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Description of key information

In an acute oral toxicity study conducted according to OECD 423, female Wistar rats were given a single oral dose of the target substance Ytterbium zirconium oxide (purity 1.73% HfO2,15.85% Yb2O3, 82.36% ZrO2) in sterile water at dosage of  2000 mg/kg bw. Animals were observed for 14 days. No mortality and signs of toxicity were recorded during the observation period.  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 acute toxicity and no classification is warranted according to the CLP regulation 1272/2008.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted on 17th December 2001
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes
Specific details on test material used for the study:
Name used in the study: Ytterbium zirconium oxide
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals 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
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
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Sex:
female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Mortality:
No mortality was observed
Clinical signs:
No significant changes in clinical signs were observed
Body weight:
None of the animals showed weight loss during vthe observation period
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
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Acute toxicity: via inhalation route

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Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

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 1.73% HfO2,15.85% Yb2O3, 82.36% ZrO2) in sterile water at dosage of  2000 mg/kg bw. Animals were observed for 14 days. No mortality and no signs of toxicity were recorded during the observation period.  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.

Justification for classification or non-classification

Based on the available data, the target substance Ytterbium stabilized Zirconium and Hafnium Oxide does not warrant classification for acute toxicity according to CLP regulation 1272/2008. The oral LD50 value is considered to exceed 2000 mg/kg bw.