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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Draize Test Dermal Toxicity FDA 1975
Deviations:
yes
Remarks:
Modified Draize test
GLP compliance:
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:
magnesium(2+) lithium(1+) sodium bis(oxosilanebis(olate))
Details on test material:
Optigel SH is another commercial name for Laponite T2 and is the same test substance

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Animals were acclimated at least 4 days prior to test. Housed in galvanised or s.s cages and kept in a 12hr day/night cycle. Room temperaturs kept between 65-75 deg F. Fed and watered. 24 hours prior to test the animals were re-examined. Any with skin problems or in poor health were not used.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: two sites per animal, one shaved only, the other shaved and abraded
Vehicle:
physiological saline
Controls:
not required
Amount / concentration applied:
0.5 g of test material moistened with saline were applied to each test site
Duration of treatment / exposure:
Wrapping and test article removed after 24 hours. Remaining test article was gently washed from the skin with water and dried with paper towel.
Observation period:
Test sites were examined after 24 and 72 hours
Number of animals:
Six

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours and 72 hous after application
Score:
0.18
Reversibility:
no data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
This substance is not a primary dermal irritant to rabbits under the consition of the test. A score in the range 0.1-0.9 is classed as "potential for slight irritation, rarely irritating to people - no warning required"