Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-268-6 | CAS number: 1317-37-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to GLP and valid methods, therefore it is considered relevant, reliable and adequate for classification.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- 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
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Iron sulphide
- EC Number:
- 215-268-6
- EC Name:
- Iron sulphide
- Cas Number:
- 1317-37-9
- Molecular formula:
- FeS
- IUPAC Name:
- sulfanylideneiron
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Method
- Target gene:
- hisitdine; (Salmonella typhimurium)
tryptophan; (Escherichia coli)
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- - Type and identity of media :Soft agar containing 0.5 mM histidine and biotin or 5 μg/mL tryptophan
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media :Soft agar containing 0.5 mM histidine and biotin or 5 μg/mL tryptophan
- Properly maintained: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- Preliminary toxicity test: Salmonella typhimurium tester strain TA100 at 50, 100, 200, 400, 800, 1600, 3200 and 5000 µg/plate test doses along with a sterile water control
Mutation assay: 50, 158, 500, 1580 and 5000 µg/plate (plate incorporation)
Confirmatory mutation assay: 100, 266, 707, 1880 and 5000 µg/plate (preincubation).
In a preliminary toxicity test, the mean number of revertant colonies was more or less comparable to the SW control plates up to the highest tested dose of 5000 μg/plate, both in the presence and absence of metabolic activation. No toxicity of the test item was seen as the intensity of the bacterial background lawn was comparable to that of the SW control plates up to 5000 μg/plate, both in the presence and absence of metabolic activation. The test item did not cause precipitation on the basal agar plates in any of the tested doses either in the presence or in the absence of metabolic activation. Based on these observations, 5000 µg/plate was tested as the maximum dose in the initial as well as the confirmatory mutation assay. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile water
- Justification for choice of solvent/vehicle: Sterile water is one of the compatible vehicles with this test system.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoantrhacene
- Remarks:
- Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537 with S9 (4µg/plate) and E.Coli WP2uvrA (pKM101) with S9 (30µg/plate)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Salmonella typhimurium TA 98 without S9 (2µg/plate)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Salmonella typhimurium TA 100, TA 1535 without S9 (1µg/plate)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Salmonella typhimurium TA 1537 without S9 (50µg/plate)
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitroquinoline-1-oxide
- Remarks:
- E.Coli WP2uvrA (pKM101) without S9 (4µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) in the initial mutation assay;
Preincubation in the confirmatory assay
DURATION
- Preincubation period: no data
- Exposure duration: 67 hours
SELECTION AGENT (mutation assays): histidine/ tryptophan
NUMBER OF REPLICATIONS: 3 (initial and confirmatory mutation assay); 2 (preliminary toxicity test)
DETERMINATION OF CYTOTOXICITY
- Method: other: mean number of revertant colonies/plate compared to the respective vehicle controls; intensity of the bacterial background lawn compared to that of the controls; precipitation - Evaluation criteria:
- To determine a positive result, there should be a dose related increase in the mean revertants per plate of at least one tester strain over a minimum of two increasing concentrations of the test item either in the presence or absence of the metabolic activation system.
The test will be judged positive, if the increase in mean revertants at the peak of the dose response is equal to or greater than 2 times the mean vehicle control value for strains TA98, TA100 and WP2uvrA (pKM101) or equal to or greater than 3 times the mean vehicle control value for strains TA1535 and TA1537.
An equivocal response is a biologically relevant increase in a revertant count that partially meets the criteria for evaluation as positive. This could be a dose responsive increase that does not achieve the respective threshold cited above or a non dose responsive increase that is equal to or greater than the respective threshold cited. A response will be evaluated as negative, if it is neither positive nor equivocal.
Results and discussion
Test results
- 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
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Stability and homogeneity analysis results of dose formulations were provided.
The test item was found to be homogeneous and stable in sterile water after 24 hours at 500 and 100000 μg/mL at room temperature.
The concentration analysis results for the initial mutation assay indicate that the actual mean concentrations of the analyzed dose levels were between 91.1 and 104.8 % of their respective nominal target dose. The concentration analysis results of the dose formulation samples of the confirmatory mutation assay indicate that the actual mean concentrations of the analyzed dose levels were between 93.5 and 108.4 % of their respective nominal target concentrations. - Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 1. Summary Results of Initial Bacterial Reverse Mutation Assay in the Presence of Metabolic Activation
Treatment [µg/plate] |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA (pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
Vehicle control - SW(100 µL) |
26 |
2 |
NA |
115 |
8 |
NA |
14 |
1 |
NA |
10 |
1 |
NA |
135 |
4 |
NA |
50 |
27 |
1 |
1.01 |
112 |
3 |
0.98 |
15 |
2 |
1.02 |
11 |
1 |
1.06 |
135 |
8 |
1.00 |
158 |
27 |
2 |
1.04 |
111 |
9 |
0.97 |
12 |
2 |
0.81 |
11 |
1 |
1.03 |
138 |
3 |
1.02 |
500 |
24 |
2 |
0.92 |
116 |
5 |
1.01 |
13 |
1 |
0.93 |
10 |
1 |
1.00 |
137 |
9 |
1.01 |
1580 |
22 |
3 |
0.82 |
105 |
7 |
0.91 |
15 |
1 |
1.02 |
10 |
1 |
0.94 |
129 |
3 |
0.96 |
5000 |
26 |
2 |
1.00 |
114 |
12 |
0.99 |
14 |
2 |
1.00 |
11 |
1 |
1.06 |
132 |
3 |
0.98 |
Positive control |
524c |
18c |
19.89c |
868c |
17c |
7.55c |
142c |
17c |
9.91c |
123c |
12c |
11.90c |
553d |
4d |
4.09d |
aValues are means of three replicates and are rounded off to the nearest whole number. bRatio of treated/vehicle control (mean revertants per plate) cTA98, TA100, TA1535, TA1537: 2-Aminoanthracene (4 µg/plate) dWP2uvrA(pKM 101): 2-Aminoanthracene (30 µg/plate) NA: Not applicable |
Table 2. contd.Summary Results of Initial Bacterial Reverse Mutation Assay in the Absence of Metabolic Activation
Treatment [µg/plate] |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA (pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
Vehicle control - SW(100 µL) |
25 |
3 |
NA |
111 |
6 |
NA |
12 |
2 |
NA |
11 |
3 |
NA |
139 |
2 |
NA |
50 |
25 |
2 |
0.99 |
115 |
4 |
1.04 |
11 |
2 |
0.94 |
10 |
2 |
0.97 |
134 |
4 |
0.97 |
158 |
25 |
3 |
1.00 |
115 |
8 |
1.04 |
14 |
4 |
1.17 |
11 |
3 |
1.03 |
134 |
3 |
0.96 |
500 |
26 |
2 |
1.03 |
114 |
9 |
1.03 |
13 |
3 |
1.08 |
10 |
1 |
0.94 |
137 |
11 |
0.99 |
1580 |
27 |
2 |
1.08 |
107 |
12 |
0.97 |
12 |
3 |
1.03 |
11 |
1 |
1.00 |
137 |
3 |
0.99 |
5000 |
27 |
3 |
1.07 |
106 |
4 |
0.96 |
12 |
3 |
1.00 |
11 |
1 |
1.06 |
137 |
2 |
0.99 |
Positive control |
237c |
6c |
9.34c |
549d |
16d |
4.96d |
144d |
14d |
11.97d |
114e |
9e |
10.66e |
557f |
16f |
4.01f |
a Values are means of three replicates and are rounded off to the nearest whole number. b Ratio of treated/vehicle control (mean revertants per plate) c TA98: 2-Nitrofluorene (2 µg/plate), d TA100, TA1535: Sodium azide (1 µg/plate) e TA1537: 9-Aminoacridine (50 µg/plate) f W P2uvrA(pKM 101): 4-Nitroquinoline-1-oxide (4 µg/plate) NA: Not applicable |
Table3. Summary Results of Confirmatory Bacterial Reverse Mutation Assay in the Presence of Metabolic Activation
Treatment [µg/plate] |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA (pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
Vehicle control - SW(100 µL) |
25 |
1 |
NA |
105 |
9 |
NA |
13 |
2 |
NA |
10 |
2 |
NA |
131 |
2 |
NA |
100 |
24 |
3 |
0.96 |
104 |
7 |
0.99 |
15 |
3 |
1.13 |
11 |
2 |
1.06 |
129 |
2 |
0.98 |
266 |
26 |
5 |
1.05 |
109 |
10 |
1.03 |
13 |
2 |
1.00 |
10 |
1 |
0.97 |
134 |
2 |
1.02 |
707 |
23 |
3 |
0.95 |
102 |
3 |
0.97 |
14 |
4 |
1.10 |
10 |
1 |
0.97 |
135 |
4 |
1.03 |
1880 |
25 |
4 |
1.01 |
105 |
4 |
1.00 |
13 |
3 |
1.03 |
11 |
1 |
1.03 |
136 |
3 |
1.04 |
5000 |
24 |
4 |
0.97 |
109 |
9 |
1.03 |
15 |
1 |
1.13 |
11 |
3 |
1.10 |
133 |
2 |
1.01 |
Positive control |
520c |
10c |
21.07c |
882c |
34c |
8.40c |
153c |
7c |
11.79c |
113c |
6c |
10.97c |
559d |
16d |
4.25d |
a Values are means of three replicates and are rounded off to the nearest whole number. b Ratio of treated/vehicle control (mean revertants per plate) c TA98, TA100, TA1535, TA1537: 2-Aminoanthracene (4 µg/plate) d WP2uvrA(pKM 101): 2-Aminoanthracene (30 µg/plate) NA: Not applicable |
Table 4. contd.Summary Results of Confirmatory Bacterial Reverse Mutation Assay in the Absence of Metabolic Activation
Treatment [µg/plate] |
No. of revertants/platea |
||||||||||||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA (pKM101) |
|||||||||||
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
Mean |
SD |
Ratiob |
|
Vehicle control - SW(100 µL) |
25 |
2 |
NA |
104 |
3 |
NA |
14 |
4 |
NA |
10 |
4 |
NA |
134 |
7 |
NA |
100 |
24 |
2 |
0.95 |
107 |
9 |
1.03 |
13 |
3 |
0.93 |
11 |
2 |
1.03 |
129 |
7 |
0.97 |
266 |
27 |
3 |
1.07 |
101 |
1 |
0.97 |
12 |
5 |
0.90 |
11 |
2 |
1.03 |
135 |
5 |
1.01 |
707 |
23 |
3 |
0.92 |
101 |
3 |
0.97 |
13 |
3 |
0.95 |
10 |
2 |
1.00 |
132 |
3 |
0.99 |
1880 |
25 |
3 |
0.99 |
105 |
5 |
1.01 |
14 |
3 |
1.02 |
11 |
3 |
1.10 |
133 |
3 |
1.00 |
5000 |
25 |
3 |
0.99 |
112 |
8 |
1.07 |
13 |
3 |
0.93 |
11 |
3 |
1.10 |
134 |
2 |
1.00 |
Positive control |
239c |
9c |
9.55c |
552d |
20d |
5.30d |
145d |
16d |
10.63d |
115e |
9e |
11.10e |
565f |
9f |
4.21f |
a Values are means of three replicates and are rounded off to the nearest whole number. b Ratio of treated/vehicle control (mean revertants per plate) c TA98: 2-Nitrofluorene (2 µg/plate), d TA100, TA1535: Sodium azide (1 µg/plate) e TA1537: 9-Aminoacridine (50 µg/plate) f WP2uvrA(pKM 101): 4-Nitroquinoline-1-oxide (4 µg/plate) NA: Not applicable |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative with and without metabolic activation
All criteria for a valid study were met as described in the study plan. It is concluded that the test item, Tribotecc®-Ferrostar, was not mutagenic in this bacterial reverse mutation test at the tested doses and under the conditions of testing employed. - Executive summary:
The test item, iron sulfide (Tribotecc®-Ferrostar) was tested for its mutagenic potential in the bacterial reverse mutation assay. The study was conducted using TA98, TA100, TA1535 and TA1537 strains of Salmonella typhimurium and WP2uvrA (pKM101) strain of Escherichia coli. The study consisted of a preliminary toxicity test and two mutation assays (plate incorporation and preincubation) comprising four independent experiments. The bacterial tester strains were exposed to the test item in the presence and absence of metabolic activation system (S-9 fraction prepared from Aroclor 1254 induced rat liver).
In a preliminary toxicity test, the mean number of revertant colonies was more or less comparable to the SW control plates up to the highest tested dose of 5000 µg/plate, both in the presence and absence of metabolic activation. No toxicity of the test item was seen as the intensity of the bacterial background lawn was comparable to that of the SW control plates up to 5000 µg/plate, both in the presence and absence of metabolic activation. The test item did not cause precipitation on the basal agar plates in any of the tested doses either in the presence or in the absence of metabolic activation. Based on these observations, 5000µg/plate was tested as the maximum dose in the initial as well as the confirmatory mutation assay.
In the initial mutation assay, the test item was exposed in triplicate to 50, 158, 500, 1580 and 5000 µg/plate test doses in the presence and absence of metabolic activation using direct plate incorporation procedure. In the confirmatory assay, the test item was exposed in triplicate to concentrations of 100, 266, 707, 1880 and 5000 µg/plate in the presence and absence of metabolic activation using pre-incubation procedure. The vehicle control (SW) and the appropriate positive controls were tested simultaneously. The mean and standard deviation of numbers of revertant colonies were calculated for each test dose and the controls for all the tester strains.
The results from the initial as well as from the confirmatory assays, indicate the tested doses showed no positive mutagenic increase in the mean numbers of revertant colonies for all tester strains when compared to the respective vehicle control plates, either in the presence or absence of metabolic activation.The mean numbers of revertant colonies neither doubled for strains TA98, TA100 and WP2uvrA (pKM101) nor tripled for strains TA1535 and TA1537 when compared to the respective vehicle control plates, either in the presence or in the absence of the metabolic activation at any of the tested doses.The study indicated that Tribotecc®-Ferrostar was not mutagenic in this Bacterial Reverse Mutation Assay up to the highest tested dose of 5000 µg/plate.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.