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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
Eye irritation
Administrative data
- 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)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- 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.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- Deviations:
- no
- 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
- Test material form:
- liquid
1
Test animals / tissue source
- 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
Test system
- 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
Results and discussion
In vivo
Resultsopen allclose all
- 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.
Any other information on results incl. tables
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 |
Applicant's summary and conclusion
- 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.
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