Registration Dossier

Diss Factsheets

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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
EC Number:
915-617-9
Molecular formula:
C13H22O2
IUPAC Name:
3-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde; 4-(4-hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Thomas R. Hanna, Nashanic Station, N. J., USA
- Age at study initiation: adult
- Weight at study initiation: 2.5 - 3.1 kg
- Housing: singly under standard laboratory conditions. No extraneous material was used in cages
- Diet: 100 g of Purina Rabbit Chow supplemented by whole oats daily, ad libitum
- Water: ad libitum

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
Duration of treatment / exposure:
A single instillation
Observation period (in vivo):
24, 48, 72 hour, and 4, 7 and 10 days after dosing
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE:
- Washing: not performed

SCORING SYSTEM:
- Draize

TOOL USED TO ASSESS SCORE:
- Fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
iris score
Basis:
animal: #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #4
Time point:
24/48/72 h
Score:
1.33
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal: #2, #3, #6
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal: #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
All of the animals had slight opacity over approximately 50% of the cornea 24 hours after dosing, which had cleared by 48 hours. At 24 hours the opaque areas retained dye. Conjunctival redness, observed in all animals 24 hours after dosing, had subsided by 72 hours, when all scores were 0. At Day 4 and Day 7 all scores were 0, and the eyes did not retain fluorescein dye.
The primary ocular irritation score was 19.7 at 24 hours, 2.3 at 48 hours and 0 at 72 hours, day 4 and day 7.
Other effects:
All animals remained healthy and showed normal behaviour throughout the study.

Applicant's summary and conclusion

Interpretation of results:
other: Not irritating
Remarks:
in accordance with EU CLP (EC no 1272/2008 and its amendments)
Conclusions:
The test substance is not irritating to rabbit eyes.
Executive summary:

Eye irritating properties of test substance were studied in a pre-GLP study with rabbits, conducted according to a protocol similar to OECD TG 405. A single instillation of 0.1 mL undiluted test substance into the eyes of 6 rabbits resulted in mean scores of 0.3, 0.1, 1.1 and 0.3 for cornea, iris, conjunctiva and chemosis, respectively, over 24, 48 and 72 hours. All effects were fully reversible within 72 hours. Based on these results, the test substance was concluded to be non-irritating to rabbit eyes.