Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 258-476-2 | CAS number: 53320-86-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 2010
- 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:
- 2 010
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:
- 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[Li0.3Mg5.5Si8O20(OH)4]
- IUPAC Name:
- magnesium(2+) lithium(1+) sodium bis(oxosilanebis(olate))
- Details on test material:
- Batch 09-3286-2
White solid
Constituent 1
Test system
- Vehicle:
- physiological saline
- Remarks:
- 20% dilution
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP
- Value:
- 3.8
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- In vitro scores were as follows:
-Ve control (saline solution) = 2.4
+Ve control (known irritant) = 153.6
Test Item = 3.8
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) and thus deemed to be not irritating to eyes.
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.
