Zirconium oxide, hafnium and ytterbium doped

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2016-06-08 to 2016-09-26

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted on 17th 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 oxide, hafnium and ytterbium doped

EC Number:

945-888-9

Molecular formula:

Yb0.109Hf0.013Zr0.879O1.949

IUPAC Name:

Zirconium oxide, hafnium and ytterbium doped

Specific details on test material used for the study:

Name used in the study: Ytterbium zirconium oxide

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 nulliparous and non-pregnant: Yes
- Age at study initiation: 9-10 weeks
- Weight at study initiation: Step 1 : 161-178 g Step 2: 163-179 g
- Fasting period before study: 16-19 hours prior to dosing and 4 hours after dosing
- Housing: Full barrier in an air-conditioned room
- Diet (e.g. ad libitum): Yes
- Water (e.g. ad libitum): Yes, Tap water, sulphur acidified to a pH value of approximately 2.8
- Acclimation period: at least 5 days

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:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL
- Justification for choice of vehicle: Vehicle possesses non-toxic characteristics
- Lot/batch no. (if required): Sigma, MKBQ9948V
- Expiry Date: 07/2016

MAXIMUM DOSE VOLUME APPLIED: 10mL/kg bw

Doses:

Single dose of 2000 mg/kg bw

No. of animals per sex per dose:

3 females per step / 2 steps performed

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: After dosing for 14 days
- Frequency of weighing: Days 1, 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Effect levels 2

Sex:

female

Dose descriptor:

LD0

Effect level:

2 000 mg/kg bw

Mortality:

No mortality was observed

Clinical signs:

other: No significant changes in clinical signs were observed

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:

GHS criteria not met

Conclusions:

A single oral dose of Ytterbium zirconium oxide to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. Thus, the LD50 can be considered to be greater than 2000 mg/kg bw.

Executive summary:

In an acute oral toxicity study conducted according to OECD 423, groups of fasted, 9 -10 weeks old, female Wistar rats were given a single oral dose of  Ytterbium zirconium oxide (purity 15.85% Yb2O3, 82.36% ZrO2) in sterile water at dosage of  2000 mg/kg bw and observed for 14 days. A single oral dose of Ytterbium zirconium oxide was not associated with any mortality and signs of toxicity.  Based on the results, the LD50 can be considered to be greater than 2000 mg/kg bw and thus, the target substance has no obligatory labelling requirement for toxicity and no classification is warranted according to the CLP regulation 1272/2008.