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Diss Factsheets
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EC number: 283-900-8 | CAS number: 84775-71-3 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ocimum basilicum, Labiatae.
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1964
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-GLP, pre-guideline study which seems to be performed under standardized conditions.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other:
- Remarks:
- Information is derived from read across
- Justification for type of information:
- The read across justification is presented in the acute toxicity endpoint summary and the accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 790 mg/kg bw
- 95% CL:
- > 2 440 - < 3 180
- Remarks on result:
- other: Slope function 1.3 (95% CI 1.2-1.4)
- Interpretation of results:
- other: Not acute toxic
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- The acute oral toxicity test showed a LD50 of 2790 mg/kg bw. Based on this result, the test substance is considered to have a relatively low acute toxicity hazard via the oral route. In accordance with the criteria outlined in the UN-GHS legislation, the substance should be classified for acute oral toxicity (Acute Tox. 5 / H303).
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 964
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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
- Test material form:
- liquid
1
Test animals
- Species:
- rat
- Strain:
- Osborne-Mendel
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: young adults
- Weight at study initiation: no data
- Fasting period before study: 18 hours
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Not specified
- Doses:
- Not specified
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: The usual observation period was 2 weeks; in a few cases, where no acute toxic signs were seen, the animals were observed for only one week.
- Frequency of observations and weighing: Frequency not known, all animals were maintained under close observation for recording toxic signs and time of death. Such observation was continued until animals appeared normal or showed weight gain. - Statistics:
- LD50's were computed by the method of Litchfield & Wilcoxon (1949).
Results and discussion
- Preliminary study:
- Not relevant
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 790 mg/kg bw
- 95% CL:
- > 2 440 - < 3 180
- Remarks on result:
- other: Slope function 1.3 (95% CI 1.2-1.4)
- Mortality:
- Time of death between 4 and 18 hours after exposure
- Clinical signs:
- other: Ataxia was observed soon after treatment
- Gross pathology:
- Not specified
Applicant's summary and conclusion
- Interpretation of results:
- other: Not acute toxic
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- The acute oral toxicity test showed a LD50 of 2790 mg/kg bw. Based on this result, the test substance is considered to have a relatively low acute toxicity hazard via the oral route. In accordance with the criteria outlined in the UN-GHS legislation, the substance should be classified for acute oral toxicity (Acute Tox. 5 / H303).
- Executive summary:
The acute oral toxicity of Linalool to rats was investigated, in a study performed similar to OECD TG 401. Ten Osborne-Mendel rats per concentration were used, the substance was administered orally via gavage, in a fasted state. Clinical signs and mortality were recorded over a 2 week period. The rats showed ataxia soon after treatment and mortality was observed after 4 -18 hrs. The LD50 was determined to be 2790 mg/kg body weight (confidence interval 2440 -3180).
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