Octahydrocyclopenta[c]pyrrole

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)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Octahydrocyclopenta[c]pyrrole

EC Number:

227-114-5

EC Name:

Octahydrocyclopenta[c]pyrrole

Cas Number:

5661-03-0

Molecular formula:

C7H13N

IUPAC Name:

octahydrocyclopenta[c]pyrrole

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Test concentrations with justification for top dose:

10, 100, 500, 1000, 2500 and 5000 µg/plate.

Vehicle / solvent:

distilled water

Controls

Negative solvent / vehicle controls:

yes

Remarks:

dimethylsulfoxide

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

mitomycin C

other: 2-anthramine

Remarks:

Tested with S9 mix : only 2-anthramine.

Details on test system and experimental conditions:

The five strains were supplied by BNAmes' Laboratory, stored in a cryoprotective medium in a liquid nitrogen container.
The day before treatment, cultures were inoculated from frozen permanents : a scrape was taken under sterile conditions and put into approximately 6ml of nutrient broth. The nutrient broth was the placed under agitation in an incubator at 37°C for about 14 hours, to produce bacterial suspensions. Each strain derived from Salmonella Typhimurium LT2 contains one mutation in the histidine operon, resulting in a requirement for histidine.

In addition, to increase their sensitivity to mutagenic substances, further mutations have been added (see table below)

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

The test substance does not show mutagenic activity in the bacterial reverse mutation test on Salmonella Typhimurium.

Executive summary:

The test substance was freely soluble in the vehicle, at 50 mg/ml.

Consequently, with a maximum dose volume of 100 µl/plate, the dose-levels for the preliminary toxicity test were : 10, 100, 500, 1000, 2500 and 5000 µg/plate.

The evaluation of toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.

Since the test substance was sometimes toxic, the choice of the highest dose-level was based on the level of toxicity, according to the criteria specified in the international guidelines.

In the absence of S9 mix, no increase in the number of revertant colonies, in comparison to the vehicle control values, was noted in both mutagenicity experiments.

Since equivocal results were observed in the two first experiments with S9mix (for 1535 strain, at high dose levels- 2500 and 5000), a third experiment was performed with modified conditions (i.e preincubation method) => no increase in the number of colonies was noted in the TA 1535 strain. Therefore, it was concluded that the observed increased in the first experiment was not biologically relevant.

The number of revertants in the vehicle and positive controls was as specified in the acceptance criteria => the study was therefore considered valid.