Registration Dossier

Administrative data

Endpoint:
in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
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:
other: The experiment was done according to the standard method of in vivo micronucleus. However, in the article it is not mentioned GLP status and positive control.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
yes
Remarks:
no positive control, only one sampling time (30hr)
GLP compliance:
not specified
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): alpha-Hexylcinnamaldehyde
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: Not reported
- Physical state: Not reported
- Analytical purity: Not reported
- Impurities (identity and concentrations): Not reported
- Composition of test material, percentage of components: Not reported
- Isomers composition: Not reported
- Purity test date: Not reported
- Lot/batch No.: Not reported
- Expiration date of the lot/batch: Not reported
- Radiochemical purity (if radiolabelling): Not reported
- Specific activity (if radiolabelling): Not applicable
- Locations of the label (if radiolabelling): Not applicable
- Expiration date of radiochemical substance (if radiolabelling): Not applicable
- Stability under test conditions: Not reported
- Storage condition of test material: Not reported
- Other: Not reported

Test animals

Species:
mouse
Strain:
NMRI
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: purchased from Ivanovas GmbH, Kisslegg
- Age at study initiation: 10-14 week old
- Weight at study initiation: Not reported
- Assigned to test groups randomly: [no/yes, under following basis: ] Not reported
- Fasting period before study: Not applicable
- Housing: Not reported
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: Not reported


ENVIRONMENTAL CONDITIONS
- Temperature (°C):
- Humidity (%):
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):


IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: Olive oil
- Justification for choice of solvent/vehicle: Not reported
- Concentration of test material in vehicle: Not reported
- Amount of vehicle (if gavage or dermal): Not applicable
- Type and concentration of dispersant aid (if powder): Not applicable
- Lot/batch no. (if required): Not reported
- Purity: Not reported
Details on exposure:
The dose was given i.p. once using Olive oil as a vehicle. Eights animals were used for each dose.
Duration of treatment / exposure:
The mice were killed and bone-marrow smears were prepared 30 hr after treatment.
Frequency of treatment:
treated once
Post exposure period:
The mice were killed and bone-marrow smears were prepared 30 hr after treatment.
Doses / concentrations
Remarks:
Doses / Concentrations:
0(olive oil), 324, 540, 756 mg/kg bw
Basis:
other: nominal in olive oil
No. of animals per sex per dose:
eight
Control animals:
yes, concurrent vehicle
Positive control(s):
Not reported

Examinations

Tissues and cell types examined:
The mice were killed and bone-marrow smears were prepared 30 hr after treatment.
Details of tissue and slide preparation:
CRITERIA FOR DOSE SELECTION:


TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):


DETAILS OF SLIDE PREPARATION:


METHOD OF ANALYSIS:


OTHER:
Evaluation criteria:
If significantly differenct from concurrent vehicle control, the result was judged as positive.
Statistics:
Statistical significance was determined according to the methods of Kastenbaum & Bowman (1970).

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
not specified
Vehicle controls validity:
valid
Negative controls validity:
not applicable
Positive controls validity:
not specified

Any other information on results incl. tables

 Dose (mg/kg)  Surviving/treated mice  Mean no. of micronucleated PE/1000 PE
 1 x 756  8/8  2.4
 1 x 540  8/8  1.8
 1 x 324  8/8  2.1
 0  8/8  1.0

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative
Under the study conditions it is concluded that HCA is neither clastogenic nor aneugenic.
Executive summary:

In an in vivo micronucleus assay (Wild et al., 1983), performed similarly to the OECD guideline No. 474 with minor deviations, male/female NMRI mice were exposed to alpha-Hexylcinnamaldehyde (HCA) diluted in olive oil by a single intraperitoneal dose. Different concentrations (324, 540, 756 mg/kg bw) were tested (8 animals per dose). 30 hours after the injection, the bone marrow cells were collected and one thousand polychromatic erythrocytes were observed in order to quantify the number of micronucleated polychromatic erythrocytes. Concurrent vehicle animals were used as negative control, no data was available on positive control.

Under the test conditions, there was no significant increase of micronucleated plychromatic erythrocytes, if compared with the concurrent control. No mortality was observed.

Therefore, under the study conditions it is concluded that HCA is neither clastogenic nor aneugenic.