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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
acute toxicity: oral
Remarks:
in vitro study using 3T3 cell line to calculate the oral LD50
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: in vitro cytotoxicity test using 3T3 cells
Version / remarks:
The in vitro test allows to determine the IC50, used to derive the LD50.
GLP compliance:
no
Remarks:
(study performed according to SOP in a laboratory that conforms to GLP but report not audited by the QAU)
Test type:
other: in vitro cytotoxicity using Neutral Red Uptake viability test
Limit test:
no

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

Results and discussion

Effect levels
Key result
Dose descriptor:
LD50
Effect level:
ca. 479.2 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Calculated LD50 from IC50 value (58.2 µg/mL)
Mortality:
Not specified
Clinical signs:
other: Not applicable (test in vitro)
Gross pathology:
Not applicable (test in vitro)

Any other information on results incl. tables

LC50 was calculated from IC50 value (58.2 µg/mL) using a linear regression formula.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
In this study conducted with Trans-4-Methyl Cyclohexyl Isocyanate, an intermediate product of Glimepiride synthesis, the calculated LD50 was 479.2 mg/kg, in the range 300 < LD50 < 2000 and can therefore be considered as harmful and classified in Category 4 of the Globally Harmonized Classification System (R22/H302).