Registration Dossier
Registration Dossier
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EC number: 910-245-3 | CAS number: -
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation
- Remarks:
- other: Assessment
- Type of information:
- other: Expert Assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Expert assessment as opposed to experimental result
Data source
Reference
- Reference Type:
- other: Expert Assessment
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
- Principles of method if other than guideline:
- Assessment
- GLP compliance:
- no
- Type of study:
- not specified
Test material
- Reference substance name:
- Reaction mass of disodium metasilicate and sodium hydroxide
- EC Number:
- 910-245-3
- Molecular formula:
- NaOH Na2SiO3
- IUPAC Name:
- Reaction mass of disodium metasilicate and sodium hydroxide
Constituent 1
Results and discussion
In vitro / in chemico
Results
- Remarks on result:
- not measured/tested
- Remarks:
- It has an aqueous pH of >13; the high pH makes testing inappropriate
Any other information on results incl. tables
Assessment
Applicant's summary and conclusion
- Interpretation of results:
- other: Not applicable
- Executive summary:
This substance is a multi-constituent substance consisting of sodium hydroxide (215-185-5, 1310-73-2) and disodium metasilicate (229-912-9, 6834-92-0). It is the by-product of a reaction between zircon (EC no 239-019-6) and sodium hydroxide; after hydrolysis, this substance is the water-soluble fraction. The substance in water has a pH of >13 due to the presence of significant amounts of sodium hydroxide. The substance as produced would be highly corrosive to skin due to the alkali; testing would not be required to demonstrate this as the properties of sodium hydroxide are well-known. In vivo testing of the substance would be inappropriate on animal welfare grounds, and such testing for substances where the pH is >11 is prohibited. The substance is classified based on this as skin corrosion/irritation, category 1A (H314), i.e. corrosive. Disodium metasilicate (229-912-9) has been tested for skin sensitisation. This would not contribute at all to the corrosiveness due to the sodium hydroxide present in this substance. In view of the corrosive nature of this substance, its potential for sensitisation is essentially irrelevant.
The above should be considered as an expert statement to waive the requirement for testing for skin sensitisation under REACH Annex VIII for endpoint 8.3
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.
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