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Toxicological information

Eye irritation

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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:
1988
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

1
Chemical structure
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

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.