trans-4-Methylcyclohexyl isocyanate

Skin irritation / corrosion

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

Test material information

Constituent 1

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).