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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP conform study following US regulation for the enforcement of the "Federal Hazardous Substances Act 16 CFR 1500". Reports are not as detailed as modern protocols but include all required information. The principles and methodology used for testing are comparable to modern OECD 423 guideline. As no relevant deficiencies have been detected, the study is considered to be reliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: US Regulation of the Federal Hazardous Substances Act (16 CFR 1500)
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
boranylidyneamine
EC Number:
701-292-9
Cas Number:
10043-11-5
Molecular formula:
BN
IUPAC Name:
boranylidyneamine
Details on test material:
- Name of test material (as cited in study report): 89-006 (UHP 2020)
- Substance type: inorganic
- Physical state: solid
- Analytical purity: < 98.5 %
- Impurities (identity and concentrations): B2O3 0.1 %, carbon 0.4 %, ammonia 90 ppm, lead 20 ppm
- Stability under test conditions: stable
- Storage condition of test material: room temperature in plastic bag
- Particle size: D50 4.3 µm

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Sprague-Dawley Inc.
- Age at study initiation: young
- Weight at study initiation: 211-258 g
- Fasting period before study: yes
- Housing: wire mesh suspension cages, 5 per cage
- Diet (e.g. ad libitum): purina laboratory chow
- Water (e.g. ad libitum): water ad libitum
- Acclimation period: min. 2 days

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Administration / exposure

Route of administration:
other: esophagel intubation
Vehicle:
corn oil
Remarks:
25% (v/v)
Doses:
5 g/kg body weight, calculated by using post-fasted body weights
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observation 2,5, 4,5 and 5 hours after dosing and once each day until end of the 14 day observation period. Body weights measured on the day of dosing and at the end of 14 day period.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured
Clinical signs:
other: No clinical signs observed
Gross pathology:
No observations in all rats
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The results of the performed test on acute oral toxicity of hexagonal boron nitride to rats demonstrated that the LD50 is > 5.000 mg/kg body weight. Hexagonal boron nitride is therefore not classified as hazardous.