Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
PBT assessment does not apply
Justification:

A PBT and vPvB assessment shall be conducted as foreseen in Article 14 (3) (d) in conjunction with Annex I Section 4 according to the criteria as laid down in Annex XIII. According to Annex XIII of regulation (EC) 1907/2006 a PBT and vPvB assessment shall not apply to inorganic substances, but shall apply to organo-metal. Organo-metal compounds are defined as organic compounds that contain at least one metal or metalloid atom bound to a carbon atom. Because in metal carboxylates, the metal cation is only bound to the negatively charged oxygen in the carboxyl group via an ionic bond, fatty acids, C9-13-neo-, zinc salts are considered as an inorganic substance, and thus a PBT and vPvB assessment is not required.

The organic moiety of this metal salt, i.e. fatty acids, C9-13-neo- (CAS: 68938-07-8), does not have PBT properties because it does not meet the criteria for bioaccumulation (BCF is <2000 L/kg wet weight based on predictions Epi Suite 4.00) and toxicity (no CMR or STOT RE classification, long-term NOEC or EC10 values for marine or freshwater organisms are >0.01 mg/L based on read-across to data for the structural analogue neodecanoic acid, CAS 26896-20-8).