Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented study report which meets basic scientific principles, not according to current guidelines
Cross-reference
Reason / purpose:
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: Acceptable, well documented study report which meets basic scientific principles, not according to current guidelines
Justification for type of information:
See attached justification in section 13.2
Reason / purpose:
read-across source
Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no
Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 3.19 kg, female 3.44 kg
Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl into other eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 100%
Duration of treatment / exposure:
continuously
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Gradings for corneal opacity, conjunctival redness and chemosis were converted into numerical grading system acc. to Draize.

Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe


Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe
4= very severe
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
1.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h

Animal 1: male

Animal 2: female

Results:

Readings Animal Erythema chemosis Corneal opacity Additional findings
1h 1 2 1 1 miosis
2 2 3 2 miosis
3 h 1 2 1 1 discharge
2 2 2 2 discharge
24 h 1 1 1 2 mucosal hemorrhages
2 2 1 2 mucosal hemorrhages
72 h 1 1 0 1 mucosal hemorrhages
2 1 0 3 mucosal hemorrhages, scar
4 d 1 1 0 1 mucosal hemorrhages
2 1 0 3 mucosal hemorrhages, scar
7 d 1 1 0 1  
2 1 0 1 scar
8 d 1 1 0 1  
2 1 0 1 scar
Mean 24 - 72 h 1 1 0.5 1.5  
2 1.5 0.5 2.5  
Mean   1.25 0.5 2

No effects reported for iris.

No effects observed for eyes treated with NaCl.

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report Date:
1972

Materials and methods

Principles of method if other than guideline:
Internal BASF method was used
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Hydroxycitronellal (HCA); 3.7-Dimethyl-7-hydroxyoctanol-1
- Physical state: liquid
- Purity: approx. 99%

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male 3.19 kg, female 3.44 kg

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: NaCl into other eye of same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50 µl
- Concentration (if solution): 100%
Duration of treatment / exposure:
continuously
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM:
Gradings for corneal opacity, conjunctival redness and chemosis were converted into numerical grading system acc. to Draize.

Chemosis (Swelling) and cornea (Opacity):
0 = none
1 = slight
2 = well defined
3 = severe
4 = very severe


Conjunctival redness (Redness):
0 = normal
1 = slight
2 = well defined
3 = severe
4= very severe

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
1.25
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72h
Remarks on result:
probability of weak irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24, 72 h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 d
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: not specified for 48h

Any other information on results incl. tables

Animal 1: male

Animal 2: female

Results:

Readings Animal Erythema chemosis Corneal opacity Additional findings
1h 1 2 1 1 miosis
2 2 3 2 miosis
3 h 1 2 1 1 discharge
2 2 2 2 discharge
24 h 1 1 1 2 mucosal hemorrhages
2 2 1 2 mucosal hemorrhages
72 h 1 1 0 1 mucosal hemorrhages
2 1 0 3 mucosal hemorrhages, scar
4 d 1 1 0 1 mucosal hemorrhages
2 1 0 3 mucosal hemorrhages, scar
7 d 1 1 0 1  
2 1 0 1 scar
8 d 1 1 0 1  
2 1 0 1 scar
Mean 24 - 72 h 1 1 0.5 1.5  
2 1.5 0.5 2.5  
Mean   1.25 0.5 2

No effects reported for iris.

No effects observed for eyes treated with NaCl.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
In the study for eye irritation of the test item applied to eyes of two Vienna White rabbits, reactions were evaluated for eight days. As result, mean scores (24, 72 hours) for corneal opacity, conjunctival redness and chemosis were 1.5, 1 and 0.5, for animal 1 and 2.5, 1.5 and 0.5 for animal 2, respectively. Conjunctival redness and corneal opacity were not reversible within the eight day observation period. The test substance has been found to be irritating to eyes under the chosen testing conditions.