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EC number: 201-134-4 | CAS number: 78-70-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- The current study is not performed under GLP. The study can be compared with the OECD Guideline 405, is well documented and considered scientifically acceptable.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- slightly different scoring system
- GLP compliance:
- 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
- Details on test material:
- - Name of test material (as cited in study report): Linalool
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: No data
- Weight at study initiation: 2.2 to 3.2 kg
ENVIRONMENTAL CONDITIONS: No data
IN-LIFE DATES: No data
Test system
- Vehicle:
- other: groundnut oil
- Controls:
- other: not relevant
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration (if solution): 100% (product in its natural state); 30%, 10% and 3% (product in solution using groundnut oil).
VEHICLE: Groundnut oil; no further data. - Duration of treatment / exposure:
- No data
- Observation period (in vivo):
- After 1 hour, then 1, 2, 3, 4, and 7 days after application.
- Number of animals or in vitro replicates:
- 6 rabbits per concentration
- Details on study design:
- REMOVAL OF TEST SUBSTANCE: No data
SCORING SYSTEM: Numerical scoring system with degrees of severity:
1) Conjunctiva
- Lachrymal secretions (A): 0, 1, 2, 3
- Chemosis (edema) (B): 0, 1, 2, 3, 4
- Redness of the palpebral conjunctiva (C): 0, 1, 2, 3
- Coefficient of effect on conjunctiva: 2 (A+B+C)
2) Iris
- Effect on the iris (A1): 0, 1, 2
- Coefficient of the effect on the iris: 5 A1
3) Cornea
- Degree of opacity (A2): 0, 1, 2, 3, 4
- Surface of opacity (B2): 1, 2, 3, 4
- Coefficient of the effect on the cornea: 5 A2 B2
SCORING PARAMETERS USED FOR EU CLASSIFICATION:
Interpretation of the eye irritation results was performed according to the parameters used for EU classification (67/548/EEC), although this was not done in study report. Substance needs to be classified as eye irritant if:
- Cornea opacity (degree) equal to or greater than 2 but less than 3, and/or
- Iris lesion (effect) equal to or greater than 1 but not greater than 1.5, and/or
- Redness of the conjunctivae equal to or greater than 2.5, and/or
- Edema of the conjunctivae (chemosis) equal to or greater than 2.
SCORING PARAMETERS USED FOR CLP CLASSIFICATION:
Interpretation of the eye irritation results was performed according to the parameters used for CLP classification (1272/2008/EC), although this was not done in study report. Substance needs to be classified as eye irritant if:
- Corneal opacity (degree) = 1 and/or
- Iritis (lesion/effect) = 1, and/or
- Conjunctival redness = 2 and/or
- Conjunctival oedema (chemosis) = 2.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.18
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100% concentration
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 30% concentration
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 10% concentration
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 3% concentration
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 2.29
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: 100% concentration
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.28
- Remarks on result:
- other: 30% concentration
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 10% concentration
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 3% concentration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.41
- Reversibility:
- fully reversible within: 4 days
- Remarks on result:
- other: 100% concentration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 30% concentration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 10% concentration
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 3% concentration
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1
- Remarks on result:
- other: 100% concentration
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 30% concentration
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 10% concentration
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: 3% concentration
- Irritant / corrosive response data:
- Very slight conjunctival irritation with cornea involvement, fully reversible within 7 days.
- Other effects:
- No data
Any other information on results incl. tables
Results relevant for evaluation of the eye irritation potential related to the EU (67/548/EEC) and CLP (1272/2008/EC) classification are given in the "overall irritation/corrosion results". This represents the mean of the animals and timepoints. Group mean animal data per timepoint are given below:
Concentration | Timepoint | Conjunctiva chemosis score | Conjunctivae redness score | Iris score | Cornea opacity score |
100% | 24 hrs | 0.33 | 1.67 | 0.67 | 1 |
48 hrs | 0 | 3 | 0.17 | 1 | |
72 hrs | 0.2 | 2.2 | 0.4 | 1 | |
30% | 24 hrs | 0 | 0.5 | 0 | 0 |
48 hrs | 0 | 0.17 | 0 | 0 | |
72 hrs | 0 | 0.17 | 0 | 0 | |
10% | 24 hrs | 0 | 0 | 0 | 0 |
48 hrs | 0 | 0 | 0 | 0 | |
72 hrs | 0 | 0 | 0 | 0 | |
3% | 24 hrs | 0 | 0 | 0 | 0 |
48 hrs | 0 | 0 | 0 | 0 | |
72 hrs | 0 | 0 | 0 | 0 |
Maximum score is 110 for all concentration and timepoints.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the condtions of this study, it was observed that only the undiluted test material caused adverse effects on the eyes of rabbits. These effects were fully reversible within 7 days. Linalool will be classified as eye irritant according to the criteria outlined in Annex I of Regulation (EC) 1272/2008.
- Executive summary:
0.1 mL of the test substance in its natural state, or of the oil-based solution was applied in the tear duct of the left eye of each rabbit (New Zealand White) weighing between 2.2 and 3.2 kg. Six rabbits were used per concentration. Concentrations used were 100% (product in its natural state), and 30%, 10% and 3% (product in solution using groundnut oil). Observation period was 7 days.
The undiluted product was a moderate irritant to the eye. Effects were fully reversible within 7 days. As an oil-based solution the product produced no irritant effect at concentrations up to 30% in the eye. At the 100% concentration, only one conjunctivae score (at 48 hrs after exposure) was >2.5, which is the limit as set out in the EU classification directive. However, at the other timepoints the score was below 2.5 and therefore this result is neglected for EU classification. The other scores are all below the applicable limits. Based on these results, linalool will not be classified as eye irritant according to the criteria outlined in Annex VI of 67/548/EEC.
Regarding CLP classification a limit of 2.0 for the conjunctivae redness is used, which is exceeded for the 100% concentration tested (as it was shown to have a mean of 2.29 over the three timepoints). In addition, the corneal opacity score for the 100% concentration was found to be 1.0, which is as high as the limit applicable under CLP. The other scores are all below the applicable limits set out in the CLP regulation. Based on these results, linalool will have to be classified as eye irritating for the 100% concentration, but not for concentrations up to 30% according to the criteria outlined in Annex I of Regulation (EC) 1272/2008/EC.
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