Registration Dossier
Registration Dossier
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EC number: 215-208-9 | CAS number: 1313-59-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
- Short term toxicity and local toxicity endpoints were waived, based on corrosive potential and for animal welfare consideration
- Repeated toxicity endpoints were based on breakdown product (sodium hydroxide).
The instantaneous hydrolysis of disodium oxide (Na2O - n°CAS 1313 -59 -3) according the reaction:
Na2O + H2O -> 2NaOH
was confirmed by industrial practice (see section 5.1.2 of the IUCLID dossier). In contact with moist skin or mucous membranes (water), disodium oxide is quasi-instantaneously decomposed into sodium hydroxide. Disodium oxide appears then not available in the body due to its quasi-instantaneously degradation on contact with moist skin or mucous membranes.
For these reasons, this approach was followed for the hazard characterization of disodium oxide:
There are sufficient data on the breakdown product (sodium hydroxide n°CAS: 1310 -73 -2) which were already evaluated (European RAR and REACH registration). This breakdown substance is exempted to Registration following Annex V (Entry I) for this register dossier.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study technically not feasible
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Annex XI, section 2, testing (OECD 421) is technically not feasible as a consequence of the properties of the substance (hydrolytically unstable substance and quasi-instantaneously degraded in contact with moist skin or mucous membranes). See Attached justification for more details.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Sodium oxide quasi-instantaneously degraded in contact with moist skin or mucuous membranes to form Sodium Hydroxide. Testing Sodium oxide for fertility toxicity is for this reason not relevant at all, but breakdown products have to be considered. There are sufficient data on the breakdown products (Sodium hydroxide n°CAS: 1310 -73 -2) which were already evaluated (European RAR and REACh registration) and there is no classification elaborated for toxicity to reproduction. For these reasons, no classification could be set for toxicity to reproduction.
Additional information
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.
