Reaction mass of nitrosylsulphuric acid and sulphuric acid

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline-equivalent proprietary study.

Cross-reference

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Principles of method if other than guideline:

No method is stated, however the method is equivalent to the contemporary OECD 471 guideline.

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Reference

Name:

Unnamed

Type:

Constituent

Type:

Constituent

Details on test material:

White powder, 89.5% purity

Method

Target gene:

Reversion to histidine independence in histidine-deficient mutant Salmonella typhimurium strains.

Species / strain

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

other: pKM 101 plasmid, deep rough, uv repair deficient

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced male Sprague-Dawley rat liver S9 fraction

Test concentrations with justification for top dose:

0 (solvent control), 20, 100, 500, 2500 and 12500 ug/plate; initial assay.
0 (solvent control), 775, 1550, 3100, 6200 and 12400 ug/plate; confirmatory assay

Vehicle / solvent:

Demineralised water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: sodium azide, nitrofurantoin, 4-phenylenediamine (-S9); 2-aminoanthracene (+S9)

Details on test system and experimental conditions:

Plate incorporation method: 48-hour exposure time

Evaluation criteria:

A reproducible and concentration-related increase (of at least twice the negative control count) in the number of revertant colonies of at least one strain was stated to be the criteria for a positive response.

Statistics:

Not applicable.

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:

cytotoxicity

Remarks:

In some strains

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No further information

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

No evidence of mutagenicity was seen under the conditions of this assay.

	Initial assay
	TA98		TA100		TA1535		TA1537
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
Solvent control	17	29	102	116	13	18	13	12
20	17	32	90	113	16	17	13	15
100	23	34	117	110	12	16	12	13
500	30	35	121	103	19	16	16	11
2500	19	17	114	117	13	10	15	13
12500	15	12	59	71	8	-	7	-
Positive control	202	1020	385	698	1080	167	183	76
	Confirmatory assay
Solvent control	15	22	65	98	13	13	13	9
775	13	30	70	90	12	20	8	13
1550	14	31	60	82	13	15	10	11
3100	15	26	66	68	14	14	10	11
6200	11	14	62	59	11	11	5	5
12400	10	-	60	-	13	-	4	4
Positive control	88	832	241	696	1021	224	107	89

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with and without S9

The test material was not found to be mutagenic under the conditions of this study.

Executive summary:

The mutagenicity of sodium hydrogensulphate monohydrate was investigated in an Ames test (plate incorporation method) using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537. Quuadruplicate cultures of each strain were exposed for 48 hours to the test material (dissolved in demineralised water) in the absence and presence of an exogenous metabolic acitvation system (Aroclor 1254 -induced male Sprague-Dawley rat S9 fraction) at concentrations of 0 (solvent control), 20, 100, 500, 2500 and 12500 ug/plate.

Evidence of cytotoxicity (reduced numbers of revertant colonies) was seen at the highest concentration in the absence of S9 and at 2500 and 12500 ug/plate in the presence of S9. Exposure to the test material did not induce any increase in the numbers of revertant colonies of any strain. Appropriate positve control compounds (sodium azide, nitrofurantoi, 4 -nitrophenylenediamine and 2 -aminoanthracene) produced large increases in the numbers of revertant colonies, confirming the sensitivity of the assay. Results were confirmed in an independently repeated assay using concentrations of 0 (solvent control), 775, 1550, 3100, 6200 and 12400 ug/plate; cytotoxicity (reduced numbers of revertant colonies) was seen at 6200 and 12400 ug/plate.

No evidence of mutagenicity was seen under the conditions of this assay.