Registration Dossier
Registration Dossier
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EC number: 215-208-9 | CAS number: 1313-59-3
Endpoint summary
Administrative data
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.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- 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 407) 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
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Sodium oxide is quasi-instantaneously degraded in contact with moist skin or mucuous membranes to form Sodium hydroxide. Testing Sodium oxide for long term toxicity is for this reason not relevant at all, but breakdown product has to be considered (classification for sodium hydroxide has been elaborated in the frame of REACH and non classification is elaborated). For these reasons, no classification could be set for repeated toxicity.
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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