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
Study period:
No date
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: All information in this endpoint has been provided by the ECHA using the 12 years rule. This data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
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
Details on test material:
This information is not provided in the migrated NONS file provided by ECHA.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
This information is not provided in the migrated NONS file provided by ECHA.

Test system

Vehicle:
other: This information is not provided in the migrated NONS file provided by ECHA.
Controls:
other: This information is not provided in the migrated NONS file provided by ECHA.
Amount / concentration applied:
41 mg
Duration of treatment / exposure:
This information is not provided in the migrated NONS file provided by ECHA.
Observation period (in vivo):
This information is not provided in the migrated NONS file provided by ECHA.
Number of animals or in vitro replicates:
3 rabbits
Details on study design:
This information is not provided in the migrated NONS file provided by ECHA.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Max. score:
1
Remarks on result:
other: Maximum duration: 48 h; Maximum 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:
0.3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
chemosis score
Max. score:
1
Remarks on result:
other: Maximum duration: 24 h; Maximum 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
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
cornea opacity score
Max. score:
0
Remarks on result:
other: Maximum duration: 0h; Maximum 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
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Irritation parameter:
iris score
Max. score:
0
Remarks on result:
other: Maximum duration: 0h; Maximum value at end of observation period: 0 (related to all animals)
Irritant / corrosive response data:
Reversibility of any observed effect within 3 days.
Other effects:
This information is not provided in the migrated NONS file provided by ECHA.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] has been determined not to be irritant to eye.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule.

The eye irritation has been determined according to the EU Method B.5 and in compliance with GLP.

The test item [1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol] has been determined not to be irritant to rabbit eye. It is not classified for eye irritation according to the criteria of DSD and CLP.