Rape oil, reaction products with diethanolamine

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:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: NTP study considered to be well conducted and meet generally accepted scientific principles, acceptable for assessment. Conducted with the structural analogue oleic acid diethanolamine condensate.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

secondary source

Title:

Unnamed

Year:

2001

Materials and methods

Test guideline

Qualifier:

no guideline followed

Deviations:

not applicable

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:

Oleic acid diethanolamine condensate

IUPAC Name:

Oleic acid diethanolamine condensate

Constituent 2

Reference substance name:

N,N-bis(2-hydroxyethyl)oleamide

EC Number:

202-281-7

EC Name:

N,N-bis(2-hydroxyethyl)oleamide

Cas Number:

93-83-4

Molecular formula:

C22H43NO3

IUPAC Name:

N,N-bis(2-hydroxyethyl)octadec-9-enamide

Details on test material:

- Name of test material (as cited in study report): Oleic acid diethanolamine condensate (CAS 93-83-4)

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

Remarks:

Doses / Concentrations:
0, 50, 100, 200, 400 and 800 mg/kg bw/day
Basis:
nominal conc.

No. of animals per sex per dose:

5 animals per sex per dose were evaluated for micronuclei induction

Control animals:

yes

Positive control(s):

Not applicable

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

Sex:

male/female

Genotoxicity:

negative

Toxicity:

not specified

Vehicle controls validity:

valid

Negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Under the conditions of 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 wk.

Executive summary:

A study was conducted to assess the clastogenic potential of the test substance.The test substance was applied dermally for 13 wk at 0, 50, 100, 200, 400 and 800 mg/kg bw. Peripheral blood samples were obtained from male and female mice, and smears were immediately prepared and fixed in absolute methanol.

 

Under the conditions of the study, 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 wk.