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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:
13 March 1989 to 25 September 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Molecular formula:
C14H24O1
IUPAC Name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Constituent 2
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Constituent 3
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2S)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2S)-rel-
Constituent 4
Chemical structure
Reference substance name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Molecular formula:
C15H24O
IUPAC Name:
Cyclopentanone, 2-[(2R)-2-[(1R)-4-methyl-3-cyclohexen-1-yl]propyl]-, (2R)-rel-
Test material form:
liquid
Specific details on test material used for the study:
Substance name (as stated in the report): NECTARYL - LRG 1371
Identification for the study: 07683 D9 001
Description: colourless slightly viscous liquid
Batch: AS1241001

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Species, strain: New-Zealand hybrid albino rabbit vaccinated against myxomatosis (Lyomyxovax N.D. - Rhone Merieux - 69223 Lyon - France).
- Supplier: E.S.D. (Romans - 01400 Chatillon Sur Chalaronne - France)
- Age: adult
- Number and sex: 6 males
- Weight at the beginning of treatment: 2.45 to 2.55 kg
- Cages: individually housed in polystyrene cages, with perforted flooring (interior dimensions 560 x 355 x 315 mm)
- Temperature : 17 - 21°C
- Humidity: 50 to 68 % R.H.
- Lighting artificial, 12 hours out of 24 (photoperiod = 7h30 - 19h30)

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
test substance as supplied
Controls:
yes, concurrent negative control
Amount / concentration applied:
- Dose level : 0.1 ml per animal of the test substance as supplied (undiluted)
Duration of treatment / exposure:
- Frequency: the test substance was applied once only
- Duration: instillation
Observation period (in vivo):
Ocular examinations were performed in the order in which the animals were treated, 1 hour after administration of the test substance, then at 24, 48 and 72 hours
Number of animals or in vitro replicates:
- Group: a single treated group of 6 male rabbits.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
cornea opacity score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #6
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #5
Time point:
24/48/72 h
Score:
1.33
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 72h

Any other information on results incl. tables

The evaluation of ocular reversibility was not performed because no severe ocular lesion was observed 72 hours after administration of the test substance.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
The test substance is considered to be irritating to eyes (Category 2) according to GHS criteria.
Executive summary:

The evaluation of acute ocular irritation and reversibility of NECTARYL in the rabbit was performed according the OECD Guideline No. 405.

The test substance was applied as supplied in the amount of 0.1 ml per animal, into the inferior conjunctival sac of one eye of each of the 6 Zealand hybrid albino male rabbits.

The ocular examinations were performed 1 hour after after administration of the test substance, then at 24, 48 and 72 hours.

Mean values were calculated from the evaluation of the ocular lesions performed in all the rabbits examined at 24, 48 and 72 hours.

The test substance is considered to be irritating to eyes (Category 2) according to GHS criteria

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