Amines, C12-18-alkyldimethyl, N-oxides

Genetic toxicity: in vivo

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

Test material information

Constituent 1

Reference substance name:

N,N-Dimethyl-1-methyldodecylamine oxide

IUPAC Name:

N,N-Dimethyl-1-methyldodecylamine oxide

Constituent 2

Reference substance name:

60729-78-4

Cas Number:

60729-78-4

IUPAC Name:

60729-78-4

Test animals

Species:

mouse

Strain:

ICR

Sex:

male/female

Details on test animals or test system 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