Dipraseodymium trioxide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 March 1994 to 16 March 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Read-across performed with structurally similar substance.

Cross-reference

Reason / purpose for cross-reference:

other: read-across target

Reference

Endpoint:

acute toxicity: oral

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted on read-across material

Justification for type of information:

Read-across performed with structurally similar substance.

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

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

Test material information

Constituent 1

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:

- Substance type: mono-constituent substance
- Physical state: solid (black powder)
- Storage condition of test material: at room temperature

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:

methylcellulose

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

Key result

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:

other: Not classified in accordance with EU criteria

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.

Executive summary:

An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guideline OECD 401 under GLP conditions.

Groups of fasted, 6 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in an aqueous solution of methylcellulose at 0.5 % at a dose of 2000 mg/kg bw (dose volume 10 mL/kg) and observed for 14 days.

No mortality and no clinical sign were observed during the study. The body weight gains of the treated rats were normal. No gross abnormalities were observed at necropsy.

The oral LD50 (males and females) was >2000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria.