Registration Dossier

Administrative data

Endpoint:
in vivo mammalian germ cell study: cytogenicity / chromosome aberration
Remarks:
Type of genotoxicity: chromosome aberration
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
1982
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read-across to cetrimonium 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

GLP compliance:
yes
Type of assay:
other: Bone marrow cytogenetic assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
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.