Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
09-25 February 2010
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:
2010
Report date:
2010

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:
Silicic acid, lithium magnesium sodium salt
EC Number:
258-476-2
EC Name:
Silicic acid, lithium magnesium sodium salt
Cas Number:
53320-86-8
Molecular formula:
Na0.7+ [(Si8Mg5.5Li0.3) O20(OH)4]0.7-
IUPAC Name:
Silicic acid, lithium magnesium sodium salt

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Doses:
2000mg/kg body weight dosed once only
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 200mg/ml of the test material in arachis oil giving a total initial dose of 2000mg/kg body weight. No mortality was observed so a further 4 female rats were treated to the same dose.
Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Hunched posture on day of dosing in three rats. Nothing after that.
Body weight:
Increase in body weight as expected
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