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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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Cytogenetic effect of some amine oxides and organic ammonium salts on mouse somatic cells
Author:
Szabova E & Devínsky F
Year:
1988
Bibliographic source:
Casopis Pre Farmaceuticku Vedu A Prax 57(1):1-5

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test substance was dissolved in water and administered at a concentration of 235 mg/kg bw. The control animals received 0.1 mg/10 g water.
Animals were processed at intervals of 6, 24, 48 and 72 h following administration of the substance. The bone marrow was washed into a test tube with calf serum and centrifuged at 1000 rpm for 5 min then dried in air and, after 24h, fixed for 3 min in methanol. When dry, preparations were stained in Giemsa-Romanowski stain diluted with 1:3 with distilled water.
The incidence of micronuclei in polychromatic erythrocytes was evaluated and the results were subjected to the t-test at p<0.05
GLP compliance:
no
Type of assay:
micronucleus assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
mouse
Strain:
ICR
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: VELAZ, Prague
- Age at study initiation: 8 weeks
- Weight at study initiation: 25-30 g
- Assigned to test groups randomly: [no/yes, under following basis: ]
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum):
- Water (e.g. ad libitum):
- Acclimation period:

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

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
- Vehicle(s)/solvent(s) used: water
- Amount of vehicle (if gavage or dermal): 0.1 mL/10 g
Details on exposure:
PREPARATION OF DOSING SOLUTIONS: The test substance was dissolved in water. No further details given

Duration of treatment / exposure:
6,24,48,72 h after treatment
Frequency of treatment:
Single dose
Post exposure period:
none
Doses / concentrations
Remarks:
Doses / Concentrations:
235 mg/kg
Basis:
nominal in water
No. of animals per sex per dose:
total of 12 animals
Control animals:
yes

Examinations

Statistics:
Student's t-test

Results and discussion

Test results
Sex:
male/female
Genotoxicity:
negative
Toxicity:
no effects
Additional information on results:
The incidence of micronuclei in polychromatic erythrocytes in males and females is shown in Table 1

Any other information on results incl. tables

Table 1: Incidence (%) of micronuclei after oral administration of amine oxide

Time (h)

Control

Male 235 mg/kg

Female 235 mg/kg

 

6

 

0.2

0.2

 

24

0.16

0.2

0.2

 

48

 

0.07

0.15

 

72

 

0.13

0.05

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): negative