Registration Dossier
Registration Dossier
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EC number: 230-660-7 | CAS number: 7250-67-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Chemically-Induced Unscheduled DNA Synthesis in Primary Rat Hepatocyte Cultures: A Comparison with Bacterial Mutagenicity Using 218 compounds
- Author:
- Gregory S. Probst, Robert E. McMahont, L. E. Hill, Christina Z. Thompson, J.K. Epp, and S.B. Neal
- Year:
- 1 981
- Bibliographic source:
- Environmental Mutagenesis 3: 11-32 (1981)
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to determine the mutagenic nature of Pyrrolidinoethyl chloride
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(2-chloroethyl)pyrrolidine hydrochloride
- EC Number:
- 230-660-7
- EC Name:
- N-(2-chloroethyl)pyrrolidine hydrochloride
- Cas Number:
- 7250-67-1
- Molecular formula:
- C6H12ClNClH
- IUPAC Name:
- 1-(2-chloroethyl)pyrrolidine hydrochloride
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): 1-(2-Chloroethyl)pyrrolidine hydrochloride
- Molecular formula (if other than submission substance):C6H12ClN.HCl
- Molecular weight (if other than submission substance): 170.08 g/mole
- Smiles notation (if other than submission substance): N1(CCCl)CCCC1.Cl
- InChl (if other than submission substance): FSNGFFWICFYWQC-UHFFFAOYSA-N
- Substance type: Organic
- Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material: Pyrrolidinoethyl chloride
- Molecular formula: C8H9Cl3O
- Molecular weight: 227.517 g/mole
- Substance type: organic
- Physical state: No data available
- Purity : No data available
- Impurities (identity and concentrations): No data available
Method
- Target gene:
- Histidine
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: G46, TA1535, TA100, C3076, TA1537, D3052, TA1538, and TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli, other: WP2 and WP2 uvrA-
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction was derived from the livers of Aroclor 1254 pretreated rats
- Test concentrations with justification for top dose:
- No data
- Vehicle / solvent:
- No data
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- not specified
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: No data
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
- Any supplementary information relevant to cytotoxicity: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for an increase in the number of revertants/plate
- Statistics:
- No data available
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: C3076, TA1537, D3052, TA1538, and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: G46, TA1535, TA100
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- S. typhimurium, other: G46, TA1535, TA100
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Additional information on results:
- No data available
Applicant's summary and conclusion
- Conclusions:
- Pyrrolidinoethyl chloride induced gene mutation in Salmonella typhimurium strains G46, TA1535, TA100 and E. coli strain WP2 uvrA without metabolic activation system. It however failed to induce gene mutation in Salmonella typhimurium (C3076, TA1537, D3052, TA1538, and TA98) and Escherichia coli (WP2) in the presence and absence of S9 metabolic activation system.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of Pyrrolidinoethyl chloride. The study was performed using the modified Ames assay using eight histidine auxotrophs of Salmonella typhimurium (G46, TA1535, TA100, C3076, TA1537, D3052, TA1538, and TA98) and two tryptophan auxotraphs of Escherichia coli (WP2 and WP2 uvrA-) with and without S9 metabolic activation system. The inocula of ten bacterial tester strains were streaked across square agar plates containing a concentration gradient of test compound and mutagenicity was scored by noting the number of tester strains showing mutant colonies over a given concentration range. The test compound was incorporated into four gradient plates to give a tenfold concentration range per plate, thus providing a 10,000-fold concentration range for the test. Pyrrolidinoethyl chloride induced gene mutation in Salmonella typhimurium strains G46, TA1535, TA100 and E. coli strain WP2 uvrA without metabolic activation system at a minimum mutagenic concentration of 0.6 nanomoles/mL. It however failed to induce gene mutation in Salmonella typhimurium (C3076, TA1537, D3052, TA1538, and TA98) and Escherichia coli (WP2) in the presence and absence of S9 metabolic activation system.
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