Registration Dossier
Registration Dossier
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EC number: 222-813-1 | CAS number: 3618-72-2
Categories
- Category name:
- 7.3.2 - Disperse dyes category – eye irritation
Justifications and discussions
- Category definition:
- The category is determined for chemicals that:
− are mono-azo disperse dyes
− are halogen compounds presenting chlorine or bromine atom(s)
− have very low water solubility or are not soluble in water.
Therefore, a category approach can be justified on the basis that all the seven targets described in section 1 of the present document are identified as category members since they meet all the requirements. Five source substances can be categorised as well: ID239 - Disperse Yellow UZ 3217-A (EC 400-090-5), ID248 - Disperse Red FC 38583 (EC 407-310-9), ID255 - Disperse Red CLA 282 (EC 416-240-8), ID257 - Disperse Red 378 (EC 424-290-7) and ID259 - Marine Cla 926 (EC 430-500-8). The others source substances described in section 1 cannot be considered for the present category approach as they do not meet all the required characteristics.
For a full justification of the selection of key, supporting and discarded studies see the attached document 7.3.2 – Disperse dyes category - Appendix I.pdf. - Category description:
- The category approach can be explained on the basis that all the category members are structurally similar disperse dyes which have similar physicochemical properties, particularly regarding their poor water soluble or not soluble behaviour
- Category rationale:
- The choice of the target and the potential source substances that compose the category was based on a clustering method described in 7.3.2 – Disperse dyes category - ClusteringMethod.pdf. This method allows to calculate the similarity of each potential source with the targets and the similarity among the targets. The comparison between two molecules is based on the Tanimoto Coefficient that compares the Daylight fingerprints (as calculated in Python by RDKit) of the two molecules.
In this case, among the pool of potential sources (the ones with a reliable value for the endpoint of interest) the sources ID239 - Disperse Yellow UZ 3217-A (EC 400-090-5), ID248 - Disperse Red FC 38583 (EC 407-310-9), ID255 - Disperse Red CLA 282 (EC 416-240-8), ID257 - Disperse Red 378 (EC 424-290-7) and ID259 - Marine Cla 926 (EC 430-500-8) were selected based on their similarity with the targets and the quality of the available data. The similarity of each source substance to each of the targets is discussed and shown in the attached document 7.3.2 – Disperse dyes category - Appendix I.pdf.
The target and the source substances can be considered in the applicability domain of the category due to their high structural similarity (higher than 0.82 between targets and not lower than 0.707 overall the category members).
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