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EC number: 231-907-1 | CAS number: 7778-53-2
- 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
Three studies are available to assess the acute oral toxicity of tripotassium orthophosphate. All studies indicate that tripotassium orthophosphate has a low potential for systemic toxicity following acute administration via the oral route. A weight of evidence approach has been implemented to reduce unnecessary animal testing. The LD50 of tripotassium orthophosphate is known to be > 2,000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
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:
- weight of evidence
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Twenty Wister-derived rats were fasted for 24 h prior to administration of the test substance by oral gavage of a g/kg bw basis. Each animal received the desired dosage in a single administration. The animals were observed for signs of toxicity and survival at 1, 3, 6, 24, 48 and 72 h and daily thereafter for a total of 14 days. Body weights were taken at 7 and 14 days. All animals were autopsied and observed for gross pathological organ changes.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Zartman Farms, Douglassvillle, Pa.
- Age at study initiation: no data
- Weight at study initiation: no data
- Fasting period before study: approximately 24 prior to testing.
- Housing: individually
- Diet: adlibitum
- Water: no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: no data
- Amount of vehicle: no data
- Justification for choice of vehicle:no data
- Lot/batch no.: no data
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: no data
DOSAGE PREPARATION: no data
CLASS METHOD
- Rationale for the selection of the starting dose: no data - Doses:
- 2.44, 3.26, 4.07, 4.48 and 4.89 g/kg bw.
- No. of animals per sex per dose:
- 4 animals per dose, sex ratio not specified.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations for signs of toxicity were taken at 1, 3, 6, 24, 48, 72 and daily thereafter for a total of 14 days. Body weights were taken initially at 7 and 14 days.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs and body weight - Statistics:
- The 24-h and 14-day LD50 determination was calculated in accordance with the method of Miller and Tainter (1944).
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 260 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Dose-related mortality was observed.
- Clinical signs:
- other: Male and female rats exhibited respiratory depression, ataxia, loss of righting, ptosis, piloerection, decreased locomotor activity.
- Gross pathology:
- Autopsies revealved no outstanding gross pathological organ changes.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 for 20 rats at 24 h and 14 days was 4.26 ± 0.15 g/kg bw.
This study is considered to fulfil the data requirements as defined under Annex XI, section 1.2. of Regulation (EC) N. 1907/2006 (REACH) as part of a weight of evidence approach and no further testing is considered necessary. - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Single oral dose - 20 % aqueous solution applied to 5 rabbits (male and female).
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- other: No data
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Single dose was administered as a 20 % aqueous solution - Doses:
- 3160, 3980, 5010 and 6310 mg/kg.
- No. of animals per sex per dose:
- Either 2 males and 3 females , or 3 males and 2 females per group.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4 500 mg/kg bw
- 95% CL:
- >= 4 000 - <= 5 060
- Remarks on result:
- other: 20 % aqueous solution
- Mortality:
- See table.
- Clinical signs:
- other: Reduced appetite and activity (1 to 2 days in survivors), increasing weakness, collapse and death.
- Gross pathology:
- Lung and liver hyperaemia and acute gastrointestinal inflammation was observed in decedents.
In survivors, the viscera appeared normal. - Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The single oral dose LD50 of tripotassium phosphate was 4500 mg/kg with 95 % confidence limits of 4000 - 5060 mg/kg.
This study is considered to fulfil the data requirements as defined under Annex XI, section 1.2. of Regulation (EC) N. 1907/2006 (REACH) as part of a weight of evidence approach and no further testing is considered necessary. - Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: No data
- Deviations:
- not specified
- Principles of method if other than guideline:
- Acute oral screening test in male rats.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- other: 'standard acute oral screen'
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- No data
- Doses:
- 1000 and 4640 mg/kg
- No. of animals per sex per dose:
- Males only.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No data
- Preliminary study:
- No data
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 1 000 mg/kg bw
- Mortality:
- At 4640 mg/kg all 4 animals died by 18 h.
- Clinical signs:
- other: Acute depression and pain reaction at 4640 mg/kg dose level.
- Gross pathology:
- Corrosion of gastrointestinal tract.
- Other findings:
- No data.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- The acute oral LD50 of tripotassium orthophosphate, under the conditions of the test, was reported to be > 1000 mg/kg.
This study is considered to fulfil the data requirements as defined under Annex XI, section 1.2. of Regulation (EC) N. 1907/2006 (REACH) as part of a weight of evidence approach and no further testing is considered necessary.
Referenceopen allclose all
Table 2. Survival for the acute oral toxicity of MCTR-7 -75 in rats:
Dose |
No. per group |
Hour |
Day |
Total |
|||||||||||||||
1 |
3 |
6 |
24 |
48 |
72 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||
2.44 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
3.26 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4.07 |
4 |
4 |
4 |
4 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
4.48 |
4 |
4 |
4 |
4 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
4.89 |
4 |
4 |
3 |
3 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Table 3. Clinical observations for the acute LD50 study of MCTR-7 -75 in rats:
Dose g/kg bw |
Animal No. & sex |
Hour |
Day |
|||||||||||||||
1 |
3 |
6 |
24 |
48 |
72 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
2.44 |
1 M |
A-R PT-D |
R-D PT |
R-D PT |
D-P |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
2 M |
A-R PT-D |
R-D PT |
R-D PT |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
3 F |
A-R PT-D |
R-D PT |
R-D PT |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
4 F |
A-R PT-D |
R-D PT |
R-D PT |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
3.26 |
1 M |
R-A PT-D |
Rr-R PT |
PT D-P |
PT D-P |
D |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
2 M |
R-A PT-D |
Rr-R PT |
PT D-P |
PT D-P |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
3 F |
R-A PT-D |
Rr-R PT |
PT D-P |
PT D-P |
D |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
4 F |
R-A PT-D |
Rr-R PT |
PT D-P |
PT D-P |
D |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
4.07 |
1 M |
Rr-R PT |
Rr-R PT |
A-Rr R-PT |
D-P |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
2 M |
Rr-R PT |
Rr-R PT |
DEATH |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 F |
Rr-R PT |
Rr-R PT |
PT P-D |
D |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
4 F |
Rr-R PT |
Rr-R PT |
PT P-D |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
4.48 |
1 M |
Rr-R PT |
Rr-R PT |
DEATH |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2 M |
Rr-R PT |
Rr-R PT |
Rr-R PT |
DEATH |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 F |
Rr-R PT |
Rr-R PT |
DEATH |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 F |
Rr-R PT |
Rr-R PT |
P PT-D |
D |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
|
4.89 |
1 M |
Rr-R PT |
Rr-R PT |
Rr-R PT |
DEATH |
|
|
|
|
|
|
|
|
|
|
|
|
|
2 M |
Rr-R PT |
Rr-R PT |
Rr-R PT |
DEATH |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3 F |
Rr-R PT |
Rr-R PT |
DEATH PT |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4 F |
Rr-R PT |
DEATH |
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A = ataxia
D - decreased locomotor activity
N - normal
P - piloerection
PT - ptosis
R - respiratory depression
RR - loss of righting reflex
Table 4. Individual body weights:
Dose g/kg bw |
Animal no. & sex |
Test day |
Dose (g/kg bw) |
Animal no. & sex |
Test day |
||||
0 |
7 |
14 |
0 |
7 |
14 |
||||
2.44 |
1 M |
240 |
275 |
305 |
4.48 |
1 M |
210 |
- |
- |
2 M |
220 |
255 |
295 |
2 M |
230 |
- |
- |
||
3 F |
200 |
225 |
235 |
3 F |
200 |
- |
- |
||
4 F |
210 |
220 |
230 |
4 F |
205 |
215 |
235 |
||
3.26 |
1 M |
220 |
240 |
375 |
4.89 |
1 M |
230 |
- |
- |
2 M |
240 |
255 |
295 |
2 M |
220 |
- |
- |
||
3 F |
210 |
220 |
230 |
3 F |
225 |
- |
- |
||
4 F |
210 |
220 |
235 |
4 F |
210 |
- |
- |
||
4.07 |
1 M |
235 |
265 |
290 |
|||||
2 M |
235 |
- |
- |
||||||
3 F |
220 |
275 |
235 |
||||||
4 F |
225 |
230 |
240 |
Table 1. Single oral dose - 20 % aqueous solution:
Dosage (mg/kg) |
Average initial weight |
Mortalities/dosed |
Time of mortality |
|||
Male |
Female |
Male |
Female |
Combined |
||
3160 |
235 |
225 |
0 / 3 |
0 / 2 |
0 / 5 |
One to two days |
3980 |
215 |
245 |
0 / 2 |
2 / 3 |
2 / 5 |
|
5010 |
225 |
235 |
2 / 3 |
1 / 2 |
3 / 5 |
|
6310 |
220 |
230 |
2 / 2 |
3 / 3 |
5 / 5 |
Table 1. Dose/response data:
Dose (mg/kg) |
Conc. (%) |
Mortality ratio |
Mortality interval |
Animal wt. range |
Weight change |
1000 |
20 |
0 / 4 |
- |
190 g |
|
4640 |
20 |
4 / 4 |
18 h |
170 g |
- |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 260 mg/kg bw
- Quality of whole database:
- LD50 > 2,000 mg/kg bw
Three studies are available to assess the acute oral toxicity of tripotassium orthophosphate in addition a number of supporting data on analogous substances are available to support the conclusion. All studies indicate that tripotassium orthophosphate has a low potential for systemic toxicity following acute administration via the oral route.
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
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
Both the Na+ and the K+ cation have a similar biological function and therefore orthophosphate salts of these types are not considered to differ in their systemic toxicity profile; differences arise in their local effects profile due to the increasing or decreasing acidity/alkalinity and buffering capacities of the substances. This has been shown not to have an effect on systemic toxicity. In addition, both salts have been shown to be of similar low toxicity in acute oral studies. These studies are supported by a number of acute oral studies on similar compounds which all show potassium and sodium orthophosphates to possess low systemic toxicity via the oral route (See section 7.2.1.) and therefore comparisons can be drawn to allow read-across for the acute inhalation endpoint.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.
4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’. - Reason / purpose for cross-reference:
- read-across: supporting information
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-3 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Environmental Protection Agency Toxic Substances Health Effects Test Guidelines, October 1984 (PB82-232984) Acute Inhalation Toxicity Study
- 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
- Qualifier:
- according to guideline
- Guideline:
- other: FMC Acute Inhalation Toxicity Protocol Number 27
- Deviations:
- no
- GLP compliance:
- yes
- 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
- Source: Charles River Laboratories, Kingston, NY.
- Age at study initiation: young adult
- Weight at study initiation: males: 274 ± 9.1; females 217 ± 7.3
- Fasting period before study: not reported
- Housing: Individually housed in stainless steel suspended rat cages. Desorb bedding was used in the litter pans.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a minimum of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 69 - 73ºF
- Humidity (%): 41 - 70 %
- Photoperiod (hrs dark / hrs light): 12 h dark/ 12 h light - 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: Rochester type exposure chamber
- Exposure chamber volume: 150 L
- Method of holding animals in test chamber: 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. The cage position assignment ensured equal distribution of both sexes throughout the cage bank.
- Source and rate of air: breathing grade compressed air
- System of generating particulates/aerosols: a BGI Wright dust feeder II was used to generate the test atmosphere. The test material was desiccated and packed into large dust cups. Breathing grade compressed air was metered to the Wright dust feeder through 1/4 inch teflon tubing by a Matheson® 605 rotameter with metal float. Rotameter back pressure was controlled using a Matheson®3104-C regulator. The dust feeder back pressure was controlled using a Marshalltown® back pressure gauge. The test material was made airborne by compressed air dispersing the material into the exposure chamber. The concentration of the test atmostphere was controlled by the delivery rate setting of the wright dust feeder.
- Method of particle size determination: the aerodynamic particle size distribution was determined by gravimetric analysis of the test material collected on the impactor stages and subsequent determination of the MMAD, geometric SD and other particule size parameters by logarithmic-probability plotting.
- Temperature, humidity, pressure in air chamber: Chamber and room air temperature and relative humidity were monitored continuously during the exposure with FMC wet/dry bulb hygrometers. Measurements were recorded at 30 min intervals.
At the end of the exposure, the chamber was cleared for 30 min by drawing room air through it at the same flow rate (31.9 L/min) prior to removing the animals.
TEST ATMOSPHERE
- Brief description of analytical method used: chamber air samples were taken on Gelman® Type A/E 47 mm glass fibre filters held in cassettes at approximately 1 h intervals during 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 concentration was calculated by dividing filter weight gain by the sample volume. The samples were taken from the centre of the chamber directly over the animal exposure caging.
Atmospheric monitoring:
The chamber homogeneity determination showed that the test atmosphere was homogeneously distributed throughout the test chamber (cv = 7.10 %).
The dust feeder was operated at what was considered a maximum setting which would allow reliable operation. At this setting the delivery rate required the dust feeder to be manually assisted during the exposure. The chamber airflow was operated at as low flow rate which would allow timely chamber equilibrium and maintain a slight negative pressure in the chamber. 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.
- Samples taken from breathing zone: yes
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): The MMADs ranged from 5.87 to 6.82 μm with geometric standard deviations ranging from 2.55 to 2.92. The fraction of particles less than or equal to 1 μm in mass aerodynamic diameter, based on the log probability graphs, ranged from 0 to 3.6 %. The fraction of particles less than or equal to 10 μm in mass aerodynamic diameter, based on the log probability graphs, ranged from 65.9 to 69.1 %. These results indicated the test material was respirable in size to the rat. The MMAD represents the smallest size that could be acheived in this study. The material had a static electric charge when generated causing the particles to agglomerate and / or adhere to surfaces inside the chamber.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- chamber air samples were taken on Gelman® Type A/E 47 mm glass fibre filters held in cassettes at approximately 1 h intervals during exposure to determine the airborne concentration of test material
- Duration of exposure:
- 4 h
- Concentrations:
- Nominal concentration: 37.35 mg/L
Mean analytical data ±SD (Gravimetric concentration): 0.83 ± 0.065 mg/L - No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were observed for signs of toxicity and mortality at 15 min intervals during the first h 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.
- Necropsy of survivors performed: yes, all animals were sacrificed and submitetd to gross necroscopy.
- Other examinations performed: body weights were recorded on days 0, 1, 2, 4, 7 and 14. - Statistics:
- None reported
- Preliminary study:
- No data
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.83 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: The incidence of clinical signs were highest at the removal from chamber observations. Clinical signs noted during the exposure included lacrimation and squinting eyes. Clinical signs noted following the exposure incuded chromodacryorrhea, lacrimation, n
- Body weight:
- Most animals lost weight through day 1 of the study and then began to gain weight in a normal pattern. At termination all animals had exhibited increases in body weight over their day 0 values.
- Gross pathology:
- There were no gross internal lesions observed in any animal necropsy.
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the test material caused no mortality when administered for 4 h to Sprague Dawley rats at a mean, maximum attainable concentration of 0.83 mg/L. Based on this, the LC50 for monosodium phosphate is considered to be greater than 0.83 mg/L. This study is considered to be acceptable and to adequately satisfy both the guideline requirement and the regulatory requirement for this endpoint.
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
See read-across justification report under Section 13 ‘Assessment Reports’.
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
In accordance with REACH Annex XI, Section 1.5, of Regulation (EC) No. 1907/2006 (REACH) the standard testing regime may be adapted in cases where a grouping or read-across approach has been applied.
The similarities may be based on:
(1) a common functional group
(2) the common precursors and/or the likelihood of common breakdown products via physical or biological processes, which result in structurally similar chemicals; or
(3) a constant pattern in the changing of the potency of the properties across the category
Both the Na+ and the K+ cation have a similar biological function and therefore orthophosphate salts of these types are not considered to differ in their systemic toxicity profile; differences arise in their local effects profile due to the increasing or decreasing acidity/alkalinity and buffering capacities of the substances. This has been shown not to have an effect on systemic toxicity. In addition, both salts have been shown to be of similar low toxicity in acute oral studies. These studies are supported by a number of acute oral studies on similar compounds which all show potassium and sodium orthophosphates to possess low systemic toxicity via the oral route (See section 7.2.1.) and therefore comparisons can be drawn to allow read-across for the acute inhalation endpoint.
2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
See read-across justification report under Section 13 ‘Assessment Reports’.
3. ANALOGUE APPROACH JUSTIFICATION
See read-across justification report under Section 13 ‘Assessment Reports’.
4. DATA MATRIX
See read-across justification report under Section 13 ‘Assessment Reports’. - Reason / purpose for cross-reference:
- read-across: supporting information
- Reason / purpose for cross-reference:
- read-across source
- Duration of exposure:
- h
- Preliminary study:
- No data
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 0.83 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- other: The incidence of clinical signs were highest at the removal from chamber observations. Clinical signs noted during the exposure included lacrimation and squinting eyes. Clinical signs noted following the exposure incuded chromodacryorrhea, lacrimation, n
- Body weight:
- Most animals lost weight through day 1 of the study and then began to gain weight in a normal pattern. At termination all animals had exhibited increases in body weight over their day 0 values.
- Gross pathology:
- There were no gross internal lesions observed in any animal necropsy.
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Tripotassium orthophosphate was considered to have an LC50 of greater than 0.83 mg/L as found in the source study performed with monosodium phosphate.
- Executive summary:
Tripotassium orthophosphate was considered to have an LC50 of greater than 0.83 mg/L as found in the source study performed with monosodium phosphate. As explained in the justification for type of information, the differences in molecular structure between tripotassium orthophosphate and monosodium phosphate are unlikely to lead to differences in the acute toxicty that are higher than the typical experimental error of the test method.
Referenceopen allclose all
Table 4. The concentration presented should be considered the maximum available:
Exposure Date |
Mean Analytical Data ± SD (mg/L) |
Nominal Concentration (mg/L) |
Mortality |
|
Gravimetric Concentration |
# Dead / # Exposed |
|||
Male |
Female |
|||
1993-08-06 |
0.83 ± 0.065 |
37.35 |
0 / 5 |
0 / 5 |
Table 5. Mean body weights (g) ± SD:
|
Study day |
|||||
0 |
1 |
2 |
4 |
7 |
14 |
|
Males |
274 ± 9.1 |
270 ± 10.4 |
277 ± 11.1 |
293 ± 10.3 |
313 ± 10.6 |
348 ± 13.4 |
Females |
217 ±7.3 |
218 ± 5.9 |
215 ± 6.1 |
222 ± 6.8 |
228 ± 9.9 |
238 ± 10.2 |
Table 6. Incidence of clinical signs: Male
Observation |
Time after treatment |
|||||||||||||||
Day 0 |
Day 1 |
Day 2 |
Day 3 |
|||||||||||||
Hour |
||||||||||||||||
PT |
0.25 |
0.50 |
0.75 |
1 |
2 |
3 |
4 |
R |
1PE |
AM |
PM |
AM |
PM |
AM |
PM |
|
Chromodacryorrhea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Lacrimation |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
5 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Continued:
Observation |
Day |
||||||||||||||||||||
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||||
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
|
|
Chromodacryorrhea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Lacrimation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
PE - Post exposure
PT - Prior to exposure
R - Removal from chamber
Incidence of clinical signs: Female
Observation |
Day 0 |
Day 1 |
Day 2 |
Day 3 |
||||||||||||
Hour |
||||||||||||||||
PT |
0.25 |
0.50 |
0.75 |
1 |
2 |
3 |
4 |
R |
1PE |
AM |
PM |
AM |
PM |
AM |
PM |
|
Lacrimation |
0 |
2 |
3 |
3 |
3 |
3 |
2 |
0 |
5 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
3 |
3 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Continued:
Observation |
Day |
||||||||||||||||||||
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||||
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
|
|
Lacrimation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
PE - Post exposure
PT - Prior to exposure
R - Removal from chamber
Table 7. Individual body weights:
Animal # |
Day 0 (g) |
Day 1 (g) |
Day 2 (g) |
Day 4 (g) |
Day 7 (g) |
Day 14 (g) |
Male |
||||||
AC8941M |
262 |
260 |
266 |
280 |
299 |
330 |
AC8942M |
277 |
268 |
277 |
292 |
311 |
351 |
AC8943M |
281 |
683 |
293 |
307 |
327 |
365 |
AC8944M |
282 |
279 |
283 |
298 |
319 |
354 |
AC8945M |
266 |
261 |
268 |
287 |
309 |
340 |
Mean |
274 |
270 |
277 |
293 |
313 |
348 |
SD |
± 9.1 |
± 10.4 |
± 11.1 |
± 10.3 |
± 10.6 |
± 13.4 |
|
||||||
Female |
||||||
AC8951F |
209 |
212 |
212 |
216 |
223 |
228 |
AC8952F |
227 |
223 |
222 |
231 |
242 |
251 |
AC8953F |
221 |
223 |
216 |
223 |
225 |
238 |
AC8954F |
217 |
220 |
220 |
224 |
232 |
245 |
AC8955F |
211 |
211 |
207 |
214 |
216 |
228 |
Mean |
217 |
218 |
215 |
222 |
228 |
238 |
SD |
± 7.3 |
± 5.9 |
± 6.1 |
± 6.8 |
± 9.9 |
± 10.2 |
AC - rat
M - Male
F - Female
Table 8. Individual necropsy findings:
Animal |
Type, Time of Death |
Term Body Weight (g) |
Body Weight Change (g) |
Internal Findings |
Male |
||||
AC8941M |
S (14) |
330 |
+ 68 |
No gross lesions |
AC8942M |
S (14) |
351 |
+ 74 |
No gross lesions |
AC8943M |
S (14) |
365 |
+ 84 |
No gross lesions |
AC8944M |
S (14) |
354 |
+ 72 |
No gross lesions |
AC8945M |
S (14) |
340 |
+ 74 |
No gross lesions |
Female |
||||
AC8951F |
S (14) |
228 |
+ 19 |
No gross lesions |
AC8952F |
S (14) |
251 |
+ 24 |
No gross lesions |
AC8953F |
S (14) |
238 |
+ 17 |
No gross lesions |
AC8954F |
S (14) |
245 |
+ 28 |
No gross lesions |
AC8955F |
S (14) |
228 |
+ 17 |
No gross lesions |
AC - Rat
M - Male
F - Female
S ( ) - Sacrificed (study day)
Table 4. The concentration presented should be considered the maximum available:
Exposure Date |
Mean Analytical Data ± SD (mg/L) |
Nominal Concentration (mg/L) |
Mortality |
|
Gravimetric Concentration |
# Dead / # Exposed |
|||
Male |
Female |
|||
1993-08-06 |
0.83 ± 0.065 |
37.35 |
0 / 5 |
0 / 5 |
Table 5. Mean body weights (g) ± SD:
|
Study day |
|||||
0 |
1 |
2 |
4 |
7 |
14 |
|
Males |
274 ± 9.1 |
270 ± 10.4 |
277 ± 11.1 |
293 ± 10.3 |
313 ± 10.6 |
348 ± 13.4 |
Females |
217 ±7.3 |
218 ± 5.9 |
215 ± 6.1 |
222 ± 6.8 |
228 ± 9.9 |
238 ± 10.2 |
Table 6. Incidence of clinical signs: Male
Observation |
Time after treatment |
|||||||||||||||
Day 0 |
Day 1 |
Day 2 |
Day 3 |
|||||||||||||
Hour |
||||||||||||||||
PT |
0.25 |
0.50 |
0.75 |
1 |
2 |
3 |
4 |
R |
1PE |
AM |
PM |
AM |
PM |
AM |
PM |
|
Chromodacryorrhea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Lacrimation |
0 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
5 |
2 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Continued:
Observation |
Day |
||||||||||||||||||||
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||||
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
|
|
Chromodacryorrhea |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Lacrimation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
PE - Post exposure
PT - Prior to exposure
R - Removal from chamber
Incidence of clinical signs: Female
Observation |
Day 0 |
Day 1 |
Day 2 |
Day 3 |
||||||||||||
Hour |
||||||||||||||||
PT |
0.25 |
0.50 |
0.75 |
1 |
2 |
3 |
4 |
R |
1PE |
AM |
PM |
AM |
PM |
AM |
PM |
|
Lacrimation |
0 |
2 |
3 |
3 |
3 |
3 |
2 |
0 |
5 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
3 |
3 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
2 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Continued:
Observation |
Day |
||||||||||||||||||||
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||||||||
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
AM |
PM |
|
|
Lacrimation |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Material on fur |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Nasal discharge |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Squinting eyes |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Death (cumulative) |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
PE - Post exposure
PT - Prior to exposure
R - Removal from chamber
Table 7. Individual body weights:
Animal # |
Day 0 (g) |
Day 1 (g) |
Day 2 (g) |
Day 4 (g) |
Day 7 (g) |
Day 14 (g) |
Male |
||||||
AC8941M |
262 |
260 |
266 |
280 |
299 |
330 |
AC8942M |
277 |
268 |
277 |
292 |
311 |
351 |
AC8943M |
281 |
683 |
293 |
307 |
327 |
365 |
AC8944M |
282 |
279 |
283 |
298 |
319 |
354 |
AC8945M |
266 |
261 |
268 |
287 |
309 |
340 |
Mean |
274 |
270 |
277 |
293 |
313 |
348 |
SD |
± 9.1 |
± 10.4 |
± 11.1 |
± 10.3 |
± 10.6 |
± 13.4 |
|
||||||
Female |
||||||
AC8951F |
209 |
212 |
212 |
216 |
223 |
228 |
AC8952F |
227 |
223 |
222 |
231 |
242 |
251 |
AC8953F |
221 |
223 |
216 |
223 |
225 |
238 |
AC8954F |
217 |
220 |
220 |
224 |
232 |
245 |
AC8955F |
211 |
211 |
207 |
214 |
216 |
228 |
Mean |
217 |
218 |
215 |
222 |
228 |
238 |
SD |
± 7.3 |
± 5.9 |
± 6.1 |
± 6.8 |
± 9.9 |
± 10.2 |
AC - rat
M - Male
F - Female
Table 8. Individual necropsy findings:
Animal |
Type, Time of Death |
Term Body Weight (g) |
Body Weight Change (g) |
Internal Findings |
Male |
||||
AC8941M |
S (14) |
330 |
+ 68 |
No gross lesions |
AC8942M |
S (14) |
351 |
+ 74 |
No gross lesions |
AC8943M |
S (14) |
365 |
+ 84 |
No gross lesions |
AC8944M |
S (14) |
354 |
+ 72 |
No gross lesions |
AC8945M |
S (14) |
340 |
+ 74 |
No gross lesions |
Female |
||||
AC8951F |
S (14) |
228 |
+ 19 |
No gross lesions |
AC8952F |
S (14) |
251 |
+ 24 |
No gross lesions |
AC8953F |
S (14) |
238 |
+ 17 |
No gross lesions |
AC8954F |
S (14) |
245 |
+ 28 |
No gross lesions |
AC8955F |
S (14) |
228 |
+ 17 |
No gross lesions |
AC - Rat
M - Male
F - Female
S ( ) - Sacrificed (study day)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- LC50 >830 mg/m3
One key study is available to assess the acute inhalation toxicity of the analogous substance sodium dihydrogenorthophosphate.
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- .
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Applied as a 40 % aqueous solution.
- GLP compliance:
- no
- Remarks:
- Study pre-dates GLP
- Test type:
- other: no data
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- water
- Details on dermal exposure:
- TEST MATERIAL
- Concentration: 40 % aqueous solution - Duration of exposure:
- 24 h
- Doses:
- 5010 and 7940 mg/kg
- No. of animals per sex per dose:
- 1 male only at 5010 mg/kg dose; 1 male and 1 female at 7940 mg/kg dose.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Other examinations performed: Clinical signs - Statistics:
- No data
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 7 940 mg/kg bw
- Remarks on result:
- other: 40 % aqueous solution
- Mortality:
- There were no mortalities.
- Clinical signs:
- other: Reduced appetite and activity (2 to 3 days).
- Gross pathology:
- Viscera appeared normal in survivors.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 of tripotassium phosphate when applied dermally as a 40 % aqueous solution was > 7940 mg/kg.
This study is considered to fulfil the data requirements as defined under Annex XI, section 1.2. of Regulation (EC) N. 1907/2006 (REACH) as part of a weight of evidence approach and no further testing is considered necessary. - Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 11-03-1987 to 25-03-1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not applicable
- Principles of method if other than guideline:
- Ten New Zealand white rabbits (5 per dose) were treated with tripotassium phosphate at dosage levels of 20 and 300 mg/kg. The test material was in contact with the intact skin for 24 h under an occlusive wrap. Observations were conducted at approximately 3 h on the day of dosing and daily thereafter for 14 days. Skins were scored for irritation (Draize method) at approximately 24, 48, 72h after application as well as days 4, 7 and 14 of the study. Body weights were recorded on Day 0, 7 and 14 of the study. A gross necropsy was performed on all animals.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals Inc., Denver, Pennsylvania.
- Age at study initiation: Young adult
- Weight at study initiation: 2.20 - 2.96 kg
- Housing: Individually in stainless steel rabbit cages with DACB cageboard bedding was used in the litter pans
- Diet: Ad libitum
- Water: Ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 68 - 77 ºF
- Humidity (%): 28 - 44 %
- Photoperiod (hrs dark / hrs light): 12 h fluorescent light and 12 h dark.
IN-LIFE DATES: 11-03-1987 to 25-03-1987 - Type of coverage:
- occlusive
- Vehicle:
- physiological saline
- Details on dermal exposure:
- TEST SITE
- Area of exposure: The trunk from the scapular to the pelvic region
- % coverage: Not stated but covered by a 4 x 4 inch gauze
- Type of wrap if used: 8 ply 4 x 4 inch gauze pad held in place with hypoallergenic tape. The test site was occluded with impervious plastic sheeting
REMOVAL OF TEST SUBSTANCE
- Washing: The test sites were wiped with clean gauze moistened with tap water.
- Time after start of exposure: approximately 24 h after application.
TEST MATERIAL
- Amount applied: 300 mg/kg and 20 mg/kg
- Constant volume or conc: Moistened with physiological saline - Duration of exposure:
- 24 h
- Doses:
- 20 and 300 mg/kg
- No. of animals per sex per dose:
- 5 males/dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for toxicity were conducted at approximately 3 h on the day of dosing and daily thereafter for 14 days. Skins were scored for irritation (draize method) at approximately 24 ,48 and 72 h after application, as well as 4, 7 and 14 of the study. Body weights were recorded on Day 0, 7 and 14 of the study.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, mortality and skin irritation
- Statistics:
- No data
- Preliminary study:
- Not applicable
- Sex:
- male
- Dose descriptor:
- approximate LD50
- Effect level:
- > 300 mg/kg bw
- Mortality:
- There were no deaths attributed to the administration of the test material.
- Clinical signs:
- other: There were no clinical signs attributed to the administration of the test material.
- Gross pathology:
- There were no treatment related gross internal lesions observed in any animal at necropsy.
- Other findings:
- Skin irritation: Several test sites had slight erythema, slight oedema and desquamation. One rabbit in the 300 mg/kg group had moderate erythema, focal necrosis, eschar and desquamation. At termination on Day 14, one rabbit in the 300 mg/kg group had eschar and desquamation and one rabbit in the20 mg/kg group had desquamation.
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the conditions of the study the test material was temporarily approximated to be slightly irritating and practically non-toxic. This study is not considered to be suitable for classification and labelling according to Regulation (EC) No 1272/2008 (EU CLP), as the highest dose level was 300 mg/kg bw. This study is provided to support the conclusion that sodium and potassium orthophosphates are of low systemic toxicity.
This study is considered to fulfil the data requirements as defined under Annex XI, section 1.2. of Regulation (EC) No. 1907/2006 (REACH) as part of a weight of evidence approach and no further testing is considered necessary. - Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- No data
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: no data
- Deviations:
- not specified
- Principles of method if other than guideline:
- An acute screening test in rabbits.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No data
- Duration of exposure:
- No data
- Doses:
- 4640 mg/kg
- No. of animals per sex per dose:
- 2 animals, sex not specified
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Statistics:
- No data
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 4 640 mg/kg bw
- Mortality:
- There was no mortality
- Clinical signs:
- other: Skin irritation and corrosion were observed. No apparent signs of toxicity were observed.
- Gross pathology:
- No data
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No apparent signs of toxicity were observed under the test conditions. The LD50 was determined to be >4640 mg/kg bw. Local effects of skin irritation and corrosion were observed.
This study is considered to fulfil the data requirements as defined under Annex XI, section 1.2. of Regulation (EC) N. 1907/2006 (REACH) as part of a weight of evidence approach and no further testing is considered necessary.
Referenceopen allclose all
Table 1. Applied as a 40 % aqueous solution
Dosage (mg/kg) |
Initial weight |
Mortalities/dosed |
|||
Male |
Female |
Male |
Female |
Combined |
|
5010 |
2.1 |
- |
0 / 1 |
- |
0 / 1 |
7940 |
2.3 |
1.9 |
0 / 1 |
0 / 1 |
0 / 2 |
Table 2. Mean body weights ± SD:
Dosage level (mg/kg) |
Mean body weights ± SD (kg) |
||
Day |
|||
0 |
7 |
14 |
|
300 |
2.52 ± 0.220 |
2.33 ± 0.172 |
2.45 ± 0.167 |
20 |
2.39 ± 0.322 |
2.19 ± 0.139 |
2.53 ± 0.216 |
Table 1. Dose/response data:
Dose (mg/kg) |
Conc. (%) |
Mortality ratio |
Mortality interval |
Animal wt. range |
Weight change |
4640 |
Neat |
0 / 2 |
- |
2600g |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 4 640 mg/kg bw
- Quality of whole database:
- LD50 > 2000 mg/kg bw
One key study and a number of supporting studies are provided. All studies support no classification.
Additional information
Justification for classification or non-classification
Acute toxicity: oral:The acute oral median dose (LD50) of tripotassium orthophosphate in the rats was reported to be 4260 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).
Acute toxicity: inhalation: The acute inhalation median concentration (LC50) of the analogous substance sodium dihydrogenorthophosphate in male and female rats was estimated to be greater than 0.83 mg/L. The result was achieved at the maximum attainable concentration and is considered to be equivalent to a limit test conducted at 5 mg/L and therefore sodium dihydrogenorthophosphate is not considered to be classified according to Regulation (EC) No 1272/2008 (EU CLP). In addition the authors state that the particles of sodium dihydrogenorthophosphate were prone to agglomeration and / or adherence to the surfaces of the chamber and therefore it stands to reason that this study is acceptable for assessment and no further animal testing is justified.
This result is deemed to be adequate for read-across to tripotassium orthophosphate and therefore tripotassium orthophosphate is considered to be of a similar low risk for systemic toxicity via the inhalation route.
Therefore, it can be reliably concluded that tripotassium orthophosphate does not exhibit systemic toxicity via the inhalation route and should not be classified according to Regulation (EC) No 1272/2008 (EU CLP) and it is deemed scientifically unjustified to repeat this study with tripotassium orthophosphate in vivo.
Acute toxicity: dermal: The acute dermal median dose (LD50) of dipotassium hydrogenorthophosphate in the female Wistar strain rat was estimated to be greater than 4640 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). No further studies are considered to be necessary.
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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