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PBT assessment

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PBT assessment: overall result

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Name:
l-limonene
Type of composition:
legal entity composition of the substance
State / form:
liquid
Related composition:
Composition 3
Reference substance:
Composition 1
Name:
l-limonene
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
PBT assessment does not apply
Justification:

No substance of the category “monocyclic terpenes” (dextro-Limonene, laevo-Limonene, Dipentene, Alpha Terpinene, Terpinolene, Gamma Terpinene…) and also Camphene were found to meet the PBT / vPvB criteria.

 

Persistence (P) assessment

D-limonene and the constituents of dipentene are structurally similar compounds. All of them are included in the same chemical-structure category of monocyclic terpenes.

It is therefore considered that they have the same potential for biodegradation. Dipentene was found to be readily biodegradable (biodegradation in activated sludge> 60% ThOD) in an OECD 301D closed bottle test (Van Ginkel, 2010). D-limonene was also found to be readily biodegradable according to OECD 301 criteria.

Therefore, based on initial persistence screening d-limonene and dipentene are not expected to meet the Persistent (P) or very Persistent (vP) criteria.

 

Bioaccumulation (B) assessment

Bioconcentration Factors (BCF) were calculated using three softwares: 1) BCFWIN from EPI Suite v4.0, 2) BCFBAF from EPI Suite v4.0 and 3) OASIS v.1.1.11. 

D-limonene: The geometric mean of the three predicted BCF results in a BCF of 683. The estimation results clearly indicate BCF < 2000 L/kg. Consistently the Log Kow is below 4.5 (4.38) and it is assumed that the affinity for lipid will not exceed the B criterion. 

Therefore the substancesd-limonene is not expected to meet the Bioccumulative (B) or very bioaccumulative (vB) criteria.

Dipentene: The geometric mean of the three predicted BCF results in a BCF of 956. The estimation results clearly indicate BCF < 2000 L/kg., consistently the Log Kow is slightly over 4.5 (4.59) and it is assumed that the affinity for lipid will slightly exceed the B criterion. Therefore dipentene meets the Bioccumulative criteria (B) but not the vB criteria. 

 

 

Toxicity (T) assessment

            Environmental toxicity

All aquatic EC50/LC50 are higher than 0.1 mg/L, therefore the substances are not candidate for T. Substances were identified as not PB not vPvB, further toxicity assessment is not needed.

None of the measured or calculated data for d-limonene and dipentene exceed the criteria for toxicity stipulated in the ECHA’s Guidance on information requirements and chemical safety assessment - Part C: PBT Assessment (2008). Therefore the members of this category are not considered toxic (T).

  

           Human Health Hazards assessment (T)

                        Carcinogenicity

The available data indicate that members of Category d-limonene and dipentene do not warrant classification for carcinogenicity under GHS/CLP. 

                       Mutagenicity

d-limonene and dipentene are not genotoxic or mutagenic and do not warrant classification for mutagenicity under GHS/CLP.

                        Reproductive Toxicity

The available data indicate that d-limonene and dipentene are not toxic to reproduction and do not warrant classification under GHS/CLP.