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The Stilbene Fluorescent Whitening Agents (SFWA), also sometimes referred to as stilbene optical or fluorescent brighteners, are treated as members of a category, comprising the following fifteen substances (CAS numbers): 4404-43-7, 16090-02-1, 13863-31-5, 4193-55-9, 70942-01-7, 27344-06-5, 42355-78-2, 67786-25-8, 28950-61-0, 16324-27-9, 16470-24-9, 17958-73-5, 41098-56-0, 68971-49-3, 52301-70-9. Of the fifteen category members, fourteen were registered under REACh. For these fourteen registered substances tests were conducted according to the data requirements of the associated tonnage band. According to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006, substances may be considered as a category provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The substances within the category are based on these principles are considered to apply to these general rules. In addition some of the proposed members where firstly assessed within the chemical category of Stilbene Fluorescent Whitening Agents recognized under the framework of the US HPV Chemical Challenge Program. In each case of read-across, the best suited read-across was chosen where possible, or a weight of evidence approach in accordance with Annex XI, Item 1.2, of Regulation (EC) No 1907/2006. Nevertheless, as it can be seen in the data matrix of the category justification in IUCLID Section 13, all reliable data in the category support the hazard assessment of each category member by showing a consistent pattern of results.

For a detailed reference list please refer to the CSR or IUCLID section 13.

At least one reliable study for each of the three acute trophic levels are here reported. The EC50s are greater than 100 mg/l and no general toxicity at high doses was observed.

The outcomes on the substance under registration (CAS 67768-25-8) are supported by several consistent studies mainly performed on the analogous substance of the Stilbene Fluorescent Whitening Agents category CAS 16470-24-9, the dihydroxyethyl derivative tetrasulphonated sodium salt. This substance can be considered the best representative within the category, since it has the same sulphonation degree than CAS 67786-25-8, a very high structural similarity (Tanimoto distance > 0.9) and a very high water solubility (650 g/l vs 1000 g/l of CAS 67786-25-8). The category Justification Report is attached to Section 13 of the dossier.

Impurities of the analogous substance are not impairing the similarity.

Regarding long-term studies, a Daphnia magna reproductive study is available on the similar substance 16470-24-9. The result of the chronic reproductive Daphnia study on the analogous substance has been considered to establish the NOEC for the substance (NOEC = 6.59 mg/l).

No further long-term studies are proposed, since significant direct and indirect exposure is unlikely due to the risk management measures that will be applied at industrial level and discussed in details within the exposure scenario to avoid any release of the substance directly in the municipal waste water treatment. The local RCR in surface water is calculated as 0.266 and 0.0052 based on estimated and monitored quantities, respectively, demonstrating that the risk for aquatic compartment is controlled.