Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
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 applicable
Principles of method if other than guideline:
Six rabbits each received a single dermal application at a dose level of 2g/kg bodyweight. The skin of three animals was abraided and the other three animals skin remained in tact. The test site was occluded for 24 hours after which time the wrap and test material were removed. The animals were observed for pharmacologic activity 1,3,6 and 24 hours after treatment and daily afterwards for 14 days. After this time the rabbits were euthenased and subjected to gross necropsy.
GLP compliance:
yes
Test type:
fixed dose 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:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
The rabbits 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 12 hour day/night cycle. Equal numbers of males / females were used and weighed prior to the test.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
physiological saline
Duration of exposure:
24 hours
Doses:
2g/kg bodyweight
No. of animals per sex per dose:
Three male, three female

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
One animal suffered diarrhea between 3-6 hours after administration
Body weight:
Approx 2.3 kg
Gross pathology:
No gross changes observed

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 dermally to rabbits under the conditions of this test