Neodymium oxide

Acute Toxicity: oral

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: Study conducted to GLP in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

Cited as Directive 79/831 Annex V part B

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neodymium oxide

EC Number:

215-214-1

EC Name:

Neodymium oxide

Cas Number:

1313-97-9

Molecular formula:

Nd2O3

IUPAC Name:

dineodymium(3+) trioxidandiide

Test material form:

solid: particulate/powder

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: 6 - 7 weeks
- Weight at study initiation: 160 - 200 g (males), 140 - 180 g (females)
- Fasting period before study: yes (16 - 17 hr)
- Housing: 2 or 5 animals in plastic cages (365 x 225 x 180 mm) containing a sterilised and vacuum-cleaned sawdust litter
- Food consumption: ad libitum
- Water consumption: ad libitum
- Acclimation period: data not available

ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 1.5 °C
- Humidity: 55 ± 15 %
- Air changes: 10 per hour
- Photoperiod: data not available

In-life dates: data not available

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

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: 1 h, 2 h, 4 h, 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 water. 2 males and 2 females were used per dose. Mortality checks were performed at 1, 2, 4 h, 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

Based on:

test mat.

Mortality:

No mortality was observed in rats dosed with 0 or 5000 mg/kg bw.

Clinical signs:

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

Gross pathology:

No gross abnormalities were observed at necropsy.

Other findings:

- Organ weights, Histopathology: not performed
- Potential target organs: no abnormality at necropsy
- Other observations: none

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The oral LD50 (males and females) was >5000 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.

Executive summary:

An acute oral toxicity limit test was conducted to assess the test material in accordance with the standardised guideline EU Method B.1.

Groups of fasted, 6 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material in aqueous solution at a dose of 5000 mg/kg bw and observed for 14 days.

No mortality and no clinical signs 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 >5000 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.