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EC number: 207-439-9 | CAS number: 471-34-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19 November 2007 to 11 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Calcium carbonate
- EC Number:
- 207-439-9
- EC Name:
- Calcium carbonate
- Cas Number:
- 471-34-1
- Molecular formula:
- CH2O3.Ca
- IUPAC Name:
- calcium carbonate
- Test material form:
- solid: bulk
- Details on test material:
- - Name of test material (as cited in study report): Calcium carbonate
- Substance type: powder
- Physical state: solid
- Lot/batch No.: D7059
- Storage condition of test material: room temperature in the dark
Constituent 1
- Specific details on test material used for the study:
- Bulk calcium carbonate
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 205-237 g
- Fasting period before study: overnight prior to dosing
- Housing: suspended polypropylene cages furnished with soft woodflakes and fitted with stainless steel lids.
- Diet: ad libitum (except overnight prior to dosing and 3-4 hours after dosing)
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of continuous artificial light in each 24 hour period.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg - Doses:
- 2000 mg/kg
- 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: general observations - at 0.5, 1, 2 and 4 hours after dosing then again at least once daily for 14 days; bodyweights were recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs. - Statistics:
- No data
Results and discussion
- Preliminary study:
- The female test animal did not die during the study following a single oral dose of 2000 mg/kg bw. There were no clinical signs during the preliminary study.
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities occurred.
- Clinical signs:
- other: No clinical signs of systemic toxicity were observed.
- Gross pathology:
- No adverse effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley rat was estimated to be > 2000 mg/kg bw
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