1-methyl-2-pyrrolidone

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-methyl-2-pyrrolidone

EC Number:

212-828-1

EC Name:

1-methyl-2-pyrrolidone

Cas Number:

872-50-4

Molecular formula:

C5H9NO

IUPAC Name:

1-methylpyrrolidin-2-one

Test material form:

liquid

Specific details on test material used for the study:

Laboratory identification number 77/585, not further specified

Method

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA1535, TA100, TA1537

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

metabolic activation (S9 mix from Arochlor 1254 treated male Sprague-Dawley rats)

Test concentrations with justification for top dose:

Experiment 1: 3.15, 10, 31.5, 100, 315, 1000, 3000, 10000, and 30000 µL/plate with S9 mix
Experiment 2: 31.5, 100, 315, 1000, 3000, 10000, and 30000 µL/plate without S9 mix

Vehicle / solvent:

DMSO or water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

3-methylcholanthrene

benzo(a)pyrene

other: 2-aminoanthracene; N-methyl-N-nitro-N-nitrosoguanidine

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 72 hours

NUMBER OF REPLICATIONS: Concentrations were tested in duplicate

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

Not indicated.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA1535, TA100, TA1537

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

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
No confounding factors were described.

ADDITIONAL INFORMATION ON CYTOTOXICITY
Since a reduction of the his background lawn was not evident even at the highest dose of N-methylpyrrolidone, an overshadowing of a possible mutagenicity by toxicity is unlikely.

Applicant's summary and conclusion

Conclusions:

No mutagenic potential was measured in the in vitro gene mutation study in bacteria.

Executive summary:

N-Methylpyrrolidone was tested for mutagenicity with Salmonella typhimurium TA 100, TA 1537 and TA 98. Seven different concentrations from 31.5 to 30,000 nl per plate were used in the experiments for direct mutagenicity. In the experiments with S-9 Mix nine concentrations from 3.15 to 30,000 nl per plate were tested. The test compound was dissolved at all concentrations. No mutagenicity was observed with the test compound under all these conditions. This was also the case when an epoxide hydratase inhibitor was added to the S-9 Mix in order to increase the sensitivity of the test towards compounds which are activated to mutagenic epoxides (this experiment was performed with TA 98). Since a reduction of the his background lawn was not evident even at the highest dose of N-methylpyrrolidone, an overshadowing of a possible mutagenicity by toxicity is unlikely.