Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
15-Jan-1992 to 11-Mar-1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Performed in accordance with OECD guideline and GLP compliant.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD guideline 405
Deviations:
yes
Remarks:
Due to a malfunction of a thermohygrograph the temperature and the relative humidity in the animal room were not recorded on two days. This deviation was not considered to have affected the integrity of the study performed.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Test animals
SPF-derived male New Zealand White rabbits (2.5-3.0 kg) were obtained from Harlan Olac, Zeist, The Netherlands. The animals were inspected for signs of illness at the beginning of the acclimatization period. No abnormalities were detected.

Animal care
Three rabbits were individually housed in stainless steel wire cages KK 102. Sawdust, woodchips, or other extraneous material that might produce eye irritation were excluded. The rabbits received 80 g food (a standard laboratory diet LKK-20, Hope Farms, Woerden, The Netherlands) per day during the acclimatization period of 12 days. During the experiment the animals had free access to food and water.

Animals were housed in room no. 301, CDA Ill with the following animal room conditions:

Temperature 18-20°c;
Relative humidity 60-74%;
Artificial light from 7 a.m. till 7 p.m.;
Radio-sound on 12 hours per day;
Ventilation approximately 16 air changes per hour.

Test system

Vehicle:
not specified
Controls:
other: The other eye, remaining untreated, served as a control.
Amount / concentration applied:
A quantity of 0 .1 g of Retroketal was placed in the conjunctiva! sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed.
Duration of treatment / exposure:
Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3 males
Details on study design:
After the acclimatization period, both eyes of each rabbit were examined with the aid of a slit­lamp. Only those rabbits without eye defects or signs of irritation were used. A quantity of 0 .1 g of Retroketal was placed in the conjunctiva! sac of the left eye by gently pulling the lower lid away from the eyeball to form a cup into which the test substance was placed. The lids were then gently held together for one second and the rabbit was released. The other eye, remaining untreated, served as a control.

Readings of reactions were made in all three rabbits at 1, 24, 48 and 72 hours after treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Reversibility:
not specified
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Very slight iritis and swelling of the conjunctiva was observed in one animal at 1 hour after application of the test material. No significant eye irritation in three rabbits was observed. The test material is therefore classified as not irritant to the eye according to EEC labelling regulations. No symbol and no risk phrase are required.