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EC number: 228-601-5 | CAS number: 6303-21-5
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 January 2012 - 22 May 2012
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions.
- Justification for type of information:
- Justification of the read across:
In the current assessment, data from sodium phosphinate were used to evaluate the phosphinic acid properties. Phosphinic acid is commercially prepared as the result of pH adjustment of the sodium phosphinate salt. The main assumption is that sodium is not significant in respect of all the properties under consideration which are expected to be related to the phosphinate anion. In dilute aqueous conditions of environmental pH (5-9) the salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. In human health hazard assessment, irritant and corrosive properties are studied on the phosphinic acid itself due to the low pH of the acid form, as a read-across approach is not relevant. However as mutagenicity tests and long term toxicity tests are performed in dilute aqueous conditions, no pH effect is expected and only intrinsic properties of the active compound is studied. Therefore the read across approach is applied in the present dossier.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- developmental toxicity
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Justification of the read across:
In the current assessment, data from sodium phosphinate were used to evaluate the phosphinic acid properties. Phosphinic acid is commercially prepared as the result of pH adjustment of the sodium phosphinate salt. The main assumption is that sodium is not significant in respect of all the properties under consideration which are expected to be related to the phosphinate anion. In dilute aqueous conditions of environmental pH (5-9) the salt will behave no differently to the parent acid, at identical concentration of the particular speciated form present and will be fully dissociated. In human health hazard assessment, irritant and corrosive properties are studied on the phosphinic acid itself due to the low pH of the acid form, as a read-across approach is not relevant. However as mutagenicity tests and long term toxicity tests are performed in dilute aqueous conditions, no pH effect is expected and only intrinsic properties of the active compound is studied. Therefore the read across approach is applied in the present dossier.
Please also refer to the Read across Justification document provided in Section 13 - Reason / purpose for cross-reference:
- read-across source
- Species:
- rat
- Strain:
- Sprague-Dawley
- Analytical verification of doses or concentrations:
- yes
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
See attached background material - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: Based on all parameters observed
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
See attached background material - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: based on the absence of toxicologically significant effects
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day
- Basis for effect level:
- other: Based on increased slight development variation
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
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
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Sodium phosphinate
- Physical state: white crystalline solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: breeder: Charles River Laboratories France, L’Arbresle, France.
- Age at study initiation: approximately 9-11 weeks old on the first day of treatment
- Mean body weight at the first day of treatment, i.e day 6 : 279 g (a range of 224 g to 350 g)
- Fasting period before study: no
- Housing: polycarbonate cages (Tecniplast 2154, 940 cm²) with stainless steel lids and containing autoclaved sawdust
- Diet: SSNIFF R/M-H pelleted diet (free access)
- Water: tap water filtered with a 0.22 µm filter (free access)
- Acclimation period: a period of 4 or 5 days before the beginning of the treatment period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h/12 h.
IN-LIFE DATES: 12 February 2012 to 07 March 2012.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- purified water obtained by reverse osmosis
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Dose-levels were calculated in terms of sodium phosphinate monohydrate (CAS 10039 56 2, MW 103.977 g/mol) which is the form supplied by the Sponsor.
The test item was administered as a solution in the vehicle. The test item was mixed with the required quantity of vehicle.
The test item dose-formulations were prepared on a weekly basis based on available stability data and were stored in brown glass bottles at room temperature "prior to use".
VEHICLE
- Concentration in vehicle: 20, 60 and 200 mg/mL
- Amount of vehicle (if gavage): 5 mL/kg/day. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Type of method: HPLC-IC.
Before the start of treatment the suitability of the proposed preparation process was confirmed by analysis of the stability.
In the stability study, a range of dose-formulations were prepared at levels which cover the lowest and highest concentrations proposed for use in the study, and then stored at room temperature with no specific protection against light or humidity.
Results indicated satisfactory stability of the dose-formulations after 9 days storage at room temperature. - Details on mating procedure:
- - Impregnation procedure: purchased time pregnant
- Proof of pregnancy: Detection of vaginal plug - Duration of treatment / exposure:
- day 6 to day 20 post-coitum
- Frequency of treatment:
- Daily
- Duration of test:
- 21 days
- No. of animals per sex per dose:
- 24 mated females per dose.
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
The dose-levels were selected in agreement with the Sponsor, on the basis of a preliminary 2 week toxicity study in the rat and on the basis of a combined repeated dose study with the reproduction/developmental toxicity screening test in rats in which dose-levels of 101, 309 and 1080 mg/kg/day elicited no toxicity.
Therefore, 1000 mg/kg/day which is also the maximum recommended dose in the OECD 414 guideline, was selected as the high-dose level. The low-dose and mid-dose have been selected using a ratio representing a three-fold interval (i.e. 100 and 300 mg/kg/day).
- Rationale for animal assignment: stratified procedure base.
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS:
- Time schedule: at least twice a day during the treatment period.
DETAILED CLINICAL OBSERVATIONS:
- Time schedule: once a day during the treatment period.
BODY WEIGHT (GAIN):
- Time schedule: 2-3 times per week until day 21 post-coitum.
FOOD CONSUMPTION:
- Time schedule: 2-3 times per week until day 21 post-coitum.
POST-MORTEM MACROSCOPIC EXAMINATION:
- Sacrifice on day 21 post-coitum.
- Examined: principal thoracic and abdominal organs - Ovaries and uterine content:
- The ovaries and uterine content were examined after termination, including::
- Gravid uterus weight
- Number of corpora lutea
- Number of implantations
- Number of early resorptions
- Number of late resorptions
- Number of uterine scars, evaluation of placenta - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: approximately half per litter
- Skeletal examinations: Yes: remaining live fetuses per litter
- Head examinations: Yes: approximately half per litter
- Other : number dead and live, body weight, sex - Statistics:
- Mean values were compared by one-way analysis of variance and Dunnett test (mean values being considered as normally distributed and variances being considered as homogeneous).
Percentage values were compared by Fisher exact probability test. - Indices:
- % Pre-implantation loss = 100 * (Number of corpora lutea - Number of implantation sites) / Number of corpora lutea
% Post-implantation loss = 100 * (Number of implantation sites - Number of live fetuses) / Number of implantation sites
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
See attached background material
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: Based on all parameters observed
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
See attached background material
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- >= 300 mg/kg bw/day
- Basis for effect level:
- other: Based on increased slight development variation
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Basis for effect level:
- other: based on the absence of toxicologically significant effects
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The data from toxicity of sodium phosphinate are used to assess the toxicity of phosphinic acid as it is commercially prepared as the result of pH adjustment of sodium phosphinate salt. Therefore conclusions are the same.
Sodium phosphinate was administered by gavage, once daily, from day 6 to 20 post-coitum, inclusive, to mated female Sprague-Dawley rats at dosages of 100, 300 or 1000 mg/kg/day.
On the basis of the results obtained in this study:
- the No Observed Adverse Effect Level (NOAEL) for maternal parameters was considered to be 1000 mg/kg/day,
- the No Observed Effect Level (NOEL) for embryo-fetal development was considered to be 300 mg/kg/day, based on increased slight development variation (increased incomplete ossifications or increased ossification points in a few foetuses at 1000 mg/kg/day),
- the NOAEL for embryo-fetal development was considered to be 1000 mg/kg/day, based on the absence of toxicologically significant effects at this dose level.
The test item and the Phosphinic acid are not considered to have any teratogenic potential. - Executive summary:
The data from toxicity of sodium phosphinate are used to assess the toxicity of phosphinic acid as it is commercially prepared as the result of pH adjustment of sodium phosphinate salt. Therefore conclusions are the same.
The objective of this prenatal developmental toxicity study was to evaluate the potential toxic effects of the test item, sodium phosphinate, on the pregnant female and on embryonic and fetal development following daily oral administration (gavage) to pregnant female rats from implantation to the day prior to the scheduled hysterectomy (day 6 to day 20 post‑coitum inclusive).
Methods
Three groups of 24 mated Sprague-Dawley rats were administered the test item once daily from day 6 to day 20 post-coitum, by gavage, at dosages of 100, 300 or 1000 mg/kg/day. An additional group of 24 mated females received the vehicle, purified water obtained by reverse osmosis, under the same experimental conditions and acted as the control group.A dose volume of 5 mL/kg/day was used.
The animals were checked daily for mortality and/or clinical signs. Body weight and food consumption were recorded at designated intervals. On day 21post-coitum (p.c.), females were sacrificed and submitted to macroscopic post-mortem examination. Hysterectomy was performed and the numbers of corpora lutea, implantations, early and late resorptions, and live and dead fetuses were recorded. The fetuses were weighed, sexed and examined for external, soft tissue and skeletal abnormalities.
Results
The test item concentrations in the administered dosage forms analyzed in weeks 1 and 3 remained within an acceptable range of variation (-5.3% to +1.0%) when compared to the nominal values.
Pregnancy status
At termination on day 21 p.c., there were 24, 24, 24 and 23 dams with live fetuses in the vehicle control, 100, 300 and 1000 mg/kg/day groups, respectively.
Mortality
There were no unscheduled deaths.
Clinical signs
There were no clinical observations in the 100 and 300 mg/kg/day groups. At 1000 mg/kg/day, there were a few clinical signs (piloerection and ptyalism) probably due to the taste of the test item. These findings were not considered to be adverse or toxicologically relevant.
Body weight, body weight change and food consumption
There were no toxicologically significant effects on mean body weights, mean body weight changes or mean food consumption.
Necropsy and hysterectomy data
At necropsy, there were no effects on mean gravid uterus weight and no macroscopic changes which were considered to be associated with treatment with the test item.
There were no biologically significant effects on mean hysterectomy data (pre- and post‑implantation losses and, early and late resorptions).
Fetal examination
There were no effects of the treatment with the test item on mean foetal body weights or foetal sex ratios.
External examination: there were no effects on the incidence of external variations per foetuses or per litter. There were no external malformations.
Soft tissues examination: there were no soft tissue variations and no malformations considered to be related to treatment with the test item.
Skeletal examination:
- There were no toxicological significant findings at examination of foetal cartilages [at 300 and 1000 mg/kg/day, the slight but statistically increases in the number of foetuses with cartilage of thoracic vertebrae present (21.0 and 25.8% vs. 12.3% in controls, p<0.05 and 0.01, respectively) were treatment-related but considered of non toxicological significance].
- At 100 and 300 mg/kg/day, there were no treatment-related variations. At 1000 mg/kg/day, there was an increased number of litters with fetuses with ossification point of the 14th thoracic vertebra (47.8% vs. 8.3% in controls, p<0.01) anda slight increase in the number of fetuses with incomplete ossification of thoracic vertebrae centrum (23.9 % vs. 11.7% in controls, p<0.01). While probably treatment-related, these findings were considered to represent slight development variations and to be non adverse.
- There were no treatment-related malformations. At 1000 mg/kg/day, an increase in the number of foetuses with absence of lumbar vertebrae was observed (1.9% vs. 0.0 % in controls). As the incidence was low, not statistically significant and in the absence of other malformations, this finding was considered to be incidental.
Conclusion
The test item was administered by gavage, once daily, from day 6 to 20 post-coitum, inclusive, to mated female Sprague-Dawley rats at dosages of 100, 300 or 1000 mg/kg/day.
On the basis of the results obtained in this study:
- the No Observed Adverse Effect Level (NOAEL) for maternal parameters was considered to be 1000 mg/kg/day,
- the No Observed Effect Level (NOEL) for embryo-foetal development was considered to be 300 mg/kg/day, based on increased slight development variation (increased incomplete ossifications or increased ossification points in a few foetuses at 1000 mg/kg/day),
- the NOAEL for embryo-foetal development was considered to be 1000 mg/kg/day, based on the absence of toxicologically significant effects at this dose level.
The test item and the Phosphinic acid are not considered to have any teratogenic potential..
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.
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