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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
data not available
Reliability:
1 (reliable without restriction)
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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals 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 was observed in rats dosed with 0 or 5000 mg/kg bw yttrium oxide.
Clinical signs:
No clinical signs was 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 (Guillot & Lheritier, 1986), 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.

Oral LD50 Combined (males and females) > 5000 mg/kg bw

No clinical signs and no mortality were observed during the study.

Yttrium oxide is not classified based on the result of this acute toxicity study.

This acute oral study is classified as acceptable. It does satisfy the guideline requirement for an acute oral study (EU B.1) in the rat.