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Genetic toxicity: in vitro

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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 Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report date:
2007

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
EC Number:
272-379-2
EC Name:
9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol
Cas Number:
68815-51-0
Molecular formula:
C18 H34 O2 . C4 H12 N2 O
IUPAC Name:
2-(2-aminoethylamino)ethanol; (Z)-octadec-9-enoic acid
Details on test material:
- Name of test material (as cited in study report): Kerocom F 100
- Physical state: Solid, brown (melt)
- Analytical purity: 100%
- Purity test date: 18.06.07
- Stability under test conditions: The stability of the test substance under storage as indicated by the sponsor
- Storage condition of test material: room temperature
- Homogeneity: The homogeneity of the test substance was guaranteed by melting up to about 40°C before preparation of the test substance formulations.
- Date of production: 22 May 2007

Method

Target gene:
his or trp operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver S9 mix
Test concentrations with justification for top dose:
20 μg - 5 000 μg/plate (SPT);
62.5 μg - 2 500 μg/plate (PIT; TA 1535 without S9 mix);
156.3 μg - 2 500 μg/plate (PIT; TA 1535 with S9 mix);
25 μg - 2 500 μg/plate (PIT; TA 100; without S9 mix);
156.3 μg - 2 500 μg/plate (PIT; TA 100 with S9 mix);
12.5 μg - 2 500 μg/plate (PIT; TA 1537, without S9 mix);
312.5 μg - 5 000 μg/plate (PIT; TA 1537 with S9 mix);
12.5 μg - 2 500 μg/plate (PIT; TA 98 without S9 mix);
156.3 μg - 2 500 μg/plate (PIT; TA 98 with S9 mix);
312.5 μg - 5 000 μg/plate (PIT; E. coli with and without S9 mix);
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: acetone had been demonstrated to be suitable in bacterial reverse mutation tests; historical control data with acetone used as vehicle are available
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
Remarks:
without S9 mix: strains TA 1535, TA 100
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 4-nitro-o-phenylendiamine (NOPD)
Remarks:
without S9 mix: strain: TA98
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
without S9 mix:strain TA1537
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
without S9 mix: E.coli WP2 uvrA
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene (2-AA)
Remarks:
with S9 mix for all strains
Details on test system and experimental conditions:
1st Experiment
Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA
Doses: 0; 20; 100; 500; 2 500 and 5 000 μg/plate
Type of test: Standard plate test with and without S9 mix
Number of plates: 3 test plates per dose or per control

2nd Experiment
Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA
Doses: 0; 156.3; 312.5; 625; 1 250 and 2 500 μg/plate
Type of test: Standard plate test with and without S9 mix
Number of plates: 3 test plates per dose or per control

3rd Experiment
Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA
Doses: 0; 156.3; 312.5; 625; 1 250 and 2 500 μg/plate (TA 1535, TA 100, TA 98 with and without S9 mix)
0; 156.3; 312.5; 625; 1 250 and 2 500 μg/plate (TA 1537 without S9 mix)
0; 312.5; 625; 1 250; 2 500 and 5 000 μg/plate (TA 1537 with S9 mix; E. coli with and without S9 mix)
Type of test: Preincubation test with and without S9 mix
Number of plates: 3 test plates per dose or per control

4th Experiment
Strains: TA 1535, TA 100, TA 1537, TA 98
Doses: 0; 62.5; 125; 250; 500 and 1 000 μg/plate (TA 1535)
0; 25; 50; 100; 200 and 400 μg/plate (TA 100)
0; 12.5; 25; 50; 100 and 200 μg/plate (TA 1537 and TA 98)
Type of test: Preincubation test without S9 mix
Number of plates: 3 test plates per dose or per control
Evaluation criteria:
The test chemical is considered positive in this assay if the following criteria are met: a dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.

A test substance is generally considered non-mutagenic in this test if the numbers of revertants for all tester strains were within the historical negative control range under all experimental conditions in at least two experiments carried out independently of each other.

Results and discussion

Test resultsopen allclose all
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:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
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
Untreated negative controls validity:
not examined
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 individual test results of the study are attached as pdf document to this endpoint study record.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative