Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Method by Stern M et al.: Toxicology in vitro 12, 455-461 (1998); EpiOcular Tissue Model
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Remarks:
Method by Stern: MTT assay; viability (%); ET50 > 60 min
Time point:
other: 3, 30, 60 min
Score:
91 - 101
Reversibility:
other: not relevant: in vitro assay
Remarks on result:
other: EpiOcular Tissue Model
Irritant / corrosive response data:
An ET50 value of T-126 was determined to be above 60 min.

Applicant's summary and conclusion

Conclusions:
T-126 should be categorized as non/minimal irritant.