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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
Endpoint summary
Administrative data
Description of key information
Serious eye damage/eye irritation: not irritating (OECD 405/ EEC
Guideline B.5, GLP)
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- other justification
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06-09-1999 to 10-09-1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline No. 405 (Acute Eye Irritation/Corrosion) and EEC Guideline Method B.5
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- other: New Zealand White (SPF albino)
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Deutschland GmbH, Stolzenseeweg 32-36, 88353 Kißleg, Germany
- Weight at study initiation: 1.7 - 2.0 kg
- Housing: Caged individually in PPO cages (floor area: 2576 cm2) with perforated floor.
- Diet (e.g. ad libitum): Pelleted complete rabbit diet "Altromin 2123" from Altromin, D-32791 Lage, Lippe, was available ad libitum
- Water (e.g. ad libitum): Domestic quality drinking water (acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth) ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): 10 times/hour
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light - Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL - Duration of treatment / exposure:
- 24 hrs
- Observation period (in vivo):
- 1 hr, 24 hr, 48 hr and 72 hr.
- Number of animals or in vitro replicates:
- 4 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
SCORING SYSTEM: Method of Draize/Grading of Ocular Lesions in OECD Guideline 405 with additions noted below in Tables 1 and 2.
TOOL USED TO ASSESS SCORE: The eyes were examined and the grade of ocular reaction was recorded 1 hr and 24 hrs later. After the first 24 hr reading, fluorescein was instilled. After rinsing with 20 ml 0.9% sodium chloride solution the eyes were examincd again using UV-light to detect possible
corneal damage.
Only the left eye was treated. The right eye remained untreated and served as control. - Irritation parameter:
- cornea opacity score
- Remarks:
- - opacity
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- - redness
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Individual animal data is presented below (Table 3)
- Interpretation of results:
- not irritating
- Conclusions:
- The substance L-carvone was not irritating in the eyes of New Zealand White rabbits.
- Executive summary:
In a primary eye irritation study (01628) 0.1mL of L-carvone (undiluted) was instilled into the conjunctival sac of the left eye of young adult New Zealand White (SPF albino) rabbits (4/females) for 24 hours. The eye was not washed after instillation of the test article. Animals then were observed for 1 hr, 24 hr, 48 hr and 72 hrs after dosing. Irritation was scored by the method of Draize/Table: Grading of Ocular lesions (OECD 405) with additions noted in Tables 1 and 2.
The following mean values, based on the results from the 24, 48 and 72 hour readings,were calculated - cornea opacity: 0; iris lesion: 0; oedema of conjunctiva (chemosis): 0; redness of conjunctiva: 0.4.
In this study, L-carvone is not an eye irritant based on the results of this OECD guideline/GLP study.
Reference
Table 3: Scores for ocular lesions (all animals)
Rabbit No./ Weight per kg | 1h | 24h | 24h | 48h | 72h | Individual mean score* | |
F | |||||||
1627 / 2.0 | Cornea opacity, degree | 0 | 0 | 0 | 0 | 0 | 0 |
Cornea opacity, area | 0 | 0 | 0 | 0 | 0 | ||
Iris | 1 | 0 | - | 0 | 0 | 0 | |
Conjunctiva: Redness | 2 | 1 | - | 0 | 0 | 0.33 | |
Chemosis | 1 | 0 | - | 0 | 0 | 0 | |
Discharge | 0 | 0 | - | 0 | 0 | ||
1628 / 1.9 | Cornea opacity, degree | 0 | 0 | 0 | 0 | 0 | 0 |
Cornea opacity, area | 0 | 0 | 0 | 0 | 0 | ||
Iris | 0 | 0 | - | 0 | 0 | 0 | |
Conjunctiva: Redness | 2 | 1 | - | 0 | 0 | 0.33 | |
Chemosis | 1 | 0 | - | 0 | 0 | 0 | |
Discharge | 1 | 0 | - | 0 | 0 | ||
1629 / 1.7 | Cornea opacity, degree | 0 | 0 | 0 | 0 | 0 | 0 |
Cornea opacity, area | 0 | 0 | 0 | 0 | 0 | ||
Iris | 0 | 0 | - | 0 | 0 | 0 | |
Conjunctiva: Redness | 2 | 1 | - | 0 | 0 | 0.33 | |
Chemosis | 1 | 0 | - | 0 | 0 | 0 | |
Discharge | 1 | 0 | - | 0 | 0 | ||
1630/ 1.8 | Cornea opacity, degree | 0 | 0 | 0 | 0 | 0 | 0 |
Cornea opacity, area | 0 | 0 | 0 | 0 | 0 | ||
Iris | 1 | 0 | - | 0 | 0 | 0 | |
Conjunctiva: Redness | 2 | 1 | - | 1 | 0 | 0.67 | |
Chemosis | 1 | 0 | - | 0 | 0 | 0 | |
Discharge | 0 | 0 | - | 0 | 0 |
F: Reading after instillation of Fluorescein
* Only the scores from the readings after 24, 48 and 72 hours are included in the calculation of the individual mean scores
Table 4: Summary of mean values from Table 3
Mean Value | |
cornea opacity | 0 |
iris lesion | 0 |
redness of conjunctiva | 0.4 |
oedema of conjunctiva (chemosis) | 0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
In accordance with Column 2 of ANNEX VIII, an in vivo skin irritation study does not need to be conducted as an acute toxicity study by the dermal route does not indicate skin irritation up to the limit dose level (2000 mg/kg bw).
Serious eye damage/eye irritation
An in vitro eye irritation study was not required as an in vivo study was available.
In a primary eye irritation study (OECD 404/GLP) 0.1mL of L-carvone (undiluted) was instilled into the conjunctival sac of the left eye of young adult New Zealand White (SPF albino) rabbits (4/females) for 24 hours. The eye was not washed after instillation of the test article. Animals then were observed for 1 hr, 24 hr, 48 hr and 72 hrs after dosing. Irritation was scored by the method of Draize/Table: Grading of Ocular lesions (OECD 405) with additions noted in Tables 1 and 2. The following mean values, based on the results from the 24, 48 and 72 hour readings,were calculated - cornea opacity: 0; iris lesion: 0; oedema of conjunctiva (chemosis): 0; redness of conjunctiva: 0.4. In this study, L-carvone is not an eye irritant.
The results from this study are acceptable to use in the human health
risk assessment.
Justification for classification or non-classification
Based on the available information in the dossier, the substance L-carvone (CAS No. 6485-40-1) does not need to be classified for skin irritation/corrosion or serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.
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