Registration Dossier
Registration Dossier
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EC number: 235-111-5 | CAS number: 12069-32-8
Endpoint summary
Administrative data
Description of key information
According to Annex I of Regulation (EC) 1272/2008 the test item Boron Carbide B4C is unclassified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 03 - April 23, 2010
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No. 440/2008,L 142, Annex Part B, 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EPA OPPTS 870.1000 (Acute toxicity testing background)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP according to German Chemikaliengesetz and Directive 2004/9/EC
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species/strain: Healthy rats, WISTAR rats Crl: WI(Han) (Full-Barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: female, non-pregnant, nulliparous
Age at the beginning of the study: 9 - 10 weeks old
Body weight at the beginning of the study:
Animals no. 1 - 3, step 1: 157 - 164 g;
Animals no. 4 - 6, step 2: 166 - 178 g;
The animals were derived from a controlled full barrier maintained breeding system (SPF).
Housing and Feeding Conditions
- Full-barrier in an air-conditioned room
- Temperature: 22 ± 3°C
- Relative humidity: 55 ± 10%
- 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 regular
intervals)
- The animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 040509)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days). - Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Remarks:
- (Sigma, lot no. 038K0009, expiry date: 1110412010
- Details on oral exposure:
- 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 16 to 19 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.
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 10 ml and to achieve a dose of 2000 mg/kg body weight at a dose volume of 10 ml/kg body weight. The dose formulations were made shortly before each dosing occasion.
The test item was administered at a single dose by gavage using a feeding tube. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 females per dose per step
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
A 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.
The animals were weighed on day 1 (prior to the administration) and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed:
- 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.
- body weight
- gross necropsy: All gross pathological changes were recorded. - Statistics:
- Not relevant due to no toxic effects observed in Limit test
- Preliminary study:
- Not applicable
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no mortalities, Limit Test
- Mortality:
- No intercurrent deaths (see table 1)
- Clinical signs:
- other: other: No signs of toxicity observed (see table 2)
- Gross pathology:
- No abnormalities detected (see table 4)
- Interpretation of results:
- not classified
- Conclusions:
- Under the conditions of the present study, single oral application of the test item Boron Carbide B4C to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality.
The median lethal dose of Boron Carbide B4C after single oral administration to female rats, observed over a period of 14 days is: LD50 cut off (rat): unclassified
In conformity with the criteria given in Annex VI to Commission Directive 2001/591 EC the test item Boron Carbide B4C has no obligatory labelling requirement for toxicity.
According to Annex I of Regulation (EC) 1272/2008 the test item Boron Carbide B4C was unclassified.
According to OECD-GHS (Globally Harmonized Classification System) the test item Boron Carbide B4C has no obligatory labelling requirement for toxicity. - Executive summary:
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was suspended in a vehicle (cottonseed oil) at a concentration of 0.2 g/ml- and administered at a dose volume of 10 ml/kg. All animals after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study without showing any signs of toxicity. Throughout the 14-day observation period, the weight gain of the animals was within the expected range. At necropsy, no macroscopical findings were observed in any animal of any step. On the basis of the test results given below and in conformity with the criteria given in Annex VI to Commission Directive 2001/591EC as well as in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.
Reference
Table 1: Results per Step
| Step | Sex/no. | Dose (mg/kg) | Number of animals | Number of intercurrent deaths |
| 1 | female/ 1-3 | 2000 | 3 | 0 |
| 2 | female/ 4-6 | 2000 | 3 | 0 |
Table 1: LD50 cut off
Dose (unit) | Number of animals investigated | Number of intercurrent deaths | LD50 cut off |
2000 mg/kg bodyweight | 6 | 0 | unclassified |
Table 2: Clinical Signs - Individual Data
Animal no. /sex | Time of observation post-dose | Observations |
1/female | during the whole observation period | no signs of toxicity |
2/female | during the whole observation period |
no signs of toxicity |
3/female | during the whole observation period |
no signs of toxicity |
4/female | during the whole observation period |
no signs of toxicity |
5/female | during the whole observation period |
no signs of toxicity |
6/female | during the whole observation period |
no signs of toxicity |
Table 3: Absolute Body Weights in g and Body Weight Gain in %
Animal no. /sex | g Day 1 | g Day 8 | g Day 15 | % Day 1-15 |
1 /female | 157 | 188 | 197 | 26 |
2 /female | 164 | 194 | 200 | 22 |
3/female | 162 | 179 | 189 | 17 |
4 /female | 166 | 182 | 184 | 11 |
5 /female | 178 | 207 | 205 | 15 |
6/female | 169 | 191 | 195 | 15 |
Table 4:Macroscopical Findings - Individual Data
Animal no./sex | Organ | Findings at the necropsy |
1 /female | - | NAD |
2 /female | - | NAD |
3/female | - | NAD |
4 /female | - | NAD |
5 /female | - | NAD |
6/female | - | NAD |
NAD: No Abnormalities Detected
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 02 - April 12, 2010
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission Regulation (EC) No 440/2008,L 142, Annex Part B, 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- GLP according to Chemikaliengesetz and Directive 2004/9/EC
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals:
Species/strain: Healthy rats, WISTAR Crl: WI(Han) (Full-Barrier)
Source: Charles River, 97633 Sulzfeld, Germany
Sex: male and female. The female animals were nulliparous and non-pregnant.
Body weight at the beginning of the study: females: 210 - 218 g, males 237 - 261 g
Age at the beginning of the study: females: 8 - 9 weeks, males: 8 - 9 weeks old
Number of animals: 5 male and 5 female
The animals were derived from a controlled full-barrier maintained breeding system (SPF).
Housing and Feeding conditions:
Full barrier in an air-conditioned room
- Temperature: 22 ± 3°C
- Relative humidity: 55 ± 10%
- Artificial light, sequence being 12 hours Iight,72 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 regular intervals)
- The animals were kept individually in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 101109)
- Certificates of food, water and bedding are filed at BSL BIOSERVICE
- Adequate acclimatisation period (at least five days) - Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- Preparation of the Animals:
Approximately 25 hours before the test, the fur was removed from the dorsal area of the trunk by using an electric clipper. Care was taken to avoid abrading the skin, and only animals with healthy intact skin were used. No less than 10% of the body surface was cleared for the application. Prior to the application a detailed clinical observation was made of all animals.
Application:
Water (Aqua ad injectionem (B. Braun Melsungen, lot no. 7494A191, expiry date: 11/2010) was used as vehicle due to its non-irritating
characteristics.
The test item was applied at a single dose (2000 mg/kg bw), uniformly over an area which was approx. 10% of the total body surface. The test item was held in contact with the skin by a dressing throughout a 24-hour period. The dressing consisted of a gauze-dressing and non-irritating tape and was fixed with an additional dressing in a suitable manner.
Dose Level:
The test item was applied at a single dose of 2000 mg/kg body weight to each animal.
Exposure Period:
The test item was held in contact with the skin throughout a 24-hour period. At the end of the exposure period residual test item was removed by
using lukewarm tap water. - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
A 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). Thereafter, the animals were observed for clinical signs once daily until the end of the observation period.
The animals were weighed on day 1 (prior to the application) and on days 8 and 15.
- Necropsy of survivors performed:
All animals were subjected to gross necropsy. All gross pathological changes were recorded
- Other examinations performed:
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. Attention was directed to observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. - Statistics:
- Not applicable, no clinical signs of irritation or mortality.
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No intercurrent deaths could be observed for any of the 10 animals tested (5 male, 5 female)
- Clinical signs:
- other: other: The test item showed no signs of dermal irritation and no acute dermal toxicity characteristics after a single dose application. Slight scratches were observed in 1 of 5 female and 2 of 5 male animals, but these symptoms are not assumed to be relat
- 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. (see table 6)
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study, single dermal application of the test item boron carbide to rats at a dose of 2000 mg/kg body weight was associated neither with significant signs of skin irritation nor with signs of toxicity or mortality. In conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item boron carbide has no obligatory labelling requirement for toxicity (for details see Evaluation of Results). The dermal LD50 was determined to be > 2000 mg boron carbide/kg body weight. According to Annex I of Regulation (EC) 1272/2008 the test item boron carbide does not require classification for acute percutaneous toxicity since neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000 mg/kg body weight. According to OECD-GHS (Globally Harmonized Classification System) the test item boron carbide does not require classification for acute percutaneous toxicity since neither mortalities nor significant clinical signs of toxicity were observed at a dose of 2000 mg/kg body weight.
- Executive summary:
On the basis of the test results and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC as well as in Annex I of Regulation (EC) 1272/2008, the substance should be not classified.
Limittest: Yes
LD50: > 2000 mg/kg body weight
Species/strain: WISTAR Crl: WI(Han) rats
Vehicle (moistening): Aqua ad injectionem
Number of animals: 5 male and 5 female
Duration of exposure: 24 hours
Method: OECD 402, EC 440/2008, OPPTS 870.1200
Table 1: Results per Step
Sex Dose (mg/kg bw)
Number of Animals
Number of Intercurrent Deaths
male 2000 5 0 female 2000 5 0 - Signs of toxicity related to dose level used, time of onset and duration:
No treatment-related effects were observed.
- Effect on organs (related to dose level):
No treatment related effects were observed.
- Signs of irritation:
No treatment related effects were observed.
Reference
Table 1: Clinical Signs of Systemic Toxicity - Individual Data - Females
AnimalNo./ Sex |
Time of Observation (post-dose) |
Observations (for signs of dermal irritation, see Table 3) |
11/female |
during the entire observation period |
nf |
12/female |
during the entire observation period |
nf |
13/female |
during the entire observation period |
nf |
14/female |
during the entire observation period |
nf |
15/female |
during the entire observation period |
nf |
Table 2: Clinical Signs of Systemic Toxicity - Individual Data - males
AnimalNo./ Sex |
Time of Observation (post-dose) |
Observations (for signs of dermal irritation, see Table 4) |
21/female |
during the entire observation period |
nf |
22/female |
during the entire observation period |
nf |
23/female |
during the entire observation period |
nf |
24/female |
during the entire observation period |
nf |
25/female |
during the entire observation period |
nf |
Table 3: Skinlrritation-Individual Data –Females
Day after Start of Application |
AnimalNo. 11 |
AnimalNo. 12 |
AnimalNo. 13 |
AnimalNo. 14 |
AnimalNo. 15 |
|||||
E/O |
comments |
E/O |
comments |
E/O |
comments |
E/O |
comments |
E/O |
comments |
|
day1 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
s |
day2 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day3 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day4 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day5 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day6 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day7 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day8 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day9 |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
nf |
day10 |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
nf |
day11 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day12 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day13 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day14 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s (not on application site) |
day15 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s (not on application site) |
Comments: E:erythema; O: oedema;1,2,3,4: scoring system laid down in OECD Guideline 404 d: desquamation;es:eschar; s : scratches; N (mm) : necrosis;nf: no findings reversibility: c : completely reversed;nc: not completely reversed; n : not reversed * black discolouration of the application site due to the test item |
||||||||||
Table 4: Skinlrritation-Individual Data - Males
Day after Start of Application |
AnimalNo. 21 |
AnimalNo. 22 |
AnimalNo. 23 |
AnimalNo. 24 |
AnimalNo. 25 |
|||||
E/O |
comments |
E/O |
comments |
E/O |
comments |
E/O |
comments |
E/O |
comments |
|
day1 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day2 |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
0/0 |
* |
day3 |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
slight es |
0/0 |
nf |
day4 |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
slight es |
0/0 |
nf |
day5 |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
day6 |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
day7 |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
day8 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
day9 |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
nf |
day10 |
0/0 |
nf |
0/0 |
nf |
0/0 |
slight s |
0/0 |
nf |
0/0 |
nf |
day11 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day12 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day13 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day14 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
day15 |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
0/0 |
nf |
Comments: E:erythema; O: oedema;1,2,3,4: scoring system laid down in OECD Guideline 404 d: desquamation;es:eschar; s : scratches; N (mm) : necrosis;nf: no findings reversibility: c : completely reversed;nc: not completely reversed; n : not reversed * black discolouration of the application site due to the test item |
||||||||||
Table 5: Absolute Body Weights in g and Body Weight Gain in %
AnimalNo. / Sex |
Day 1 |
Day 1 |
Day 1 |
% Day 1-15 |
11 female |
210 |
209 |
213 |
1 |
12 female |
212 |
215 |
222 |
5 |
13 female |
211 |
209 |
223 |
6 |
14 female |
211 |
214 |
221 |
5 |
15 female |
218 |
219 |
227 |
4 |
21 male |
239 |
259 |
286 |
20 |
22 male |
241 |
263 |
282 |
17 |
23 male |
261 |
286 |
306 |
17 |
24 male |
249 |
273 |
303 |
22 |
25 male |
237 |
244 |
280 |
18 |
Table 6:Macroscopical Findings - Individual Data - Males and Females
AnimalNo./Sex |
Organ |
Findings at theNecropsy |
11 female |
|
nsf |
12 female |
|
nsf |
13 female |
|
nsf |
14 female |
|
nsf |
15 female |
|
nsf |
21 male |
|
nsf |
22 male |
|
nsf |
23 male |
|
nsf |
24 male |
|
nsf |
25 male |
|
nsf |
nsf: no specific findings
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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