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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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Name:
Hexanedioic acid, dibutyl ester
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Hexanedioic acid, dibutyl ester
Name:
Hexanedioic acid, dibutyl ester
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
Hexanedioic acid, dibutyl ester
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for Dibutyl adipate (CAS 105-99-7) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012d).

Persistence

Dibutyl adipate (CAS 105-99-7) is readily biodegradable in one study according to OECD 301C (90% (O2 consumption) after 14 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 Dibutyl adipate (CAS 105-99-7) is expected to be low. The substance is rapidly metabolised and excreted by organisms and thus an accumulation is not expected. This is supported by calculated low BCF/BAF values (BCF/BAF: 12.55 L/kg; Arnot-Gobas estimate, upper trophic). Thus the substance is not considered to be B or vB.

Toxicity

Dibutyl adipate (CAS 105-99-7) is considered as not toxic. The substance is not acutely toxic to aquatic organisms. A chronic toxicity is not expected since the substance is not persistent and has a low potential for bioaccumulation. 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.