Slags, sponge iron production by coal reduction in retort

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The genetic toxicity of the test item was assessed in accordance with OECD Guideline 471.  The test item was considered to be non-mutagenic under the conditions of this test.

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) did not induce structural chromosomal aberrations in human lymphocytes in vitro OECD Guideline 473.

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) is not mutagenic under the conditions of the OECD 471 test.

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) are neither cytotoxic nor mutagenic under the conditions of the HPRT (Hypoxanthin-Guanin-Phosphoribosyltransferase) gene mutation test according to EU 440/2008 B.17.

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Study period:

14 May 2015 - 04 June 2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Reason / purpose for cross-reference:

reference to same study

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)

Deviations:

no

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Target gene:

Not required

Species / strain / cell type:

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

Details on mammalian cell type (if applicable):

Non-mammalian study

Species / strain / cell type:

E. coli WP2 uvr A

Details on mammalian cell type (if applicable):

Non-mammalian study

Metabolic activation:

with and without

Metabolic activation system:

phenobarbitone/β-naphthoflavone induced rat liver S9

Test concentrations with justification for top dose:

Experiment 1 - Plate Incorparation Method - 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Experiment 2 - Preincubation Method - 15, 50, 150, 500, 1500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle/Solvents used : sterile distilled water.
- The test item was insoluble in sterile distilled water, dimethyl sulphoxide, dimethyl formamide, polyethylene glycol 400 and acetonitrile at 50 mg/mL, acetone at 200 mg/mL and tetrahydrofuran at 200 mg/mL in solubility checks performed in–house. The test item formed the best doseable suspension in sterile distilled water at a maximum concentration of 25 mg/mL, therefore, this solvent was selected as the vehicle.

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

N-ethyl-N-nitro-N-nitrosoguanidine

Remarks:

2, 3, 5 µg/plate respectively for WP2uvrA, TA100, TA1535

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

80 μg/plate for TA1537

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

0.2 μg/plate for TA98

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene (2AA)

Remarks:

1, 2, 10 µg/plate for TA100, TA1535&TA1537

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

5 μg/plate for TA98

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation) at multiple dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors).

EXPERIMENT 1 - PLATE INCORPARATION METHOD
Dose selection
- The test item was tested using the following method.
- The maximum concentration was 5000 µg/plate (the maximum recommended dose level).
- Eight concentrations of the test item (1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate) were assayed in triplicate against each tester strain, using the direct plate incorporation method.

Without Metabolic Activation
- 0.2 mL of the appropriate concentration of test item or vehicle or 0.1 mL of the appropriate positive control was added to 2 mL of molten trace amino-acid supplemented media containing 0.1 mL of one of the bacterial strain cultures and 0.5 mL of phosphate buffer.
- These were mixed and overlayed onto a Vogel-Bonner agar plate.
- Negative (untreated) controls were also performed on the same day as the mutation test.
- Each concentration of the test item, appropriate positive, vehicle and negative controls, and each bacterial strain, was assayed using triplicate plates.
With Metabolic Activation
- The procedure followed was the same as described above except that following the addition of the test item formulation and bacterial culture; 0.5 mL of S9-mix was added to the molten trace amino-acid supplemented media instead of phosphate buffer.

Incubation and Scoring
- All of the plates were incubated at 37 °C+/- 3 °C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system.
- The plates were viewed microscopically for evidence of thinning (toxicity).
- Manual counts were performed at 5000µg/plate due to excessive test item precipitation.
- Addition manual counts were required due to revertant colonies spreading slightly, distorting the plate count.

As Experiment 1 was deemed negative, Experiment 2 was performed using the pre-incubation method in the presence and absence of metabolic activation

EXPERIMENT 2 - PRE-INCUBATION METHOD
Dose selection
- The dose range used for the main test was determined by the results of Experiment 1 and was 15 to 5000 µg/plate.
- Six test item concentration were selected to achieve both four non-toxic dose levels and the potential toxic limit of the test item following the change in test methodology.

Without Metabolic Activation
- 0.1mL of appropriate bacterial strain culture, 0.5mL of phosphate buffer and 0.2mL of the test item formulation or solvent or 0.1mL of appropriate positive control were incubated at 37°C ± 3°C for 20 minutes (with shaking) prior to addition of 2mL of molten amino-acid supplemented media and subsqquent plating onto Vogel-Bonner plates.
- Negative (untreated) controls were also performed on the same day as the muttaion test emplying the plate incorparation method.
- All testing was performed in triplicate.


With Metabolic Activation
- The procedure was the same as described above except that following the addition of the test item formulation and bacterial strain culture, 0.5 mL of S9-mix was added to the tube instead of phosphate buffer, prior to incubation at 37 °C± 3 °C for 20 minutes (with shaking) and addition of molten amino-acid supplemented media.
- All testing for this experiment was performed in triplicate.

Incubation and Scoring
- All of the plates were incubated at 37 °C +/- 3 °C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system.
- The plates were viewed microscopically for evidence of thinning (toxicity).
- Manual counts were performed at 5000µg/plate because of excessive test item preciptiation.
- Additional manual counts were rrequired, predominantly due to interference in the base agar; minor precipitation of salts/dust particles/marks on the base of the plates slightly distorting the counts.



NUMBER OF REPLICATIONS: 3 replicates of each strain at each concentration both in the presence and absence of S9

NUMBER OF CELLS EVALUATED:
All strains 0.9 to 9 * 10>9



ACCEPTANCE CRITERIA:

All tester strain cultures should exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls (negative controls). Acceptable ranges are presented as follows:
TA1535: 7 to 40
TA100: 60 to 200
TA1537: 2 to 30
TA98: 8 to 60
WP2uvrA: 10 to 60

Evaluation criteria:

Evaluation Criteria
There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain
(especially if accompanied by an out-of-historical range response (Cariello and
Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met. Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this
type will be reported as equivocal.

Statistics:

MAHON, G.A.T., et al (1989). Analysis of data from microbial colony assays. In: KIRKLAND D.J., (eds.). Statistical Evaluation of Mutagenicity Test Data: UKEMS sub-committee on guidelines for mutagenicity testing. Cambridge University Press Report, pp. 26-65.

Key result

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:

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Key result

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

See attached Tables 2 - 5 for results

- The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate.

- There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the first mutation test (plate incorporation method)

- Consequently the same maximum dose level was used in the second mutation test.

- Similarly, there was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the second mutation test (pre-incubation method).

- A test item precipitate (black specks in appearance) was observed at 5000 μg/plate in Experiment 1 (plate incorporation method) and from 1500 μg/plate in the second mutation test (pre-incubation method). This observation did not prevent the scoring of revertant colonies.

- There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method).

- Similarly, no toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 2 (pre-incubation method).

- Small, statistically significant increases in revertant colony frequency were observed in the second mutation test at 1500 μg/plate (TA100 and TA1535) in the absence of S9-mix only. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant counts at the statistically significant dose levels were within the in-house historical untreated/vehicle control range for each tester strain and the maximum fold increase was only 1.5 times the concurrent vehicle controls

Conclusions:

The genetic toxicity of the test item was assessed in accordance with OECD Guideline 471. The test item was considered to be non-mutagenic under the conditions of this test.

Executive summary:

Introduction

The test method was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF, the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Regulation (EC) number 440/2008 of 30 May 2008 and the USA, EPA OCSPP harmonized guideline - Bacterial Reverse Mutation Test.

Methods

Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with suspensions of the test item using both the Ames plate incorporation and pre-incubation methods at up to eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors). The dose range for Experiment 1 was predetermined and was 1.5 to 5000 μg/plate. The experiment was repeated on a separate day (pre-incubation method) using fresh cultures of the bacterial strains and fresh test item formulations. The dose range was amended following the results of Experiment 1 and was 15 to 5000 μg/plate. Six test item concentrations were selected in Experiment 2 in order to achieve both four non-toxic dose.

Results

The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated. The maximum dose level of the test item in the first experiment was selected as the maximum recommended dose level of 5000 μg/plate. There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the first mutation test (plate incorporation method) and consequently the same maximum dose level was used in the second mutation test. Similarly, there was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation (S9-mix), in the second mutation test (pre-incubation method). A test item precipitate (black specks in appearance) was observed at 5000 μg/plate in Experiment 1 (plate incorporation method) and from 1500 μg/plate in the second mutation test (pre-incubation method). This observation did not prevent the scoring of revertant colonies.

There were no significant increases in the frequency of revertant colonies recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 1 (plate incorporation method). Similarly, no toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation (S9-mix) in Experiment 2 (pre-incubation method). Small, statistically significant increases in revertant colony frequency were observed in the second mutation test at 1500 μg/plate (TA100 and TA1535) in the absence of S9-mix only. These increases were considered to be of no biological relevance because there was no evidence of a dose-response relationship or reproducibility. Furthermore, the individual revertant counts at the statistically significant dose levels were within the in-house historical untreated/vehicle control range for each tester strain and the maximum fold increase was only 1.5 times the concurrent vehicle controls.

Conclusion

Petrit T was considered to be non-mutagenic under the conditions of this test.

Reference 2

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

The available identification data for the Target and the Source substance support the read-across hypothesis. Adequate, reliable and available scientific information indicate that the Target and Source substance have, or are very likely to have, similar (eco)toxicological properties. There are no indications that constituents other than those identified for the substances or impurities may influence the validity of the read-across. There is no evidence that additional toxicological mechanisms, other than those identified in the read-across hypothesis, may be acting or have an adverse effect on the validity of the read-across.

Reason / purpose for cross-reference:

read-across source

Type of assay:

bacterial reverse mutation assay

Vehicle / solvent:

no

Key result

Species / strain:

S. typhimurium, other: TA97a, TA98 TA100, TA102, TA1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

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

Vehicle controls validity:

not applicable

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results negative

Slag, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) is not mutagenic under the conditions of the test.

Executive summary:

For determination of the mutagenic potential of slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14 was performed. As the slags are inorganic solids, a leachate of the slags was prepared as prescribed by DIN 38414-S4 (100 g/L).

Two experiments were performed:

In the first experiment, 5 concentrations of the leachate (ranging from 10060 to 101 µg/plate, nominal concentration) were used. 5 genetically manipulated strains of Salmonella typhimurium (TA 97a, TA 98, TA 100, TA 102 and TA 1535) were exposed to the slags both in the presence and in the absence of a metabolic activation system (S9) for 48 hours, using the plate incorporation method.

In the second experiment, 5 concentrations of the leachate (ranging from 10160 to 635 µg/plate) were tested using the pre-incubation method.

Both experiments yielded the same results: None of the concentrations caused any significant increase in the number of revertant colonies in the tested bacterial strains. The slags had no mutagenic effect towards Salmonella typhimurium, strainsTA 97a, TA 98, TA 100, TA 102 and TA 1535. The slags exhibited no sign of toxicity towards the bacteria. No inconsistencies were observed in the sterility control and in the determination of the titre. The numbers of spontaneous revertants of the negative controls were in the normal range, and all positive controls showed mutagenic effects with and without metabolic activation.

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) are not mutagenic under the conditions of the Ames test.

Reference 3

Endpoint:

in vitro gene mutation study in mammalian cells

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Justification for type of information:

The available identification data for the Target and the Source substance support the read-across hypothesis. Adequate, reliable and available scientific information indicate that the Target and Source substance have, or are very likely to have, similar (eco)toxicological properties. There are no indications that constituents other than those identified for the substances or impurities may influence the validity of the read-across. There is no evidence that additional toxicological mechanisms, other than those identified in the read-across hypothesis, may be acting or have an adverse effect on the validity of the read-across.

Reason / purpose for cross-reference:

read-across source

Type of assay:

mammalian cell gene mutation assay

Vehicle / solvent:

water

Key result

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with and without

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results negative

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) are neither cytotoxic nor mutagenic under the conditions of the HPRT (Hypoxanthin-Guanin-Phosphoribosyltransferase) gene mutation test according to EU 440/2008 B.17.

Executive summary:

To investigate the cytotoxic and mutagenic potential of ferrous slags, a test according to the EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test) was performed with slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm). The investigation tests the potential of the slag applied as DIN 38414 S4 leachates, to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster.

Two independent experiments were performed, using two parallel cultures each. The first main experiment was performed with and without liver microsomal activation and a treatment period of 4 hours. The second experiment was performed with a treatment time of 4 hours with and 24 hours without metabolic activation, up to 10 % v/v of the undiluted extract being the maximum possible concentration of aqueous extracts in the HPRT test system.

No substantial and reproducible dose dependent increase of the mutation frequency was observed in all experiments. The sensitivity of the test system, and the effectiveness of the metabolic activation system, was confirmed by tests with reference mutagens, used as positive controls.

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) did not induce gene mutations at the HPRT locus in V79 cells. Slags are neither cytotoxic nor mutagenic under the conditions of the HPRT (Hypoxanthin-Guanin-Phosphoribosyltransferase) gene mutation test according to EU 440/2008 B.17.

Reference 4

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

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

Adequacy of study:

key study

Justification for type of information:

The available identification data for the Target and the Source substance support the read-across hypothesis. Adequate, reliable and available scientific information indicate that the Target and Source substance have, or are very likely to have, similar (eco)toxicological properties. There are no indications that constituents other than those identified for the substances or impurities may influence the validity of the read-across. There is no evidence that additional toxicological mechanisms, other than those identified in the read-across hypothesis, may be acting or have an adverse effect on the validity of the read-across.

Reason / purpose for cross-reference:

read-across source

Type of assay:

in vitro mammalian chromosome aberration test

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Key result

Species / strain:

lymphocytes: human

Metabolic activation:

with and without

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Conclusions:

Interpretation of results
negative

Slags, ferrous metal, blast furnace (air cooled - ABS), granular (8-11 mm) did not induce structural chromosomal aberrations in human lymphocytes in vitro.

Executive summary:

In both independent experiments, no toxicity was detected and neither a statistically significant nor a biologically relevant increase of structural chromosomal aberrations was observed at the evaluated concentration. Furthermore, no increase in the frequencies of polyploid metaphases was found after treatment with the test item as compared to the frequencies of the controls.

In conclusion, under the experimental conditions reported, Slag, ferrous metal, blast furnace did not induce structural chromosomal aberrations in human lymphocytes in vitro.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

For determination of the genetic toxicity potential of slags, steelmaking, converter (BOS) and natural stone from a quarry in Serra, Brasilia, tests according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) were performed. As the substances are inorganic solids, leachates were prepared with a L/S (liquid/solid) of 1:4 (250 g/L).

Slags, steelmaking, converter (BOS) and natural stone from a quarry in Serra, Brasilia, are not mutagenetic or cytotoxic when tested according to OECD Guideline 474. They do not need to be classified as mutagenic. No signal word and no hazard statement is required.

Link to relevant study records

Reference

Reference 1

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

Interpretation of results (migrated information): negative not mutagenic
Slags, steelmaking (SMS) and natural stone form a quarry in Serra, Brasilia, are not mutagenetic or cytotoxic under when tested according to OECD Guideline 474.

Executive summary:

For determination of the genetic toxicity potential of slags, steelmaking (SMS) and natural stone from a quarry in Serra, Brasilia, tests according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) were performed. As the substances are inorganic solids, leachates were prepared with a L/S (liquid/solid) of 1:4 (250 g/L).

Slags, steelmaking (SMS) and natural stone from a quarry in Serra, Brasilia, are not mutagenetic or cytotoxic when tested according to OECD Guideline 474. Theydo not need to be classified as mutagenic. No signal word and no hazard statement is required.

Reference 2

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: gene mutation

Type of information:

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

Adequacy of study:

key study

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

Interpretation of results (migrated information): negative not mutagenic
Slags, steelmaking, converter (BOS) and natural stone form a quarry in Serra, Brasilia, are not mutagenetic or cytotoxic under when tested according to OECD Guideline 474.

Executive summary:

For determination of the genetic toxicity potential of slags, steelmaking, converter (BOS) and natural stone from a quarry in Serra, Brasilia, tests according to OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test) were performed. As the substances are inorganic solids, leachates were prepared with a L/S (liquid/solid) of 1:4 (250 g/L).

Slags, steelmaking, converter (BOS) and natural stone from a quarry in Serra, Brasilia, are not mutagenetic or cytotoxic when tested according to OECD Guideline 474. Theydo not need to be classified as mutagenic. No signal word and no hazard statement is required.

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

In accordance with the CLP Regulation, no 1272/2008, a substance should be classified as mutagenic if there is evidence that it may induce heritable mutations in the germ cells of humans. The test material was found to be non-mutagenic in an in vitro Ames test. Therefore, based on the available data, the test item does not meet the criteria for classification.