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EC number: 207-889-6 | CAS number: 499-75-2
- 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
Skin irritation/corrosion: Corrosive (OECD 404/GLP)
Serious eye damage/eye irritation: Not irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
-Piurity: 100%
-Spec No.:3362701 - Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- other: intact skin
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Duration of treatment / exposure:
- 4 hrs
- Observation period:
- 7 days
- Number of animals:
- 4
- Irritation parameter:
- erythema score
- Basis:
- other: Animals 1-4
- Time point:
- 24 h
- Score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- other: Animals 1-4
- Time point:
- 48 h
- Score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- other: Animals 1-4
- Time point:
- 72 h
- Score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: Animals 3-4
- Time point:
- 24 h
- Score:
- 2
- Irritation parameter:
- edema score
- Basis:
- other: Animals 1-4
- Time point:
- 48 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- other: Animals 1-4
- Time point:
- 72 h
- Score:
- 0
- Irritant / corrosive response data:
- In animal 1, severe erythema was evident from 24-72 hrs and was still present at 7 days. Severe edema was present at 1 hr but disappeared after 48 hrs. Eschar and hardened skin was noted from 24 hrs to day 7.
In animal 2, severe erythema was evident from 24-72 hrs and was still present at 7 days. Severe edema was present at 1 hr but disappeared after 24 hrs. Eschar and hardened skin was noted from 24 hrs to day 7.
In animal 3, severe erythema was evident from 24-72 hrs and was still present at 7 days. Moderate edema was present at 1 hr which decreased to slight edema at 24 hrs; it disappeared by 48 hrs. Eschar was noted at 24 hrs and eschar/hardened skin was noted from 48 hrs to 72 hrs. The animal was dead by day 7.
In animal 4, severe erythema was evident from 24-72 hrs and was still present at 7 days. Moderate edema was present at 1 hr which decreased to slight edeam at 24 hrs; it disappeared by 48 hrs. Eschar and hardened skin was noted from 48 hrs to day 7. - Interpretation of results:
- other: Corrosive
- Conclusions:
- In an in vivo rabbit skin irritation/corrosion study, carvacrol was corrosive.
- Executive summary:
In a primary dermal irritation study (TR066), 4 female rabbits were dermally exposed (intact skin) to 0.5mL of Carvacrol (100%, undiluted) for 4 hours. Animals then were observed for 7 days after dosing. Irritation was scored by the method of Draize.
Carvacrol is corrosive based on the average scores calculated from the numerical values given to the irritation observed at the 24, 48 and 72 hour observations which were 4 for erythema and 0.4 for oedema.
This in vivo skin irritation/corrosion study in the rabbit is acceptable and satisfies the guideline requirement for an OECD 404 study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study need not be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/corrosion
There is an in vivo skin irritation study in rabbits available and a supporting publication from the ECVAM in vitro skin corrosivity validation study.
In a primary dermal irritation key study (ECETOC, 1995), 4 female rabbits were dermally exposed (intact skin) to 0.5mL of Carvacrol (100%, undiluted) for 4 hours. Animals then were observed for 7 days after dosing. Irritation was scored by the method of Draize. In this study, Carvacrol is corrosive to the skin based on the following mean values (24, 48 and 72 hr readings):
Erythema for all animals: 4
Edema for animal 1: 0.33
Edema for animal 2: 0
Edema for animal 3: 0.66
Edema for animal 4: 0.66.
Carvacrol was one of 60 chemicals used in the ECVAM in vitro skin corrosivity validation study (Barrett, 1998). The data was compared to the existing in vivo data provided in the ECETOC TR066 (1995) report. The result of the in vitro validation study is indicated as corrosive (C) with UN Packing groups II/III. Under CLP, this is equivalent to Skin corrosion Category 1B/C. At worst case, Skin corrosion Category 1B will be chose.
The conclusion from these studies is acceptable to use in the human health risk assessment.
Eye damage/eye irritation
The study does not need to be conducted because the available information indicates that the criteria are met for classification as corrosive to the skin.
Justification for classification or non-classification
Based on the available information in the dossier, the substance Carvacrol (CAS No. 499-75-2) is classified as Skin corrosive Category 1B at worst case and does not need to classified for serious eye damage/eye irritation when considering the criteria outlined in Annex I of 1272/2008/EC.
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