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EC number: 231-967-9 | CAS number: 7782-87-8
- 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 mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-09-22 till
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study according to the OECD guideline 476 and the EU Method B.17 performed in compliance to GLP standards
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
Test material
- Reference substance name:
- Sodium phosphinate
- EC Number:
- 231-669-9
- EC Name:
- Sodium phosphinate
- Cas Number:
- 7681-53-0
- Molecular formula:
- H3O2P.Na
- IUPAC Name:
- sodium phosphinate
- Reference substance name:
- sodium hypophosphite
- IUPAC Name:
- sodium hypophosphite
- Details on test material:
- - Name of test material: Sodium hypophosphite; tested as monohydrate as the anhydrous form (CAS 7681-53-0) is highly hygroscopic and difficult to handle without specific precautions.
- Physical state: white crystalline solid (powder)
- Odour: none
- Supplier: Rhodia UK-Oldbury
- Batch number: 90113D
- Expiry date: June 2010
- Storage condition of test material: room temperature, stored in a tightly closed container in a dry and well-ventilated place, opening of the container restricted to the minimum needs, protected from humidity for eight days
- Disposal: incinerate the residues at an approved waste disposal site only
- Purity: 99.5%
- Impurities (identity and concentrations):
Phosphite (Na2HPO3): 0.14%
- Certificate of analysis:
Analysis number: ITC/09/01/04
Analysis date: 2009-01-27
No more data availabe
Constituent 1
Constituent 2
Method
- Target gene:
- Thymidine kinase locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- Checked for Mycoplasma contamination: yes
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix, liver microsomal fraction (S9 fraction) of rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/mL for both 3h and 24h exposure
Preliminary study: highest recommended dose-level of 5000 µg/mL induced an increase of osmolality in the culture medium of more than 50 mOsm/kg H2O, consequently the highest selected dose-level for the main test was 2500 µg/mL - Vehicle / solvent:
- - Vehicle:
Test substance: culture medium (RPMI)
Positive controls: distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: without S9 mix, 25 µg/mL (3h treatment) or 5 µg/mL (24h treatment)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- Migrated to IUCLID6: with S9 mix, 3 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: first experiment 3h with and without S9 mix; second experiment 3 h with S9 mix and 24h without S9 mix (as results of the first experiment were negative)
- Expression time (cells in growth medium): 48 hours (at 37°C in a humidified atmosphere of 5% CO2/95% air)
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: 2 cultures/dose-level and at least duplicate cultures for the controls
NUMBER OF CELLS EVALUATED: 2 x 10^5 cells/mL
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth; relative suspension growth; cloning efficiency
No more data available - Evaluation criteria:
- IWGT recommendations were followed and a positive result is considered when following criteria are fulfilled :
- at least at one dose-level the mutation frequency minus the mutation frequency of the vehicle control equals or exceeds the global evaluation factor (126 x 10E-6 for the microtiter method)
- a dose-related trend is demonstrated by a statistically significant trend test
Unless considered as clearly positive, the reproducibility of a positive effect should be confirmed.
Noteworthy increases in the mutation frequency observed only at high levels of cytotoxicity (RTG lower than 10%), but with no evidence of mutagenicity at dose-levels with RTG between 10 and 20%, is not considered as positive result.
A test item is determined to be non-mutagenic when there is no culture showing an Adj. RTG value between 10-20% if:
- there is at least one negative data point between 20 and 25% Adj. RTG and no evidence on mutagenicity in a series of data points between 100 to 20% Adj. RTG
- there is no evidence of mutagenicity in a series of data points between 100 to 25% and there is also a negative data point between 10 and 1% Adj. RTG - Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No
- Effects of osmolality:Yes, at the dose-level of 5000 µg/mL the osmolality was equal to 391 mOsm/kg H2O (302 for the vehicle control). At dose-levels of 2500 and 1250 µg/mL the osmolality values were 348 and 320 mOsm/kg H2O respectively.
- Solubility: freely soluble in the vehicle at 100 mg/mL
- Precipitation: No precipitate was observed for the final dose-level of 5000 µg/mL using a treatment volume of 1000 µL/20mL
- Other confounding effects: None
COMPARISON WITH HISTORICAL CONTROL DATA:
The values obtained in these experiments for the vehicle and positive control are in agreemant with the historical data (see overall remarks) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The cloning efficiencies CE2 and the mutation frequencies of the vehicle and positive controls were as specified in the acceptance criteria. The study was therefore considered valid.
Since the test item was freely soluble, non-toxic in the preliminary test and no precipitate was observed at the highest dose-level of 5000 µg/mL, the highest dose-level was set at this value.
Cytotoxicity and mutagenicity results
- Experiments without S9 mix (Table 1: first experiment, 3h treatment and table 2: second experiment, 24h treatment)
No noteworthy cytotoxicity was induced in either experiment, since no noteworthy decrease in the Adj. RTG was observed at any dose-level.
No noteworthy increase in the mutation frequency was noted at any dose-level.
- Experiments with S9 mix (Table 3: first experiment, 3h treatment and table 4: second experiment, 3h treatment)
No noteworthy cytotoxicity was induced in either experiment, since no noteworthy decrease in the Adj. RTG was observed at any dose-level.
No noteworthy increase in the mutation frequency was noted at any dose-level.
Table 1: Cytotoxicity and mutagenicity results of the first experiment without S9 mix, 3h treatment
Doses µg/mL |
Cytotoxicity |
Mutagenicity |
||||
Adj. RTG % |
Adj. RSG % |
RCE2 % |
MF x10-6 |
R |
||
0 |
C1 |
100 |
100 |
100 |
144 |
1.0 |
C2 |
100 |
100 |
100 |
219 |
1.0 |
|
78.13 |
C1 |
89 |
110 |
81 |
190 |
1.3 |
C2 |
122 |
92 |
132 |
164 |
0.8 |
|
156.3 |
C1 |
90 |
91 |
99 |
217 |
1.5 |
C2 |
135 |
109 |
124 |
145 |
0.7 |
|
312.5 |
C1 |
85 |
95 |
89 |
177 |
1.2 |
C2 |
125 |
107 |
117 |
160 |
0.7 |
|
625 |
C1 |
65 |
161 |
41 |
225 |
1.6 |
C2 |
133 |
133 |
100 |
170 |
0.8 |
|
1250 |
C1 |
107 |
106 |
101 |
129 |
0.9 |
C2 |
150 |
128 |
117 |
165 |
0.8 |
|
2500 |
C1 |
72 |
86 |
83 |
152 |
1.1 |
C2 |
125 |
125 |
100 |
178 |
0.8 |
|
MMS 25 µg/mL |
C1 |
30 |
48 |
62 |
788 |
5.5 |
C2 |
46 |
76 |
60 |
857 |
3.9 |
Adj. RTG: Adjusted relative total growth
Adj. RSG: Adjusted relative suspension growth
RCE2: relative cloning efficiency
MF: Mutation frequency
R: Ration between mutation frequency of treated cells/mutation frequency of control cells
Table 2: Cytotoxicity and mutagenicity results of the second experiment without S9 mix, 24h treatment
Doses µg/mL |
Cytotoxicity |
Mutagenicity |
||||
Adj. RTG % |
Adj. RSG % |
RCE2 % |
MF x10-6 |
R |
||
0 |
C1 |
100 |
100 |
100 |
96 |
1.0 |
C2 |
100 |
100 |
100 |
77 |
1.0 |
|
78.13 |
C1 |
135 |
119 |
114 |
60 |
0.6 |
C2 |
112 |
85 |
132 |
95 |
1.2 |
|
156.3 |
C1 |
116 |
94 |
124 |
58 |
0.6 |
C2 |
102 |
98 |
104 |
86 |
1.1 |
|
312.5 |
C1 |
134 |
93 |
144 |
44 |
0.5 |
C2 |
119 |
105 |
114 |
71 |
0.9 |
|
625 |
C1 |
128 |
96 |
133 |
46 |
0.5 |
C2 |
122 |
115 |
106 |
53 |
0.7 |
|
1250 |
C1 |
103 |
109 |
94 |
76 |
0.8 |
C2 |
94 |
98 |
96 |
80 |
1.0 |
|
2500 |
C1 |
112 |
89 |
126 |
65 |
0.7 |
C2 |
127 |
102 |
124 |
59 |
0.8 |
|
MMS 25 µg/mL |
C1 |
75 |
74 |
101 |
453 |
4.7 |
C2 |
72 |
93 |
77 |
440 |
5.7 |
Adj. RTG: Adjusted relative total growth
Adj. RSG: Adjusted relative suspension growth
RCE2: relative cloning efficiency
MF: Mutation frequency
R: Ration between mutation frequency of treated cells/mutation frequency of control cells
Table 3: Cytotoxicity and mutagenicity results of the first experiment with S9 mix, 3h treatment
Doses µg/mL |
Cytotoxicity |
Mutagenicity |
||||
Adj. RTG % |
Adj. RSG % |
RCE2 % |
MF x10-6 |
R |
||
0 |
C1 |
100 |
100 |
100 |
175 |
1.0 |
C2 |
100 |
100 |
100 |
173 |
1.0 |
|
78.13 |
C1 |
102 |
76 |
134 |
166 |
0.9 |
C2 |
112 |
123 |
92 |
161 |
0.9 |
|
156.3 |
C1 |
109 |
83 |
132 |
116 |
0.7 |
C2 |
88 |
97 |
90 |
191 |
1.1 |
|
312.5 |
C1 |
107 |
85 |
126 |
223 |
1.3 |
C2 |
99 |
132 |
75 |
202 |
1.2 |
|
625 |
C1 |
115 |
102 |
112 |
154 |
0.9 |
C2 |
104 |
105 |
99 |
204 |
1.2 |
|
1250 |
C1 |
116 |
82 |
142 |
177 |
1.0 |
C2 |
109 |
78 |
139 |
131 |
0.8 |
|
2500 |
C1 |
121 |
92 |
132 |
150 |
0.9 |
C2 |
96 |
100 |
96 |
190 |
1.1 |
|
MMS 25 µg/mL |
C1 |
40 |
70 |
57 |
955 |
5.5 |
C2 |
31 |
62 |
50 |
1115 |
6.5 |
Adj. RTG: Adjusted relative total growth
Adj. RSG: Adjusted relative suspension growth
RCE2: relative cloning efficiency
MF: Mutation frequency
R: Ration between mutation frequency of treated cells/mutation frequency of control cells
Table 4: Cytotoxicity and mutagenicity results of the second experiment with S9 mix, 3h treatment
Doses µg/mL |
Cytotoxicity |
Mutagenicity |
||||
Adj. RTG % |
Adj. RSG % |
RCE2 % |
MF x10-6 |
R |
||
0 |
C1 |
100 |
100 |
100 |
67 |
1.0 |
C2 |
100 |
100 |
100 |
72 |
1.0 |
|
78.13 |
C1 |
79 |
56 |
142 |
78 |
1.2 |
C2 |
89 |
89 |
100 |
85 |
1.2 |
|
156.3 |
C1 |
115 |
73 |
157 |
59 |
0.9 |
C2 |
96 |
68 |
140 |
78 |
1.1 |
|
312.5 |
C1 |
97 |
58 |
166 |
99 |
1.5 |
C2 |
104 |
102 |
101 |
66 |
0.9 |
|
625 |
C1 |
89 |
63 |
142 |
61 |
0.9 |
C2 |
84 |
67 |
124 |
68 |
1.0 |
|
1250 |
C1 |
108 |
95 |
114 |
57 |
0.9 |
C2 |
111 |
114 |
97 |
52 |
0.7 |
|
2500 |
C1 |
87 |
58 |
149 |
70 |
1.1 |
C2 |
95 |
78 |
121 |
76 |
1.1 |
|
MMS 25 µg/mL |
C1 |
12 |
37 |
32 |
1551 |
23.2 |
C2 |
9 |
36 |
24 |
1830 |
25.6 |
Adj. RTG: Adjusted relative total growth
Adj. RSG: Adjusted relative suspension growth
RCE2: relative cloning efficiency
MF: Mutation frequency
R: Ration between mutation frequency of treated cells/mutation frequency of control cells
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under these experimental conditions, no noteworthy increase in the mutation frequency was observed, both with and without S9 mix. Sodium hypophosphite did not show any mutagenic activity in the in vitro mammalian cell gene mutation test with L5178Y TK+/- mouse lymphoma cells. - Executive summary:
The potential of sodium hypophosphite to induce mutations in L5178Y TK+/- mouse lymphoma cells was assessed according to OECD guideline 476 and EU method B.17). The study was conducted in compliance with the principles of Good Laboratory Practice regulations on the monohydrate form of the test item as the anhydrous form is highly hygroscopic and difficult to handle without specific precautions.
A preliminary toxicity test was performed to define the dose-levels of sodium hypophosphite to be used for the mutagenicity study. The test item was
tested in two independant experiments, both with and without a metabolic activation system, the S9 mix, prepared from a liver microsomal fraction of rats induced with Aroclor 1254. Vehicle controls and positive controls were included in both experiments.
Mouse lymphoma L5178Y TK+/- cells were exposed to the following dose-levels of sodium hypophosphate (two cultures/dose-level) for both experiments: 78.13, 156.3, 312.5, 625, 1250 and 2500 µg/mL. The treatment duration of the first experiment was 3 hours with and without S9 mix and that of the second experiment was 3 hours with S9 mix and 24 hours without S9 mix (as the results of the first experiment were negative). After an expression time of 48 hours at 37°C in a humidified atmosphere of 5% CO2/95% air, trifluorothymidine was used as selection agent. The evaluation of toxicity was performed on the basis of decreasing values for adjusted relative total growth (Adj. RTG), relative suspension growth (Adj. RSG) and cloning efficiency (CE2) and/or increase in mutation frequency.
The cloning efficiencies (CE2) and the mutation frequencies for the vehicle and positive controls were as specified in the acceptance criteria. The study was therefore considered valid.
No toxicity was noted in these experiments, both with and without S9 mix. The test item did not induce any significant increase in the mutation frequency, both with and without S9 mix.
Under these experimental conditions sodium hypophosphite did not show any mutagenic activity in the in vitro mammalian cell gene mutation test
using mouse lymphoma cells.
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