animals showed a range of symptoms including diarrhea, hypoactivity, ataxia, decrease limb tone, bradypnea, piloerection, absence of grasping reflex

Gross pathology:

No significant visible lesions were observed

Other findings:

No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 was found to be 0.85 g/kg in males and 0.53 g/kg in females. Therefore it is classified as Category 4, signal word warning, hazard statement H302: Harmful if swallowed.

Executive summary:

The test substance Busan 11-M1 was administered to 8 rats/sex/dose male and female Sprague-Dawley rats in dosages administered at 0.34, 0.50, 0.73, 1.07, 2.31, 5.0 g/kg. The test animals were observed for 14 days following administration. Under the conditions of this study, the oral LD50 of the test substance was determined to be 0.85 g/kg in males and 0.53 g/kg in females . Based on this result, Busan 11-M1 is classified as Category 4, signal word warning, hazard statement H302: Harmful if swallowed in accordance with Regulation EC No. 1272/2008.