Registration Dossier
Registration Dossier
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EC number: 285-349-9 | CAS number: 85085-18-3
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 17 March - 12 April 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study carried out in a GLP facility by trained personnel using recommended OECD test methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- EC Number:
- 285-349-9
- EC Name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- Cas Number:
- 85085-18-3
- Molecular formula:
- Na0.7[Mg5.3Li0.7Si8O20(OH)0.0F4.0]
- IUPAC Name:
- Synthetic fluorohectorite
- Details on test material:
- Test material Bx # is 09-2151-1, manufactured 31/05/2009
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200mg/ml
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle: Substance disperses in water
- Starting dose was 300mg/kg/bw
- Rationale for the selection of the starting dose: Absence of data regarding toicity - Doses:
- An initial dose of 300mg/kg body weight was dosed to a single rat. In the absence of toxicity, the dose was increased to 2000mg/kg body weight on one rat and then in the absence of mortality a further four rats were dosed once only at 2000mg/kg
- No. of animals per sex per dose:
- Five female rats in total
- Control animals:
- no
Results and discussion
- Preliminary study:
- One female rat was dosed with 10 ml/kg oral gavage with the 30mg/ml of the test material in water giving a total initial dose of 300mg/kg body weight. No toxicity was observed so a further 1 female rats was treated at a higher dose of 2000mg/kg/bw. In the absence of mortality further rats were tested at te higher dose.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Hunched posture on day of dosing in one rats. Nothing after that.
- Gross pathology:
- No abnormalities were noted at necropsy
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information no deaths nor abnormalities Criteria used for interpretation of results: EU
- Conclusions:
- This test material showed no signs of being acutely toxic by oral exposure to rats
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