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:
2000
Report Date:
2000

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, F-01400 Chatillon sur Chalaronne / France
- Age at study initiation: Male 15 weeks. Females 15 and 16 weeks.
- Weight at study initiation: 2.7 - 3.0 kg
- Housing: Individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 - 70 %
- Air changes: 10 - 15/hour
- Photoperiod: 12 hours light/12 hours dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s): 0.1 ml (per animal)
- Concentration: undiluted as delivered by the sponsor
- pH: 6
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 (1 male, 2 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
The treated eyes were not rinsed after application.

SCORING SYSTEM:
Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.

TOOL USED TO ASSESS SCORE:
Eye examinations made with a Varta Cliptrix diagnostic-lamp.

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:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 224 to 72 hours
Score:
ca. 0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
other: redness
Basis:
mean
Time point:
other: 24 to 72 hours
Score:
ca. 0.3
Max. score:
2
Reversibility:
fully reversible
Irritant / corrosive response data:
IRRITATION:
Hypermeric blood vessels of the conjunctivae and nictitating membranes to diffuse conjunctival blood vessels were noted in all animals at the 1 hour reading and disappeared 24 hours after treatment (1 animal) or diminished to be clear at 48 hours (2 animals). Slight swelling of the conjunctivae and nictitating membrane was observed in two animals at the 1 hour reading and disappeared 24 hours later. The sclera was slightly to markedly reddened in all animals at the 1 hour reading and persisted with less severity in only one animal at 24 hours before disappearing at 48 hours.
The mean values from 24 to 72 hours (criteria for evaluation according the EEC Commission Directive 93/21/EEC) were 0 for corneal opacity, 0 for iris lesions, 0.3 for redness of the conjunctivae and 0 for chemosis of the conjunctivae.
All eye reactions were clear within 72 hours after treatment.

COLORATION:
No staining of the treated eyes by the test item was observed.

CORROSION:
No corrosion was observed at any of the measuring intervals.
Other effects:
No clinical signs of systemic toxicity were observed in the anilmals during the study and no mortality occured.

Any other information on results incl. tables

Individual Eye Irritation Scores

Animal Number

Sex

Evaluation Interval

Corneal Opacity

Iris

Conjunctivae

Redness

Chemosis

67

68

69

M

F

F

1 hour

0

0

0

0

0

0

2

1

2

1

0

1

67

68

69

M

F

F

24 hours

0

0

0

0

0

0

1

0

1

0

0

0

67

68

69

M

F

F

48 hours

0

0

0

0

0

0

0

0

1

0

0

0

67

68

69

M

F

F

72 hours

0

0

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based upon the criteria stated in EEC Commission Directive 93/21/EEC, classification of CA 2814 B (Intermediate of CGA 276854) is not required.
Executive summary:

The primary eye irritation potential of CA 2814 B (Intermediate of 276854) was investigated by instillation of 0.1 ml into one eye of three young adult New Zealand White rabbits. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours after application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion. 

 

Hypermeric blood vessels of the conjunctivae and nictitating membranes to diffuse conjunctival blood vessels were noted in all animals at the 1 hour reading and disappeared 24 hours after treatment (1 animal) or diminished to be clear at 48 hours (2 animals). Slight swelling of the conjunctivae and nictitating membrane was observed in two animals at the 1 hour reading and disappeared 24 hours later. The sclera was slightly to markedly reddened in all animals at the 1 hour reading and persisted with less severity in only one animal at 24 hours before disappearing at 48 hours. 

 

The mean values from 24 to 72 hours (criteria for evaluation according the EEC Commission Directive 93/21/EEC) were 0 for corneal opacity, 0 for iris lesions, 0.3 for redness of the conjunctivae and 0 for chemosis of the conjunctivae. 

 

All eye reactions were clear within 72 hours after treatment. 

 

No staining of the treated eyes by the test item was observed. 

 

No corrosion was observed at any of the measuring intervals. 

 

Based upon the criteria stated in EEC Commission Directive 93/21/EEC, classification of CA 2814 B (Intermediate of CGA 276854) is not required.