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EC number: 237-574-9 | CAS number: 13845-36-8
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration
Cross-reference
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
- Endpoint:
- chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- 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
1. Both substances are inorganic salts of a monovalent cation from Group 1A of the periodic table, and triphosphoric acid. Thus, they share the Na+ or K+ cation and P3O105- anion.
2. Both the Na+ and the K+ cation have a similar biological function and therefore triphosphate 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.
3. In addition, both salts have been shown to be of similar low toxicity in acute oral studies and therefore comparisons can be drawn to allow read-across. Therefore it is not considered to be scientifically justified to perform any further in vivo studies.
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:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- Deviations:
- yes
- Remarks:
- See attached expert statement.
- GLP compliance:
- no
- Remarks:
- Predates GLP
- Limit test:
- no
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Groups of 5 animals/cage; cages had bottoms with wood shavings, tap water from local water supply and Purina Fox Chow ad libitum, diets prepared weekly and stored in covered containers. Standard diet is considered to meet the nutritional requirements of the test animals. Information on homogeneity and stability of test material in diet is not included. Frequency of changes in cage bedding and cage cleaning are not documented. Since standard diet and tap water were used; fresh diets were prepared weekly and phosphates are stable in food, this aspect of the study can be considered acceptable.
- Route of administration:
- oral: feed
- Vehicle:
- not specified
- Details on oral exposure:
- no data.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable.
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- ad libitum and daily in diet.
- Remarks:
- Doses / Concentrations:
0.05%, 0.5% and 5%
Basis:
nominal in diet - No. of animals per sex per dose:
- 50
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- no data.
- Positive control:
- No data.
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No data
- Assessments: appetite, condition of coat, feces and evidence of illness or tumor
BODY WEIGHT: Yes
- Time schedule for examinations: weekly during the first 3 months and every 2 weeks thereafter
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): yes
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: pre-experimentally and at monthly intervals for the first 6 months, every 2 months of the first year, and every 3 months during second year.
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: 5 male and 5 female
- Parameters examined: Hemoglobin, red blood cell counts, white blood cell counts and differential counts
CLINICAL CHEMISTRY: No
HISTOPATHOLOGY: Yes
- Animals: 10 males and 10 females
- Organs examined: brain, lungs, heart, liver, spleen, kidneys, adrenals, gonads, stomach, large and small intestine, urinary bladder, bone marrow and muscle
URINALYSIS: Yes
- Time schedule for collection of urine: At least three times a year
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: sugar and protein
NEUROBEHAVIOURAL EXAMINATION: No
OTHER:
BONE ANALYSIS
-Samples of bone removed at time of autopsy for examination to detect any gross abnormalities in morphology or calcification. Femurs of left leg radiographed and lengths measured. Wet weights, dry weights and ash weights recorded.
ORGAN WEIGHTS: Yes
- Organs: liver, kidneys, lungs, brain, stomach, heart, spleen - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (see table in attachments)
HISTOPATHOLOGY: Yes (see table in attachments) - Statistics:
- No data.
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Mortalities were high as a result of intercurrent epidemics of infections. The highest mortality (80%) over the 2 year period was observed in females in the 5% dose group. Respiratory infection and pericarditis-peritonitis were the most prominent causes of death.
BODY WEIGHT AND WEIGHT GAIN
Femur lengths and body weights in males and females in the 5% TPP group were smaller than those of control animals, indicating a true reduction in growth.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study)
Food consumption measurements made after 1 month and again after 3 months on the experimental regimen showed that there was some effect responsible for the growth retardation in the rats given 5% TPP diet.
HAEMATOLOGY
At 1 year there was evidence of anaemia in male rats of the 5% dose group. The red blood cells counts, haemoglobin values and haematocrits were somewhat lower than those observed in the other groups. Otherwise the haematological indices were within normal limits.
URINALYSIS
Urine analyses for sugar and protein were normal.
ORGAN WEIGHTS
Organ weights, recorded at the time of sacrifice were mostly in the normal ranges but revealed increased kidney weight-body weight ratios on the average in both male and female rats given the diet containing 5% TPP. There were also slight increase in the weights of liver, testes, brain, stomach and heart possibly attributable to the smaller body weight. In some instances increases in liver and kidney weights relative to body weights were observed in female rats in the 5% dose group.
HISTOPATHOLOGY: NON-NEOPLASTIC
A thorough histological study of the tissues in the rats with increased kidney weight showed the presence of a definable 'chronic tubular nephropathy' (a kidney lesion) in all the rats, male and female given the 5% TPP diet. Rats given 0.5% TPP and 0.05% TPP did not exhibit changes that could be identified as chronic tubular nephropathy. There was no indication that TPP is carcinogenic. The tumors observed were of the types usually found in old rats, and their incidence was the same in all groups.
BONE ANALYSIS
The femurs in both sexes in the 5% group contained slightly more water and slightly less organic matter as compared with controls. The ash content and ratios of calcium to phosphorous were normal for both sexes. Radiographically the bones of rats appeared normal for all dose groups. - Dose descriptor:
- NOEL
- Effect level:
- 0.5 other: % in diet
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- gross pathology
- organ weights and organ / body weight ratios
- other: At the next dosing tier effects observed included: Growth depression, increased kidney weight, chronic tubular nephropathy in the kidney
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 5 other: % in diet
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- not specified
- Relevant for humans:
- not specified
- Conclusions:
- According to the discussion presented in the attached expert statement this study satisfies the regulatory requirements for this endpoint and has therefore been considered suitable as a key study.
At a dose of ca. 250mg/kg bw/day (0.5% in diet), the test material did not demonstrate any adverse effect and is therefore considered not be classified in accordance with Regulation (EC) no 127/2008 (EU CLP).
At the highest dose tested, (5.0% in diet), the major findings were limited to; growth retardation, increased kidney weights and chronic tubular nephropathy.
- See the attached expert statement for further discussion and mortality tables.
- See attached tables.
Summary of results.
1. Growth depression was noted for the male rats given the diet containing 5% TPP during the entire period. Diets containing 0.5% TPP or less did not retard growth.
2. Mortalities were high; higher in the female group given the diet containing 5% TPP than in the other groups.
3. Food consumption measurements made after 1 month and again after 3 months on the diets indicated that there was some specific toxic effect of 5% TPP in the diet responsible for the growth reduction.
4. Urine analyses gave normal values for sugar and protein.
5. Repeated blood samples gave, for the most part, normal haematological values. Some evidence of anemia was found, particularly in the male rats given the 5% TPP diet.
6. Organ weights were normal except for increased kidney weightbody weight ratios in both male and female rats given the 5% TPP diet. Liver weight-body weight ratios were increased in the female rats on this high level diet.
7. A thorough histological study revealed a characterized, "chronic tubular nephropathy" in the kidneys of all rats, male and female, given the 5% TPP diet. No histological changes were found in the tissues of the rats given 0.05% or 0.5% TPP diets that were attributed to the administration of the tripolyphosphate.
Data source
Materials and methods
Results and discussion
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.