Cerium trifluoride

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 January 1987 - 22 January 1987

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:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

see below

Principles of method if other than guideline:

The acclimation period prior to the administration of the test material is not specified; the protocol states that it was a minimum of 48 hours. This deviation was not considered to have had an impact on the outcome of the study.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Cerium trifluoride

EC Number:

231-841-3

EC Name:

Cerium trifluoride

Cas Number:

7758-88-5

Molecular formula:

CeF3

IUPAC Name:

cerium 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: Ico rats: OFA.SD (IOPS Caw)
- Age at study initiation: 5 - 7 weeks
- Weight at study initiation (prior to fasting): 182 - 193 g (males); 170 - 185 g (females)
- Fasting period before study: yes (15 - 20 hours)
- Housing: 5 animals in stainless steel mesh cages (343 x 250 x 140 mm)
- Food consumption: ad libitum with the exception of the pre-dose fast and 3 - 4 hours following the administration of the test material.
- Water consumption: ad libitum
- Acclimation period: minimum of 48 hours

ENVIRONMENTAL CONDITIONS:
- Temperature: 22 ± 3 °C
- Humidity: 30 - 70 %
- Photoperiod: 12 hours light-dark cycle was maintained (photoperiod 0730 to 1930).

IN-LIFE DATES: From: 7 January 1987 To: 22 January 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 10 % aqueous dispersion of gum arabic

Details on oral exposure:

VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Preparation of the suspension: the powdered test material was put in a 20 % (w/v) suspension made immediately prior to administration in a 10 % (w/v) aqueous dispersion of gum arabic.

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:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> behaviour and mortality: 15 minutes after administration of the test material, then after 1, 2 and 4 hours. Daily observations were then made for the 14 day duration of the observation period.
> weighing: one day before treatment, and on days 1, 8 and 15 after treatment
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed in rats dosed with 2000 mg/kg bw.

Clinical signs:

other: No clinical signs were observed.

Gross pathology:

No gross abnormalities were observed at necropsy.

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 ≥ 2000 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 guideline OECD 401.

Groups of fasted, 5 - 7 week old Sprague-Dawley rats (5 per sex) were given a single oral dose of the test material administered as a 20 % suspension (w/v) in an aqueous dispersion of 10 % (w/v) of gum arabic at a dose of 2000 mg/kg bw and observed for 14 days.

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 ≥ 2000 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.