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

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation (bacterial reverse mutation assay / Ames test, GLP, OECD TG471): negative with and without metabolic activation
[Schering AG, Report No. X186 -draft-, 1997-01-17]

 

Link to relevant study records

Reference

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

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

Target gene:

Histidine gene locus

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

ZK 39166 did not show a mutagenic potential in a bacterial reverse mutation assay (Ames test in S. typhimurim strains TA 1535, TA 100, TA 1537, TA 1538 and TA98) when tested up to the highest recommended dose level of 5.0 mg/plate in the absense or presence of extrinsic metabolic activation (liver S9 mix from Aroclor 1254 -treated rats).

 

Justification for classification or non-classification

Based on the results there is no classification required according to Directive 67/548/EEC and Regulation (EC) 1272/2008 (CLP).