Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin irritation using read across from Linalool (OECD TG 404): irritating
Eye irritation using read across from Linalool (OECD TG 405): irritating
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- 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 irritation / corrosion endpoint summary and the accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other:
- Remarks:
- Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Test 3
- Interpretation of results:
- other: Skin irritant (Category 2)
- Remarks:
- accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Under the test conditions (OECD TG 404 and GLP), the substance is considered to be a skin irritant.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Data was obtained from studies performed between 1981 and 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- study acquired from reliable secondary source therefore no detailed documentation.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Albino
- Details on test animals or test system and environmental conditions:
- Not specified.
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Remarks:
- Intact skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume): 0.5 ml
- Concentration (if solution): 100% - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 7 days
- Number of animals:
- Test 1: 3 animals
Test 2: 4 animals
Test 3: 4 animals - Details on study design:
- Multi patch studies were selected for this publication because the multi-patch studies were assumed not to contravene with OECD Test Guideline 404. Additionally, no interference was reported between reactions on different patch sites in the multi-patch studies.
TEST SITE
- Area of exposure: Flank
- % coverage: Not specified
- Type of wrap if used: Semi-occlusive patches (multi-patch)
OBSERVATION TIME POINTS
After 1, 24, 48, 72h and 7 days.
SCORING SYSTEM: according to Draize (adopted by OECD TG 404) - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other:
- Remarks:
- Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 1
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within:
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 2
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Test 3
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: Test 3
- Irritant / corrosive response data:
- Desquamation from skin surface appeared as follows:
Test 1: at day 2 (1 animal), 3 (1 animal marked) and 7 (1 animal marked)
Test 2: at day 1 (1 animal slight), 2 (1 animal slight), 3 (1 animal slight),and 7 (2 animals marked, 1 animal slight)
Test 3: at day 3 (1 animal slight) and 7 (1 animal marked, 3 animals slight) - Interpretation of results:
- other: Skin irritant (Category 2)
- Remarks:
- accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Under the test conditions (OECD TG 404 and GLP), the substance is considered to be a skin irritant.
- Executive summary:
The skin irritation potential of Linalool has been tested according to OECD TG 404. Two multi patch test were performed with 4 rabbits each and one single patch test was performed with 3 rabbits. All studies were performed with 0.5 mL undiluted test substance applied on the flank for 4 hours under semi-oclussive conditions. The animals were observed for 7 days after exposure and skin irritation was scored according to the Draize scoring system. Under the conditions of the test the substance was found to be skin irritating.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- 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 irritation / corrosion endpoint summary and the accompanying files are also attached there.
- Reason / purpose for cross-reference:
- read-across source
- GLP compliance:
- no
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Interpretation of results:
- other: Eye irritant (Category 2)
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this study, Linalool is considered to be irritating to the rabbit eye.
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 8 August 1988 - 28 September 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Pre-GLP, study based on OECD guideline 405 (1981)
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Savo. Med. Verzichstierzuchten GMBH
- Housing: The animals were housed in fully airconditioned rooms.
- Diet (e.g. ad libitum): 130 g per animal per day, Kliba 341, 4mm
- Water (e.g. ad libitum): approximately 250 ml per animal per day
- Acclimation period: At least 8 days before the start of the study.
- Temperature (°C): 20- 24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml per animal - Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 15 days
- Number of animals or in vitro replicates:
- 2 males, 1 female
- Details on study design:
- The substance was applied to the conjunctival sac of the right eyelid.
REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
- Chemosis and Cornea: 0=none/normal, 1= slight, 2=well-defined, 4=severe, 5= very severe
- Area of cornea involved: 1 = >0; <1/4, 2= >= 1/4; < 1/2, 3= >=1/2; <3/4, 4= >=3/4
- Iris: 0= normal, 1= circumcorneal redness, 2= Iritis
- Conjunctivae redness: 0=none/normal, 1= slight, 2=well-defined, 4=severe - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- male
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 15 days
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- female
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritant / corrosive response data:
- Loss of corneal tissue was observed, but was found to be reversible. In addition pupil contraction, loss of hair at margins of eyelids, marginal vascularization of the cornea and small retractions in the eyelids were observed.
- Interpretation of results:
- other: Eye irritant (Category 2)
- Remarks:
- in accordance with EU CLP (EC 1272/2008 and its updates)
- Conclusions:
- Under the conditions of this study, Linalool is considered to be irritating to the rabbit eye.
- Executive summary:
- An eye irritation study was performed for Linalool, based on OECD guideline 405 and pre-GLP (Klimisch 2). The test item was applied by instillation of 0.1 ml into the left eye of each of three young adult Vienna White rabbits. The treated eye was not washed and the untreated eye served as control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours and 8 and 15 d after application of the test item. The mean score was calculated across 3 scoring times (24/48 /72 hours after instillation). The individual mean scores for corneal opacity were 1.00 for all three animals. The individual mean scores for Iris were 0.3, 0.3, 1.0, the conjunctivae were 2.0, 2.0 and 3.0 for reddening, respectively, and 1.0, 0.0 and 0.3 for chemosis. The instillation of Linalool into the eye resulted in pupil contraction, loss of hair at margins of eyelids, marginal vascularization of the cornea, loss of corneal tissue, and small retractions in the eyelids. These effects were reversible and were no longer evident 15 days after treatment (in 1 animal retractions of eyelids and loss of hair at margins of eyelids were still present). Based on the results obtained in the present study the test substance is considered irritant but not corrosive damage to the rabbit eye.
Referenceopen allclose all
TABLE 1: EYE IRRITATION SCORES - INDIVIDUAL VALUES | |||||||||
Animal Number | Sex | Evaluation Interval* | Corneal Opacity | Area of Corneal Opacity | Iris | Conjunctivae Redness | Chemosis | Discharge | |
Symptoms | |||||||||
1 | M | 1 | 4 | 0 | 2 | 2 | 2 | PC | |
2 | M | 1hour | 0 | 0 | 0 | 2 | 2 | 3 | |
3 | F | 0 | 0 | 0 | 2 | 2 | 3 | ||
1 | M | 1 | 4 | 0 | 2 | 1 | 1 | PC | |
2 | M | 24 hours | 1 | 2 | 0 | 2 | 0 | 1 | |
3 | F | 1 | 2 | 1 | 3 | 1 | 1 | PC | |
1 | M | 1 | 4 | 0 | 2 | 1 | 0 | PC | |
2 | M | 48 hours | 1 | 4 | 0 | 2 | 0 | 0 | |
3 | F | 1 | 3 | 1 | 3 | 0 | 1 | PC/LC | |
1 | M | 1 | 3 | 1 | 2 | 1 | 2 | PC/LC/RE | |
2 | M | 72 hours | 1 | 3 | 1 | 2 | 0 | 0 | PC/LC |
3 | F | 1 | 3 | 1 | 3 | 0 | 0 | PC/LC | |
1 | M | 1 | 1 | 0 | 0 | 0 | 0 | RE/MV/LH/LC | |
2 | M | 8 days | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | F | 0 | 0 | 0 | 0 | 0 | 0 | ||
1 | M | 0 | 0 | 0 | 0 | 0 | 0 | RE/LH | |
2 | M | 15 days | 0 | 0 | 0 | 0 | 0 | 0 | |
3 | F | 0 | 0 | 0 | 0 | 0 | 0 | ||
* Examinations were performed at the specified times after instillation of the test item.PC= pupils contracted, LC= loss of corneal tissue, LH= loss of hair at margins of eyelids, MV= marginal vascularization of the cornea, RE= small retractions in the eyelids |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
The potential for skin and eye irritation for Basil oil was assessed by using read across from Linalool (CAS No.: 78-70-6). First the experimental skin and eye irritation information for Linalool will be summarised. Thereafter the read across jusitifcation is presented. The accompanying files are attached in the present endpoint summary.
Skin irritation in vivo (Linalool)
The skin irritation potential of Linalool has been tested according to OECD TG 404. Two multi patch test were performed with 4 rabbits each and one single patch test was performed with 3 rabbits. All studies were performed with 0.5 mL undiluted test substance applied on the flank for 4 hours under semi-oclussive conditions. The animals were observed for 7 days after exposure and skin irritation was scored according to the Draize scoring system. Under the conditions of the test the substance was found to be skin irritating.
Eye irritation in vivo (Linalool)
Read across justification
Basil oil obtained from the stems and leaves of Ocimum basilicum by steam distillation (Basil oil linalool type) CAS no: 84775-71-3 (target) and its skin and eye irritating properties using read across from Linalool, CAS no: 78-70-6 (source)
Introduction and hypothesis for the substance-based read across approach
Basil oil - Linalool type is a UVCB which consists of hydrocarbon constituents some of which include oxygen. Its major constituents are Linalool(contains a tertiary OH group and two C=C bonds)and Eucalyptol(contains a cyclic ether group. The full composition is given at the end of the document in the data matrix. For Basil oil - Linalool type (target) no skin and eye irritation data are available. Therefore additional information is used in accordance with Article 13 of REACH where it is said that lacking information can be generated whenever possible by applying alternative methods such SARs, grouping and read-across. For assessing the skin and eye irritation of Basil oil - Linalool type, the irritation data of Linalool are used, which is the main constituent of Basil oil - Linalool type.
Hypothesis:Basil oil - Linalool type(target)is expected to have similar skin and eye irritating properties as Linalool (source).
Available skin information:The source substance Linalool has been tested in a well performedOECDTG 404 study. The test substance was applied undiluted to intact rabbit skin under semi-occlusive conditions. Three independent experiments were performed, and the skin irritation was scored according to the Draize scoring system. Mean erythema values at 24/48/72 hours for test 1, 2 and 3 were determined to be 1.9, 2 and 1.7 (individual values are all ≤2). The mean oedema values at 24/48/72 hours for test 1, 2 and 3 were determined to be 1.4, 1.4 and 0.4 (individual values are all ≤2). Erythema was not fully reversible after 7 days. In addition desquamation was also noted. Based on these data the test substance was considered irritating to the rabbit skin.
Available eye information
The source substance Linalool (CAS 78-70-6) has been tested in anOECDTG 405 study, pre-GLP (Klimisch 2). The test item was applied by instillation of 0.1 ml into the left eye of each of three young adult Vienna White rabbits. The treated eye was not washed and the untreated eye served as control. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours and 8 and 15 d after application of the test item. The mean score was calculated across 3 scoring times (24/48 /72 hours after instillation). The individual mean scores for corneal opacity were 1.00 for all three animals. The individual mean scores for Iris were 0.3, 0.3, 1.0, the conjunctivae were 2.0, 2.0 and 3.0 for reddening, respectively, and 1.0, 0.0 and 0.3 for chemosis. The instillation of Linalool into the eye resulted in pupil contraction, loss of hair at margins of eyelids, marginal vascularization of the cornea, loss of corneal tissue, and small retractions in the eyelids. These effects were reversible and were no longer evident 15d after treatment (in 1 animal retractions of eyelids and loss of hair at margins of eyelids were still present). Based on the results obtained in the present study the test substance is considered irritant but not corrosive damage to the rabbit eye.
Target and Source chemical(s): The information onBasil oil - Linalool type(target)and the information from Linalool (source) are presented in the Data matrix 1. This includes chemical structure of source,physico-chemical properties and toxicological information, relevant for skin and eye irritation.
Purity / Impurities:
The impurities are not relevant forBasil oil linalool type(target) as it is a UVCB (Naturally Complex Substance), the Linalool content is >45 and < 62 %.
Analogue justification
According to REACH Annex XI an analogue approach and structural alert information can be used to replace testing when information from different sources provides sufficient evidence to conclude that this substance has or does not have a particular dangerous property. The result derived should be applicable for C&L and/or risk assessment and be presented with adequate and reliable documentation.
Analogue selection:
Linaloolwas selected as analogue source because Basil oil – Linalool type consist of at least 45% Linalool.
Structural similarities and differences:Basil oil linalool type (target) contains mostly Linalool. Linalool has a tertiary alcohol, a terminal double bond and a terminal isopropene group. Such (functional) groups are also present in the other constituents: Alpha-bergamotene(contains two C=C double bonds), Germacrene D (contains three C=C double bonds), Gamma-cadinene (contains two C=C double bonds), Alpha-cadinol (contains a C=C bond and a tertiary OH group), Beta-elemene (contains three C=C double bonds), Alpha-bulnesene (contains two C=C double bonds), , Myrcene (contains three C=C double bonds) and Gamma elemene (contains three C=C double bonds). Two constituents have other functional groups: Eugenol (contains C=C double bonds (aromatic and aliphatic), an alcohol and ether group) and Estragole (contains C=C double bonds (aromatic and aliphatic), and an ether group).
Bioavailability:All constituent of Basil oil – Linalool type have similar molecular weights and on this basis a similar bioavailability. The log Kows of the constituents have a somewhat wider range: 2.4 to 5.6. The constituents with log Kow > 4 will be somewhat less penetrating the skin and eye membranes and possibly of a lower irritation potential. These higher log Kow constituents will therefore not be more conservative.
Reactivity: For skin and eye irritation reactivity of the parent is the key property. The constituents of Basil oil – Linolool type are expected to have a similar reactive potential based on the (functional) groups present. There are no corrosion indicators such as acidic or base groups. Linalool has skin and eye irritating properties and therefore Basil – oil Linalool type has skin and eye irritating properties.
Remaining uncertainties: For some constituents (Eucayptol and Estragole) skin and eye information is present indicating the same irritation potential as Linalool and therefore skin and eye irritation properties of Linalool present the irritation potential of Basil oil – Linalool type.
Conclusions for skin and eye irritation
For Basil oil -Linalool type skin and eye irritation information is not available. This substance contains mainly Linalool and therefore the skin and eye irritation effects of Linalool derived from OECD TG 404 and 405 studies) can be used to assess these. The other constituent do not have structural features that indicate a more severe classification. Linalool is a skin and eye irritant Cat 2 and therefore the target substance Basil oil - Linalool type will similarly classified.
Final hazard conclusion: Basil oil – Linalool type is a skin and eye irritant Cat 2.
Data matrix 1. Basil oil – Linalool type (target) and Linalool (source) information to support the read across for skin and eye irritation
CHEMICAL NAME |
Basil oil linalool type |
Linalool* |
Molecular structure |
N/A |
|
|
Target |
Source |
CAS |
84775-71-3 |
78-70-6 |
REACH registration |
To be registered (Annex VII) |
REACH registration |
EINECS |
283-900-8 |
201-134-4 |
Molecular formula |
N/A |
C10H18O |
Molecular weight |
Around 150 |
154.253 g/mol |
Physico-chemical properties |
||
Appearance |
Clear liquid (IFF, 2017) |
Clear liquid |
Melting point (˚C) |
<-20(IFF, 2017) |
>-74 |
Vapour pressure (Pa) |
29.1 (IFF, 2017) |
27 |
Exp. Water solubility (mg/l) |
940.5 (IFF, 2017) |
1560 |
Exp. Log Kow |
2.4-5.6 (IFF, 2017) |
2.9 |
Human health |
|
|
Skin irritation |
Read Across |
Skin Irrit. Cat. 2(OECD TG 404) |
Eye irritation |
Read Across |
Eye Irrit. Cat. 2(OECD TG 405) |
* Hazard properties from ECHA disseminated dossier (accessed March 2018)
Data matrix 2. Composition of Basil oil – Linalool typeand skin and eye information available for these constituents
NAME |
CAS |
Basil oil – Linalool type |
|
Skin irritation* |
Eye irritation* |
|
|
Minimum |
Maximum |
|
|
Linalool |
126-91-0 / 78-7--6 |
45.00% |
62.00% |
Skin Irrit. Cat. 2 |
Eye Irrit. Cat. 2 |
Eucalyptol |
470-82-6 |
3.00%
|
12.00%
|
Skin Irrit. Cat. 2 |
Eye Irrit. Cat. 2 |
Alpha-bergamotene |
17699-05-7 |
0.01%
|
8.00%
|
Not available |
Not available |
Eugenol |
97-53-0 |
0.01% |
8.00% |
Skin Irrit. Cat. 2 |
Eye Irrit. Cat. 2 |
Germacrene D |
37839-63-7 |
1.00% |
5.00% |
Not skin irritant |
Not eye irritant |
Gamma-cadinene |
39029-41-9 |
1.00% |
5.00% |
Not available |
Not available |
Alpha-cadinol |
481-34-5 |
0.50% |
5.00% |
Not available |
Not available |
Beta-elemene |
33880-83-0 |
0.50% |
5.00% |
Not available |
Not available |
Alpha-bulnesene |
3691-11-0 |
0.10% |
3.00% |
Not available |
Not available |
Estragole |
140-67-0 |
< 0.01% |
3.00% |
Skin Irrit. Cat. 2 |
Not eye irritant |
Myrcene |
123-35-3 |
< 0.01% |
2.00% |
Not available |
Not available |
Gamma elemene |
3242-08-8 |
< 0.01% |
2.00% |
Not available |
Not available |
Other minor and unknown constituents |
N/A |
5.00% |
20.00% |
|
|
Unknown |
|
|
|
|
|
*Skin and eye irritation information is derived from C&L inventory or ECHA disseminated dossier (accessed March 2018)
Justification for classification or non-classification
Based on the available data, the substance needs to be classified for skin irritation (Skin Irrit. 2 / H315) and eye irritation (Eye Irrit. 2 / H319) in accordance with the criteria outlined in EU CLP (EC no 1272/2008 and its amendments).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.