Rape oil, reaction products with diethanolamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

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: Study well documented, meets generally accepted scientific principles, acceptable for assessment and compliant with GLP. 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:

publication

Title:

Unnamed

Year:

1999

Materials and methods

Principles of method if other than guideline:

Suspensions of bacterial cells are exposed to the test substance by the plate incorporation method in the presence and in the absence of an exogenous metabolic activation system. In this method, the suspensions are mixed with an overlay agar and plated immediately onto the minimal medium and incubated for two days at 37˚C, The results are interpreted by counting the revertant colonies and comparing to the number of spontaneous revertant colonies on solvent-control plates.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

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

Constituent 2

Reference substance name:

Oleic acid diethanolamine condensate

IUPAC Name:

Oleic acid diethanolamine condensate

Details on test material:

Name of test material (as cited in study report): Oleic acid diethanolamine condensate (ODEA) obtained from Radian Corporation (Austin, TX).

Method

Target gene:

No data

Species / strain

Species / strain / cell type:

other: S. typhimurium TA97, TA98, TA100 and TA1535

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver)

Test concentrations with justification for top dose:

Without metabolic activation: 0, 0.1, 0.3, 1, 3.3 and 10 µg/plate
With metabolic activation: 0, 3.3, 10, 33, 100 and 200 µg/plate

Vehicle / solvent:

Ethanol

Controls

Controls 1

Untreated negative controls:

yes

Remarks:

(solvent control)

Negative solvent / vehicle controls:

yes

Remarks:

(Ethanol)

True negative controls:

not specified

Positive controls:

yes

Remarks:

(for strains TA100 and TA1535)

Positive control substance:

sodium azide

Remarks:

absence of metabolic activation

Controls 2

Untreated negative controls:

yes

Remarks:

(solvent control)

Negative solvent / vehicle controls:

yes

Remarks:

(Ethanol)

True negative controls:

not specified

Positive controls:

yes

Remarks:

(for strain TA 98)

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

absence of metabolic activation

Controls 3

Untreated negative controls:

yes

Remarks:

(solvent control)

Negative solvent / vehicle controls:

yes

Remarks:

(Ethanol)

True negative controls:

not specified

Positive controls:

yes

Remarks:

(for strain TA 97)

Positive control substance:

9-aminoacridine

Remarks:

absence of metabolic activation

Controls 4

Untreated negative controls:

yes

Remarks:

(solvent control)

Negative solvent / vehicle controls:

yes

Remarks:

(Ethanol)

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (all strains)

Remarks:

metabolic activation

Details on test system and experimental conditions:

- Test medium: Top agar supplemented with L-histidine and d-biotin
- Method of application: In agar (plate incorporation)
- Duration of incubation: 2 d at 37 °C
- Number of replicates: Three

Evaluation criteria:

- Positive response: Reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination.
- Equivocal response: An increase in revertants that are not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of m utagenicity.
- Negative response: When no increase in revertant colonies is observed following chemical treatment.
- There is no minimum percentage or fold increase required for a chemical to be judged positive or weakly positive.

Statistics:

Not reported

Results and discussion

Test results

Species / strain:

S. typhimurium, other: S. typhimurium TA97, TA98, TA100 and TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(at ≥3.3 µg/plate without metabolic activation; at 200 µg/plate with metabolic activation) .

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

None

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
other: Negative with and without metabolic activation

Under the test conditions, the test substance, was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation.

Executive summary:

A NTP study was conducted to determine the mutagenic potential of the test substance.

Salmonella typhimurium strains TA97, TA98, TA100 and TA1535 were treated with the test substance using the Ames plate incorporation method at up to five dose levels for each bacterial strain, in triplicate, both with and without the addition of S9 mix (i.e., Aroclor induced rat and hamster liver homogenate metabolising system). The dose range was 0.1 to 10 µg/plate (-S9 -mix) and 3.3 to 200 µg/plate (+S9 -mix).

 

Cytotoxicity was observed at ≥3.3 µg/plate without metabolic activation and at 200 µg/plate with metabolic activation. No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test substance, either with or without metabolic activation.The vehicle (ethanol) control or the negative control plates produced counts of revertant colonies within the normal range. All the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies, both with and without the S9 -mix.

 

Under the test conditions, the test substance was not mutagenic in Salmonella typhimurium strain TA97, TA98, TA100, or TA1535, with or without S9 metabolic activation.