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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
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

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
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:
Remarks on result:
other: 72 h
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

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