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EC number: 229-352-5 | CAS number: 6485-40-1
- 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
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Endpoint summary
Administrative data
Description of key information
Skin sensitisation: Sensitising (OECD Guideline 429/GLP)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21-08-06 to 30-08-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: OECD Guideline study and GLP compliant. No justification of the choice of vehicle was given.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca/Ola/Hsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK Limited, Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 15-17.4g
- Housing: Maximum of 4 per cage, in cages suitable for animals of this strain and weight range,
- Diet (e.g. ad libitum): RM1 diet (Special Diet Services Ltd., Essex, UK) ad libitum.
- Water (e.g. ad libitum): Mains water ad libitum.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C (± 3°C)
- Humidity (%): 30-70%
- Air changes (per hr): Minimum of 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark, 12 hours light - Vehicle:
- other: 1:3 ethanol/diethylphthlate
- Concentration:
- Test substance: 2.5, 5, 10, 25 and 50% w/v in 1:3 ethanol/diethylphthlate
- No. of animals per dose:
- 4 animals per dose
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: The lab tests the reliability of the test system every 6 months. Postive control study used for comparison: 19-25th July 2006 (Study No.: GM8020). Hexyl cinnamic aldehyde (Sigma Aldrich) was used as the positive control. The vehicle for the positive control was acetone in olive oil (4:1) The criterion for a positive response is that one of more concentrations of the test substance should elicit a 3-fold or greater increase isotope incorporation relative to the vehicle control group.
TREATMENT PREPARATION AND ADMINISTRATION: Test substance (2.5, 5, 10, 25 or 50% w/v) in 25μL vehicle/vehicle alone applied to dorsum of each ear. The procedure was repeated for 3 consecutive days. Three days after the third application, 250μL of phosphate-buffered saline (PBS) containing 20 μCi of 3H-methyl thymidine (2.0Ci/mmol specific activity) was injected into all test and control mice via the tail vein. Five hours later the animals were killed via halothane and the draining auricular lymph node of each ear was excised into PBS.
A single-cell suspension was prepared by gentle mechanical disaggregation through 200 micron-mesh stainless steel gauze.
The cell suspensions were then washed three times by centrifugation with approx. 10mL PBS. and the DNA
precipitated with 3mL 5% trichloroacetic acid (TCA) at 4C overnight. Pellets were re-suspended in 1 mL TCA.
The lymph node suspensions were transferred to scintaillaiton vials and 10 ML scintillant was added prior to β-scintillation using a Apckard Tri-Carb 3100TR Liquid Scintillation Counter. - Statistics:
- The EC3 value was calculated by interpolating between two points on the SI axis, one immediately above, and the other immediately below, the SI value of three. The vehicle-treated control value (SI=1) cannot be used for the latter. Where the data points lying immediately above and below the SI value of 3 have the co-ordinates (a,b) and (c,d) respectively, then the EC3 value may be calculated using the following equation :
EC3 = c + [(3-d)/(b-d)] x (a-c).
The quantity applied per squared centimetre was derived from this value, assuming that the area of the mouse ear is 1 cm2 and that 1μL is equiavalent to 1mg. - Positive control results:
- There was no positive control study conducted concurrently. However, the reliability of the test system was confirmed by the most recent positive control assay (Hexyl cinnamic aldehyde; 19-25th July 2006 (Study No.: GM8020; Table 2).
- Parameter:
- SI
- Value:
- 0
- Test group / Remarks:
- Contorol
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 2.5%
- Parameter:
- SI
- Value:
- 1.5
- Test group / Remarks:
- 5%
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 5
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 5.7
- Test group / Remarks:
- 50%
- Parameter:
- EC3
- Value:
- 10.7
- Test group / Remarks:
- EC3 value 10.7% (2675 μg/cm2)
- Interpretation of results:
- sensitising
- Conclusions:
- The test substance, I-carvone in 1:3 ethanol/diethylphthlate is a skin sensitiser under the conditions of the test with an EC3 value of 10.7% (2675 μg/cm2).
- Executive summary:
In a dermal sensitization study (GM8030-REG) with L-carvone (in 1:3 ethanol/diethylphthlate), young adult CBA/Ca/Ola/Hsd mice (4 females) were tested in the Local Lymph Node Assay. The reliability of the test system was confirmed by the most recent positive control assay (Hexyl cinnamic aldehyde; July 2006; Study number: GM8020).
Treament with L-carvone at 2.5, 5, 10, 25 and 50% w/v in 1:3 ethanol/diethylphthlate resulted in resulted in stimulation indices of 1, 1.5, 2.9, 5, and 5.7 respectively. The EC3 value giving rise to a 3 fold increase in lymphocyte proliferation was calculated to be 10.7% (2675 μg/cm2).
In this study, L-carvone is a dermal sensitizer.
Reference
Table 2:Skin sensitisation potenital of the positive control substance (Hexyl cinnamic aldehyde)
[study run within a six month interval (19-25th July 2006; Study No.: GM8020)]
Concentration of hexylcinnamaldehyde (% w/v) | Number or lymph nodes assayed | Disintegrations per minute (dpm) | dpm per lymph node | Test: control ration (SI) |
0 (vehicle only) | 8 | 5939 | 742 | N/A |
5 | 8 | 10111 | 1264 | 1.7 |
10 | 8 | 13747 | 1718 | 2.3 |
25 | 8 | 38015 | 4752 | 6.4 |
Vehicle: Acetone in olive oil (4:1)
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Skin sensitisation (in vitro)
This test was waived as an in vivo skin sensitisation study (LLNA) was available.
Skin sensitisatio (in vivo)
One local lymph node study was available and was chosen as the key study.
In a dermal sensitization study (OECD 429/GLP) with L-carvone (in 1:3 ethanol/diethylphthlate), young adult CBA/Ca/Ola/Hsd mice (4 females) were tested in the Local Lymph Node Assay. The reliability of the test system was confirmed by the most recent positive control assay (Hexyl cinnamic aldehyde; July 2006; Study number: GM8020). Treament with L-carvone at 2.5, 5, 10, 25 and 50% w/v in 1:3 ethanol/diethylphthlate resulted in resulted in stimulation indices of 1, 1.5, 2.9, 5, and 5.7 respectively. The EC3 value giving rise to a 3 fold increase in lymphocyte proliferation was calculated to be 10.7% (2675 μg/cm2). In this study, L-carvone is a dermal sensitizer.
The results from this study are acceptable to use in the human health risk assessment.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
L-carvone (CAS 6485-40-1) is classified as: Skin sensitiser Category 1B (H317: May cause allergic skin reaction) when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.
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