1-methylpyrrolidine

Genetic toxicity: in vitro

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- and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

1983

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Version / remarks:

1996

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Version / remarks:

1992

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-methylpyrrolidine

EC Number:

204-438-5

EC Name:

1-methylpyrrolidine

Cas Number:

120-94-5

Molecular formula:

C5H11N

IUPAC Name:

1-methylpyrrolidine

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20, 100, 500, 2500, 5000 µg/plate (standard plate test)
125, 250, 500, 1000, 1500 µg/plate (preincubation test)

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9-mix: 2-aminoanthracene (all strains); without S9-mix: 2-aminoanthracene (all strains), N-methyl-N'-nitro-N-nitrosoguanidine (TA1535, 100), 4-nitro-o-phenylenediamine (TA98), 9-aminoacridine (TA1537) and N-ethyl-N'-nitro-N-nitrosoguanidine (E.coli)

Details on test system and experimental conditions:

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

DURATION
- Preincubation period: 20 min
- Expression time (cells in growth medium): 48-72 h

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

The test chemical is considered positive in this assay if the following criteria are met:
A dose-related and reproducable increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

Statistics:

The arithmetic mean of the counted colonies per concentration was calculated.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

A bacteriotoxic effect was observed in the preincubation test depending an the strain and test conditions at about > 1000 µg/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: A bacteriotoxic effect was observed in the preincubation test depending an the strain and test conditions at about > 1000 ug/plate.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Number of revertants per plate (mean of three plates), test 1

	strain TA98		strain TA100		strain TA1535		strain TA1537
conc. [µg/mL]	-MA	+MA	-MA	+MA	-MA	+MA	-MA	+MA
0 (water)	27	46	159	158	20	20	12
20	27	46	157	158	20	22	10
100	26	37	157	159	19	20	11
500	22	29	127	157	20	16	10
2500		8		83		8
5000
4-nitro-o-phenyleridiamine 10 µg	1266
2-Aminoanthracene 2.5 µg		1215		1536		135		147
N-methyl-N' -nitro-N-nitrosoguanidine 5 µg			2239		1424
9-aminoacridine 100 µg							472

 

 

 

Table 2: Number of revertants per plate (mean of three plates), test 2

	strain TA98		strain TA100		strain TA1535		strain TA1537		E. coli WP2 uvrA
conc. [µg/mL]	-MA	+MA	-MA	+MA	-MA	+MA	-MA	+MA	-MA	+MA
0 (water)	30	48	137	151	13	12	10	11	33	38
125	28	39	141	154	13	15	13	11	32	39
250	35	46	136	152	16	12	9	10	33	35
500	35	46	158	139	12	15	9	12	35	41
1000	28	46	104	119	10	15	6	9	22	37
1500	34	38	108	135	-	12	1	12	17	27
4-nitro-o-phenyleridiamine 10 µg	1113
2-Aminoanthracene 2.5 µg*		786		662		88		129		112
N-methyl-N' -nitro-N-nitrosoguanidine 5 µg			1297		1083
9-aminoacridine 100 µg							346
N-ethylN-nitro-N-nitrosoguanidine 10 µg									772

  *except for E.coli: 60 µg