Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid

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: Comparable to guideline study with acceptable restrictions. Only four salmonella strains were used. No data about analytical purity of test substance.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

Only 4 strains tested (TA1535, 1537, 98, 100); no strain for detection of oxidising damage or cross-linking involved.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid

EC Number:

936-609-1

Molecular formula:

C40H32CrN4O12S2-R+] . [C36H28ClCrN7O10S2-R+] . [C34H26Cl2CrN8O8S2-R+]; R+ = NH4+, Na+ or H+

IUPAC Name:

Reaction products of diazotized 2-amino-4-(methylsulfonyl)-phenol with 2-(3-Chlorophenyl)-2,4-dihydro-5-methyl-3H-pyrazol-3-one and Methyl-7-hydroxy-1-naphthylcarbamate – and chromium (III) 2:1, salted by ammonium, sodium and acid

Test material form:

other: solid

Details on test material:

Purity: No data.
Description: brown dyestuff

Method

Target gene:

HIS

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-Mix from the liver of Aroclor 1254 induced male Sprague-Dawley rats

Test concentrations with justification for top dose:

0.2, 2, 20, 200, 2000 µg per plate

Vehicle / solvent:

Dimethylsulfoxide (DMSO)

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: Without S9-mix: N-Methyl-N´-Nitro-N-Nitrosoguanidine (MNNG; 1.6 µg, TA1535, TA100); 9-Aminoacridine (50 µg, TA1537); Daunomycin (5 µg, TA98); With S9-mix: 2-anthramine (25 µg, all strains)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)

REPLICATES: triplicate

Evaluation criteria:

The criteria of mutagenicity used in this test are a doubling of the spontaneous reversion rate and a dose-effect relationship.

Results and discussion

Test results

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Remarks:

Cytotoxicity (absence of background) was observed microscopically. No further details were discussed.

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxicity (absence of background) was observed microscopically. No further details were discussed. A slight cytotoxic effect of the substance in the high dose group could be concluded in the strains TA1535, 1537, 98 by reviewing the raw data. A slight effect of the solvent DMSO on the spontaneous reversion frequency could be observed in the tester strain TA100.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1: Overview over mean reversion rates in the assay with Orasol Brown 2GL in the various tester strains with and without metabolic activation.

	Without S9-mix				With S9-mix
Substance	Strain
	TA1535	TA1537	TA98	TA100	TA1535	TA1537	TA98	TA100
Spontaneous reversion	8	7	23	128	14	11	39	115
DMSO	9	5	16	66	10	11	37	71
Positive control	910	177	2354	861	958	155	2485	1844
Orasol 0.2 µg	10	3	15	72	14	11	35	81
Orasol 2 µg	10	3	17	73	11	15	29	78
Orasol 20 µg	5	4	13	59	12	10	39	84
Orasol 200 µg	11	5	11	65	16	10	60	85
Orasol 2000µg	7	5	14	45	9	7	23	77

.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative