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Diss Factsheets

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study (GLP) with acceptable restrictions (strain combination not suitable for the detection of cross links)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Principles of method if other than guideline:
According to Ames et al. Mut. Res., 31, 347-364, 1975
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2-pyrrolidone
EC Number:
210-483-1
EC Name:
2-pyrrolidone
Cas Number:
616-45-5
Molecular formula:
C4H7NO
IUPAC Name:
pyrrolidin-2-one

Method

Target gene:
his-
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
S. typhimurium TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254 induced rat liver
Test concentrations with justification for top dose:
0, 110, 1100, 5500, 11000, 27500, 55000, 110000 and 165000 µg/plate (= 0, 0.1, 1.0, 5.0, 10, 25, 50, 100 and 150 µL/plate)
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
2-nitrofluorene
sodium azide
other: without metabolic activation: Quinacrine mustard and with metabolic activation: 2-Anthramine
Details on test system and experimental conditions:
METHOD OF APPLICATION: plate incorporation

NUMBER OF REPLICATIONS: 3
Evaluation criteria:
Evaluations considered if a dose-response was observed and strain-specific evaluation criteria. For strains TA-1535, TA-1537 and TA-1538, the data set is evaluated as positive if a dose-response is observed over a minimum of three test concentrations and the increase in revertants is equal to or greater than three times the solvent control value at the peak of the dose-response. The solvent control value should be within the normal range for evaluating the results. For strains TA-98 and TA-100, the data set is evaluated as positive if a dose-response is observed over a minimum of three test concentrations and the increase in revertants achieves a doubling of the solvent control value at the peak of the dose-response. The solvent control value should be within the normal range for evaluating the results.
Statistics:
Formal statistical methods were not used to evaluate the data.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA1535, TA1537, TA1538, TA98, TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
165000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Standard plate test (110-16500 µg/plate)   
Strain Metabolic activation system mean revertants in Controls maximum revertant factor dose dependency Assessment
TA 98 no 25.7 1.2 no negative
  yes 46.3 1.0 no negative
TA 100 no 147.7 1.0 no negative
  yes 140.3 1.0 no negative
TA 1535 no 25.3 1.0 no negative
  yes 17.3 1.0 no negative
TA 1537 no 5 1.7 no negative
  yes 10.3 1.1 no negative
TA 1538 no 13 1.1 no negative
  yes 16 1.8 no negative
      
Standard plate test II(110-16500 µg/plate)   
Strain Metabolic activation system mean revertants in Controls maximum revertant factor dose dependency Assessment
TA 98 no 28.3 1.1 no negative
  yes 49 1.0 no negative
TA 100 no 127 1.2 no negative
  yes 142.7 1.1 no negative
TA 1535 no 20.7 1.2 no negative
  yes 15 1.2 no negative
TA 1537 no 7.7 1.6 no negative
  yes 12 1.0 no negative
TA 1538 no 12 1.2 no negative
  yes 22 1.2 no negative

Applicant's summary and conclusion

Conclusions:
Interpretation of results: negative
2-Pyrrolidone is negative in this Ames Test
Executive summary:

The test item was examined in the 5 Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver).

The experiments were carried out as plate incorporation tests. The test item was completely dissolved in distilled water. The solvent served as the negative control.

Preliminary test

Concentrations of test substance were selected based on a preliminary toxicity assay at 14 concentration levels using two-fold dilutions from a high concentration of 150 microliter per plate (for liquids). As no significant toxicity was observed, 150 microliters per plate was used as the top concentration in the studies.

Main study

Eight concentrations ranging from 0.1 to 150 μL test substance/plate were employed in the plate incorporation test (in detail the following concentrations were employed: 0, 0.1, 1.0, 5.0, 10, 25, 50, 100 and 150 microliters per plate for all strains in both of the two independent repeats: with and without metabolic activation).

Cytotoxicity was noted in the plate incorporation test, carried out without and with metabolic activation at 165000 µg/plate..

No increase in revertant colony numbers as compared with control counts was observed for the test substance, tested up to a concentration of 150 μL/plate, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively. The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.

In conclusion, under the present test conditions the test substance 2 -pyrrolidone tested up to a concentration of 150 µL/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 1538 in the plate incorporation test carried out without and with metabolic activation.