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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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 levelsopen allclose all
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:
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.