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Diss Factsheets

Toxicological information

Eye irritation

Currently viewing:

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:
1974
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

Constituent 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
Details on test material:
- Name of test material (as cited in study report): Linalool

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.