Yttrium oxide (Y2O3), europium-doped

Acute Toxicity: oral

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:

data not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was performed according to EU guidelines and GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Yttrium (III) oxide

Cas Number:

1314-36-9

Molecular formula:

Y2O3

IUPAC Name:

Yttrium (III) oxide

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: IFFA CREDO (Saint- Germain sur l'Arbresle, France)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation: 160 - 200 g (males), 140 - 180 g (females)
- Fasting period before study: yes (16 - 20 hr)
- Housing: 2 or 5 animals in stainless steel cages (342 x 252 x 180 mm)
- Food consumption: UAR entretien AO4, ad libitum
- Water consumption: ad libitum
- Acclimation period: data not available

ENVIRONMENTAL CONDITIONS:
- Temperature: 22 +/- 3 °C
- Humidity: 30 - 70 %
- Air changes: 10 per hour
- Photoperiod: data not available

In-life dates: data not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 10% arabic gum aqueous dispersion

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 g test item / 100 mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: no data
- Lot/batch no.: no data
- Purity: no data

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

0, 5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 1h, 2h, 4h, and on days 1, 2, 4, 7 and 14 after treatment
> weighing: one day before treatment, and on days 0, 7 and 14 after treatment
- Necropsy of survivors performed: yes

Statistics:

no statistical analysis was used

Results and discussion

Preliminary study:

3 doses (1000, 2500 and 5000 mg/kg bw) were tested. The vehicle was an aqueous dispersion of 10% arabic gum. 2 males and 2 females were used per dose. Mortality checks were performed at 1, 2, 4h, and then on days 1, 2, 4, 7 and 14.
No mortality was observed.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No mortality were observed in rats dosed with 0 or 5000 mg/kg bw yttrium oxide.

Clinical signs:

other: No clinical signs were observed in rats dosed with 0 or 5000 mg/kg bw yttrium oxide.

Gross pathology:

No gross abnormalities were observed at necropsy.

Other findings:

- Organ weights: no data
- Histopathology: no data
- Potential target organs: no data
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Yttrium oxide is not classified based on the LD50 in males and females (Oral LD50 Combined (males and females) > 5000 mg/kg bw).

Executive summary:

In an acute oral toxicity study, groups of fasted, 6-7 week old Sprague Dawley rats (5/sex) were given a single oral dose of yttrium oxide (> 99.9 % a.i.) in aqueous dispersion of 10% arabic gum at dose of 5000 mg/kg bw (limit test) and observed for 14 days. No clinical signs and no mortality were observed during the study. Therefore, the oral LD50 combined (males and females) is > 5000 mg/kg bw.