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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:
Not applicable (test in vitro)
Body weight:
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).