4-methoxy-3-nitro-N-phenylbenzamide

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:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Well perfored study similar to OECD guideline using a deviating set of tester strains as compared to actual guidelines. However reliability is restricted because the unknown purity of the test sample allows no final conlusion regarding the mutagenic potential of the substance which is subject to registration.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: authors guideline similar to OECD 471

Deviations:

no

Principles of method if other than guideline:

TA 100, 1535, 1537, 97, 98 with and without metabolic activation, metabolic activation with Aroclor 1254-induced hamster liver S-9 (10%), or with Aroclor 1254-induced rat liver S-9 (10%), preincubation method, Concentrations tested: 0.0 - 1000.0 µg/plate

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-methoxy-3-nitro-N-phenylbenzamide

EC Number:

202-572-9

EC Name:

4-methoxy-3-nitro-N-phenylbenzamide

Cas Number:

97-32-5

Molecular formula:

C14H12N2O4

IUPAC Name:

4-methoxy-3-nitro-N-phenylbenzamide

Details on test material:

- Name of test material (as cited in study report): 4-Methoxy-3-nitro-N-phenylbenzamide
- Analytical purity: not stated

Method

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 97

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced hamster or rat liver S-9 (10%)

Test concentrations with justification for top dose:

0.0, 1.0, 3.0, 10.0, 16.0, 33.0, 100.0, 333.0, 1000.0 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

other: 4-nitro-o-phenylenediamine, 2-aminoanthracene

Evaluation criteria:

A chemical was judged mutagenic (+) or weakly mutagenic (+W) if it produced a reproducible, dose-related response over the solvent control, under a single metabolic activation condition, in replicate trials. A chemical was judged questionable (?) if the results of individual trials were not reproducible, if increases in his revertants did not meet the criteria for a "+W" response, or if only single doses produced increases in his revertants in repeat trials. Chemicals were judged nonmutagenic ( —) if they did not meet the criteria for a mutagenic or questionable response.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

other: TA100 pos. without MA, with MA rat, and with MA hamster / TA1535 neg. without MA, with MA rat, and with MA hamster / TA1537: neg. without MA, and pos. with MA rat, and with MA hamster / TA98: neg. without MA, and pos. with MA rat, and with MA hamster

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

other: TA97: weakly pos. without MA, and pos. with MA rat, and with MA hamster

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

The test item exerts mutagenic activity in the reverse bacterial mutation assay with and without metabolic activation.

Executive summary:

Mutagenic activity of the test item was investigated in Salmonella typhimurium strains TA 100, 1535, 1537, 97, and 98 with and without metabolic activation (induced rat or hamster liver S-9 (10%)) at concentrations of 0.0, 1.0, 3.0, 10.0, 16.0, 33.0, 100.0, 333.0, 1000.0 µg/plate using the preincubation method. Mutagenic response in terms of a relevant increases in his revertants was determined as follows:

	Without metabolic activation	With metabolic activation (rat)	With metabolic activation (hamster)
TA 100	positive	positive	positive
TA1535	negative	negative	negative
TA1537	negative	positive	positive
TA98	negative	positive	positive
TA 97	weakly positive	positive	positive

The appropriate reference mutagenes showed distinct positive mutagenic effects.