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Registration Dossier
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EC number: 285-349-9 | CAS number: 85085-18-3
Eye irritation
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:
- 2 011
- 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
- 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(1.00+/-0.99)[(Si8Mg(5.0+/-1.0)Li(1.00+/-0.99) O20 (OH)4-x Fx](1.00+/-0.99); with x=2.5+/-1.5
- IUPAC Name:
- Silicate(2-), hexafluoro-, disodium, reaction products with lithium magnesium sodium silicate
- Details on test material:
- Batch 09-2151-1
White solid - powder
Constituent 1
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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