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EC number: 233-343-1 | CAS number: 10124-56-8
- 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
Acute oral toxicity: Three studies are available for the acute oral toxicity endpoint. All studies indicate that sodium hexametaphosphate has a low potential for systemic toxicity following acute administration via the oral route.
The key study (Bradshaw, 2010) has been conducted to a current guideline (OECD 420) and according to GLP. The acute oral median dose (LD50) of sodium hexametaphosphate in the female Wistar strain rat was estimated to be greater that 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This conclusion is supported by the additional data provided for this endpoint.
Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of sodium metaphosphate. Sodium metaphosphate was considered to exhibit a low potential toxicity via the inhalation route and is not expected to be of significant concern.
The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) of sodium metaphosphate in male and female rats was estimated to be > 3.69 mg/L (the maximum attainable concentration).
Acute dermal toxicity: Testing was waived on the basis that further in vivo testing is considered to be scientifically unjustified.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- EThe study was performed between 11 March 2010 and 06 April 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Date of inspection: 15 September 2009 Date of signature: 26 November 2009
- Test type:
- fixed dose procedure
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
Harlan Laboratories UK Limited, Bicester, Oxon, UK.
- Age at study initiation:
At the start of the study the animals were eight to twelve weeks of age.
- Weight at study initiation:
The bodyweight variation did not exceed ± 20% of the initial/mean bodyweight of any previously dosed animal(s).
- Fasting period before study:
overnight fast immediately before dosing
- Housing:
The animals were housed in groups of up to four in suspended solid floor polypropylene cages furnished with woodflakes.
- Diet (e.g. ad libitum):
(2014 Teklad Global Rodent diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK) was allowed ad libitum throughout the study.
- Water (e.g. ad libitum):free access to mains drinking water
- Acclimation period:acclimatisation period of at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
19 to 25°C
- Humidity (%):
30 to 70%
- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light):
lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
IN-LIFE DATES: From: Day 1 To: Day 14 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle:
For the purpose of the study the test material was freshly prepared, as required, as a suspension in distilled water to give a dose level of 2000mg/kg bodyweight.
- Amount of vehicle:
Not stated
- Justification for choice of vehicle:
Distilled water was the preferred vehicle of the test method.
- Lot/batch no. :
Not stated
- Purity:
Not stated
MAXIMUM DOSE VOLUME APPLIED:
10ml/kg
DOSAGE PREPARATION:
Not applicable
CLASS METHOD :
Not applicable
- Rationale for the selection of the starting dose:
Using available information on the toxicity of the test material, 2000 mg/kg was chosen as the starting dose. - Doses:
- Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a suspension in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
- No. of animals per sex per dose:
- 1 female at 2000 mg/kg
4 females at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration:
14 days
- Frequency of observations and weighing:
Clinical observations were made ½, 1, 2, and 4 hours after dosing and then daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed:
Yes
- Other examinations performed:
Clinical signs, body weight. - Statistics:
- Not available
- Preliminary study:
- A sighting test at a dose level of 2000 mg/kg was performed.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 95% confidence limits not given in study report.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: No signs of systemic toxicity were noted.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- - Organ weights:
Not recorded
- Histopathology:
Not recorded
- Potential target organs:
Not recorded
- Other observations:
None - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (EU CLP - Unclassified).
This study has been selected as the key study because the results are sufficient in order to derive a reliable conclusion on classification and labelling in accordance with Regulation EC (No.) 1272/2008 (EU CLP). Sodium metaphosphate is not considered to be classified according to Regulation (EC) No. 1272/2008 (EU CLP). - Executive summary:
Introduction. The study was performed to assess the acute oral toxicity of the test material in the Wistar strain rat. The method was designed to meet the requirements of the following:
OECD Guidelines for Testing of Chemicals No 420 “Acute Oral Toxicity - Fixed Dose Method” (adopted17 December 2001)
Method B1bisAcute Toxicity (Oral) of Commission Regulation (EC) No. 440/2008
Method. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test material, as a solution in distilled water, at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Mortality. There were no deaths.
Clinical Observations. There were no signs of systemic toxicity.
Bodyweight. All animals showed expected gains in bodyweight.
Necropsy. No abnormalities were noted at necropsy.
Conclusion. The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (EU CLP- Unclassified).
Reference
Table 1 Individual Clinical Observations and Mortality Data
Dose Level mg/kg |
Animal Number and Sex |
Effects Noted After Dosing |
Effects Noted During Period After Dosing |
||||||||||||||||
½ |
1 |
2 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2000 |
1-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2-0 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-1 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-2 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
2-3 Female |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0= No signs of systemic toxicity
Table2 Individual Bodyweights and Bodyweight Changes
Dose Level mg/kg |
Animal Number and Sex |
Bodyweight (g) at Day |
Bodyweight Gain (g) During Week |
|||
0 |
7 |
14 |
1 |
2 |
||
2000 |
1-0 Female |
186 |
193 |
202 |
7 |
9 |
2-0 Female |
171 |
180 |
198 |
9 |
18 |
|
2-1 Female |
171 |
186 |
199 |
15 |
13 |
|
2-2 Female |
174 |
184 |
193 |
10 |
9 |
|
2-3 Female |
175 |
190 |
206 |
15 |
16 |
Table3 Individual Necropsy Findings
Dose Level |
Animal Number |
Time of Death |
Macroscopic Observations |
2000 |
1-0 Female |
Killed Day 14 |
No abnormalities detected |
2-0 Female |
Killed Day 14 |
No abnormalities detected |
|
2-1 Female |
Killed Day 14 |
No abnormalities detected |
|
2-2 Female |
Killed Day 14 |
No abnormalities detected |
|
2-3 Female |
Killed Day 14 |
No abnormalities detected |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LD50 >2000 mg/kg bw
Key study is performed according to guideline and under GLP (Klimisch reliability 1).
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Strain Reference: Sprague-Dawley (Crl:CDBR VAF Plus)
- Source: Charles River Laboratories, Kingston, NY
- Age at study initiation: The actual age of the rats was not specified, only that they were young adults.
- Weight at study initiation (± SD): Males: 281 ± 9.4 g; Females: 243 ± 15.7 g
- Fasting period before study: No data
- Housing: Animals were housed individually in stainless steel suspended rat cages. Deosorb bedding was used in the litter pans.
- Diet: Purina Laboratory Rodent Chow 5001 available ad libitum
- Water: Tap water available ad libitum
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 23 °C (quoted in the study as 69 - 73 °F)
- Humidity (%): 41 - 70%
- Air changes (per hr): 14.0 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 h fluorescent light and 12 h dark cycle - Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: The Rochester type exposure chamber was made of stainless steel and glass and was operated dynamically. The calculated 99% equilibrium time for the chamber at a flow rate of 35.0 L per minute was 19.7 minutes (equivalent to 14.0 "air changes per hour").
- Exposure chamber volume: 150 L
- Method of holding animals in test chamber: The test animals were assigned to and housed in individual compartments of a wire mesh cage bank (all on the same horizontal level) during the exposure.
- Source and rate of air: Breathing grade compressed air was used and the total chamber air flow rate was 35.0 L/minute.
- Method of conditioning air: No data
- System of generating particulates/aerosols: The test material was generated using a BGI Wright Dust Feeder II. The test material was desiccated and packed into large dust cups. Breathing Grade compressed air was metered to the Wright dust feeder through teflon tubing by a Matheson® 605 rotameter with a metal float. Rotameter back pressure was controlled using a Matheson® 3104C regulator. The dust feeder back pressure was monitored using a Marshalltown® back pressure gauge. The test material was made airborne by the compressed air dispersing the material into the exposure chamber. The concentration of the test atmosphere was controlled by the delivery rate setting of the Wright dust feeder.
- Method of particle size determination: The samples were drawn through a Sierra 218 cascade impactor at 2.78 liters per minute. The aerodynamic particle size distribution was determined by gravimetric analysis of the amount of test material collected on the impactor stages and subsequent determination of the mass median aerodynamic diameter (MMAD), geometric standard deviation and other particle size parameters by logarithmic-probability plotting.
- Treatment of exhaust air: The chamber air was exhausted from the bottom of the chamber and passed through an orifice tube system which continuously monitored airflow and then through a commercial filter box. The filter box was connected to a line leading to additional filters and an exhaust fan on the roof. The exhaust operated at a flow rate of 35.0 liters per minute, creating a slight negative pressure in the chamber, which was considered to be the total chamber air flow rate. The entire exposure system and primary exhaust filter were contained in a fume hood.
- Temperature, humidity, pressure in air chamber: The mean temperature and relative humidity in the chamber were 19.44 °C (67±1.5 °F) and 63±3.8%, respectively. The pressure in the air chamber was not measured.
TEST ATMOSPHERE
- Brief description of analytical method used: The airborne concentration of the test material was determined gravimetrically.
- Samples taken from breathing zone: Yes - Chamber air samples were taken on glass fiber filters held in cassettes at approximately one hour intervals during the exposure to determine the airborne concentration of test material. The airborne concentration of the test material was determined gravimetrically by drawing a known amount of chamber air through the filter. The samples were taken from the center of the chamber directly over the animal exposure caging.
The difference between gravimetric and nominal concentration was attributed to sedimentation of larger particles and/or adhesion of the test material to surfaces in the exposure chamber.
VEHICLE
- Not applicable: The test material was administered as received and a vehicle was not used.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The fraction of particles less than or equal to 1 µm in mass aerodynamic diameter, based on the log-probability graphs, ranged from 0.8 to 12.2%. The fraction of particles less than or equal to 10 µm in mass aerodynamic diameter, based on the log probability graphs, ranged from 78.9 to 86.4%. These results indicated the test material was respirable in size to the rat.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMADs ranged from 3.25 to 4.98 micrometers (µm) with geometric standard deviations ranging from 2.38 to 2.78. The MMAD represents the smallest size that could be achieved in this study. The material is hygroscopic causing the particles to agglomerate and/or adhere to surfaces inside the chamber. Several trials were initially performed with various generation schemes and the system which was ultimately chosen provided the best performance. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 12.68 mg/L (maximum attainable concentration)
Gravimetric concentration: 3.698 ± 0.288 mg/L - No. of animals per sex per dose:
- 5 animals/sex
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for signs of toxicity and mortality every 15 mins during the first hour of exposure, hourly for the remainder of the exposure, upon removal from the chamber, at 1 h post-exposure, twice daily thereafter for 13 days and once on day 14. Individual body weights were recorded on days 0, 1, 2, 4, 7 and 14.
- Necropsy of survivors performed: Yes
- Other examinations performed: See Table 1 for a list of recorded observations. - Statistics:
- No data
- Preliminary study:
- Not applicable
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 3.69 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- None of the animals died as a result of dosing.
- Clinical signs:
- other: See Table 1. Clinical signs noted during the exposure included lacrimation, oral discharge and squinting eyes. Clinical signs noted upon removal from the chamber and at one hour post exposure included abdominogenital staining, chromodacryorrhea, chromorhi
- Body weight:
- See Table 2 and 3.
All animals lost weight through day 1 of the study and then began to gain weight in a normal pattern. At termination all animals exhibited increased in body weight over their day 0 values. - Gross pathology:
- See table 3.
There were no gross internal lesions observed in any animal. - Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute inhalation median lethal concentration (LC50) of the test material in male/female Sprague-Dawley rats was estimated to be greater than 3.69 mg/ L of air. The study was conducted up to a maximum attainable concentration and can therefore be considered to be equivalent to a limit test conducted at 5 mg/ L. As such, sodium metaphosphate is not classified for inhalation toxicity, in accordance with Regulation EC (No.) 1272/2008 (EU CLP). This study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for this endpoint.
- Executive summary:
Introduction
The study was performed to assess the acute inhalation toxicity of the test material in the Sprague-Dawley rat. The method was designed to meet the requirements of the follwing:
OECD Guideline 403 (Acute Inhalation Toxicity)
EU Method B.2 (Acute Toxicity (Inhalation))
EPA OPP 81-3 (Acute inhalation toxicity)
Method
Five male and five female animals were exposed for a period of 4 hours to the maximum attainable concentration of the dust (test material). The analytical dose of the test material was determined to be 3.69 ± 0.288 mg/ L air. Clinical signs, bodyweight and mortality were monitored during the study, after 14 days surviving animals were subjected to gross necropsy.
Mortality
There were no deaths.
Clinical Observations
Clinical signs noted during the 14 day post-exposure observation period included alopecia on head, chromodacryorrhea, chromorhinorrhea, decreased feces and exophthalmos.
Bodyweight
All animals lost weight through day 1 of the study and then began to gain weight in a normal pattern. At termination all animals exhibited increased in body weight over their day 0 values.
Necropsy
No abnormalities were noted
Conclusion
The study was conducted up to a maximum attainable concentration and can therefore be considered to be equivalent to a limit test conducted at 5 mg/ L [actual result LC50>3.96 mg/ L]. As such, sodium metaphosphate is not classified for inhalation toxicity (EU CLP - Unclassified).
Reference
See attached tables.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LC50 > 3690 mg/m3
Key study is performed according to guideline and under GLP (Klimisch reliability 1).
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The data available for oral and inhalation routes conclude that sodium metaphosphate should not be classified according to regulation (EC) No. 1272/2008 (EU CLP). For the reasons stated above it is also considered that sodium metaphospahte will not be classified for dermal acute toxicity.
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