Registration Dossier

Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
GLP compliance:
no
Remarks:
(study performed according to SOP in a laboratory that conforms to GLP but report not audited by the QAU)

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vitro test system

Test system:
human skin model
Remarks:
Episkin
Source species:
human

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 6.1
Remarks on result:
other:
Remarks:
The test item was severely irritant.

Applicant's summary and conclusion

Interpretation of results:
Category 1B (corrosive) based on GHS criteria
Conclusions:
In this experiment, Trans-4-Methyl Cyclohexyl Isocyanate, an intermediate product of Glimepiride synthesis, was found corrosive. It does require labelling with classification 1B of the Globally Harmonized Classification System (R34/H314).