Cinnamaldehyde

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from peer reviewed journal

Data source

Reference

Reference Type:

publication

Title:

Gene mutation in vivo toxicity study of the test chemical

Author:

Sasaki et al

Year:

1990

Bibliographic source:

Mutation research

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Mutagenic effect of the test compound was evaluated in a mouse micronucleus test.

GLP compliance:

not specified

Type of assay:

other: Mouse bone marrow micronucleus test

Test material

Test material information

Constituent 1

Reference substance name:

Cinnamaldehyde

EC Number:

203-213-9

EC Name:

Cinnamaldehyde

Cas Number:

104-55-2

Molecular formula:

C9H8O

IUPAC Name:

3-phenylacrylaldehyde

Details on test material:

- Name of test material (as cited in study report): Cinnamaldehyde
- Molecular weight: 132.1612 g/mol
- Molecular formula: C9H8O
- Substance type: Organic

Test animals

Species:

mouse

Strain:

other: ddY mouse

Sex:

male

Details on test animals or test system and environmental conditions:

Details on test animals and env conditions
TEST ANIMALS
- Source: Japan SLC lnc. (Hamamatsu, Japan)
- Age at study initiation: 8 weeks (when purchased)
- Weight at study initiation: No data available
- Assigned to test groups randomly: [no/yes, under following basis: ] No data available
- Fasting period before study: No data available
- Housing: No data available
- Diet (e.g. ad libitum): No data available
- Water (e.g. ad libitum): No data available
- Acclimation period: No data available

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data available
- Humidity (%):No data available
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): No data available

IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

- Vehicle(s)/solvent(s) used: Olive oil (Kosakai Seiyaku Co., Tokyo, Japan).
- Justification for choice of solvent/vehicle: The test chemical was soluble in oliv oil
- Concentration of test material in vehicle: 0, 250, 313 or 500 mg/kg with an administration volume of 10 ml/kg.
- Amount of vehicle (if gavage or dermal): No data available
- Type and concentration of dispersant aid (if powder): No data available
- Lot/batch no. (if required): No data available
- Purity: No data available

Details on exposure:

For oral route
PREPARATION OF DOSING SOLUTIONS: The test chemical was dissolved in olive oil at a concentration of 0, 250, 313 or 500 mg/kg

DIET PREPARATION
- Rate of preparation of diet (frequency): No data available
- Mixing appropriate amounts with (Type of food): No data available
- Storage temperature of food: No data available

Duration of treatment / exposure:

24 hrs

Frequency of treatment:

No data available

Post exposure period:

0, 3, 6, 9, 12, 15, 18 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 250, 313 or 500 mg/kg
Basis:
no data

No. of animals per sex per dose:

No data available

Control animals:

yes, concurrent vehicle

Positive control(s):

Positive controls
No data available
- Justification for choice of positive control(s): No data available
- Route of administration: No data available
- Doses / concentrations: No data available

Examinations

Tissues and cell types examined:

Bone marrow cells

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: No data available

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Bone marrow cells were sampled 24 h after irradiation with X-rays. The cells were at a time interval of 0, 3, 6, 9, 12, 15, 18 hours.

DETAILS OF SLIDE PREPARATION: No data available

METHOD OF ANALYSIS: No data available

OTHER: Mice were irradiated with X-rays at 200 rad using a Hitachi X-ray machine with an adjusted Victreen dosimeter. After irradiation the flavoring was administered orally at 0, 250, 313 or 500 mg/kg. Bone marrow cells were sampled 24 h after the irradiation. In the time-course study, cinnamaldehyde at 500 mg/kg was given to mice immediately after the irradiation and bone marrow cells were sampled periodically. The micronucleus assay was performed according to the methods described by Schmid (1976).

Evaluation criteria:

The frequencies of polychromatic erythrocytes with micronuclei (MNPCEs) per 1000 polychromatic erythrocytes (PCEs), and PCEs per 1000 red blood cells per mouse were determined.

Statistics:

Student's t-test

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

RESULTS OF RANGE-FINDING STUDY
- Dose range: No data available
- Solubility: No data available
- Clinical signs of toxicity in test animals: No data available
- Evidence of cytotoxicity in tissue analyzed: No data available
- Rationale for exposure: No data available
- Harvest times: No data available
- High dose with and without activation: No data available
- Other: No data available

RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): No data available
- Induction of micronuclei (for Micronucleus assay): The frequencies of polychromatic erythrocytes with micronuclei (MNPCEs) per 1000 polychromatic erythrocytes (PCEs), and PCEs per 1000 red blood cells per mouse were determined
- Ratio of PCE/NCE (for Micronucleus assay): No data available
- Appropriateness of dose levels and route: No data available
- Statistical evaluation: Student's t-test

Applicant's summary and conclusion

Conclusions:

The test chemical did not induce gene mutation in vivo in male ddY mice as observed by the mouse micronucleus test.

Executive summary:

A mouse micronucleus test was conducted to evaluate the mutagenic nature of the test chemical in vivo in male ddYmice. The test compound was dissolved in olive oil and given to male mice at a dose range of 0, 250, 313 or 500 mg/kg. Mice were irradiated with X-rays at 200 rad using a Hitachi X-ray machine with an adjusted Victreen dosimeter. After irradiation the flavoring was administered orally at the above-mentioned dosage. Bone marrow cells were sampled 24 h after the irradiation. In the time-course study, the test chemical at 500 mg/kg was given to mice immediately after the irradiation and bone marrow cells were sampled periodically at 0, 3, 6, 9, 12, 15, 18 hours. X-ray-induced chromosome aberrations were suppressed when the test chemical was given orally to mice after X-ray irradiation. Chromosome aberrations were monitored by the occurrence of polychromatic erythrocytes with micronuclei in bone marrow cells. The frequency of micronuclei was depressed about 55-60% without toxicity of the test compounds to the bone marrow. Based on the results of the current study, it is proven that the test chemical did not induce gene mutation in vivo in male ddY mice as observed by the mouse micronucleus test.