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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
No data
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Diboron trioxide
EC Number:
215-125-8
EC Name:
Diboron trioxide
Cas Number:
1303-86-2
Molecular formula:
B2O3
IUPAC Name:
bicyclo[1.1.1]diboroxane
Details on test material:
- Name of test material: Diboron trioxide (anhydrous boric acid)
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: 5C183709
- Other: CHE dispensary No. 0604/95-1341

Test animals

Species:
rat
Strain:
other: Crl:CD.BR
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd., Margate
- Age at study initiation: 5 - 8 weeks of age
- Weight at study initiation: 142 - 217 g
- Housing: Up to 5 rats were accommodated in suspended stainless steel mesh cages (dimensions 55 x 34 x 20 cm). The cages were suspended over carboard lined trays for collection of excreta. The liners were replaced at least twice weekly.
- Diet: Ad libitum except during fasting period
- Water: Ad libitum
- Fasting period before study: 18 h prior to dosing until 3 h after dosing
- Acclimation period: 6 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 C
- Humidity (%): 40 - 70 % relative humidity
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12 dark/light; typically 0600 to 1800 h.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Amount of vehicle: 10 mL/kg
- Lot/batch no.: 1132


MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg


DOSAGE PREPARATION: All formulations were used on the day of preparation.
Doses:
1540 and 2600 mg/kg
No. of animals per sex per dose:
5 males per dose
Control animals:
no
Details on study design:
No data
Statistics:
No data

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 600 mg/kg bw
Based on:
test mat.
Remarks on result:
other: There were no deaths at this dose level.
Mortality:
No animal died following administration.
Clinical signs:
other: No clinical signs were observed for animals dosed at 1540 mg/kg. Piloerection was apparent from approximately 15 min after dosing and for the remainder of Day 1, for all 5 males dosed at 2600 mg/kg. Two rats were lethargic three hours after dosing and on
Gross pathology:
No macroscopic changes were observed during necropsy of Day 15 for animals at 2600 mg/kg.
Isolated changes seen in two rats dosed at 1540 mg/kg included a few red foci on the thymus (animals no 677) and pale lungs and distension of the jejunum (animal No. 678).
Other findings:
No data

Any other information on results incl. tables

Clinical signs following treatment at dose level 2600 mg/kg:

Clinical sign

Animal No.

Time of

first observation

Time

of recovery

675

M

658

M

659

M

660

M

661

M

Pilo-erection

+

+

+

+

+

0.25 h

Day 2

Lethargy

-

+

-

+

-

3 h

Day 2

Tachypnoea

-

+

-

-

-

3 h

Day 2

+/- = sign present or absent

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A single oral administration of anhydrous boric acid to groups of five fasted rats at dose levels of 1540 or 2600 mg/kg resulted in no deaths. The acute median lethal oral dose was therefore considered to be greater than 2000 mg/kg bw.
Based on the results of this study, the general Classification and Labelling Requirements as stated in EC No 1272/2008, indicate that no classification is required for anhydrous boric acid in respect of its acute oral toxicity.