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EC number: 233-149-7 | CAS number: 10045-86-0
- 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:
- November 10, 2015 until November 26, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Regulation (EC) No. 440/2008, dated May 31, 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Iron orthophosphate
- EC Number:
- 233-149-7
- EC Name:
- Iron orthophosphate
- Cas Number:
- 10045-86-0
- Molecular formula:
- FePO4
- IUPAC Name:
- iron(3+) phosphate
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix (Aroclor 1254-induced)
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 500, 2000 or 5000 μg
Two preliminary cytotoxicity tests (plate incorporation test, without and with metabolic activation) were carried out in test strain TA100.
5000 μg/plate was chosen as top concentration as no signs of cytotoxicity were noted. - Vehicle / solvent:
- - Vehicle used: 0.05 M HCl solution
- Justification for choice of vehicle: The test item was not soluble in any of the solvents recommended, dimethylsulfoxide (DMSO), ethanol, acetone or 0.05 M H2SO4 solution, therefore HCl was used.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- HCl solution
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation: TA1535, TA100
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- HCl solution
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- without metabolic activation: TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- HCl solution
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without metabolic activation: TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- HCl solution
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without metabolic activation: TA102
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- HCl solution
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation: TA98, TA102, TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-amino-anthracene
- Remarks:
- with metabolic activation: TA100, TA1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
Preincubation Method:
- Preincubation period: 20 minutes at 37°C
In agar (plate incorporation)/ Preincubation method
- Exposure duration: 48 - 72 hours
NUMBER OF REPLICATIONS: 3 per concentration and experiment
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (colony counter) - Evaluation criteria:
- Mutagenicity
The test item is considered to show a positive response if:
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537 and 1.5-fold of the solvent control for TA102 in both independent experiments.
- in addition, a significant (p ≤ 0.05) concentration (log value)-related effect (Spearman’s rank correlation coefficient) is observed;
- positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
Cytotoxicity
Cytotoxicity is defined as a reduction in the number of colonies by more than 50% compared with the vehicle control and/or a scarce background lawn.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate with and without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate with S9-mix/ without S9-mix (only plate incorporation test)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate in plate incorporation test without S9-mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 μg/plate in plate incorporation test with S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Yes, test item precipitation was noted in both experiments, each carried out without and with metabolic activation, at concentrations of 316 μg/plate and higher in all test strains.
RANGE-FINDING/SCREENING STUDIES: Yes top concentration was determined to be 5000 μg/plate.
HISTORICAL CONTROL DATA (ranges, means and standard deviation and confidence interval (e.g. 95%) see table no.1)
- Positive historical control data: Valid, within the expected range
- Negative (vehicle) historical control data: Valid, within the expected range
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: Colony counter
Cytotoxicity (reduction of the number of revertants by more than 50%) was noted in the following experiments at the top concentration of 5000 μg/plate:
Plate incorporation test:
without S9: in test strains TA98, TA100, TA1535 and TA1537;
with S9: in test strains TA98, TA102 and TA1537;
Preincubation test:
without S9 in test strains: TA1535 and TA1537
with S9 in test strains: TA98 and TA1537.
Any other information on results incl. tables
Table 1: Historical control data of negative and positive control values of the years 2012-2014 (n=97 studies)
Data obtained from plate incorporation and preincubation tests
Negative Reference Item
Strain |
TA98 |
|
TA100 |
|
TA102 |
|
TA1535 |
|
TA1537 |
|
S9 -mix |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
Mean |
29.9 |
31.4 |
144.0 |
143.7 |
275.3 |
279.3 |
18.6 |
18.1 |
6.5 |
6.6 |
SD |
6.1 |
6.3 |
20.5 |
20.2 |
16.0 |
16.6 |
4.5 |
4.5 |
2.1 |
2.3 |
Min |
12 |
18 |
100 |
101 |
224 |
245 |
10 |
8 |
2 |
0 |
Max |
49 |
50 |
191 |
189 |
319 |
319 |
31 |
42 |
11 |
18 |
Positive Reference Item
Strain |
TA98 |
|
TA100 |
|
TA102 |
|
TA1535 |
|
TA1537 |
|
S9 -mix |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
- |
+ |
|
2-NF |
BP |
SA |
2-AA |
MMC |
BP |
SA |
2-AA |
9-AC |
BP |
Mean |
178.8 |
176.9 |
925.2 |
932.9 |
972.4 |
963.8 |
140.4 |
142.6 |
90.9 |
90.4 |
SD |
65.1 |
65.1 |
96.3 |
88.4 |
115.8 |
104.8 |
44.8 |
45.6 |
40.0 |
38.4 |
Min |
91 |
83 |
463 |
703 |
759 |
757 |
51 |
49 |
26 |
28 |
Max |
434 |
433 |
1209 |
1181 |
1637 |
1571 |
382 |
371 |
272 |
257 |
2-NF : 2-nitro-fluorene
BP: Benzo[a]pyrene
SA: Sodium azide
2-AA: 2-amino-anthracene
MMC: Mitomycin C
9-AC: 9-amino-acridine
Main test
Table 1: Plate incorporation test; without metabolic activation
Test substance µg/plate |
|
Number of reverted colonies |
||||
|
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
31.6 |
mean |
34.7 |
120.0 |
288.7 |
19.0. |
9.0 |
|
SD |
2.1 |
3.6 |
11.8 |
5.3 |
1.0 |
100 |
mean |
36.0 |
119.0 |
258.3 |
15.7 |
9.3 |
|
SD |
2.6 |
2.6 |
2.9 |
5.5 |
0.6 |
316 |
mean |
30.7 # |
123.0 # |
284.0 # |
16.3 # |
8.3 # |
|
SD |
8.7 |
6.1 |
2.6 |
1.2 |
1.2 |
500 |
mean |
24.0 # |
137.7 # |
264.7 # |
18.0 # |
6.0 # |
|
SD |
3.5 |
3.2 |
1.5 |
1.0 |
1.0 |
2000 |
mean |
21.0 # |
112.0 # |
287.7 # |
21.3 # |
6.0 # |
|
SD |
1.7 |
1.0 |
6.4 |
4.2 |
1.7 |
5000 |
mean |
10.7 # |
59.3 # |
156.7 # |
7.3 # |
1.7 # |
|
SD |
0.6 |
9.9 |
0.6 |
3.1 |
0.6 |
Negative reference item 100 μL/plate |
||||||
|
mean |
27.0 |
140.3 |
259.3 |
18.0 |
8.3 |
|
SD |
1.0 |
1.2 |
4.2 |
4.4 |
0.6 |
Positive reference item |
|
2-NF |
SA |
MMC |
SA |
9-AC |
Concentration μg/plate |
|
10 |
10 |
10 |
10 |
100 |
|
mean |
154.0 |
966.7 |
1198.0 |
136.3 |
114.7 |
|
SD |
11.3 |
2.5 |
25.4 |
10.7 |
4.0 |
2-NF : 2-nitro-fluorene
SA: Sodium azide
MMC: Mitomycin C
9-AC: 9-amino-acridine
# test item precipitation
SD standard deviation
mean (n = 3)
Table 2: Plate incorporation test; with metabolic activation
Test substance µg/plate |
|
Number of reverted colonies |
||||
|
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
31.6 |
mean |
24.0 |
121.7 |
270.3 |
15.7 |
5.7 |
|
SD |
2.6 |
15.4 |
3.8 |
1.2 |
1.2 |
100 |
mean |
24.3 |
119.0 |
268.0 |
18.7 |
6.0 |
|
SD |
4.2 |
10.4 |
6.1 |
6.4 |
0.0 |
316 |
mean |
25.3 # |
134.7 # |
279.7 # |
13.7 # |
7.3 # |
|
SD |
2.1 |
8.5 |
20.2 |
0.6 |
2.3 |
500 |
mean |
37.7 # |
113.7 # |
261.3 # |
14.7 # |
6.3 # |
|
SD |
0.6 |
0.6 |
11.6 |
2.5 |
2.5 |
2000 |
mean |
34.0 # |
122.7 # |
293.7 # |
13.3 # |
5.3 # |
|
SD |
1.0 |
1.2 |
4.2 |
0.6 |
1.2 |
5000 |
mean |
11.3 # |
70.7 # |
128.3 # |
7.3 # |
1.7 # |
|
SD |
0.6 |
3.2 |
0.6 |
1.2 |
0.6 |
Negative reference item 100 μL/plate |
||||||
|
mean |
27.7 |
119.0 |
274.3 |
14.0 |
6.7 |
|
SD |
0.6 |
3.0 |
18.8 |
1.0 |
1.5 |
Positive reference item |
|
BP |
2-AA |
BP |
2-AA |
BP |
Concentration μg/plate |
|
10 |
2 |
10 |
2 |
100 |
|
mean |
157.0 |
963.3 |
1161.0 |
135.3 |
104.7 |
|
SD |
8.2 |
6.0 |
2.0 |
15.6 |
17.2 |
BP: Benzo[a]pyrene
2-AA: 2-amino-anthracene
Table 3: Preincubation test; without metabolic activation
Test substance µg/plate |
|
Number of reverted colonies |
||||
|
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
31.6 |
mean |
23.0 |
146.0 |
264.7 |
20.3 |
8.0 |
|
SD |
0.0 |
4.4 |
1.2 |
0.6 |
1.7 |
100 |
mean |
27.7 |
144..3 |
286.3 |
16.7 |
5.0 |
|
SD |
1.5 |
7.0 |
1.5 |
5.1 |
1.0 |
316 |
mean |
30.3 # |
148.3 # |
272.7 # |
18.3 # |
7.3 # |
|
SD |
1.2 |
7.5 |
11.0 |
0.6 |
0.6 |
500 |
mean |
26.3 # |
134.0 # |
289.0 # |
19.0 # |
7.3 # |
|
SD |
4.6 |
10.0 |
5.3 |
3.6 |
0.6 |
2000 |
mean |
23.0 # |
122.3 # |
264.3 # |
13.3 # |
6.3 # |
|
SD |
2.6 |
2.1 |
22.2 |
2.3 |
1.5 |
5000 |
mean |
16.3 # |
82.3 # |
182.0 # |
8.3 # |
1.0 # |
|
SD |
3.1 |
4.0 |
25.0 |
0.6 |
0.0 |
Negative reference item 100 μL/plate |
||||||
|
mean |
26.3 |
146.3 |
288.3 |
19.0 |
5.0 |
|
SD |
5.9 |
2.9 |
14.4 |
7.8 |
0.0 |
Positive reference item |
|
2-NF |
SA |
MMC |
SA |
9-AC |
Concentration μg/plate |
|
10 |
10 |
10 |
10 |
100 |
|
mean |
144.3 |
916.3 |
887.3 |
110.7 |
52.0 |
|
SD |
2.1 |
10.4 |
4.7 |
15.0 |
1.7 |
2-NF : 2-nitro-fluorene
SA: Sodium azide
MMC: Mitomycin C
9-AC: 9-amino-acridine
Table 4: Preincubation test; with metabolic activation
Test substance µg/plate |
|
Number of reverted colonies |
||||
|
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
31.6 |
mean |
23.7 |
146.0 |
257.3 |
17.3 |
3.7 |
|
SD |
0.6 |
9.8 |
5.5 |
3.2 |
0.6 |
100 |
mean |
27.7 |
139.3 |
274.0 |
17.0 |
7.7 |
|
SD |
1.2 |
5.0 |
24.3 |
7.2 |
1.2 |
316 |
mean |
29.0 # |
147.3 # |
257.3 # |
16.3 # |
7.0 # |
|
SD |
2.0 |
3.1 |
3.5 |
4.0 |
2.6 |
500 |
mean |
27.3 # |
149.3 # |
275.0 # |
23.7 # |
7.0 # |
|
SD |
1.2 |
2.1 |
10.6 |
4.7 |
0.0 |
2000 |
mean |
30.0 # |
141.3 # |
275.3 # |
19.0 # |
8.3 # |
|
SD |
1.7 |
38.8 |
4.0 |
1.0 |
1.2 |
5000 |
mean |
17.0 # |
69.0 # |
191.0 # |
7.7 # |
1.0 # |
|
SD |
0.0 |
16.8 |
2.0 |
1.5 |
0.0 |
Negative reference item 100 μL/plate |
||||||
|
mean |
34.7 |
128.3 |
281.3 |
14.7 |
6.0 |
|
SD |
1.2 |
15.3 |
27.5 |
0.6 |
2.6 |
Positive reference item |
|
BP |
2-AA |
BP |
2-AA |
BP |
Concentration μg/plate |
|
10 |
2 |
10 |
2 |
10 |
|
mean |
165.3 |
910.7 |
906.7 |
116.3 |
56.3 |
|
SD |
7.2 |
5.5 |
7.6 |
11.5 |
15.1 |
BP: Benzo[a]pyrene
2-AA: 2-amino-anthracene
Applicant's summary and conclusion
- Conclusions:
- The test item was determined to be not mutagenic in the bacterial reverse mutation test with Salmonella typhimurium strains with and without metabolic activation.
- Executive summary:
In the GLP and OECD guideline 471 compliant bacterial reverse mutation study (Ames test) the test item was tested for mutagenicity in 5 Salmonella typhimurium strains.
Following strains were used TA98, TA100, TA102, TA1535 and TA1537 in two independent experiments, each carried out without and with metabolic activation (a microsomal preparation derived from Aroclor 1254-induced rat liver). The first experiment was carried out as a plate incorporation test and the second as a preincubation test.
In the Preliminary test ranging from 0.316 to 5000 μg/plate the top concentration for the main study was determined to be 5000 μg/plate, where no signs of cytotoxicity were noted.
In the main study the test item was suspended in 0.05 M HCl solution for concentrations of 316, 500, 2000 or 5000 μg per plate. For concentrations lower than 100 μg/plate, the test item was completely dissolved. The vehicle 0.05 M HCl solution served as the negative control.
Test item precipitation was noted in both experiments, each carried out without and with metabolic activation, at concentrations of 316 μg/plate and higher in all test strains. In addition, cytotoxicity (reduction of the number of revertants by more than 50%) was noted in the following experiments at the top concentration of 5000 μg/plate:
Plate incorporation test:
without S9: in test strains TA98, TA100, TA1535 and TA1537;
with S9: in test strains TA98, TA102 and TA1537;
Preincubation:
without S9 in test strains: TA1535 and TA1537
with S9 in test strains: TA98 and TA1537
No increase in revertant colony numbers as compared with control counts was observed for the test item, tested up to concentration of 5000 μg/plate in any of the 5 test strains in two independent experiments without and with metabolic activation. The positive control items showed a significant increase in the number of colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
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