Registration Dossier
Registration Dossier
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EC number: 215-209-4 | CAS number: 1313-60-6
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
- Reprotoxicity endpoints were based on breakdown product (sodium hydroxide).
The exothermic and instantaneous hydrolysis of disodium peroxide was confirmed by industrial practice (see section 5.1.2. of the technical dossier). In contact with moist skin or mucous membranes (water), disodium peroxide is quasi-instantaneously decomposed into sodium hydroxide and oxygen. Disodium peroxide 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 peroxide:
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 scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
In accordance with REACH Annex XI, section 2, testing 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 to form sodium hydroxide). And there are sufficient data on the breakdown products (sodium hydroxide - n°CAS 1310-73-2) which were already registered in the frame of REACH. These breakdown substances are exempted to Registration following Annex V (Entry I) for this register dossier.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Sodium Peroxide quasi-instantaneously degraded in contact with moist skin or mucuous membranes to form Sodium Hydroxide. Testing Sodium Peroxide 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.
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