Registration Dossier
Registration Dossier
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EC number: 910-245-3 | CAS number: -
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- 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
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
Test animals
- Species:
- other: assessment
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Remarks on result:
- not measured/tested
Results (fetuses)
Effect levels (fetuses)
- Remarks on result:
- not measured/tested
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Assessment
Applicant's summary and conclusion
- 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 OECD SIDS Initial Assessment Report for SIAM 18 Paris, France 20-23 April, 2004 showed that silicic acid, sodium salt (215-687-4) did not demonstrate reproductive toxicity. Sodium hydroxide does not have the potential to be a developmental toxin based on the presence of only a sodium anion. Based on these data sets, no further testing is required for the reaction mass of disodium metasilicate and sodium hydroxide and no additional test is proposed.
The above should be considered as an expert statement to fulfil the REACH registration requirements under Annex VIII/IX for endpoint 8.7.
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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