Dodecan-1-ol, ethoxylated

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data from handbook or collection of data

Data source

Reference

Reference Type:

review article or handbook

Title:

Evaluation of a Three-Exposure Mouse Bone Marrow Micronucleus Protocol: Results With 49 Chemicals

Author:

M.D. Shelby et al.,

Year:

1993

Bibliographic source:

Environmental and Molecular Mutagenesis 21 :160-179

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

To evaluate the mutagenic potential of test chemical in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study.

GLP compliance:

not specified

Type of assay:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Dodecan-1-ol, ethoxylated

EC Number:

500-002-6

EC Name:

Dodecan-1-ol, ethoxylated

Cas Number:

9002-92-0

Molecular formula:

C58H118024

IUPAC Name:

Dodecan-1-ol, ethoxylated

Test material form:

liquid

Details on test material:

Name: Dodecan-1-ol, ethoxylated
CAS No.: 9002-92-0
Molecular Formula: (C2-H4-O)mult-C12-H26-O
Molecular Weight: 230.389 g/mol

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male

Details on test animals or test system and environmental conditions:

No data available

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

- Vehicle(s)/solvent(s) used: Phosphate Buffered Saline

Duration of treatment / exposure:

72 hour

Frequency of treatment:

3 times in 72 hours

Post exposure period:

No data

Doses / concentrations

Remarks:

0,31.25,62.5 and 125 mg/Kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

yes, concurrent vehicle

Positive control(s):

Positive controls; Mitomycin-C
- Route of administration: Intraperitoneal Injection
- Doses / concentrations:0.2 mg/kg

Examinations

Tissues and cell types examined:

Polychromatic and normochromatic erythrocytes were screened for the presence of micronuclei.

Details of tissue and slide preparation:

Details of tissue and slide preparation

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): 24 hour

Evaluation criteria:

The erythrocytes were observed for micronuclei. The MN results were tabulated as the mean frequency of micronucleated erythrocytes per 1000 cells per animal, plus or minus the standard error of the mean among animals within a treatment group.

Generally, a test was considered positive if (1) the trend test P value was 0.025 or less or (2) the P value for any single exposure group was 0.025/N or less where N is the number of test chemical treatment groups. Trend test P values between 0.025 and 0.05 were considered to be equivocal if accompanied by a monotonic increase in the frequency of micronuclei over the dose range investigated. All other responses were considered to be negative.

Statistics:

The frequency of micronucleated cells among NCE or PCE was analyzed by a statistical software package that tested for increasing trend over exposure groups using a one-tailed Cochran-Armitage trend test, followed by pairwise comparisons between each exposure group and the control group. In the presence of excess binomial variation, as detected by a binomial dispersion test, the binomial variance of the Cochran-Armitage test was adjusted upward in proportion to the excess variation. Pairwise comparisons between each treatment group and the concurrent solvent control group were performed using an
unadjusted one-tailed Pearson x2 test that incorporated the calculated variance inflation factor for the study.

Although statistical analyses were used as an important aid in evaluating the test results, statistical significance was not the only determining factor in arriving at an overall call for a chemical. A decision to classify a test as negative, equivocal, or positive for induction of micronuclei in this in vivo assay was based on a broader evaluation of a number of factors that determined the biological relevance of the results, including the appropriateness of the concurrent control data, the magnitude of the observed response and the presence of a dose-dependent increase in the frequency of micronucleated cells.

The percentage of polychromatic erythrocytes (%PCE) data were analyzed by a standard ANOVA to determine if significant PCE suppression or stimulation occurred.

Results and discussion

Test results

Key result

Sex:

male

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: No mutagenic potential

Additional information on results:

No data

Applicant's summary and conclusion

Conclusions:

Test substance was evaluated for its mutagenic potential in B6C3F1 male Mouse by In vivo Mammalian Somatic cell study. The test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes.

Executive summary:

In the study test substance was assessed for its possible mutagenic potential. For this purpose wasIn vivo Mammalian Somatic cell study in B6C3F1 male Mouse. The test substance was administrated by Intraperitoneal Injection by using corn oil as vehicle. The test substance was exposed at the concentration of 0, 0, 31.25, 62.5 and 125 mg/Kg for 72 hours. The dose was administrated thrice in 72 hours .The bone marrow cells were stained and observed for chromosome damage. No significant increase in the frequency of micronucleated polychromatic erythrocytes in treated animals was observed. Therefore test result was consider to be negative as there was no significant chromosome damage in micronucleated polychromatic erythrocytes. Hence the substance cannot be classified as mutant In Vivo.