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Administrative data

Endpoint:
eye irritation
Remarks:
other: BCOP in-vitro method as detailed below.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Februry 2011
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:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Determination of Eye Irritation Potential using Bovine Corneal Opacity and Permeability (BCOP) Assay. OECD Guideline 437 (2009)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

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+/-0.5)[(Si8Mg(5.2+/-0.7)Li(1+/-0.7) O20 (OH,F)4+/-1.5](1+/-0.5)-
IUPAC Name:
Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
Details on test material:
Batch 09-2151-1
White solid - powder

Test system

Vehicle:
physiological saline
Remarks:
20% dilution
Amount / concentration applied:
20% w/v solution in 0.9% w.v sodium chloride solution
Duration of treatment / exposure:
240 minutes

Results and discussion

In vivo

Results
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: 4 hours
Score:
< 2
Reversibility:
not specified
Remarks on result:
other: In vitro study
Irritant / corrosive response data:
In vitro scores were as follows:
-Ve control (saline solution) = 1.2
+Ve control (known irritant = imidazole) = 110.1
Test Item = 1.1
Other effects:
No other effects observed

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the in vitro test results for the effect of this substance on bovine corneal opacity and permeability, the score results were of the same order as the -ve control used (saline solution) i.e. ~ 1.0 and thus deemed to be not irritating to eyes. (An In Vitro irritancy score of >55.1 would need to be achieved before a material would be classed as an ocular corrosive or severe irritant).
Whilst in-vitro tests may not be as conclusive as in-vivo testing, there is sufficient evidence based on in-vivo tests that have been carried out on
Laponite type 2 ( a read-across substance of virtually identical composition and structure) and also from the fact that no ocular issues have been reported during 40+ years of manufacturing and handling this material, that there is no justification for carrying out new in-vivo tests.
Executive summary:

Laponite type 1 is not an ocular corrosive or severe irritant. No classification necessary.

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