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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Toxicological information

Genetic toxicity: in vivo

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Administrative data

Endpoint:
genetic toxicity in vivo
Remarks:
Type of genotoxicity: 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:
2015
Report date:
2015

Materials and methods

Principles of method if other than guideline:
Assessment
GLP compliance:
no

Test material

Constituent 1
Chemical structure
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

Results and discussion

Additional information on results:
Assessment

Any other information on results incl. tables

Assessment

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Assessment
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 reported that a mixture of silicic acid, sodium salt (215-687-4) and sodium polyphosphate (OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test) did not demonstrate genetic toxicity (No significant increase of chromosomal aberrations compared to negative control even at dosage levels exceeding the M.T.D. of 940 mg/kg bw.). Sodium hydroxide does not have the potential to be a genetic toxin based on the presence of only a sodium anion. The REACH text states:

8.4.2. The study does not usually need to be conducted — if adequate data from an in vivo cytogenicity test are available, or

►M3 — the substance is known to be carcinogenic category 1A or 1B or germ cell mutagenic category 1A, 1B or 2.◄

8.4.3. The study does not usually need to be conducted if adequate data from a reliable in vivo mammalian gene mutation test are available.

8.4. Appropriate in vivo mutagenicity studies shall be considered in case of a positive result in any of the genotoxicity studies in Annex VII or VIII.

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 for endpoint 8.4.2, 8.4.3 and 8.4.4.