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Toxicological information

Genetic toxicity: in vivo

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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 there is no mention of GLP status and positive control.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1983
Report Date:
1982

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

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

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
- Vehicle(s)/solvent(s) used: Olive oil
Details on exposure:
The dose was given by i.p. injection once, using olive oil as a vehicle. Eight animals were used for each dose group.
Duration of treatment / exposure:
The mice were killed and bone-marrow smears were prepared 30 hr after treatment.
Frequency of treatment:
Single injection
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:
actual ingested
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:
No further details available
Evaluation criteria:
If significantly different 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
Exposure to HCA did not result in an increase in the proportion of micronucleated PCEs.
Executive summary:

In an in vivo micronucleus assay 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 dose levels (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 polychromatic erythrocytes, if compared with the concurrent control. No mortality was observed. Therefore, under the study conditions it is concluded that HCA is not clastogenic.