Registration Dossier
Registration Dossier
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EC number: 233-739-4 | CAS number: 10341-03-4
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT assessment for Ditetradecyl fumarate (CAS 10341-03-4) 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
Ditetradecyl fumarate (CAS 10341-03-4) is considered to be readily biodegradable but failing the 14 day window. This assumption is based on a study conducted according to OECD 301B (71% (CO2 evolution) after 28 d). Thus, the test substance does not meet the screening criterion for persistence and it is not considered to be P or vP.
Bioaccumulation
The bioaccumulation potential of Ditetradecyl fumarate (CAS 10341-03-4) is expected to be low. This assumption is based on the environmental fate and on the high molecular weight of the substance. Due to the rapid biodegradability, high adsorption potential and low water solubility a low bioavailability of the substance is assumed. Furthermore the molecular weight, size and structural complexity of the substance hamper uptake and bioaccumulation. This is supported by calculated low BCF/BAF values (BCF: 0.89 L/kg, BAF 1.09 L/kg; Arnot-Gobas estimate, upper trophic). The accumulation potential of the substance is further diminished by a rapid metabolisation and excretion by organisms. Thus the substance is not considered to be B or vB.
Toxicity
Ditetradecyl fumarate (CAS 10341-03-4) is considered to be not toxic. Studies on the acute toxicity of the substance determined no effects in the range of water solubility. A chronic exposure of aquatic organisms is considered as unlikely due to the low bioavailability of the substance as a consequence of the rapid biodegradability, high adsorption potential and low water solubility of the substance. Thus bioaccumulation and chronic toxicity of the substance are not expected. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (See Section 5.9). The criteria for “T” based on mammalian effects are therefore not met. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the substance is considered to be not T.
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