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EC number: 227-815-6 | CAS number: 5989-54-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- PNEC aqua (freshwater)
- PNEC value:
- 5.4 µg/L
- Assessment factor:
- 50
- Extrapolation method:
- assessment factor
- PNEC freshwater (intermittent releases):
- 3.6 µg/L
Marine water
- Hazard assessment conclusion:
- PNEC aqua (marine water)
- PNEC value:
- 0.54 µg/L
- Assessment factor:
- 500
- Extrapolation method:
- assessment factor
STP
- Hazard assessment conclusion:
- PNEC STP
- PNEC value:
- 0.2 mg/L
- Assessment factor:
- 10
- Extrapolation method:
- assessment factor
Sediment (freshwater)
- Hazard assessment conclusion:
- PNEC sediment (freshwater)
- PNEC value:
- 1.322 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Sediment (marine water)
- Hazard assessment conclusion:
- PNEC sediment (marine water)
- PNEC value:
- 0.132 mg/kg sediment dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- PNEC soil
- PNEC value:
- 0.262 mg/kg soil dw
- Extrapolation method:
- equilibrium partitioning method
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- PNEC oral
- PNEC value:
- 133 mg/kg food
- Assessment factor:
- 30
Additional information
PNECs aqua
Several reliable studies were conducted on algae, daphnia and fish with d-limonene, the enantiomer of l-limonene and with dipentene, the racemic form (dl) of limonene. Toxicity results were similar for d-limonene and dipentene suggesting that both enantiomer have the same level of toxicity on these aquatic organisms. This hypothesis is reinforced by the estimations of the toxicity of l-limonene by a valid QSAR model (ECOSAR) which are similar to the result with d-limonene and dipentene except for algae when the result is lower especially for chronic toxicity.
From these results, it can be concluded that the toxicity of the two enantiomers, d and l limonene, regarding daphnids and fish is similar and that d-limonene and dipentene can be used as analogue of l-limonene in a read-across approach to fill data gaps. Among these studies, the geometric mean 96h-LC50 of 0,71 mg/L for fish, the lowest 48h-EC50 of 0,36 mg/L and the 21d-NOEC= 0.27 mg/L for daphnia are considered as the relevant values to be used for the purpose of risk assessment and classification and labelling. Nevertheless, for algae the lower estimated values, 72h-ErC and 72h-NOErC of 0.904 and 0.514 mg/L,for l-limonene with ECOSAR is prefered as more conservative values because detailed information on the purity of d-limonene and dipentene in the available tests is missing.
PNEC stp
One reliable ready biodegradability study on l-limonene and one reliable activated sludge respiration test (ASRIT) on dipentene (48.4% dl-limonene) were available to assess the toxicity of l-limonene to microorganisms. The result of the ASRIT on dipentene is difficult to interpret the specific toxicity of l-limonene (multi-constituents substance) however the test conclude that the test item was not harmful to activated sludge. According to ECHA, Chapter R. 7b, Endpoint specific guidance (2008), the information content of the ready biodegradability test can be used to derive a NOEC. In the case of l-limonene, the ready biodegrability test in close bottles fulfilled the requested conditions as described below :
- the compound is found to be readily biodegradable,
- test substance concentration (2 mg/L) was not above the solubility limit of l-limonene (12.3 mg/L).
- a toxicity control hasn't been included in the test but no inhibition of the endogenous respiration of the inoculum by l-limonene was detected.
Therefore, a NOEC of 2 mg/L corresponding to a good degradated tested concentration was estimated from the biodegradation test and used to derive the PNECstp.
PNEC sediment and soil
In the absence of any ecotoxicological data for sediment-dwelling organisms and terrestrial organisms, the PNECsed and the PNECsoil were calculated using the equilibrium partitioning method (EPM).
PNEC oral
A 6-month subchronic repeated dose toxicity study was performed similarly to OECD Guideline 409 with d-limonene administered through gavage to groups of adult beagle dogs (IUCLID endpoint 7.5.1, RA, 5989-27-5, Repeated dose toxicity: oral 180-d dog, Webb, 1990, RS, K).
Under the test conditions, the NOAEL and LOAEL for beagle dogs were considered to be 100 and 1000 mg/kg bw/day, respectively, based on the increased absolute and relative female kidney weight and relative male kidney weight.
A NOEC mammals-food-chr of 4 g/ kg food is derived from the NOAEL and a PNEC oral of 133 mg/kg food is calculated according to the ECHA guidance on information requirments and chemical safety assessment Chapter 10 using a convertion factor of 40 and an assessment factor of 30, respectively.
Conclusion on classification
The selected data on acute and chronic toxicity on aquatic organism issued from read-across with d-limonene and dipentene or calculated value with a valid QSAR, and relevant for classification of l-limonene are:
Acute toxicity
48h-EC50 for daphnia: 0.36 mg/L
96h-LC50 for fish: 0.72 mg/L
72h-ECr50 for algae: 0.904 mg/l
Chronic toxicity
21d-NOEC for daphnia: 0.27 mg/L
72h-NOErC for algae: 0.514 mg/L
The substance l-limonene is readily biodegradable.
The Log Kow of d-limonene was measured at 4.38 and is expected to be similar for both enantiomers. There was no experimentaly determined BCF however the retained QSAR value is 683 L/kg ww and therefore l-limonene cannot be considered not having potential to bioaccumulate.
Based on these information l-limonene should be classified:
Acute Category 1 (M-factor = 1) and Chronic Category 3 according to the CLP Regulation (EC) nº 1272/2008.
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