Registration Dossier

Toxicological information

Eye irritation

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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: see 'Remark'
Remarks:
The information of this endpoint has been provided by ECHA as a result of an inquiry, thus the full access to data in the report is not accessible to the registrant. However the reliability is estimated to be at level 1: Study conducted in accordance with generally accepted scientific principles. Possible deficiencies do not affect the quality of relevant results.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Year:
1998
Report Date:
1998

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 material form:
solid: particulate/powder
Remarks:
migrated information: powder

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
41 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
No data
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
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Max. score:
1
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: 24 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
cornea opacity score
Basis:
mean
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: h; Max. value at end of observation period: (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible
Remarks:
3 days
Irritation parameter:
iris score
Basis:
mean
Max. score:
0
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: max. duration: h; Max. value at end of observation period:(related to all animals)
Other effects:
Conjunctival redness and chemosis were observed at 1 hour reading (mx grade 2)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: not specified