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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:
24 December 1987 to 03 March 1987
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate
EC Number:
619-447-3
Cas Number:
99607-70-2
Molecular formula:
C18H22ClNO3
IUPAC Name:
heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate
Details on test material:
- Name of test material (as cited in study report): CGA185072 technical
- Physical state: solid
- Analytical purity: 91.6%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not specified
- Age at study initiation: 12-14 weeks
- Weight at study initiation: 2180 to 2550 g
- Housing: conventional laboratory housing units not otherwise specified
- Diet (e.g. ad libitum): not specified
- Water (e.g. ad libitum): not specified
- Acclimation period: not specified

IN-LIFE DATES: From: 24.02.1987 To: 03.03.1987

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
The report indicates 0.1 mL (a weight of 48 mg) was instilled into each treated eye
Duration of treatment / exposure:
The eyes were examined over a period of 7 days. No rinse out procedures were included to flush the test material away at any point
Observation period (in vivo):
Observation and assessment of ocular damage completed at 1, 24, 48 and 72 hours post-instillation and again after 7 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Standard Draize method

TOOL USED TO ASSESS SCORE: None specified - simple visual checks only

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
Signs of irritation were evident 1, 24 and 48 hours following instillation affecting the conjunctivae and cornea. No adverse effects noted for the iris.
All signs of irritation had resolved within 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
Cloquintocet-mexyl is not irritating to the eyes.
Executive summary:

An in vivo study in rabbits was conducted under GLP to OECD TG 405 to evaluate the eye irritation potential of the substance. An aliquot of 0.1 mL (48 mg) of cloquintocet-mexyl was placed into the conjunctival sac of one eye of three male New Zealand White rabbits. Ocular reactions were evaluated at 1, 24, 48, and 72 hours and 7 days following treatment. The results showed transient slightly irritating effects in the cornea and conjunctivae that had fully resolved within 72 hours. Cloquintocet-mexyl was evaluated to be not irritating to the eyes.