Dodecanamide, N,N-dibutyl-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Standards for Toxicity Investigations (Notification No. 77 of Ministry of Labor, September 1, 1988)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dibutyl=lauramide

IUPAC Name:

N,N-dibutyl=lauramide

Constituent 2

Reference substance name:

DIBULAM

IUPAC Name:

DIBULAM

Details on test material:

- Name of test material (as cited in study report): N,N-dibutyl=lauramide
-Supplier: Sanko Co., Ltd.
- Physical state: liquid
- Analytical purity: 98.2% (w/w)
- Impurities (identity and concentrations): unknown 1.8% (w/w)
- Lot/batch No.: 00804
- Stability under test conditions: stable at room temperature
- Storage condition of test material: in a cool, dark storage room

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

rat liver S9

Test concentrations with justification for top dose:

100, 500, 1000, 2000 and 5000 µg/plate (dose range finding test) 313, 625, 1250, 2500 and 5000 µg/plate (main test)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: acetone

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide (AF-2)

Remarks:

without S9, 0.01 µg/plate for TA100 and WP2 uvrA, 0.1 µg/plate for TA98

Controls 2

Positive control substance:

sodium azide

Remarks:

without S9, 0.5 µg/plate for TA1535

Migrated to IUCLID6: (NaN3)

Controls 3

Positive control substance:

other: 2-methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine-2HCI (ICR- 191)

Remarks:

without S9, 1 µg/plate for TA1537

Controls 4

Positive control substance:

other: 2-aminoanthracene (2AA)

Remarks:

with S9, 0.5 µg/plate for TA98, 1 µg/plate for TA100, 2 µg/plate for TA1535 and TA1537 and 20 µg/plate for WP2 uvrA

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Incubation period: 48 hrs at 37±0.5°C

NUMBER OF REPLICATIONS: 2

Evaluation criteria:

A positive response was achieved when the number of revertant colonies was twice or more than the solvent control, and reproducibility were obtained.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The deposition of the test substance like a transparent oil droplet was observed at 100 µg/plate or more. The number of revertant colonies in all the tester strains was less than two times that in each solvent control at any dose levels in the presence or absence of metabolic activation system. The positive controls induced a significant increase in the number of revertant colonies.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

N,N-dibutyl=lauramide had no reverse mutagenic potential.

Executive summary:

In an Ames test with Salmonella typhimurium YA1535, TA1537, TA98 and TA100 and Escherichia coli WP2 uvrA, with and without rate liver S9 activation. N,N-dibutyl=lauramide showed no reverse mutagenic potential.