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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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity evaluation of the given test chemical in rats using micronucleus assay
- Author:
- Llana-Ruiz-Cabello et al.
- Year:
- 2 016
- Bibliographic source:
- Food and Chemical Toxicology
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Principles of method if other than guideline:
- The mammalian erythrocyte MN test was performed using the given test chemical.
- GLP compliance:
- not specified
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Carvacrol
- EC Number:
- 207-889-6
- EC Name:
- Carvacrol
- Cas Number:
- 499-75-2
- Molecular formula:
- C10H14O
- IUPAC Name:
- 2-methyl-5-(propan-2-yl)phenol
- Details on test material:
- - Name of test material : 2-methyl-5-(propan-2-yl)phenol
- Common name : Carvacrol
- Molecular formula : C10H14O
- Molecular weight : 150.2196 g/mol
- Smiles notation : CC(C)c1ccc(C)c(O)c1
- InChl : 1S/C10H14O/c1-7(2)9-5-4-8(3)10(11)6-9/h4-7,11H,1-3H3
- Substance type: Organic
- Physical state: Liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- strain RjHan:WI
- Details on species / strain selection:
- The number of animals included in each group was selected according to the OECD 474 guideline a minimum of 5 analyzable animals of each sex for group (OECD 474) was selected.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: University of Sevilla Center for Animal Production and Experimentation (Espartinas, Spain).
- Age at study initiation: between 8 and 10 week-old when purchased and the animals were acclimatized to the environmental conditions for one week before the experiments (i.e. 9-11 week-old)
- Weight at study initiation: Animals were weighed after arrival
- Assigned to test groups randomly: yes
- Fasting period before study: No data
- Housing: housed in polycarbonate cages with stainless steel covers
- Diet (e.g. ad libitum): standard diet (Harlan, 2014; Harlan Laboratories, Barcelona, Spain), ad libitum.
- Water (e.g. ad libitum): water ad libitum.
- Acclimation period: the animals were acclimatized to the environmental conditions for one week before the experiments,
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 1°C
- Humidity (%): 55 ± 10%,
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 h dark/light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Justification for choice of solvent/vehicle: Test chemical was soluble in corn oil
- Concentration of test material in vehicle: 1 mL - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: All doses were prepared in corn oil at a final volume of 1 mL
- Duration of treatment / exposure:
- 0, 24 and 45 h
- Frequency of treatment:
- Single
- Post exposure period:
- 3 h
Doses / concentrations
- Remarks:
- 0 (vehicle), 81, 256 or 810 mg/kg bw
- No. of animals per sex per dose:
- 23 male and 23 female rats
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - ethylmethanesulphonate
- Route of administration: gavage
- Doses / concentrations: 200 mg/kg bw
Examinations
- Details of tissue and slide preparation:
- DETAILS OF SLIDE PREPARATION:the bone marrow cells were smeared on a glass slide, fixed in absolute methanol air dried and stained with Giemsa.
METHOD OF ANALYSIS: The polychromatic erythrocytes (PCE) among total erythrocytes (normochromatic erythrocytes (NCE) þ PCE) ratio and the PCE among NCE ratio were calculated by counting 500 erythrocytes per animal. The incidence of micronucleated immature erythrocytes (MNPCE) expressed as % MN was analyzed by counting a total of 5000 cells per animal. Five male and 5 female animals were analyzed for the negative control and the dosed groups. Moreover, 3 males and 3 females were analyzed in the case of the positive group. - Statistics:
- For the MN assay, data are presented as the mean ± SD for each group of animals and statistical analysis was performed using the analysis of variance (ANOVA) followed by Dunnett's multiple comparison tests.
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: Test chemical did not increase the % MN in immature erythrocytes at any dose tested on both sexes.
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: The MN assay OECD protocol (OECD 474) recommend a preliminary range-finding study to identify the maximum tolerated dose (MTD), which was defined by Derelanko (2000) as the highest dose to produce toxic effects without causing death and to decrease body weight (bw) by no more than 10% relative to controls. For this purpose, the Acute oral toxicity OECD 425 guideline for testing of chemicals (OECD, 2008) was followed, taking into account the historical report of the LD50 in rats described by Jenner et al. (1964). Moreover, considering the OECD 474 (2014a) guideline, the doses used in the combined MN assay were the MTD and two lower doses (Bowen et al., 2011) appropriately spaced by less than √10.
Applicant's summary and conclusion
- Conclusions:
- In vivo MN assay protocol demonstrates that the given test chemical did not induce genotoxic effects in bone marrow cells of orally exposed (81-810 mg/kg bw) Wistar rats.
- Executive summary:
The mammalian erythrocyte micronucleus test was conducted for the given test chemical on 23 male and 23 female rats. Animals were randomly divided into five groups, two control and three treatment groups: the negative control group (C-) (5 males and 5 females rats) was treated with corn oil (vehicle); the positive control group (C+) (3 males and 3 females rats) was exposed to 200 mg/kg bw ethylmethanesulfonate (EMS) and three exposed groups (5 males and 5 females rats per group) received 81, 256 or 810mg/kg bw. The number of animals included in each group was selected according to the OECD 474 and OECD 489 guidelines: a minimum of 5 analyzable animals of each sex for group (OECD 474) and a minimum of 3 animals of each sex treated with a positive control (OECD 489). All doses were prepared in corn oil at a final volume of 1 mL. Animals were dosed at 0, 24 and 45 h by gavage using anenteral feeding tube. Then, animals were sacrificed 3 h after the final dose administration. During the treatment period, clinical signs, body weight, and food and water consumption were recorded daily. Briefly, the bone marrow cells were smeared on a glass slide, fixed in absolute methanol air dried and stained with Giemsa. The polychromatic erythrocytes (PCE) among total erythrocytes (normochromatic erythrocytes (NCE) + PCE) ratio and the PCE among NCE ratio were calculated by counting 500 erythrocytes per animal. The incidence of micronucleated immature erythrocytes (MNPCE) expressed as % MN was analyzed by counting a total of 5000 cells per animal. Five male and 5 female animals were analyzed for the negative control and the dosed groups. Moreover, 3 males and 3 females were analyzed in the case of the positive group. 3 h after the final administration (45 h) of test chemical, significant differences in the PCE/total erythrocytes ratio were observed from 256 mg/kg bw with respect to the negative control group in males (p < 0.01) and females (p < 0.05). Regarding PCE/NCE ratio in male rats, a significant (p < 0.01) decrease was detected from 256 mg/kg bw. Female rats exposed to test chemical also showed a significant (p < 0.05) decrease of PCE/NCE, but only at the highest dose assayed (810 mg/kg bw). Moreover, it did not increase the % MN in immature erythrocytes at any dose tested on both sexes. Treatment with EMS as positive control induced significant decreases (p < 0.01) in the PCE/total erythrocytes and PCE/NCE ratios, and significant increases (p < 0.01) in the % MN with respect to the negative control. Hence, results from MN assay revealed that the given test chemical did not induce in vivo genotoxicity in bone marrow cells investigated.
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