Registration Dossier

Administrative data

Endpoint:
skin 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:
according to
Guideline:
other: OECD guideline 431
Deviations:
no
Principles of method if other than guideline:
Test item and reference substance is applied to 3-D human skin models (EPI-200). Thereafter, cell viability is measured by means of MTT assay.
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test system

Details on study design:
The corrosive potential of T-126 was investigated according to OECD 431. An amount of 25 mg T-126 and 25 µl water was applied to 3-D human skin models (EPI-200).

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
other: other: in vitro assay; cell viability (MTT assay)
Value:
ca. 2.25
Remarks on result:
other:
Remarks:
Time point: 3 min and 1 hr. Reversibility: other: not relevant as in vitro assay has been done. Remarks: OECD 431. (migrated information)

In vivo

Irritant / corrosive response data:
After termination of a 3-min and a 1-hr period cell viability was measured: 94% after 3 min - 93% after 1 hr as compared to controls. Classification: non-corrosive

Applicant's summary and conclusion

Conclusions:
T-126 is non-corrosive.