Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from October 3rd, 1988 to October 6th, 1988.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study performed according to the Test Guidelines 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
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
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:
not specified
Controls:
yes
Amount / concentration applied:
0.071 g (0.1 ml)
Duration of treatment / exposure:
at least 1 second.
Observation period (in vivo):
72 hours.
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 hour
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 48 hours
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
1.33
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hours
Score:
0.66
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 hours
Score:
0.66
Max. score:
1
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hour
Score:
1
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 hours
Score:
0.66
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 hours
Score:
0.66
Max. score:
1
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
0

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.