Tetradonium bromide

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:

weight of evidence

Study period:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Read-across to tetradonium bromide from data on dodecyltrimethylammonium chloride (with data reliability value of 1). Read-across justifications are provided in the endpoint summary.

Data source

Reference

Reference Type:

other: Assessment report for American Chemistry Council, Fatty Nitrogen Derivatives Panel, Cationics Task Group

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)

Version / remarks:

Bone marrow genetic assay

Deviations:

not specified

Principles of method if other than guideline:

- Principle of test: Bone marrow cytogenetic assay.
- Short description of test conditions: Oral gavage administration to female rats, daily for five days.
Dosing at three concentration levels at constant volume. Negative control: distilled water; Positive control: methylmethane sulfonate. Mitosis inhibited approx. 20 hours after last treatment by intraperitoneal injection of colchicine (1 mg/kg). The animals were sacrificed 2-4 hours later.
- Parameters analysed / observed: Bone marrow cells were examined microscopically for structural chromosome aberrations. The mitotic index (MI) for each animal was determined.

GLP compliance:

yes

Type of assay:

other: Bone marrow cytogenetic assay

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyltrimethylammonium chloride

EC Number:

203-927-0

EC Name:

Dodecyltrimethylammonium chloride

Cas Number:

112-00-5

Molecular formula:

C15H34N.Cl

IUPAC Name:

N,N,N-trimethyldodecan-1-aminium chloride

Test material form:

other: 24.7% aqueous solution

Details on test material:

- Name of test material (as cited in study report): Ammonium, dodecyltrimethyl-, chloride
- Molecular formula (if other than submission substance): C15H34N.Cl
- Molecular weight (if other than submission substance): 264.0

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

The test substance was dosed at a constant volume of 0.58 ml of solution in distilled water/150 grams of body weight.

Details on exposure:

The test substance was administered via oral gavage to five male and five female rats once daily for 5 consecutive days at doses of 16, 53.3 or 160 mg/kg. The test substance was dosed at a constant volume of 0.58 ml of solution in distilled water/150 grams of body weight.
Five animals/sex were administered the negative control, distilled water and the positive control, methylmethane sulfonate (80 mg/kg/day).

Duration of treatment / exposure:

5 days

Frequency of treatment:

Once daily

Doses / concentrations

Remarks:

Doses / Concentrations:
16, 53.3, 160 mg/kg
Basis:
nominal in water

No. of animals per sex per dose:

5

Control animals:

yes

Positive control(s):

Five animals/sex were administered the positive control, methylmethane sulfonate (80 mg/kg/day).

Examinations

Details of tissue and slide preparation:

An intraperitoneal injection of colchicine (1 mg/kg) was given to all animals to inhibit mitosis approximately 20 hours after the last treatment. The
animals were sacrificed 2-4 hours later.
Bone marrow cells were examined microscopically for structural chromosome aberrations. Fifty metaphase spreads for each animal were scored when possible. The mitotic index (MI) for each animal was determined. Each metaphase figure was scored for the number of chromosomes, and aberrations were categorized.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Remarks:

NOEL: 160 mg/kg

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The test showed no effects on mitotic index and no genotoxic effects at the conditions applied in the test.
Animals receiving the test compound and the positive control substance showed no signs of toxicity.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
No effects on mitotic index and no genotoxic effects were observed for dodecyltrimethylammonium chloride in a bone marrow cytogenetic assay. Animals receiving the test compound and the positive control substance showed no signs of toxicity.

Executive summary:

The reported study examines the genotoxicity of dodecyltrimethylammonium chloride in male and female rats by use of a bone marrow cytogentic assay. Dodecyltrimethylammonium chloride was administrated by oral gavage once daily for 5 consecutive days at doses of 16, 53.3 and 160 mg/kg in 0.58 ml of solution in destilled water/150 grams of body weight. No effects on mitotic index and no genotoxic effects were observed for dodecyltrimethylammonium chloride. Animals receiving the test compound and the positive control substance showed no signs of toxicity.