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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 2009 - February 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
boron nitride (cubic)
EC Number:
701-307-9
Cas Number:
10043-11-5
Molecular formula:
BN
IUPAC Name:
boron nitride (cubic)
Test material form:
solid: crystalline

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
Test SystemSpecies/strain: Healthy rats, WISTAR rats Crl: WI(Han) (Full-Barrier)Source: Charles River, 97633 Sulzfeld, GermanySex: female, non-pregnant, nulliparousNumber of animals: 3 per stepAge at the beginning of the study: 8 - 12 weeks oldBody weight at the beginning of the study:Animals no. I - 3, step l: 176 - 187 g;Animals no.4 - 6, step 2: 145 -205 g;The animals were derived from a controlled full-barrier maintained breeding system (SPF). According to Art. 9.2, No.7 of the German Act on Animal Welfare the animals were bred for experimental purposes. Housing and Feeding Conditions- Full barrier in an air-conditioned room- Temperature: 22°C- Relative humidity: 55%- Artificial light, sequence being 12 hours light, 12 hours dark- Air change: 10 x / hour- Free access to Altromin 1324 maintenance diet for rats and mice (lot no.1310)- Free access to tap water, sulphur acidified to a pH value of approx. 2.8 (drinking water, municipal residue control, microbiological control at regularintervals)- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 06/06/09)- Certificates of food, water and bedding are filed at BSL BIOSERVICE- Adequate acclimatisation period (at least five days, for details see Schedule)Preparation of the AnimalsThe animals were marked for individual identification by tail painting.Prior to the administration a detailed clinical observation was made of all animals.Prior to the administration food was withheld from the test animals for 20 to 22 hours (access to water was permitted). Following the period of fasting the animals were weighed and the test item was administered. Food was provided again approximately 4 hours post dosing.GavageThe test item was administered at a single dose by gavage using a feeding tube.The test item was administered at a dose volume of 5 ml/kg body weight.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Aqua ad injectionem (sterile water, B. Braun Melsungen, lot no. 7949A191, expiry date: November 2010) This vehicle was chosen due to its non-toxic characteristics.
Details on oral exposure:
DosageThe test item was administered at a single dose by gavage using a feeding tube.The test item was administered at a dose volume of 5 ml/kg body weight.Preparation of the Test ltemIn order to get the test item in a solution or suspension, which is applicable to the animals, a solubility test was performed.The test item was weighed out into a tared plastic vial on a precision balance.Homogeneity of the test item in the vehicle was maintained by vortexing the prepared suspension thoroughly before every dose administration.For all animals of the first and second step, 2 g of the test item were suspended in the vehicle to gain a final volume of 5 mL and to achieve a dose of 2000 mg/kg body weight at a dose volume of 5 ml/kg body weight.The dose formulations were made shortly before each dosing occasion.VehicleAqua ad injectionem (sterile water, B. Braun Melsungen, lot no. 7949A191, expiry date: November 2010) This vehicle was chosen due to its non-toxic characteristics.
Doses:
Dose LevelThe starting dose was selected to be 2000 mg/kg body weight. No compound related mortality was recorded for any animal of step I or 2. Based on these results and according to the acute toxic class method regime no further testing was required.
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
Observation PeriodAll animals were observed for 14 days after dosing for general clinical signs, morbidity and mortality.Weight AssessmentThe animals were weighed on day 1 (prior to the administration) and on days 8 and 15.Clinical ExaminationA careful clinical examination was made several times on the day of dosing (at least once during the first 30 minutes and with special attention given during the first 4 hours post-dose). As soon as symptoms were noticed they were recorded.Thereafter, the animals were observed for clinical signs once daily until the end of the observation period. All abnormalities were recorded.Cageside observations included changes in the skin and fur, eyes and mucous membranes. Also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern were examined. Particular attention was directed to observations of tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma.PathologyAt the end of the observation period the animals were sacrificed with an overdosage of pentobarbital injected intraperitoneally Narcoren@, manufacturer: Merial; lot no.: 193089; expiry date: August2012) at a dosage of approx. 8 mL/kg bw.All animals were subjected to gross necropsy. All gross pathological changes were recorded.Evaluation of ResultsResults were interpreted according to OECD Guideline 423, Arnex 2.Individual reactions of each animal were recorded at each time of observation.Toxic response data were recorded by dose level.Nature, severity and duration of clinical observations were described.Body weight changes were summarised in tabular form.Necropsy findings were described.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Under the conditions of the present study, single oral application of the test item Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder to rats at a dose of 2000 mg/kg body weight was not associated with mortality.
Clinical signs:
other: After a single oral dose administration of the test item all animals showed slight and transient acute clinical symptoms. Slight piloerection in 5 of 6 animals and kyphosis in one animal were observed within the first 4 hours after treatment. The brief tr
Gross pathology:
With the exception of acute injection of blood vessels in the abdominal region, which is due to the euthanasia injection, no specific gross pathological changes were recorded for any animal.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: OECD GHS
Conclusions:
Under the conditions of the present study, single oral application of the test item Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder to rats at a dose of 2000 mg/kg body weight was associated with slight signs of toxicity, but no mortality. The median lethal dose of Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder after single oral administration to female rats, observed over a period of 14 days is:LD56 cut off (rat): unclassifiedIn conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder has no obligatory labelling requirement for toxicity.According to Annex I of Regulation (EC) 1272/2008 the test item Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder was unclassified.According to OECD-GHS (Globally Harmonised Classification System) the test item Synthetic Cubic Boron Nitride Grade 2 (2 micron) Powder has no obligatory labelling requirement for toxicity.