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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:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: aqueous formulation
Details on test material:
- Name of test material (as cited in study report): Hostapur OS flüssig
- Physical state: yellow, clear liquid
- Analytical purity: not reported
- Composition of test material, percentage of components: approx. 40 % Olefin sulfonate Na salt, 60 % water; C-chainlengths: ≤C12: max. 1%, C14: approx. 65%; C16: approx. 30%; ≥C18: max. 1.5%
- Lot/batch No.: E06 137 142 dated September 1st, 1988
- Storage condition of test material: dark at 22°C
- Other: Source: Hoechst AG

Method

Target gene:
His-operon, Trp-operon
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium, other: TA98, 100, 1535, 1537, 1538
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat liver S9
Test concentrations with justification for top dose:
Experiment 1: 0, 4, 20, 100, 500, 2500, 10000 µg/plate;
Experiment 2: 0, 4, 20, 100, 500, 2500, 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA100, TA1535 without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1535 without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA98, TA1538 without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-Methyl-N-nitro-N-nitrosoguanidine
Remarks:
WP2uvrA without S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Remarks:
all strains with S9
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-Aminoanthracene
Remarks:
all strains with S9
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48 to 72 h


SELECTION AGENT (mutation assays): histidine and tryptophan prototrophy, respectively


NUMBER OF REPLICATIONS: in triplicate plates


DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (surviving fraction); other: reduction of background growth
Evaluation criteria:
Significant increase in the number of revertant colonies, dose dependent effect.
Statistics:
Means of triplicate plates

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium, other: TA100, 1535, 1537, 1538, 98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
Starting at 500 µg/plate without S9 and at 2500 µg/plate with S9
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

Any other information on results incl. tables

Maximum number of revertants (means) observed in both experiments:

 

Mean Max. Revertant number

-S9

+S9

Strain

Control

Test group (µg/plate)

Control

Test group (µg/plate)

TA100

174

187 (4)

168

180 (4)

TA1535

13

16 (4)

13

14 (4)

TA1537

6

12 (100)

10

10 (4)

TA1538

13

17 (20)

19

25 (20)

TA98

30

29 (20)

32

39 (20)

WP2uvrA

67

68 (4)

75

72 (100)

Conclusion:

There was no significant increase in revertants over control observed in any of the experiments.

Therefore, the test substance is not mutagenic in bacteria under the experimental conditions chosen.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative