Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, 01400 Chatillon sur Chalaronne, France
- Age at study initiation: Approximately 8 - 12 weeks
- Weight at study initiation: 2680 - 2790 g
- Housing: Individual
- Diet; ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 % ± 20 %
- Air changes (per hr): 13 - 14/hour
- Photoperiod (hrs dark / hrs light): 12/12 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml


Duration of treatment / exposure:
24 hours
Observation period (in vivo):
Eyes were examined and scores recorded at 1,24, 48 and 72 hours after treatment.
Number of animals or in vitro replicates:
3 females
Details on study design:
Treatment: The test article was instilled into the conjunctival sac of the left eye of each animal after gently pulling the
lower lid away from the eyeball. The lids were then gently held together for about one second.
The right eye remained untreated and served as a control.

Post-treatment wash-out: The treated eyes were gently washed with distilled water for 1 minute after the reading at 24 hours
post treatment.

SCORING SYSTEM: OECD/EEC

TOOL USED TO ASSESS SCORE: Portable hand-slit lamp (Model SL-14, Kowa Co., Dusseldorf, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
other: no effect
Irritant / corrosive response data:
Hyperaemic conjunctival blood vessels (score of 1) were observed in all animals at the 1-hour reading. All eye reactions were reversed by day 1. The results of the eye examinations for individual animals are presented in Table 1.
Mean irritation scores for eye reactions are presented in Table 2.
Other effects:
Mortality:
There was no mortality in the test.

Clinical Observations:
There were no remarkable clinical observations.

Body weights:
Body weights were not affected by treatment. Individual body weights presented din Table 3.

Classification:
According to Commission Directive 93/21/EEC, issued May 4, 1993, the results of this test indicate that CA 2219 A (Intermediate of CGA 276854) is not required to be classified for eye irritation.

Any other information on results incl. tables

 

Table 1: Individual Eye Irritation Scores

SEX / ANIMAL NO.

F / 813

F/ 893

F / 836

 

CORNEA

 

CE

TE

CE

TE

CE

TE

AFTER 1 HOUR

AFTER 24 HOURS

AFTER 48 HOURS

AFTER 72 HOURS

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

IRIS

AFTER 1 HOUR

AFTER 24 HOURS

AFTER 48 HOURS

AFTER 72 HOURS

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

CONJUNCTIVAL REDNESS

AFTER 1 HOUR

AFTER 24 HOURS

AFTER 48 HOURS

AFTER 72 HOURS

0

0

0

0

1

0

0

0

0

0

0

0

1

0

0

0

0

0

0

0

1

0

0

0

 

CONJUNCTIVAL CHEMOSIS

AFTER 1 HOUR

AFTER 24 HOURS

AFTER 48 HOURS

AFTER 72 HOURS

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

CE: CONTROL EYE   TE: TEST EYE

 

Table 2: Summary Eye Irritation Indices (OECD/EEC)

Mean Scores for 24, 48 and 72 hour readings

SEX / ANIMAL NO.

F / 813

F/ 893

F / 836

MEAN

CORNEA

0

0

0

0

IRIS

0

0

0

0

CONJUNCTIVAL REDNESS

0

0

0

0

CONJUCTIVAL CHEMOSIS

0

0

0

0

 

 

Table 3: Body Weights (g)

SEX / ANIMAL NO.

F / 813

F/ 893

F / 836

AT TEST START

AT TEST END (3 DAYS)

2680

2760

2690

2720

2790

2880

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the test results, CA 2219 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.
Executive summary:

An eye irritation/corrosion test was conducted with test article CA 2219 A (Intermediate of CGA 276854) (batch 249-GE001/SU). The test article (0.1 ml) was instilled into the conjunctival sac of one eye of three rabbits; the second eye served as a control. The test eyes were gently washed with distilled water 24 hours after treatment. Eyes were examined for irritation at 1, 24, 48 and 72 hours after treatment. 

 

Redness of the conjunctiva was observed in all animals at the 1-hour reading. All eye reactions were clear by day 1. There was no mortality. No remarkable clinical observations were recorded. Body weights were not affected by treatment. 

 

According to the test results, CA 2219 A (Intermediate of CGA 276854) is not required to be classified for eye irritation according to Commission Directive 93/21/EEC, issued May 4, 1993.