Registration Dossier
Registration Dossier
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EC number: 227-815-6 | CAS number: 5989-54-8
PBT assessment
Administrative data
PBT assessment: overall result
- Name:
- l-limonene
- Type of composition:
- legal entity composition of the substance
- State / form:
- liquid
- Related composition:
- l-limonene
- Reference substance:
- l-limonene
- Name:
- l-limonene
- Type of composition:
- boundary composition of the substance
- State / form:
- liquid
- Reference substance:
- l-limonene
- 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.
Referenceopen allclose all
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