Diphenylamine

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: Comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Diphenylamine

EC Number:

204-539-4

EC Name:

Diphenylamine

Cas Number:

122-39-4

Molecular formula:

C12H11N

IUPAC Name:

diphenylamine

Details on test material:

- Name of test material (as cited in study report):N-phenylbenzenamine (diphenylamine)
- Analytical purity:>99%

Method

Species / strain

Species / strain 1

Species / strain / cell type:

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

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S-9 (9,000 g supernatant) fractions of Aroclor 1254-induced male Sprague-Dawley rat and male Syrian hamsters livers

Test concentrations with justification for top dose:

0, 1, 3, 10, 33, 66, 100, 166, 333 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: [distilled water, DMSO, 95% ethanol and acetone]

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

concurrent solvent

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

without metabolic activation, strains TA1535 and TA100

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

concurrent solvent

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

withoutf metabolic activation, strains TA97 and TA1537

Controls 3

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

concurrent solvent

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

without metabolic activation, strain TA98

Controls 4

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

concurrent solvent

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

with metabolic activation, all strains

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 min
- Exposure duration: 2 days

DETERMINATION OF CYTOTOXICITY
- Method: other: density of the background lawn and evolution of hte number of his+ colonies

Evaluation criteria:

A chemical is judged mutagenic (+) or weakly mutagenic (+W) if it produces a reproducible dose-related response over the solvent control in replicate trials
A chemical is questionable (?) if results of individual trials are not reproducible, if increases in his+ revertants do not meet the criteria for "+W" or if only single doses produce icnreases in his+ revertants
A chemical is non mutagenic if it does not meet the criteria for questionable or mutagenic response

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

other: only values available

Test results 2

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

other: only values available

Test results 3

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

other: only values available

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

other: only values available

Test results 5

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

other: only values available

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

negative

Under the conditions of the study, diphenylamine was found non mutagenic