Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04 November 1997 to 24 November 1997
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: bulk
Details on test material:
brown crystalline solid
Specific details on test material used for the study:
Brown Solid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
At the start of the study the animal weighed 2.99 kg and was twelve to sixteen weeks old. After an acclimatisation period of at least five days the animal was given a number unique within the study which was written with a black indelible markerpen on the inner surface of the ear and on a cage label.
The animal was housed in a suspended metal cage. Free access to mains drinking water and food was allowed throughout the study.
The animal room was maintained at a temperature of 16 to 21*C and relative humidity of 46 to 71%. On occasions the temperature and relative humidity were outside the limits specified in the protocol (17°C and 70% respectively).
The rate of air exchange was approximately fifteen changes per hour and the lighting was twelve hours light and twelve hours darkness.

Test system

Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
A volume of 0.1 ml of the test material, which was found to weigh approximately 58 mg
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were made on Days 7, 14 and 21 to assess the reversibility of the ocular effects
Number of animals or in vitro replicates:
1
Details on study design:
A single application of the test material to the non-irrigated eye of one rabbit produced opalescent corneal opacity, iridial inflammation and moderate conjunctival irritation. Vascularisation of the cornea was also noted in the treated eye.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 48 and 72 hr
Score:
15
Reversibility:
not reversible
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
7 d
Score:
15
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48 h
Score:
5
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24 h
Score:
27
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Score:
32
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 7, 14 and 21 days
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 14 and 21 days
Score:
5
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
10
Reversibility:
not fully reversible within:
Remarks:
not reversible within 21 days
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test material, UK-209,947, was considered to be corrosive to the rabbit eye due to irreversible ocular damage (based on one rabbit only). The test material produced positive criteria in the treated rabbit according to EU labelling regulations and was considered to be IRRITANT to the rabbit eye. It is reasonable to assume the symbol "Xi" and highest risk phrase R 41 "RISK OF SERIOUS DAMAGE TO EYES" are therefore required.