Iron trinitrate

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:

weight of evidence

Study period:

2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

iron(2+) sulfate heptahydrate

IUPAC Name:

iron(2+) sulfate heptahydrate

Constituent 2

Reference substance name:

7782-63-0

EC Number:

616-510-7

Cas Number:

7782-63-0

IUPAC Name:

7782-63-0

Constituent 3

Reference substance name:

iron(II)sulphate heptahydrate

IUPAC Name:

iron(II)sulphate heptahydrate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): Sulfuric acid, iron(2+) salt (1:1), heptahydrate
- Molecular formula (if other than submission substance): FeSO4. 7H2O
- Molecular weight (if other than submission substance): 278.01
- Physical state: powder, blue-green crystals
- Analytical purity: 91.6 wt%
- Impurities (identity and concentrations): Mg 0.22%, Mn 0.2%, Zn 87 ppm
- Stability under test conditions:
- Storage condition of test material: room temperature under Argon
- Other: MP 64°C, Water solubility: 32.8g/l at 0°C

Method

Target gene:

His Operon (S. typhimurium strains) and Trp Operon (E. coli strain)

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 obtained from SD rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

0, 156, 313, 625, 1250, 2500, 5000 µg/plate

Vehicle / solvent:

distilled water

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: -S9: aminofluorene for TA100 and TA98; sodium azide for TA1535; TA1535: NaN3, N-ethyl-N'-nitrosogunanidine for WP2uvrA/pKM101 and 9-aminoacridine hydrochloride for TA1537 +S9: 2-amonoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours

PLATES/TEST: 3
NUMBER OF REPLICATIONS: 2 tests

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

No information but standard test guideline criteria apply

Statistics:

Colonies were counted for 3 plates. Mean values which are at least twice as high as the negative vehicle control are considered as positive. Otherwise it is considered as negative.

Results and discussion

Test results

Species / strain:

bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100; E. coli WP2 uvrA pKM 101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

Toxicity was observed at a concentration of > 2500 µg/plate with or without metabolic activation

Vehicle controls validity:

valid

Untreated negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

There was no precipitation at any test concentration.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1. Mutagenicity of ferrous sulfate heptahydrate in reverse mutation test in bacteria

		number of revertants: mean value of negative control	number of revertants: mean value of positive control	max. number of revertants: mean value of test material [µg/plate]
without S9-mix
Base-pair change type	TA100	101 ± 6	630 ± 29	113 ± 7 [5000]
	TA 1535	9.5 ± 3	436 ± 21	13 ± 3 [ 313]
	WP2uvrA/pKM101	74.5 ± 4	3227 ± 107	92 ± 7 [2500]
Frame-shift type	TA 98	15.5 ± 3	604 ± 30	20 ± 4 [156]
	TA1537	7.5 ± 2	211 ± 28	11 ± 1 [313]
without S9-mix
Base-pair change type	TA100	103 ± 6	1897 ± 202	136 ± 18 [5000]
	TA 1535	12 ± 3	241 ± 17	14 ± 5 [ 2500]
	WP2uvrA/pKM101	96 ± 7	831 ± 72	106 ± 1 [5000]
Frame-shift type	TA 98	26.5 ± 7	479 ± 30	29 ± 3 [313]
	TA1537	13 ± 3	227 ± 17	21 ± 2 [1250]

Applicant's summary and conclusion

Conclusions:

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

Ferrous sulfate heptahydrate was tested for bacterial mutagenicity according OECD 471 under GLP using the preincubation method. It did not induce an increase in reversions in any of the strains tested in either the initial or the repeat test. Solvent and positive controls gave the expected results. It is concluded that ferrous sulfate heptahydrate is not mutagenic to bacteria under the conditions of the test.

Executive summary:

Ferrous sulfate heptahydrate was tested for bacterial mutagenicity according OECD 471 under GLP using the preincubation method. It did not induce an increase in reversions in any of the strains tested in either the initial or the repeat test. Solvent and positive controls gave the expected results. It is concluded that ferrous sulfate heptahydrate is not mutagenic to bacteria under the conditions of the test.