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Toxicological information

Genetic toxicity: in vivo

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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

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 / concentrationsopen allclose all
Dose / conc.:
225 mg/kg diet
Dose / conc.:
450 mg/kg diet
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.