Amides, C8-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl)

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian germ cell study: cytogenicity / chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Not available

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2001

Materials and methods

Principles of method if other than guideline:

A study was conducted to evaluate the potential of the test material to induce micronuclei in B6C3F1 mice. After completion of a 13-wk dermal treatment period, the study animals were sacrificed and the peripheral blood samples were collected and blood smears were processed as per the standard NTP protocol. Thereafter, the slides from different test groups and control were evaluated for the induction of micronucleus.

GLP compliance:

not specified

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Amides, C18-unsatd., N,N-bis(hydroxyethyl)

EC Number:

700-972-2

Molecular formula:

C22H43NO3

IUPAC Name:

Amides, C18-unsatd., N,N-bis(hydroxyethyl)

Constituent 2

Reference substance name:

2,2'-iminodiethanol

EC Number:

203-868-0

EC Name:

2,2'-iminodiethanol

Cas Number:

111-42-2

Molecular formula:

C4H11NO2

IUPAC Name:

2,2'-iminodiethanol

Test material form:

liquid

Details on test material:

- Obtained from Henkel Corporation, Emery Group (Cincinnati, OH)
- Oleic acid diethanolamine condensate content: 47.5%.
- Other fatty acid alkanolamides: ca. 30%
- Nitrosodiethanolamine: 68 ppb.
- No nonpolar nitrosamines
- Free diethanolamine: 0.19%

Test animals

Species:

mouse

Strain:

B6C3F1

Sex:

male/female

Details on test animals or test system and environmental conditions:

No data

Administration / exposure

Route of administration:

dermal

Vehicle:

No data

Details on exposure:

No data

Duration of treatment / exposure:

13 wk

Frequency of treatment:

Assumed to be daily

Post exposure period:

Not applicable

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

0 mg/kg bw/day (nominal)

Doses / concentrations 2

Dose / conc.:

50 mg/kg bw/day (nominal)

Doses / concentrations 3

Dose / conc.:

100 mg/kg bw/day (nominal)

Doses / concentrations 4

Dose / conc.:

200 mg/kg bw/day (nominal)

Doses / concentrations 5

Dose / conc.:

400 mg/kg bw/day (nominal)

Doses / concentrations 6

Dose / conc.:

800 mg/kg bw/day (nominal)

No. of animals per sex per dose:

5 animals per sex per dose were evaluated for micronuclei induction

Control animals:

yes

Examinations

Tissues and cell types examined:

Bone marrow erythrocytes

Details of tissue and slide preparation:

Tissue: Peripheral blood
Cell: Normochromatic erythrocytes

Evaluation criteria:

No data

Statistics:

No data

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

For detailed results table kindly refer to the attached background materials section of the IUCLID.

Applicant's summary and conclusion

Conclusions:

Under the study conditions, the test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 weeks.

Executive summary:

A study was conducted to evaluate the in vivo genetic toxicity of the test substance, C18-unsatd. DEA in a micronucleus assay. The substance was applied dermally in mice for 13 weeks at 0, 50, 100, 200, 400 and 800 mg/kg bw. Peripheral blood samples were obtained from male and female animals, and smears were immediately prepared and fixed in absolute methanol. Under the study conditions, the test substance did not increase the frequencies of micronucleated normochromatic erythrocytes (NCEs) in peripheral blood of both male and female mice at the end of 13 weeks (Irwin, 2001).