Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
other: All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum.
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant. The reliability is estimated to be at level 2 at a minimum. Therefore the reliability statement below can be used: Study conducted in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of relevant results.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
not specified
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
Details on test material:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Test system

Vehicle:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Controls:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Amount / concentration applied:
20 mg

No other details provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Duration of treatment / exposure:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Observation period (in vivo):
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Number of animals or in vitro replicates:
6
Details on study design:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
mean
Time point:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Score:
0.56
Max. score:
2
Reversibility:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: Maximum duration: 72 hours. Maximum value at end of observation period: 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Score:
0.22
Max. score:
2
Reversibility:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: Maxium duration: 24 hours. Maximum value at end of observation period: 0
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Score:
0.06
Max. score:
1
Reversibility:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: Maximum duration: 24 hours. Maximum value at end of observation period: 0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Score:
0.33
Max. score:
1
Reversibility:
other: This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) provided by ECHA
Remarks on result:
other: Maximum duration: 24 hours. Maximum value at end of observation period: 0
Irritant / corrosive response data:
Reversibility of any observed effects: Changes fully reversible within 7 days.
Other effects:
This information not provided in the migrated SNIF dossier (SNIF # 001-3.0.10-01) 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 substance has been determined not to be an eye irritant.
Executive summary:

All information in this endpoint has been provided by the ECHA using the 12 year rule, this is data is not owned by the registrant.

Eye irritation properties examined by using OECD Guideline 405 (1981) EEC Directive 84/449 (1984) - Annex V - Method B5

T-1540N was demonstrated not to be an irritant to the rabbit eye.