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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.