Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

After having registered Sa 57 for the tonnage band 1 – 10 to, we now want to increase the production volume and therefore want to register Sa 57 for the tonnage band 10 – 100 to. Since products incorporating Sa 57 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 have stopped using the material and consequentially cease the registration which would not affect any other registrant since Sa 57 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 to 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. Any other test will only be initiated if genotoxicity is finally clarified. As described in this dossier, Sa 57 is not considered clastogenic even though some uncertainty remains with regard to its potential ability to disturb mitotic processes. There are conflicting data concerning the gene mutation potential from an assay with bacteria and another assay in mammalian cells. In order to clarify the available conflicting in vitro genotoxicity results with regard to their relevance in vivo, an in vivo genotoxicity testing as outlined in section 7.6.2. was conducted and only recently completed. Toxicological data other than the mentioned in vitro genotoxicity results required for the tonnage band of 10 - 100 to are therefore not yet available but will be generated and provided as soon as possible.

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available

Justification for classification or non-classification

Additional information