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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
Endpoint summary
Administrative data
Description of key information
There were no data for sensibilisation with Potassium phosphinate however a murine Local Lymph Node Assay (LLNA)(OECD 429 , EU B 42 method, GLP) is available with Sodium hypophosphite . The test item was found to be non-sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2009-05-28 till 2009-06-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study in accordance with GLP standard procedure.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: approximately 9 weeks
- Weight at study initiation (± SD): 21.4 ± 1.0 g
- Housing: individually in disposable crystal polystyrene cages (22.0 cm x 8.5 cm x 8.0 cm)
- Diet: free access to SSNIFF R/M-H pelleted maintenance diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water: free access to tap water (filtered using a 0.22 micron filter)
- Acclimation period: at least 5 days before beginning of the study
- Other:
nulliparous and non-pregnant
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): ± 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h (7:00 - 19:00)
IN-LIFE DATES: Death on 2009-06-08. - Vehicle:
- propylene glycol
- Concentration:
- 0 (control), 2.5, 5, 10, 25 or 50%
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TEST TO ASSESS IRRITANT POTENTIAL THROUGH EAR THICKNESS MEASUREMENT:
- Compound solubility: Due to the unsatisfactory solubility of the test item in the first recommended vehicles (acetone/olive oil (4/1,v/v), dimethylformamide and methyl ethyl ketone), propylene glycol was chosen from the other proposed vehicles. A homogeneous suspension was obtained at the maximum concentration of 50%. Hence concentrations for the preliminary test were 5, 10, 25 and 50%
- Irritation: The irritant potential was assessed through ear thickness measurement. The test item was non-irritant in the preliminary test, whatever the concentration. The highest concentration retained for the main test was therefore the maximal practicable concentration, according to the criteria specified in the International Guidelines.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of the test method: murine Local Lymph Node assay (LLNA)
- Criteria used to consider a positive response:
The test item was considered as a skin sensitizer when the StimuIation indices (SI) for a dose group is >= 3. Other relevant criteria such as cellularity and ear thickness were also taken into account for the interpretation of results.
TREATMENT PREPARATION
Each dosage form preparation was prepared each day separately from each other and homogenized by magnetic stirring.
ADMINISTRATION:
On days 1, 2 and 3, 25 µL of the control or dosage form preparations (i.e. test substance or reference substance) was applied to the dorsal surface of both ears. To avoid licking and to ensure an optimized application of the test materials, the animals were placed under light isoflurane anesthezia during the administration. No massage was performed but the pipette's tip was used to spread the preparation over the application sites. No rinsing was performed between each application. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- No data
- Positive control results:
- In the positive control group given hexyl cinnamic aldehyde (concentration 25%) a moderate increase in cellularity and a stimulation index exceeding the threshold value of 3 (SI = 15.30) were noted. The study was therefore considered valid.
- Parameter:
- SI
- Remarks on result:
- other: See table 1 in section remarks on results including tables and figures
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: See table 1 in section remarks on results including tables and figures
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Under the experimental conditions of this study, the test item sodium hypophosphite did not induce delayed contact hypersensitivity in the murine Local Lymph Node Assay.
- Executive summary:
The potential of sodium hypophosphite to induce delayed contact hypersensitivity was assessed in mice according to the OECD guideline 429 and to the EU Method B.42. The study was conducted in compliance with the principles of Good Laboratory Practice regulations on the monohydrated form of the test item as the anhydrous form is highly hygroscopic and difficult to handle without specific precautions.
Five groups of 4 animals were exposed to the test substance on 3 consecutive days (concentrations 2.5%, 5%, 10%, 25% and 50%) in parallel with a negative control group receiving the vehicle propylene glycol and a positive control group receiving the moderate sensitiser alpha-hexylcinnamaldehyde. After 2 days of resting, the animals were sacrificed in order to perform the proliferation assay. Changes in body weight, ear thickness were noted and the animals were checked on a regular base for clinical signs, mortality and local irritation.
A significant lymphoproliferation was noted in the positive control given alpha-hexylcinnamaldehyde. The study was therefore considered valid. No noteworthy lymphoproliferation was noted with the test substance at any tested concentration. The Stimulation Index was below 3 (range: 1.01 to 1.79) and no dose response reaction was observed.
No systemic clinical signs and mortality, neither changes in body weight, nor local irritation was observed for all tested concentrations. As a result, sodium hypophosphite was considered as not sensitising.
Reference
- Clinical examinations
- Systemic clinical signs and mortality: Neither mortality nor clinical signs were observed.- Body weight: no change in body weight compared to the control group.
- Local irritation: Neither cutaneous reactions nor notable increase in ear thickness were observed in the animals of the treated groups.
- Proliferation assay
The quantity of cells obtained in each group was satisfactory and the cellularity correlated with incorporation of3H-TdR.
The cell viability was higher than 70% in each group.
No notable lymphoproliferation was noted at any of the tested concentrations of the test substance.
- Table 1: Detailed overview of the study results
Treatment |
Conc (%) |
Cell viability |
Cellularity index |
# of nodes per group |
dpm per group |
dpm per node |
Stimulation Index |
Increase in ear thickness (% between day 1 and 6) |
Irritation level |
Vehicle |
|
90.91 |
|
8 |
891.00 |
111.38 |
|
0 |
|
Test substance |
2.5 |
90.14 |
1.60 |
8 |
1594.54 |
199.32 |
1.79 |
5.15 |
non-irritant |
Test substance |
5 |
82.14 |
1.15 |
8 |
898.61 |
112.33 |
1.01 |
3.03 |
non-irritant |
Test substance |
10 |
96.97 |
0.80 |
8 |
1099.35 |
137.42 |
1.23 |
2.04 |
non-irritant |
Test substance |
25 |
95.65 |
1.10 |
8 |
1185.10 |
148.14 |
1.33 |
4.04 |
non-irritant |
Test substance |
50 |
76.19 |
1.20 |
8 |
1268.55 |
158.57 |
1.42 |
2.94 |
non-irritant |
Positive control |
25 |
94.92 |
8.40 |
8 |
13631.16 |
1703.90 |
15.30 |
|
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One study is recorded for this endpoint and was chosen as a key study. The delayed contact hypersensitivity of sodium hypophosphite was assessed using the murine Local Lymph Node Assay . This study was conducted in compliance with the principles of Good Laboratory Practices and performed according to the OECD guideline 429 and the EU Method B.42.
Results showed no cutaneous reactions and no increase in ear thickness. No lymphoproliferation was noted. Over the range of sodium hypophosphite tested concentrations (2.5% to the maximal practicable concentration of 50%), the Stimulation Index (SI) varied from 1.01 to 1.79.
Under these test conditions, sodium hypophosphite was considered as not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Migrated from Short description of key information:
There is no reported case of respiratory sensitisation in humans.
Justification for classification or non-classification
Skin sensitisation:
According to the criteria laid down in EU regulation (EC) n°1272/2008 (CLP) and EU Directive 67/548/EEC, Potassium phosphinate has not to be classified for skin sensitisation.
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