Quaternary ammonium compounds, bis(C16-18 and C18-unsatd. alkyl)dimethyl, chlorides

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:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study predated formal guideline requirements and GLP but performed according to existing scientific standards. Reliabilty check by Expert Panel (American Chemistry Council Fatty Nitrogen Derivatives) passed.

Data source

Reference

Reference Type:

review article or handbook

Title:

In vivo mouse micronucleus assay of ditallow dimethyl ammonium chloride (DTDMAC) for mutagenic potential (only abstract available)

Author:

Wong, T.K.; Thompson, E.D.

Year:

1977

Bibliographic source:

P&RS Division. Unpublished report BSBTS # 114

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

not specified

GLP compliance:

no

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

61783-78-8

IUPAC Name:

61783-78-8

Constituent 2

Reference substance name:

Ditallowalkyldimethylammonium chloride

IUPAC Name:

Ditallowalkyldimethylammonium chloride

Details on test material:

- Name of test material (as cited in study report): Ditallowdimethylammonium chloride (DTDMAC)
- Physical state: liquid
- Analytical purity: 74.1 % active in water / isopropanol
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Radiochemical purity (if radiolabelling): n.a.
- Specific activity (if radiolabelling): n.a.
- Locations of the label (if radiolabelling): n.a.
- Expiration date of radiochemical substance (if radiolabelling): n.a.
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

mouse

Strain:

other: C3D2F1/J

Sex:

male

Details on test animals or test system and environmental conditions:

no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle(s)/solvent(s) used: physiol. saline
- Justification for choice of solvent/vehicle: recommended vehicle

Details on exposure:

Two doses 24 hours apart; sacrifice 6 and 24 hours after second dose

Duration of treatment / exposure:

two single treatments 24 hours apart

Frequency of treatment:

two single treatments 24 hours apart

Post exposure period:

6 and 24 hours respectively

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 mg/kg body weight
Basis:
actual ingested

Doses / concentrations 2

Remarks:

Doses / Concentrations:
50 mg/kg body weight
Basis:
actual ingested

Doses / concentrations 3

Remarks:

Doses / Concentrations:
500 mg/kg body weight
Basis:
actual ingested

Doses / concentrations 4

Remarks:

Doses / Concentrations:
1000 mg/kg body weight
Basis:
actual ingested

No. of animals per sex per dose:

8 male mice per group

Control animals:

yes, concurrent vehicle

Positive control(s):

no data

Examinations

Tissues and cell types examined:

bone marrow cells from both femurs

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: standard spacing

Evaluation criteria:

1000 polychromatic erythrocytes scored from each mouse and micronuclei recorded

Statistics:

analysis of variance

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

not specified

Additional information on results:

Reliability check by ACCFND Expert Panel revealed a reliability with restriction (Klimisch 2A)

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Based on the available information, ditallowdimethylammonium chloride (DTDMAC) is considered to be not mutagenic in an in vivo micronucleus test.

Executive summary:

Ditallowdimethylammonium chloride was investigated for potential mutagenic effects in an in vivo micronucleus test. Eight mice per group were used and were dosed twice within 24 hours with 0, 50, 500 or 1000 mg/kg body weight via gavage. Physiological saline was used as the control vehicle. The dosing volume was 0.2 mL per dose group. Six hours after the second dosing, one group at each dose was sacrificed. The remaining groups were sacrificed 24 hours after the second dose. Immediately after sacrifice, bone marrow cells were extracted from both femurs and processed. One thousand polychromatic erythrocytes were scored from each mouse and micronuclei were recorded. There were no statistically significant differences in the mean micronuclei of the test groups compared to the negative control group. Based on the results DTDMAC was considered negative in the in vivo micronucleus test.