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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 01-09-99 to 22-09-99
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 402 (Acute Dermal Toxicity) and Method B.3 of Commission Directive 92/69/EEC
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- L-p-mentha-1(6),8-dien-2-one
- EC Number:
- 229-352-5
- EC Name:
- L-p-mentha-1(6),8-dien-2-one
- Cas Number:
- 6485-40-1
- Molecular formula:
- C10H14O
- IUPAC Name:
- (5R)-2-methyl-5-(prop-1-en-2-yl)cyclohex-2-en-1-one
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): CARVON L SYNTH
- Physical state: liquid
- Analytical purity: 99.4%
- Lot/batch No.: 50458154
- Storage condition of test material: approximately 4 °C in the dark
- Other: For the purpose of the study the test material was used as supplied. The specific gravity was determined and used to calculate the appropriate dose volume for the required dose level.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley CD (Crl : CD (SD) IGS BR)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: Approximately eight to twelve weeks old
- Weight at study initiation: Male - 226 to 241 g; Female - 216 to 233 g.
- Housing: The animals were housed in suspended polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study.
- Diet (e.g. ad libitum): Rat and Mouse SQC Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK ad libitum
- Water (e.g. ad libitum): Mains drinking water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Within 19 to 25°C target range
- Humidity (%): Within 30 to 70% target range
- Air changes (per hr): 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back and flanks of each animal were clipped free of hair. The substance was applied uniformly to an area of shorn skin.
- % coverage: Approximating to 10% of the total body surface area
- Type of wrap if used: Surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated skin and surrounding hair was wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: After 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2.10 mL/kg (2000 mg/kg; specific gravity: 0.956) - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observed for deaths or overt signs of toxicity: 0.5, 1, 2 and 4 hours after dosing and subsequently once daily for fourteen days.
Observations for evidence of primary irritation: Once daily every 14 days.
Individual bodyweights were recorded prior to application of the test material on Day 0 and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, dermal reactions.
The dermal reactions were numerically graded daily for erythema and eschar formation [0 (no erythema) to 4 (severe erythema to slight eschar formation)] and edema [0 (no edema) to 4 (severe edema); see Draize scoring system below].
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths (Table 1).
- Clinical signs:
- other: No clinical signs of toxicity were noted during the study (Table 1).
- Gross pathology:
- No abnormal macroscopic findings at necropsy.
- Other findings:
- - Other observations: No signs of dermal irritation were noted during the study (Table 2; Draize scoring system) .
Any other information on results incl. tables
Table 1: INDIVIDUAL CLINICAL OBSERVATIONS AND MORTALITY DATA
Dose Level mg/kg | Animal Number and Sex | Effects Noted After Dosing (Hours) | Effects Noted During Period After Dosing (Days) | ||||||||||||||||
2000 mg/kg | 0.5 | 1 | 4 | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8 | 9 | 10 | 11 | 12 | 13 | 14 | ||
Male 1-0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Male 1-1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Male 1-2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Male 1-3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Male 1-4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Female 2-0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Fernale 2-1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Fernale 2-2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Female 2-3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
Female 2-4 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | ||
0 = no signs of systemic toxicity
Study report attachments:
Table 2 Individual dermal reactions (012_300)
Table 3 Individual bodyweights and weekly bodyweight changes (012_300)
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Conclusions:
- The acute dermal median lethal dose (LD50) of L-carvone in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bw.
- Executive summary:
In an acute dermal toxicity study (012_300), young adult Sprague-Dawley CD (Crl : CD (SD) IGS BR) rats (5/sex) were dermally exposed (semi-occlusive; approximately 10% of the total body surface area) to L-carvone for 24 hours in a limit test at a dose of 2000 mg/kg bw. Animals were then observed for 14 days.
The dermal LD50 Male/Female was greater than 2000 mg/kg bw (limit test). There were no treatment related clinical signs, necropsy findings, changes in body weight or signs of dermal irritation noted during the study.
This acute dermal study is classified as acceptable. It does satisfy the guideline requirement for an acute dermal study (OECD 402) in the rat.
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