Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
ca. 100 mg
Duration of treatment / exposure:
no data
Observation period (in vivo):
72 hours after treatment
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:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal: all
Max. score:
1
Reversibility:
fully reversible within: 2 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
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.33
Reversibility:
fully reversible within: 2 days
Irritation parameter:
chemosis score
Basis:
animal: all
Max. score:
1
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: Max. duration: 48 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
cornea opacity score
Basis:
animal: all
Max. score:
0
Reversibility:
other: not applicable as no effects have been observed.
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
other: not applicable as no effects have been observed.
Irritation parameter:
iris score
Basis:
animal: all
Reversibility:
other: not applicable as no effects have been observed.
Remarks on result:
other: Max. duration: 0 h; Max. value at end of observation period: 0 (related to all animals)
Other effects:
No corrosion was observed at any of the measuring intervals.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
Conclusions:
The test substance, when administered by ocular route to rabbits under the experimental conditions, is to be considered a non irritant for the eye.
Executive summary:

The test substance was found to be not irritating to rabbit eyes in a GLP study according to EU Method B.5 (ca. 100 mg applied, 3 animals).