Sodium 3-nitrobenzenesulphonate

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

Data is from study report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Principles of method if other than guideline:

To evaluate the mutagenic potential of the test chemical in mouse by micronucleus assay.

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 3-nitrobenzenesulphonate

EC Number:

204-857-3

EC Name:

Sodium 3-nitrobenzenesulphonate

Cas Number:

127-68-4

Molecular formula:

C6H5NO5S.Na

IUPAC Name:

sodium 3-nitrobenzenesulphonate

Test material form:

solid

Details on test material:

- Name of test material : Sodium 3-nitrobenzenesulphonate
- Molecular formula : C6H4NNaO5S
- Molecular weight : 225.1556 g/mol
- Smiles notation : c1(cc(ccc1)[N+](=O)[O-])S(=O)(=O)[O-].[Na+]
- InChl : 1S/C6H5NO5S.Na/c8-7(9)5-2-1-3-6(4-5)13(10,11)12;/h1-4H,(H,10,11,12);/q;+1/p-1
- Substance type : Organic
- Physical state : Solid

Test animals

Species:

mouse

Strain:

NMRI

Sex:

male/female

Details on test animals or test system and environmental conditions:

The investigations were carried out in healthy male and female NMRI mice. Animals with a mean weight of about 26 g were used for the study.
For the duration of about one week the animals were housed in Makrolon cages, type M III, in groups of 5 separately according to sex in fully air-conditioned rooms in which central air conditioning guaranteed a range of 20 - 24°C for temperature and a range of 30 - 70% for relative humidity. Before the start of the treatment, the animals were transferred to Makrolon cages, type MI, and housed individually under the same conditions until the end of the test.
The animals were identified using cage cards.
The day/night rhythm was 12 hours (12 hours light from 6.00 - 18.00 hours and 12 hours darkness from 18.00 - 6.00 hours).
Standardized pelleted feed and drinking water from bottles were available ad libitum.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

aqua dest.

Details on exposure:

single exposure

Frequency of treatment:

single exposure

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 1500, 3000, 6000 mg/kg
Basis:
no data

No. of animals per sex per dose:

5

Control animals:

yes

Positive control(s):

cyclophosphamide; vincristine

Examinations

Tissues and cell types examined:

bone marrow cells

Details of tissue and slide preparation:

In a pretest for the determination of the acute oral toxicity the highest applicable amount of 6000 mg/kg body weight was survived by all animals and led only to irregular respiration 30 minutes after treatment of the animals. Doses > 6000 mg/kg body weight could not be administered due to technical reasons (no complete mixture of aqua dest. and test substance, i.e. formation of 2 phases). Therefore, a dose of 6000 mg/kg body weight was selected
as the highest dose in the present cytogenetic study. 3000 mg/kg and 1500 mg/kg body weight were administered as further doses.
All test substance formulations were prepared immediately before the single oral administration. For control purposes, male and female animals were given merely the solvent aqua dest. by the same route, or, as positive control, cyclophosphamid or vincristine in amounts as indicated above once orally or intraperitoneally, respectively.

Evaluation criteria:

Polychromatic to normochromatic erythrocytes was observed .

Statistics:

No data

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: No mutagenic potential

Additional information on results:

The single oral administration of Ludigol Granulat in doses of 6000 mg/kg, 3000 mg/kg and 1500 mg/kg body weight did not lead to any increase in the number of polychromatic erythrocytes containing either small or large micronuclei. The rate of micronuclei was always in the same range as that of the negative control in all dose groups and at all sacrifice intervals. No inhibition of erythropoiesis determined from the ratio of polychromatic to normochromatic erythrocytes was detected.

Applicant's summary and conclusion

Conclusions:

There were no biologically relevant, significant differences in the frequency of erythrocytes containing micronuclei either between the solvent control and the 3 dose groups (6000 mg/kg, 3000 mg/kg and 1500 mg/kg) or between the various sacrifice intervals (16, 24 and 48 hours).  Thus, under the experimental conditions chosen, the test substance has no chromosome-damaging (clastogenic) effect nor does it lead to any impairment of chromosome distribution in the course of mitosis.

Executive summary:

Gene mutation toxicity study was performed by to determine the mutagenic nature of test chemical on mouse by micronucleus test. In vivo Gene mutation study was conducted in male and female mouse NMRI mouse. The test substance was exposed at the concentration of 0, 1500, 3000, 6000 mg/kg by oral gavage route of exposure.The erythrocytes containing micronuclei was observed. There were no biologically relevant, significant differences in the frequency of erythrocytes containing micronuclei either between the solvent control and the 3 dose groups (6000 mg/kg, 3000 mg/kg and 1500 mg/kg) or between the various sacrifice intervals (16, 24 and 48 hours).  Thus, under the experimental conditions chosen, the test substance has no chromosome-damaging (clastogenic) effect nor does it lead to any impairment of chromosome distribution in the course of mitosis. Hence the test chemical is not likely to classify as a gene mutant in vivo.