Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 285-349-9 | CAS number: 85085-18-3
Eye irritation
Administrative data
- Endpoint:
- eye irritation, other
- 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:
- Na0.7[Mg5.3Li0.7Si8O20(OH)0.0F4.0]
- IUPAC Name:
- Synthetic fluorohectorite
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
