Neodymium trifluoride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

not reported

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Neodymium trifluoride

EC Number:

237-253-3

EC Name:

Neodymium trifluoride

Cas Number:

13709-42-7

Molecular formula:

F3Nd

IUPAC Name:

neodymium trifluoride

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Appearance: pink powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Sprague-Dawley OFA (IOPS)
- Age at study initiation: 6 - 7 weeks
- Weight at study initiation (prior to fasting): 160 - 200 g (males); 140 - 180 g (females)
- Fasting period before study: yes (17 hours)
- 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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 10 % aqueous dispersion of gum arabic

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 50 g test item / 100 mL
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 animals per sex per dose.

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 1, 2 and 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

Results and discussion

Preliminary study:

Mortality checks were performed at 1, 2, 4 hours, and then on days 1, 2, 4, 7 and 14.
No mortality was observed.

Effect levels

Sex:

male/female

Dose descriptor:

LD0

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.

Gross pathology:

No gross abnormalities were observed at necropsy.

Other findings:

No mortality in preliminary test

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The oral LD0 (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 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 guidelines OECD 401 and 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 a 10 % aqueous solution of gum arabic at a dose of 5000 mg/kg bw and observed for 14 days. 5 animals were dosed with the vehicle only.

No mortality and no clinical signs were observed during the study. No gross abnormalities were observed at necropsy.

The oral LD0 (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 in accordance with EU criteria.