Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guideline B.5 of the EEC Directive 84/449/EEC and OECD guideline N°405

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
A c. 700 g sample of the test substance was received from the sponsor on
September 19, 1988. It consisted of a fine, white powder, designated:
“AF-366”. Prior to application, the weight of 0.1 ml of the test substance
was assessed to be 0.071 g.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy male, young adult, New Zealand White albino rabbits, obtained from
ENKI—Konijnenfarm, Someren, the Netherlands, were used as the experimental
animals. The body weight range was 2670—3055 g. The animals ware
identified by earmarking, and subsequently housed individually in
suspended, galvanized cages, fitted with a wire—mesh floor and front. The
cages ware placed in a room, controlled for light (12 hours light42 hours
dark cycle), temperature (18 ± 3°C), ventilation (c. 10 air changes/hour),
and relative humidity (at least 40%) throughout the test period.
A standard laboratory rabbit diet and tap water ware provided ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as the control
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1ml (0.071g)
Duration of treatment / exposure:
at least 1 second
Single application without washing
Observation period (in vivo):
72 hours
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated eye was not washed after application

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
3
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48 and 72h
Score:
0.67
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritant / corrosive response data:
Remains of the test substance were observed in the treated eye of 3/3 rabbits 1 hour after instillation, but disappeared within 24 hours. At the 1-hour reading time point, 3/3 rabbits had slight to moderate conjunctivae (redness) and slight chemosis. 24 and 48 hours after instillation, 2/3 rabbits still had slight conjunctivae and chemosis. All the eye irritation effects had cleared within 72 hours.

Any other information on results incl. tables

Table 1. Results of eye irritation study

 

Rabbit #

 

Time [h]

 

conjunctivae

 

iris

 

cornea

 

redness

swelling

1

 

 

 

 

1

1

1

0

0

24

0

0

0

0

48

0

0

0

0

72

0

0

0

0

average

0.0

0.0

0.0

0.0

2

 

 

 

 

1

1

1

0

0

24

1

1

0

0

48

1

1

0

0

72

0

0

0

0

average

0.67

0.67

0.0

0.0

3

 

 

 

 

1

2

1

0

0

24

1

1

0

0

48

1

1

0

0

72

0

0

0

0

average

0.67

0.67

0.0

0.0

 

Time [h]

conjunctivae

 

iris

cornea

 

redness

swelling

 

 

average

score

1

1.33

1.00

0.00

0.00

24

0.67

0.67

0.00

0.00

48

0.67

0.67

0.00

0.00

72

0.00

0.00

0.00

0.00

24+48+72

0.45

0.45

0.00

0.00

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
On the basis of the resuits obtained it is concluded that, under the
conditions of this study and according to the EEC—standards (as published
in the Official Journal of the European Communities, L 257, Volume 26, 16
September 1983), the substance “AF—366” is not irritating or corrosive to
eyes.