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EC number: 237-410-6 | CAS number: 13775-53-6
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, unpublished report available, no restrictions, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Label: CRIOLITE SINTETICA
Description: white powder
Batch No.: 11
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Starin: Cr1:CD (SD) BR rat
- Source: Charles River Italia S.p.A.
- Age at study initiation: about 7-9 weeks
- Weight at study initiation: males 225-250 g, females 200 - 225 g
- Housing: 5 animals/sex/cage in air-conditioned rooms
- Diet (e.g. ad libitum): GLP 4RF21 pelleted diet ad libitum
- Water (e.g. ad libitum): from the municipal water main system ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 10
- Air changes (per hr): about 20/hour
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- deionized water, administrationvolume 20 ml/kg
- Doses:
- 5000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: at 30 minutes, 2, 4 and 6 hours on the first day after administration and then twice a day up to termination of the observation period.
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology, clinical signs and mortality
(since no changes were found at necropsy, histological examination was not performed)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortality was observed on animals treated at 5000 mg/kg bw (limit dose) during the post-treatment observation period.
- Clinical signs:
- other: Some of the animals showed piloerection starting 6 hours after administration. This sign lasted up to day 5. One male rat showed diarrhea, with short duration, at the 6 hour observation. All animals achieved recovery within day 6.
- Gross pathology:
- No appreciable macroscopic findings were observed.
Applicant's summary and conclusion
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