Benzoic acid, 3-[[(2,3-dihydroxypropyl)amino]carbonyl]-5-nitro-

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September to October 1996

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

no bacteria strain included to detect cross-linking mutagens

Principles of method if other than guideline:

Direct plate incorporation method performed

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid

EC Number:

602-890-1

Cas Number:

122731-58-2

Molecular formula:

C11 H12 N2 O7

IUPAC Name:

rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid

Method

Target gene:

Histidine gene locus

Species / strain

Species / strain / cell type:

other: S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

liver S9-mix from Aroclor 1254 -treated rats

Test concentrations with justification for top dose:

NIP-Monoamid: six concentrations from 0.1 to 5 mg/plate
Sodium azide: 5 µg/plate (TA 1535 and TA 100)
2-Nitrofluorene: 10 µg/plate (TA 1538 and TA 98)
9-Acridinamine: 100 µg/plate (TA 1537)
Benzo[a]pyrene: 2.5 and 5 µg/plate (TA 100 and TA 98)
Cyclophosphamide: 400 µg/plate (TA 1535)
2-Aminoanthracene: 2 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Sodium azide (TA 1535 and TA 100), 2-Nitrofluorene (TA 1538 and TA 98), 9-Acridinamine (TA 1537), Benzo[a]pyrene (TA 100 and TA 98), Cyclophosphamide (TA 1535), 2-Aminoanthracene

Results and discussion

Test results

Key result

Species / strain:

other: Salmonella typhimurium strains TA 1535, TA 100, TA 1537, TA 1538, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

the test item is not mutagen in the bacterial strains tested

Executive summary:

NIP-Monoamid was tested in the Salmonella/microsome test for point-mutagenic effects in doses up to 5000 µg/plate on the five histidine-auxotrophic Salmonella typhimurium LT2 strains TA 1535, TA 100, TA 1537, TA 1538 and TA 98.

No bacteriotoxic effects was seen and no precipitates were found in the agar.

No evidence for a mutagenic activity of NIP-Monoamid up to the maximum recommended dose level of 5 mg/plate was found.