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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
2011-01-31 to 2011-03-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 2001-12-17
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2011-01-21
Test type:
acute toxic class method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Vanadium Carbide Nitride
- Physical state: metallic grey solid
- Storage condition of test material: room temperature in a desiccator

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: approximately eight to twelve weeks of age prior to dosing (Day 1)
- Weight at study initiation: 205 - 235 g (Day 1)
- Fasting period before study: overnight prior to and approximately four hours after dosing
- Housing: they were housed in groups of three rats of the same sex, in solid bottomed polycarbonate cages with a stainless steel mesh lid. Each cage contained a quantity of autoclaved wood flake bedding.
- Diet (ad libitum, for exception please refer to "Fasting period before study" above): standard rodent diet (Rat and Mouse No. 1 Maintenance Diet); This diet contained no added antibiotic or other chemotherapeutic or prophylactic agent.
- Water (ad libitum): potable water
- Acclimation period: at least 5 days before treatment

During the acclimatisation period, each cage of animals was provided with a soft white untreated chew block and a plastic shelter for environmental enrichment. The wood blocks were removed from the cage of animals for the same period as the food on the day prior to dosing.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 23°C
- Relative humidity: 40 to 70%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
DOSAGE PREPARATION: the test substance was formulated at a concentration of 30 and 200 mg/mL in the vehicle and
administered at a volume of 10 mL/kg bodyweight. The test substance formulations were prepared on the day of dosing.
Formulations were mixed using a vortex mixer just before the dosing procedure.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as no previous toxicological information was available the initial dose level was 300 mg/kg.
Doses:
300 and 2000 mg/kg
No. of animals per sex per dose:
6 female animals
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: cages of rats were checked at least twice daily for any mortalities. Animals were observed for clinical signs soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 - morning only). The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation. The body weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Necropsy of survivors performed: yes
All animals were humanely killed on Day 15 by carbon dioxide asphyxiation.
All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded.
Statistics:
not applicable

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut off value: 5000 mg/kg bw
Mortality:
There were no deaths during the study.
Clinical signs:
There were no clinical signs of reaction to treatment throughout the study.
Body weight:
A loss in bodyweight was noted for one female of the 2000 mg/kg bw dose level group on Day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
Gross pathology:
No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
LD50 (female rats) > 2000 mg/kg bw (LD50 cut off value: 5000 mg/kg bw)
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, vanadium carbide nitrate is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, vanadium carbide nitrate is not classified as acute toxic via the oral route.