Registration Dossier
Registration Dossier
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EC number: 209-378-3 | CAS number: 574-93-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The substance was assessed as part of a category of pigments with phthalocyanine as the core structure. The substances in the category are considered not readily biodegradable based on available information of category members CAS 147 -14 -8 and CAS 12239 -87 -1 (OECD 301F, OECD 301C). Additional biodegradation studies are waived based on the low water solubility in combination with the stability of the nanomaterial. All substances in the category should therefore be considered as potentially P/vP from a precautionary point of view. The substances in the category are considered not B/vB based on available experimental studies of category members CAS 147-14-8 and CAS 1328-53-6 (BCF ≤ 74 L/kg, log Kow < 1). In addition, the substances are inert and unreactive. They do not interact with proteins, have a high molecular weight and are insoluble. Therefore, they will not be able to penetrate biological membranes.
The substances in the category do not meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenicity (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to the CLP Regulation. There is also no evidence of chronic toxicity since the substances do not meet the criteria for classification: STOT RE1 or STOT RE2 according to the CLP Regulation. Referring to the available ecotoxicity data, the substances are assessed to be neither acutely nor chronically hazardous to aquatic organisms.
In conclusion, all substances in the category are considered as not PBT/vPvB substances.
No metabolites are expected, as all substances in the category are inert.
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