2-chloropyridine

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

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study without detailed documentation

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

publication

Title:

Comparative mutagenicity of halogenated pyridines in the Salmonella typhimurium/mammalian microsome test

Author:

Claxton LD, Dearfield KL, Spanggord RJ, Riccio ES, & Mortelmans K

Year:

1987

Bibliographic source:

Mutation Research; 176:185-198

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

- missing strain TA 1535.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-chloropyridine

EC Number:

203-646-3

EC Name:

2-chloropyridine

Cas Number:

109-09-1

Molecular formula:

C5H4ClN

IUPAC Name:

2-chloropyridine

Details on test material:

- Name of test material (as cited in study report): 2-Chloropyridine
- Analytical purity: 99.0%

Method

Species / strain

Species / strain / cell type:

other: TA 97, TA 98, TA 100, and TA 102

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver microsomes (S9)

Test concentrations with justification for top dose:

0, 50, 100, 500, 1000, or 5000 (- S9) and 0, 50, 100, 500, 1000, 5000, or 7500 µg/plate (+ S9)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

- DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: - publication states "appropriate ... positive controls were run in parallel with each assay".

Details on test system and experimental conditions:

Details provided in Ames et al., 1975

Evaluation criteria:

A chemical was not designated positive or negative unless reproducible results were obtained. A positive response was defined as a reproducible, dose-related increase in histidine independent revertants over the solvent control level in at least one strain/activation combination; it was not necessary for this increase to be equal or greater than 2-fold the background.

A definitive positive or negative result was assigned to a test result when the statistical methods and visual examination of the data agreed. An equivocal response occurred when (1) test results were not reproducible, (2) a low-level but no dose-related increase in histidine positive colonies was obtained, or (3) when an increase was observed at only one dose level.

Statistics:

Publication states that "results were examined statistically by both the methods of Stead et al. (1981) and Bernstein et al. (1982)".

Results and discussion

Test results

Species / strain:

other: TA 97, TA 98, TA 100, and TA 102

Metabolic activation:

with and without

Genotoxicity:

positive

Remarks:

- only in the presence of S9 (doses of 5000 and 7500 µg/plate caused increases that were more than double the vehicle control level).

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Remarks:

- publication states that "no toxicity was observed even when the applied concentration reached 7500 µg/plate."

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

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:

Interpretation of results (migrated information):
negative without metabolic activation
positive with metabolic activation