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Toxicological information

Acute Toxicity: oral

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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

Constituent 1
Chemical structure
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:
No clinical signs were observed in rats dosed with 0 or 5000 mg/kg bw yttrium oxide.
Body weight:
No effect on weight gain were observed in rats dosed with 5000 mg/kg bw yttrium oxide as compared to controls.
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.