Biphenyl-2-ylamine

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

From the data available data from various studies and using the weight of evidence appraoch, 2-Aminobiphenyl is found to be non-mutagenic to the Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system. Estmation results also indicate that the substance biphenyl-2-ylamine is estimated to be non-genotoxic to in-vitro chromosomal abbreviation to Chinese hamster Lung (CHL) without metabolic activation.

Link to relevant study records

Reference

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Data is from peer reviewed journal

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

The Ames Salmonella/ microsome assay

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Species / strain / cell type:

S. typhimurium, other: TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat S9 mix

Test concentrations with justification for top dose:

3, 10, 30, 100, 300, ug/plate

Vehicle / solvent:

Water/DMSO

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

other: 2-aminofluorene and MNNG

Details on test system and experimental conditions:

preincubation assay

Statistics:

The mutagenic potency was calculated by taking the slope of the dose-response curve.

Species / strain:

S. typhimurium, other: TA98 and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results (migrated information):
negative

2-Aminobiphenyl is non-mutagenic to the Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system

Executive summary:

The AMES salmonella assay (preincubation protocol) was employed to test the mutagenecity of 2- Aminobiphenyl using Salmonella typhimurium strains TA98 and TA100 in the presence of aroclor 1254 induced rat S9 mix.

No. of revertant colonies did not increase for the test compound as compared to control.

 

Hence, 2-Aminobiphenyl is non-mutagenic to the Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Genetic toxicity in vitro

Studies of biphenyl-2-ylamine were reviewed for genetic toxicity in vitro from reliable sources having Klimisch rating 2.

The summary of the results are presented below:

Sr. No	Type of genotoxicity	Result	Species	Remarks
1.	Gene mutation	Negative	S. typhimurium TA 98 and TA 100 (with and without activation))	Experimental data for target chemical
2.	Gene mutation	Negative     Positive	S. typhimurium TA1535, TA1538 and TA98 (with metabolic activation)   S. typhimurium TA 100 (with metabolic activation)	Experimental data for target chemical
3.	Gene mutation	Negative	S. typhimurium TA 98 and TA 100 (with and without activation))	Experimental data for target chemical
4.	Gene mutation	Negative	Chinese hamsterLung (CHL)	QSAR predicted data

 

On the basis of studies summarized in the above table and applying weight of evidence approach, it can be observed that the test substance

biphenyl-2-ylamine is not likely to exhibit genetic toxicity effects.

Justification for selection of genetic toxicity endpoint
2-Aminobiphenyl is non-mutagenic to the Salmonella typhimurium TA98 and TA100 in the presence and absence of S9 metabolic activation system

Justification for classification or non-classification

On the basis of studies summarized in the above table and applying weight of evidence approach, it can be observed that the test substance

biphenyl-2-ylamine is not likely to exhibit genetic toxicity effects.