N,N-dimethylpyridin-4-amine

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study under GLP

Data source

Reference

Reference 1

Reference Type:

other: US government testing result

Title:

Unnamed

Year:

1995

Report date:

1995

Reference 2

Reference Type:

publication

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dimethylpyridin-4-amine

EC Number:

214-353-5

EC Name:

N,N-dimethylpyridin-4-amine

Cas Number:

1122-58-3

Molecular formula:

C7H10N2

IUPAC Name:

N,N-dimethylpyridin-4-amine

Constituent 2

Reference substance name:

N,N-dimethylpyridin(4-amine)

IUPAC Name:

N,N-dimethylpyridin(4-amine)

Test material form:

not specified

Details on test material:

No data on test material. Analytical studies were performed at Midwest Research Institute, Kansas City, MO, USA, including rigorous substance identification procedures, purity analysis and documentation of stability.

Method

Target gene:

histidine

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:

S. typhimurium TA 1538

Species / strain 3

Species / strain / cell type:

E. coli WP2 uvr A

Species / strain 4

Species / strain / cell type:

E. coli WP2 uvr A pKM 101

Species / strain 5

Species / strain / cell type:

S. typhimurium TA 102

Species / strain 6

Species / strain / cell type:

S. typhimurium, other: Strain 104

Metabolic activation:

with and without

Metabolic activation system:

Rat Liver S-9 and Hamster Liver S-9, both induced with Aroclor 1254

Test concentrations with justification for top dose:

9.77 to 10,000 micrograms/plate. See details below in "Any other information on materials and methods, including tables."

Vehicle / solvent:

water

Details on test system and experimental conditions:

Both plate incorporation and preincubation protocols were used for S. typhimurium strains TA98, TA100, TA1535 and TA1537. The preincubation protocol was used for TA1538, TA102 and 104, and E. coli UVRA with and without the PKM101 plasmid.

Evaluation criteria:

Doses selected for testing were the result of cytotoxicity observed in preliminary dose-range finding studies.
For a test article to be positive in TA98, TA100 and TA1535, a doubling in the mean number of revertants per plate was required, along with a dose response. For a positive in strains TA1537 or TA 1538, a 3-fold increase in the mean number of revertants per plate was requires, along with a dose response relationship.

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 3

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 4

Species / strain:

E. coli WP2 uvr A pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 5

Species / strain:

S. typhimurium TA 102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Test results 6

Species / strain:

S. typhimurium, other: TA 104

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

likely at precipitating levels

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

Assume that all controls are valid as these assays were performed by a reputable authoritative body, the U.S. National Cancer Instititute.
All results were negative, non-mutagenic.

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

4-Dimethylaminopyridine is not mutagenic, as tested in several strains of Salmonella typhimurium and E. coli, both with and without rat and hamster liver metabolic activation.