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EC number: 233-732-6 | CAS number: 10339-55-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 03/07/2001 - 02/09/2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Test was conducted according to OECD Test Guideline No. 474, 1997, under GLP Standards, and QA. Due to the read-across purpose it was given a Klimisch 2 rating, in accordance with the ECHA Practical guide #6 on the reporting of read-across in IUCLID. Ethyllinalool and linalool are structural homologues which differ only by a methyl-group. Their physical-chemical properties are comparable and available experimental data on same toxicological endpoints, showed identical toxicological properties. Therefore, it is assumed that all toxicological properties are as well comparable and thus read-across is justified.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Details on test material:
- - Name of test material (as cited in study report): Linalool
- Physical state: liquid
- Stability under test conditions: stable
- Storage condition of test material: In refrigerator protected from light under nitrogen
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- CD-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, Germany
- Age at study initiation: 6-8 weeks
- Weight at study initiation: Males: 29.2 ± 1.3 gr. to 31.6 ± 1.5 gr. ; Females: 24.0 ± 1.6 gr. to 25.2 ± 2.3 gr.
- Assigned to test groups randomly: yes
- Fasting period before study: 3-4 hours
- Housing: air-conditioned room; group housing of 5 animals per sex per cage in labelled polycarbonate cages containing purified sawdust as bedding material
- Diet: ad libitum standard pelleted laboratory animal diet
- Water: ad libitum tap-water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: corn oil
- Concentration of test material in vehicle: 50, 100, 150 mg/ml for dose levels 500, 1000, 1500 mg/kg bw, respectively - Details on exposure:
- no data
- Duration of treatment / exposure:
- 24 and 48 hours
- Frequency of treatment:
- once (single dose treatment)
- Post exposure period:
- 24 or 48 hours after application of Linalool animals were sacrificed, 24 hours after dosing of the vehicle and 48 hours after dosing of the positive control.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
500, 1000, 1500 mg/kg bw
Basis:
actual ingested
oral intubation
- No. of animals per sex per dose:
- Five male and five female mice were used per sampling time in each treatment group
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Cyclophosphamide
- Route of administration: single oral intubation
- Doses / concentrations: 50 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone-marrow; micronucleated polychromatic erythrocytes and ratio polychromatic erythrocytes (PCE)/normochromatic erythrocytes (NCE)
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The dose of 1500 mg/kg bw is the highest applicable one as determined by preliminary experiments (mortality and systemic toxic signs).
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): two sampling times (24 and 48hours) after oral administration of the high dose (1500 mg/kg) and one sampling time (24 hours) for the lower doses (500 and 1000 mg/kg)
DETAILS OF SLIDE PREPARATION: The preparations were air-dried, fixed for 5 min in 100% methanol and air-dried overnight. Two slides were prepared per animal. The slides were automatically stained using the "Wright-stain-procedure" in an "Ames" HEMA-tek slide stainer. The dry slides were dipped in xylene before they were embedded in MicroMount and mounted with a coverslip.
METHOD OF ANALYSIS: The number of micronucleated polychromatic erythrocytes was counted in 2000 polychromatic erythrocytes. The ratio polychromatic to normochromatic erythrocytes was determined by counting and differentiating the first 1000 erythrocytes at the same time. Micronuclei were only counted in polychromatic erythrocytes. - Evaluation criteria:
- A test substance is considered positive in the micronucleus test if:
- It induced a biologically as well as a statistically significant (Wilcoxon Rank Sum Test; two-sided test at P < 0.05) increase in the frequency of micronucleated polychromatic erythrocytes (at any dose or at any sampling time) in the combined data for both sexes or in the data for male or female groups separately.
A test substance is considered negative in the micronucleus test if:
- None of the tested concentrations or sampling times showed a statistically significant (P < 0.05) increase in the incidence of micronucleated polychromatic erythrocytes neither in the combined data for both sexes nor in the data for male or female groups separately. - Statistics:
- Averages and standard deviations were calculated and the Wilcoxon Rank Sum Test was used; two-sided test at P < 0.05
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- lethargy and ataxia in the 1st hour after dosing in all animals of the mid and high dose group; same clinical signs in 1 male and 2 females of the low dose
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 2000 and 1500 mg/kg bw
- Clinical signs of toxicity in test animals: ataxia and lethargy on day 1 after treatment within 5 min, 1.5 h and 2.5 h. 1 Sacrifice at 2000 mg/kg bw for humane reasons.
RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): no increase in the frequency of micronucleated polychromatic erythrocytes was observed in the polychromatic erythrocytes of the bone marrow of Linalool treated animals compared to the vehicle treated animals.
- Ratio of PCE/NCE (for Micronucleus assay): the animals of the groups which were treated with Linalool showed no decrease in the ratio of polychromatic to normochromatic erythrocytes, which reflects a lack of toxic effects of this compound on the erythropoiesis.
- Statistical evaluation: None of the tested concentrations or sampling times showed a statistically significant (P < 0.05) increase in the incidence of micronucleated polychromatic erythrocytes neither in the combined data for both sexes nor in the data for male or female groups separately.
Any other information on results incl. tables
Read across:
Linalool, dehydrolinalool (CAS 29717-20 -8) and ethyllinalool are structurally related substances having similar chemical structures. Difference between linalool and dehydrolinalool is the triple bond at position 1 in dehydrolinalool compared to a double bond at the same position in linalool. Both substances have similar physical-chemical properties. Ethyllinalool is a structural homologue of linalool which differs by a methyl-group only. The physical-chemical properties of ethyllinalool are comparable to the two other substances and available experimental data on the same toxicological endpoints, showed identical toxicological properties. Therefore, it is assumed that all toxicological properties are as well comparable and thus read-across is justified.
Overall, mutagenicity and genotoxicity testing was unremarkable. All three substances were negative in the Ames test. Linalool and dehydrolinalool were negative in an in vivo micronucleus test. Linalool was also negative in an in vitro chromosome aberration test and in an in vitro forward mutation testing. Although dehydrolinalool was positive in the in vitro chromosomal aberration test in the absence of metabolic activation, the next higher Tier test i.e. the in vivo MNT in the bone marrow was clearly negative.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
No increase in the frequency of micronucleated polychromatic erythrocytes was observed in the polychromatic erythrocytes of the bone marrow of Linalool treated animals compared to the vehicle treated animals. The incidence of micronucleated polychromatic erythrocytes in the bone marrow of all negative control animals were within the historical solvent control data range. Cyclophosphamide, the positive control substance, induced a statistically significant increase in the number of micronucleated polychromatic erythrocytes in both sexes. It is therefore concluded that this test is valid and that Linalool is not mutagenic in the micronucleus test under the experimental conditions described in this report. Linalool does not need to be classified as mutagenic according to the criteria outlined in Annex I of 1272/2008/EC. - Executive summary:
Linalool was tested in the Micronucleus Test in mice, to evaluate its genotoxic effect on erythrocytes in bone marrow.
Four groups each comprising 5 males and 5 females, received a single oral intubation. Two groups were dosed with 1500 mg/kg body weight, one group was dosed with 1000 mg/kg body weight and one group was dosed with 500 mg/kg body weight.
A vehicle treated group served as negative control, a group treated with a single oral intubation of cyclophosphamide (CP) at 50 mg/kg body weight served as positive control. Bone marrow of the groups treated with Linalool was sampled 24 or 48 hours after dosing. Bone marrow from the negative control group was harvested at 24 hours after dosing only and bone marrow from the positive control group was harvested at 48 hours after dosing only.
After dosing all animals treated with 1500 and 1000 mg/kg Linalool showed the following toxic signs: lethargy and ataxia. Of the group treated with 500 mg/kg Linalool, one male and two female animals showed lethargy and ataxia.
Cyclophosphamide, the positive control substance, induced a statistically significant increase in the number of micronucleated polychromatic erythrocytes in both sexes.
No increase in the frequency of micronucleated polychromatic erythrocytes was observed in the polychromatic erythrocytes of the bone marrow of animals treated with Linalool.
The groups that were treated with Linalool showed no decrease in the ratio of polychromatic to normochromatic erythrocytes compared to the vehicle controls, which reflects a lack of toxic effects of this compound on the erythropoiesis. The groups that were treated with cyclophosphamide showed a decrease in the ratio of polychromatic to normochromatic erythrocytes compared to the vehicle controls.
It is concluded that Linalool is not mutagenic in the micronucleus test under the experimental conditions described in this report. Linalool does not need to be classified as mutagenic according to the criteria outlined in Annex I of 1272/2008/EC.
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