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Toxicological information

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:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(only 4 strains tested)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooel 13
- Physical state: yellow, liquid
- Composition of test material, percentage of components: > 80% mixture of aliphatic esters and alcohols in the C range of 26 - 39; 10-20% mixture of diols and monoalcohols in the C13 range
- Lot/batch No.: from storage tank 82
- Storage condition of test material: room temperature
- Other: test substance number: 91/234

Method

Target gene:
his-operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA1535, TA1537, TA100, TA98
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver (Sprague-Dawley) S9 mix
Test concentrations with justification for top dose:
20-5000 µg/plate
Vehicle / solvent:
- solvent used: DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
(DMSO)
Positive controls:
yes
Positive control substance:
other: see: "Details on test system and conditions."
Details on test system and experimental conditions:
POSITIVE CONTROLS:
with S9 mix; for all strains: 2-aminoanthracene (10 µg/plate);
without S9 mix; for the strains TA100 and TA1535: N-methyl-N'-nitro-N-nitroso-guanidine (5 µg/plate);
without S9 mix; for the strain TA98: 4-nitro-o-phenylendiamine (10 µg/plate)
without S9 mix; for the strain TA98: 9-aminoacridine chloride monohydrate (100 µg/plate)

METHOD OF APPLICATION: in agar (plate incorporation); preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hrs (37°C)

REPLICANTS: 3

SELECTION AGENT (mutation assays): Vogel-Bonner-agar

Evaluation criteria:
a substance to be characterized as positive has to fulfill following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA1535, TA1537, TA100, TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(depending on the strain and test conditions at doses >/= 2500 µg/plate)
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
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

Standard plate test (20 - 5000 µg/plate)
Strain Metabolic activation system mean his+ revertant colonies (negative control) maximum revertant factor (conc. (µg/plate)) dose dependency Assessment maximum revertant factor (positive control)
TA 98 no 25 1.1 (20) no negative 55.6
  yes 38 1.1 (100) no negative 31.8
TA 100 no 100 1 (100) no negative 21.9
  yes 99 1.2 (20) no negative 15.3
TA 1537 no 13 1 (20, 100) no negative 82
  yes 16 1 (100) no negative 8.9
TA1535 no 17 1 (500) no negative 118.7
  yes 19 0.9 (20,100,500) no negative 11.5
Preincubation test (20 - 5000 µg/plate)
Strain Metabolic activation system mean his+ revertant colonies (control) maximum revertant factor (conc. (µg/plate)) dose dependency Assessment maximum revertant factor (positive control)
TA 98 no 25 0.9 (100) no negative 27.1
  yes 37 1 (5000) no negative 16.3
TA 100 no 105 1 (20, 100) no negative 5.5
  yes 108 1 (20) no negative 5.9
TA 1537 no 10 1.2 (100) no negative 37.5
  yes 13 1 (20) no negative 6.2
TA 1535 no 16 0.9 (100) no negative 60.1
  yes 15 0.9 (20) no negative 4.5

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

According to the results of the present study, the test substance Oxooel 13 is not mutagenic in the Salmonella typhimurium reverse mutation assay under the experimental conditions chosen here.
Executive summary:

The study is conducted according to the OECD Guideline 471 and is reliable without any restriction (deviation: only 4 strains tested).

Oxooel 13 was tested in the standard plate test as well as in the preincubation assay with and without metabolic activation (MA) in S. typhimurium TA98, TA100, TA1535 and TA1537 at dose levels of 20 -5000 µg/plate. No increase in the number of revertants was detected in any strain with and without MA. Vehicle controls and positive controls were valid. Cytotoxicity was found depending on the strain and test conditions in concentrations >/= 2500 µg/plate.

Conclusion:   

According to the results of the present study, the test substance Oxooel 13 is not mutagenic in the Salmonella typhimurium reverse mutation assay under the experimental conditions chosen here.