Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
4 (not assignable)

Data source

Reference
Reference Type:
other: extracted from ECHA database
Title:
Unnamed
Year:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Amount / concentration applied:
ca.66 mg
Number of animals or in vitro replicates:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
4
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
4
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
3
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
2
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
1
Max. score:
1
Irritant / corrosive response data:
Chenges not fully reversible within 2 days
Other effects:
Severe ocular irritation in 3/3 rabbits. Diffuse corneal opacities together with small areas of loss of the corneal epithelium were observed in all three rabbits at the one hour reading and by the 24 h reading translucent corneal opacities had developed in alla three animals. A similar level of reaction persisted in two rabbits at the 48 hr reading when an opaque corneal opacity had developed in the remaining animal. Iritis was observed in all three rabbits throughout the 48-hr observation period. A diffuse crimson red colouration of the conjunctivae accompanied by moderate or severe swelling and an extensive discharge was observed in all three rabbits at the one hour reading. Petechiae were also seen on the conkunctivae of one rabbit at this stage. At the 24-hr reading a diffuse beefy red colouration of the conkunctivae accompanied by moderate or severe swelling and moderate or extensive discharge had developed in all three rabbits.
Petechiae and white necrotic areas had developed on the nictitating membrane of the third animal.
Due to the severity of the reactions observed, all three rabbits were killed immediately following the 48 hour reading.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: Kay and Calandra classification system.
Conclusions:
The substance was classified as a severe irritant (grade 6) or very severe irritant (grade 7) according to the Kay and Calandra classification system.