2-methylcyclohexyl acetate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Remarks:

Type of genotoxicity: DNA damage and/or repair

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

10/08/1987

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

significant methodological deficiencies

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1987

Materials and methods

Principles of method if other than guideline:

An in-vivo sister chromatid exchange assay (non-standard protocol) was performed with dl-menthol. The test item was administered to mice (4 mice per group) by intraperitoneal injection at 225, 450 and 900 mg/kg. After 23 hours, 25 cells per animal the bone marrow were analyzed. Both solvent control (corn oil) and positive control (dimethylbenzanthracene) were also observed. Only 1 trial was performed.

GLP compliance:

not specified

Type of assay:

sister chromatid exchange assay

Test material

Test material information

Constituent 1

Reference substance name:

Menthol

EC Number:

201-939-0

EC Name:

Menthol

Cas Number:

89-78-1

IUPAC Name:

2-isopropyl-5-methylcyclohexanol

Details on test material:

- Name of test material (as cited in study report): dl-Menthol
- Molecular formula (if other than submission substance): C10H20O
- Molecular weight (if other than submission substance): 156.26

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: corn oil

Duration of treatment / exposure:

23 h

Frequency of treatment:

Single treatment

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

225 mg/kg diet

Doses / concentrations 2

Dose / conc.:

450 mg/kg diet

Doses / concentrations 3

Dose / conc.:

900 mg/kg diet

No. of animals per sex per dose:

4 male mice per dose

Control animals:

yes, concurrent vehicle

Positive control(s):

Dimethylbenzanthracene
- Route of administration: intreperitoneal
- Doses / concentrations: 2.5 mg/kg

Examinations

Tissues and cell types examined:

Tissue: Bone marrow
Number cells examined: 25 cells per animal.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Detailed Sister Chromatid Exchange Data (Trial 1)

Test Group		Dose	Animal	No.	SCE / Cell
		(mg/kg)	Number	Cells	Mean	±	SEM
Solvent	Corn Oil	0	6663	25	4.91	±	.528
			6664	25	3.41	±	.427
			6665	25	3.65	±	.325
			6666	25	4.34	±	.353
Average					4.08	±	.341
Test Chemical	dl-menthol	225	6648	25	3.31	±	.415
			6649	25	3.85	±	.393
			6650	25	3.50	±	.318
			6651	25	4.57	±	.355
Average					3.81	±	.277
Test Chemical	dl-menthol	450	6653	25	4.54	±	.389
			6655	25	2.26	±	.275
			6656	25	3.65	±	.380
			6657	25	3.14	±	.346
Average					3.40	±	.478
Test Chemical	dl-menthol	900	6658	25	4.81	±	.494
			6659	25	6.08	±	.665
			6660	25	2.72	±	.268
			6662	25	4.34	±	.523
Average					4.48	±	.694
Positive Control	Dimethyl-benzanthracene	2.5	6668	25	4.94	±	.421
			6669	25	4.69	±	.409
			6670	25	5.86	±	.505
			6671	25	6.85	±	.548
Average					5.59	±	.490

* indicates an incomplete evaluation, either an unconfirmed positive response (no replicate trial) or a negative response seen at only one of two harvest times (standard or extended)

Applicant's summary and conclusion

Conclusions:

An in-vivo sister chromatid exchange on bone marrow study performed with dl-menthol was determined to be negative under test conditions.

Executive summary:

An in-vivo sister chromatid exchange assay on bone marrow(non-standard protocol) was performed with dl-menthol. The test item was administered to mice (4 mice per group) by intraperitoneal injection at 225, 450 and 900 mg/kg. After 23 hours, 25 cells per animal were analyzed. Both solvent control (corn oil) and positive control (dimethylbenzanthracene) where also observed. Only 1 trial was performed. 2 -isopropyl-5 -methylcyclohexyl acetate was determined not to induce SCE in bone marrow under test conditions.