Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test carried out by GLP compliant laboratory to recognised validated methods by trained personnel

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
no guideline available
Deviations:
not specified
Principles of method if other than guideline:
Wistar albino rats were checked for health issues and acclimatised for at least 7 days prior to test initiation. They were housed in controlled humidity and temperature conditions in a day/night cycle. Equal numbers of males / females were used and weighed prior to the test. Ten rats were used. They were placed in a 95litre plexglass chamber. Air flow was 5l/min and the test material was introduced via this air stream at a static concentration of 200mg/litre for a period of 1 hour. After exposure the rats were returned to their cage and observed for signs of pharmacotoxic effects and mortality 1,3,6 and 24 hours after exposure and then daily for 14 days. After this time the rats were euthenased and subjected to gross necropsy.
GLP compliance:
yes
Test type:
fixed concentration procedure

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:
magnesium(2+) lithium(1+) sodium bis(oxosilanebis(olate))

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
inhalation: dust
Type of inhalation exposure:
whole body
Vehicle:
air
Analytical verification of test atmosphere concentrations:
not specified
Duration of exposure:
60 min
Concentrations:
200 mg/litre
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 200 mg/L air
Based on:
test mat.
Exp. duration:
60 min
Mortality:
None
Clinical signs:
other: Slight redenning of nasal discharge in 7 out of 10 rats 1 hour after exposure but then normal for the remainder of the observation period for all ten animals.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This test substance is not toxic to rats by inhalation under conditions of this test