Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997

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

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye untreated
Duration of treatment / exposure:
24 h
Observation period (in vivo):
60 min, 24, 48 ,72 hours after instillation
Number of animals or in vitro replicates:
3 rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
Cornea and Iris
Basis:
mean
Time point:
other: 1 hours to 3 days after instillation
Score:
0
Max. score:
0
Irritation parameter:
overall irritation score
Remarks:
Redness
Basis:
mean
Time point:
other: 1 hour to 2 days after instillation
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 3 days
Irritation parameter:
overall irritation score
Remarks:
Chemosis
Basis:
mean
Time point:
other: 1 hour to 2 days after instillation
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 3 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
Instillation of the TS into the rabbit eye elicited transient very slight conjuctival irritation only. All reactions had resolved by three days after instillation. No labelling required.