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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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

Constituent 1
Chemical structure
Reference substance name:
trans-4-Methylcyclohexyl isocyanate
EC Number:
608-715-5
Cas Number:
32175-00-1
Molecular formula:
C8 H13 N O
IUPAC Name:
trans-4-Methylcyclohexyl isocyanate

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).