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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:
weight of evidence
Study period:
2 March 1994 - 4 May 1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

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:
Praseodymium(III,IV) oxide
EC Number:
234-857-9
EC Name:
Praseodymium(III,IV) oxide
Cas Number:
12037-29-5
Molecular formula:
O11Pr6
IUPAC Name:
praseodymium(III,IV) oxide
Test material form:
solid: particulate/powder
Details on test material:
- Name of test material (as cited in study report): praseodyme oxide 99.9
- Substance type: mono-constituent substance
- Physical state: solid (black powder)
- Storage condition of test material: at room temperature
- Further information on test material confidential.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Age at study initiation: approximately 6 weeks
- Weight at study initiation: 165 ± 7g for the males, 159 ± 6 g for the females
- Fasting period before study: 18 hours before treatment; food was replaced approximately 4 hours after treatment.
- Housing: The animals were housed in groups of 4 to 7 animals of the same sex in polycarbonate cages (48 x 27 x 20 cm) during the acclimatisation period and groups of 5 animals of the same sex during the study. Each cage contained graded, dust-free sawdust.
- Food consumption (e.g. ad libitum): ad libitum; AO4 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France)
- Water consumption (e.g. ad libitum): ad libitum filtered water contained in bottles
- Acclimation period: 5 days during which they were observed daily
- Source: Iffa Crédo, 69210 L'Arbresle, France

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 ± 20 % relative humidity
- Air changes (per hr): 13 cycles/hour of non-recycled and filtered air
- Photoperiod (hrs dark / hrs light): 12hr/12hr

In-life dates: From 02 to 16 March 1994

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous solution of methylcellulose at 0.5 %
Details on oral exposure:
VEHICLE
The vehicle used was an aqueous solution of methylcellulose at 0.5 % (batch No. 73H0365 Prolabo, 75526 Paris, France).
Water for injections (batch No. 7860 Biosédra, 92240 Malakoff, France).

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

DOSAGE PREPARATION
On the day of the treatment, the test material was ground using a mortar and pestle, then was suspended in the vehicle.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
DETAILS ON STUDY DESIGN
- Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed frequently after administration of the test material and at least once a day for clinical signs and at least twice a day for mortality.
- Frequency of weighing: Animals were weighed just before administration of the test material and then on days 5, 8 and 15. The body weight of the animals treated with the test material was compared to laboratory historical control data for animals dosed by the oral route.
- Necropsy of survivors performed: yes (day 15)
- Other examinations performed: macroscopic examination at necropsy (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organ with obvious abnormalities)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occured during the observation period.
Clinical signs:
other: No clinical signs were observed during the study.
Gross pathology:
The macroscopic examination of the main organs of the animals sacrificed at the end of the study revealed no apparent abnormalities.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the oral LD50 of the test material was > 2000 mg/kg in rats. No signs of toxicity were observed at this dose and the test material requires no classification in accordance with EU criteria.