Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 815-131-6 | CAS number: 913171-06-9
Endpoint summary
Administrative data
Description of key information
After having registered Sa 34 for the tonnage band 1 – 10 t/a, we now want to increase the production volume and therefore want to register Sa 34 for the tonnage band 10 – 100 t/a. Since products incorporating Sa 34 are intended to have direct contact with end consumers, prior to initiating any new test we have defined potential genotoxic properties as knock-out criterion. In case of genotoxic properties, we would stop using the material and consequentially cease the registration which would not affect any other registrant since Sa 34 is proprietary to Henkel. In this case, there would be no need any more to generate more data in order to support such a registration. From our perspective this approach is the best solution from an economical as well as from an animal welfare point of view. In that respect, we have developed a testing strategy for obtaining the toxicological data required for the 10 – 100 t/a tonnage band. This testing strategy applies a tiered approach starting with the two required in vitro genotoxicity assays – gene mutation and chromosome aberration in mammalian cells (according to REACH Annex VIII). As described in this dossier, Sa 34 is considered to be clastogenic in the in vitro chromosome aberration test (OECD TG 473). In order to clarify if the in vitro genotoxicity results are relevant in vivo, the next step is to perform an in vivo genotoxicity testing as outlined in REACH Annex IX. Therefore, a testing proposal for an in vivo mammalian erythrocyte micronucleus test (OECD TG 474) was included in this dossier. Any other test required according to REACH Annex VIII will only be initiated if genotoxicity is finally clarified. Toxicological data other than the mentioned in vitro genotoxicity results required for the tonnage band of 10 - 100 t/a are therefore not yet available but will be generated and provided as soon as possible.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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.
