Zirconium carbide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017-06-28 to 2017-08-29

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17 December 2001

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Zirconium disilicide

EC Number:

234-911-1

EC Name:

Zirconium disilicide

Cas Number:

12039-90-6

Molecular formula:

ZrSi2

IUPAC Name:

zirconium disilicide

Test material form:

solid: particulate/powder

Details on test material:

- Batch No: 81704059
- Physical state: solid, powder
- Colour: grey
- Purity: 99.47%
- Expiry date: 2019-04-28
- Storage conditions: room temperature

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: In order to get the test item in a solution/suspension, Zirconium disilicide was dissolved in sterile water.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8-11 weeks
- Weight at study initiation: Step 1: 176 – 197 g, Step 2: 159 – 171 g
- Fasting period before study: 16 to 19 hours
- Housing: Full barrier in an air-conditioned room; animals were kept in groups in IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding
- Diet (e.g. ad libitum): ad libitum, food: Altromin 1324 maintenance diet for rats and mice
- Water (e.g. ad libitum): ad libitum, water: sulphur acidified to a pH value of approximately 2.8 (drinking water, municipal residue control, microbiological controls at regular intervals)
- Acclimation period: at least 5 days under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: The vehicle was chosen due to its non-toxic characteristics.
- Lot/batch no. (if required): 612118

DOSE VOLUME APPLIED: 10 mL/ kg body weight

CLASS METHOD (if applicable)
- Starting dose: The starting dose was selected to be 2000 mg/kg body weight

Doses:

2000 mg/kg body weight

No. of animals per sex per dose:

6 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: Animals were weighed on day 1 (prior to the administration) and on days 8 and 15. 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, animals were observed for clinical signs once daily until the end of the observation period.

- Necropsy of survivors performed: yes

Statistics:

N.A.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

No specific findings in any test animal during the whole observation period

Body weight:

No specific findings in any test animal during the whole observation period

Gross pathology:

No specific findings

Other findings:

N.A.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In an acute oral toxicity study in rats conducted according to OECD 423, no adverse effects were observed for Zirconium disilicide at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is determined to be greater than 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study (OECD 423), 6 fasted, 8-11 weeks old, female Wistar rats were given a single oral dose of Zirconium disilicide (99.47% purity) in sterile water at the limit dose of 2000 mg/kg bw and were observed for 14 days. All animals survived until the end of the study without showing any test item related signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no treatment-related macroscopic findings were observed in any animal of any step. Based on the results from this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw.