Dodecyl nonan-1-oate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

17 Jul - 28 Aug 1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Lack of details on test substance; no analytical purity given, 1000 erythrocytes counted for incidence of micronuclei

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

1983

Deviations:

yes

Remarks:

analytical purity of test substance not specified

Principles of method if other than guideline:

The incidence of micronuclei was counted in 1000 erythrocytes.

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Reference substance 001

Cas Number:

135800-37-2

Molecular formula:

C16H32O2 to C26H52O2

Test animals

Species:

mouse

Strain:

CD-1

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories
- Age at study initiation: 7 - 12 weeks
- Assigned to test groups randomly: yes
- Housing: 5 animals of each sex in polycarbonate cages
- Acclimation period: 7 - 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 - 26
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: corn oil

Details on exposure:

Dosing volume: 10 mL/kg

Duration of treatment / exposure:

Single dose

Frequency of treatment:

Single dose

Post exposure period:

Up to 72 h

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

1 075 mg/kg bw/day

Remarks:

1250 µL/kg bw given, calculated with density 860 mg/mL

Doses / concentrations 2

Dose / conc.:

2 150 mg/kg bw/day

Remarks:

2500 µL/kg bw given, calculated with density 860 mg/mL

Doses / concentrations 3

Dose / conc.:

4 300 mg/kg bw/day

Remarks:

5000 µL/kg bw given, calculated with density 860 mg/mL

No. of animals per sex per dose:

5

Control animals:

yes, concurrent vehicle

Positive control(s):

cyclophosphamide
- Route of administration: intraperitoneal
- Doses / concentrations: 30 mg/kg bw

Examinations

Tissues and cell types examined:

Erythrocytes of the bone marrow

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: Results of a pretest with 50, 160, 500, 1600 and 5000 µL/kg and the sponsor´s specification

DETAILS OF SLIDE PREPARATION: Immediately after sacrife, both femurs of the animal were removed and flushed with a few drops of fetal calf serum onto a clean microscope slide. A second slide was inverted and placed to the first slide. Using a circular motion, the two slides were rubbed together until the bone marrow was evenly dispersed. The two slides were gently pulled appart, air dried, fixed in methanol for approx. 10 min and again air dried.The slides were stained with Giemsa for 5 min and differentiated in distilled water afterwards.

METHOD OF ANALYSIS: at least 1000 polychromatic erythrocytes were counted for each category.

Evaluation criteria:

There should be a statistically significant increase in the number of micronucleated polychromatic erythrocytes in the treatment group over the negative control group.

Statistics:

The two-tailed Student´s t-test was applied to compare the frequency of micronucleated cells to the respective vehicle control.

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

1000 erythrocytes counted

Any other information on results incl. tables

Table 1: Mean numbers of micronucleated cells

Treatment	Micronucleated cells
	mean	SD
Vehicle control	2.26	1.41
5000 µL/kg	1.66	1.15
2500 µL/kg	1.93	1.17
1250 µL/kg	1.80	0.81
Positive control	17.20	2.62

There was no significant increase of micronucleated cells in the treatment groups compared to the negative control. The positive control was valid. No indications for mutagenicity in vivo were given.

Applicant's summary and conclusion

Conclusions:

CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.