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EC number: 231-841-3 | CAS number: 7758-88-5
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:
- 1 987
- 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
- 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
Constituent 1
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.
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