Benzenesulfonic acid, 2-amino-4,5-dichloro-

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets generally accepted scientific standards, well documented and acceptable for assessment - Follow-up study to BASF AG 40M0425/904274, investigating the ability of the test substance to cause mutations in one strain (TA 98) in the presence of Norharman.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1990

Materials and methods

Principles of method if other than guideline:

In a standard plate test, the ability of the test substance to induce frameshift mutations in S. typhimurium strain TA 98 in the presence of Norharman and metabolic activation was investigated.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3,4-Dichloroaniline-6-sulfonic acid

EC Number:

700-413-2

Cas Number:

6331-96-0

Molecular formula:

C6 H5 Cl2 N O3 S

IUPAC Name:

3,4-Dichloroaniline-6-sulfonic acid

Method

Target gene:

Histidine operon

Species / strain

Species / strain / cell type:

S. typhimurium TA 98

Metabolic activation:

with

Metabolic activation system:

1 part of induced rat liver S-9 fraction mixed with 9 parts of cofactors (MgCl2, KCl, Glu-6-p, NADP, phosphate buffer (NaH2PO4, Na2HPO2.2H2O) (1:9)

Test concentrations with justification for top dose:

- Test substance: 20, 100, 500, 2500, 5,000 µg/plate.- 200 µg/plate Norharman was added to each culture.

Vehicle / solvent:

- Vehicle: DMSO.- Justification for choice of vehicle: no data.

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Anilin

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation test) - 200 µg/plate Norharman was added to each culture.DURATION- Exposure duration: 48 hours at 37°C.NUMBER OF REPLICATIONS: 1 experiment; 3 cultures/experiment.DETERMINATION OF CYTOTOXICITY - Method: reduction in the number of spontaneous revertants or a clearing of the bacterial background lawn.

Evaluation criteria:

In general, a test chemical is considered positive if the following criteria are met:- Doubling of the spontaneous mutation rate (control).- Dose-response relationship.- Reproducibility of the results

Statistics:

No statistical evaluation needed be performed.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS- Precipitation: Precipitation of the test item was observed at 5,000 µg/plate only.RANGE-FINDING/SCREENING STUDIES:- no data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Summary of results (TA 98), with metabolic activation.

			TA 98
	Concentration (µg/plate)	S9	X (n=4)	revertant factor
test subst.	control	yes	30
	20	yes	37	1.2
	100	yes	37	1.2
	500	yes	29	1.0
	2,500	yes	35	1.2
	5,000	yes	19*	0.6
l	control	yes	30
	positive control	yes	90	3.0

* precipitation