Registration Dossier
Registration Dossier
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EC number: 274-324-8 | CAS number: 70131-50-9
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and is equivalent to a guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Bentonite, acid-leached
- EC Number:
- 274-324-8
- EC Name:
- Bentonite, acid-leached
- Cas Number:
- 70131-50-9
- Molecular formula:
- unspecified for this UVCB substance
- IUPAC Name:
- Bentonite, acid-leached
- Details on test material:
- - Name of test material (as cited in study report): Copisil D4A10 (Bentonite acid leached)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Suitable licenced dealer
- Age at study initiation: 6-9 weeks
- Weight at study initiation: 204-230 g
- Fasting period before study: 18 h
- Housing: Galvanized cages with indirect bedding
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- 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: 1, 3, 6 and 24 hours after exposure and then daily for 14 days
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- No mortalities occurred during the test
- Clinical signs:
- other: Mucoid diarrhea observed in all animals 6 hours after dosing. No clinical signs were observed thereafter
- Gross pathology:
- No gross changes were observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of bentonite acid leached was >2000mg/kg and is therefore not classified in accordance with CLP Regulation (EC) no. 1272/2008
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