Registration Dossier

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:
other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment
Cross-reference
Reason / purpose:
reference to same study

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
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:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Slight reactions observed in all three rabbits at 1, 24 and 48 hour assessments
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: Not applicable.
Remarks on result:
other: No iridial changes were apparent
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
1.2
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Slight to well defined erythema evident for all three treated eyes at assessments in first 48 hours after instillation. All reactions had resolved within 72 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 hours
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Very slight to slight chemosis evident for all three treated eyes in the first 48 hours after dosing. Fully recovered by the 72 hour assessment
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

Any other information on results incl. tables

Table 1: Summary of results

Cornea

Iris

Animal no.

 1 M

2 M

 3 M

1 M

2 M

3 M

after 1 hour

1

0

0

0

0

0

after 24 hours

1

1

1

0

0

0

after 48 hours

1

1

1

0

0

0

after 72 hours

after 7 days

0

0

0

0

0

0

0

0

0

0

0

0

mean score 24, 48, 72 h

0.67

0

Conjunctival redness

Conjunctival chemosis

after 1 hour

1

1

1

2

1

2

after 24 hours

2

2

2

1

1

1

after 48 hours

2

1

2

1

1

1

after 72 hours

after 7 days

0

0

0

0

0

0

0

0

0

0

0

0

mean score 24, 48, 72 h

1.2

0.67

M: Male 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Cloquintocet-mexyl does not trigger classification for eye irritation.
Executive summary:

To evaluate eye irritation potential, 0.1 mL (48 mg) of cloquintocet-mexyl technical, purity 91.6%, batch P. 607001/002 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 slight irritating effects in the cornea and conjunctivae that had fully resolved within 72 hours. Cloquintocet-mexyl does not trigger classification for eye irritation.