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Toxicological information

Acute Toxicity: oral

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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:
2011
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

Constituent 1
Chemical structure
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:
Na(1.00+/-0.99)[(Si8Mg(5.0+/-1.0)Li(1.00+/-0.99) O20 (OH)4-x Fx](1.00+/-0.99); with x=2.5+/-1.5
IUPAC Name:
Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
Details on test material:
Test material Bx # is 09-2151-1, manufactured 31/05/2009

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