4-nitro-o-anisidine

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:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: pre-GLP

Data source

Reference

Reference 1

Reference Type:

secondary source

Title:

Executive summary on the ETAD project T 2015 toxicological testing of major colorants, with attachments and cover letter dated June 3, 1988

Author:

ETAD

Year:

1988

Bibliographic source:

NTIS/OTS 0000621

Reference 2

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1981

Materials and methods

Principles of method if other than guideline:

no details provided; ETAD toxicological method # 005 (July 1980)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-nitro-o-anisidine

EC Number:

202-588-6

EC Name:

4-nitro-o-anisidine

Cas Number:

97-52-9

Molecular formula:

C7H8N2O3

IUPAC Name:

2-methoxy-4-nitroaniline

Constituent 2

Reference substance name:

PNOA

IUPAC Name:

PNOA

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

rat liver S-9 mix

Test concentrations with justification for top dose:

0 - 0.8-4-20-100-500 - 2500 µg/Platte, 6 concentrations

Vehicle / solvent:

acetone

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

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):
positive with metabolic activation

The test material caused gen mutations in S.typhimurium.