Registration Dossier
Registration Dossier
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EC number: 270-451-8 | CAS number: 68440-34-6
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Fatty acids, tallow, zinc salts is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
Based on the test results of two valid ready biodegradation studies (OECD 301 B and OECD 301 D) conducted with the read-across substances Fatty acids, C16-18, zinc salts (CAS No. 91051-01-3) and Zinc-12-Hydroxystearate (CAS No. 35674-68-1) (> 60% degradation in 28 days), Fatty acids, tallow, zinc salts can be regarded as readily biodegradable according to OECD criteria. Thus, it does not meet the screening criterion for persistence and it is not considered to be P or vP.
Bioaccumulation
Fatty acids, tallow, zinc salts is assumed to (at least partly) dissociate to zinc ions and free fatty acids if taken up by organisms. The cellular content of zinc is regulated in organisms, and fatty acids are metabolised via well-known pathways. Fatty acids, tallow, zinc salts is thus not expected to bioaccumulate. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of Fatty acids, tallow, zinc salts. Thus, the substance does not meet the criterion for bioaccumulative and it is not considered to be B or vB.
Toxicity
Fatty acids, tallow, zinc salts is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Long-term toxicity data is only available for algae with an ErL10 of 3.31 mg/L. Since supporting data for inorganic zinc substances show that algae represents the most sensitive trophic level, this data is considered sufficient for the hazard assessment of Fatty acids, tallow, zinc salts. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and Fatty acids, tallow, zinc salts does not fulfil the T criterion.
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.
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