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EC number: 263-336-9 | CAS number: 61931-80-4
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 08.08.1988-26.09.1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: 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:
- weight of evidence
- Justification for type of information:
- See attached justification
- Reason / purpose for cross-reference:
- read-across source
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: Mean 1.0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15d
- Remarks on result:
- other: Mean 0.6
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15d
- Remarks on result:
- other: Mean 2.3
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15d
- Remarks on result:
- other: Mean 0.4
- Irritant / corrosive response data:
- loss of corneal tissue (reversible)
- Other effects:
- pupil contraction, loss of hair at margins of eyelids, marginal vascularization of the cornea, small retractions in the eyelids
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), Linalool is considered to be "not irritating" to the rabbit eye. Based upon the referred classification (Commission Regulation 1272/2008/EC of December 16, 2008), Linalool is considered to be "irritating" to the rabbit eye (Category 2). This result is used for read-across to ethyllinalyl acetate.
- Executive summary:
The primary eye irritation potential of Linalool was investigated based on OECD test guideline no. 405. 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 test item installation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. 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 except retractions of eyelids and loss of hair at margins of eyelids were reversible and were no longer evident 15d after treatment, the end of the observation period for all animals. Retractions of eyelids and loss of hair are, however, expected to be reversible. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Based upon the standard classification criteria (Commission Directive 2001/59/EC of August 06, 2001), Linalool is considered to be "not irritating" to the rabbit eye. Based upon the referred classification (Commission Regulation (EC) 1272/2008 of December 16, 2008), Linalool is considered to be "irritating" to the rabbit eye (Category 2). This result is used for read-across to ethyllinalyl acetate.
| 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 | |||||||||
| TABLE 2: EYE IRRITATION SCORES - MEAN VALUES AFTER 24, 48 AND 72 HOURS | |||||||||
| Animal number | Sex | Corneal Opacity | N | Iris | N | Conjunctivae | |||
| Redness | N | Chemosis | N | ||||||
| 1 | M | 1.0 | 3 | 0.3 | 3 | 2.0 | 3 | 1.0 | 3 |
| 2 | M | 1.0 | 3 | 0.3 | 3 | 2.0 | 3 | 0.0 | 3 |
| 3 | F | 1.0 | 3 | 1.0 | 3 | 3.0 | 3 | 0.3 | 3 |
| N = number of available data points. | |||||||||
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Principles of method if other than guideline:
- No data
- 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:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: SAVO. MED. VERSUCHSTIERZUCHTEN GMBH- Housing: THE ANIMALS WERE HOUSED I N FULLY AIR-CONDITIONED ROOMS. CENTRAL AIR-CONDITIONING GUARANTEED ARANGE OF 2 0 - 2 4 DEGREES CELSIUS FOR TEMPERATURE AND OF 3 0 - 70% FOR RELATIVE HUMIDITY.- Diet (e.g. ad libitum): 130 g per animal per day, Kliba 341, 4mm- Water (e.g. ad libitum): 250 ml per animal per day- Acclimation period: AT LEAST 8 DAYS BEFORE THE BEGINNING OF THE STUDV: SAME HOUSING CONDITIONS AS DURING THE STUDYENVIRONMENTAL CONDITIONS- Temperature (°C): 20- 24 °C- Humidity (%): 30-70%- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 0.1 ml per animal
- Duration of treatment / exposure:
- single application to the conjunctival sac of the right eyelid; the substance was not washed out
- Observation period (in vivo):
- 15 d
- Number of animals or in vitro replicates:
- 2 male, 1 female
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): noSCORING SYSTEM: Chemosis and Cornea: 0=none/normal, 1= slight, 2=well-defined, 4=severe, 5= very severeArea of cornea involved: 1 = >0; <1/4, 2= >= 1/4; < 1/2, 3= >=1/2; <3/4, 4= >=3/4Iris: 0= normal, 1= circumcorneal redness, 2= IritisConjunctivae 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:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15 days
- Remarks on result:
- other: Mean 1.0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 15d
- Remarks on result:
- other: Mean 0.6
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 2 - <= 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 15d
- Remarks on result:
- other: Mean 2.3
- Irritation parameter:
- chemosis score
- Remarks:
- Chemosis
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 15d
- Remarks on result:
- other: Mean 0.4
- Irritant / corrosive response data:
- loss of corneal tissue (reversible)
- Other effects:
- pupil contraction, loss of hair at margins of eyelids, marginal vascularization of the cornea, small retractions in the eyelids
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 | |||||||||
| TABLE 2: EYE IRRITATION SCORES - MEAN VALUES AFTER 24, 48 AND 72 HOURS | |||||||||
| Animal number | Sex | Corneal Opacity | N | Iris | N | Conjunctivae | |||
| Redness | N | Chemosis | N | ||||||
| 1 | M | 1.0 | 3 | 0.3 | 3 | 2.0 | 3 | 1.0 | 3 |
| 2 | M | 1.0 | 3 | 0.3 | 3 | 2.0 | 3 | 0.0 | 3 |
| 3 | F | 1.0 | 3 | 1.0 | 3 | 3.0 | 3 | 0.3 | 3 |
| N = number of available data points. | |||||||||
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), Linalool is considered to be "not irritating" to the rabbit eye. Based upon the referred classification (Commission Regulation 1272/2008/EC of December 16, 2008), Linalool is considered to be "irritating" to the rabbit eye (Category 2).
- Executive summary:
The primary eye irritation potential of Linalool was investigated based on OECD test guideline no. 405. 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 test item installation. The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. 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 except retractions of eyelids and loss of hair at margins of eyelids were reversible and were no longer evident 15d after treatment, the end of the observation period for all animals. Retractions of eyelids and loss of hair are, however, expected to be reversible. No corrosion was observed at any of the measuring intervals. No staining of the treated eyes by the test item was observed. Thus, the test item did not induce significant or irreversible damage to the rabbit eye. Based upon the standard classification criteria (Commission Directive 2001/59/EC of August 06, 2001), Linalool is considered to be "not irritating" to the rabbit eye. Based upon the referred classification (Commission Regulation (EC) 1272/2008 of December 16, 2008), Linalool is considered to be "irritating" to the rabbit eye (Category 2).
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