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EC number: 231-838-7 | CAS number: 7758-29-4
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- three-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Summaries of toxicological data
- Author:
- Hodge HC
- Year:
- 1 964
- Bibliographic source:
- Fd Cosmet, Toxicol (2)147-154
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 959
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Three generations of rats were reared on diets containing 0 and 0.5% sodium tripolyphosphate. Two litters were examined in each generation. Matingwas carried out between 16 females and 8 males of each group when the rats were 100 days old.
- GLP compliance:
- no
- Remarks:
- Study predates GLP
- Limit test:
- no
Test material
- Reference substance name:
- Pentasodium triphosphate
- EC Number:
- 231-838-7
- EC Name:
- Pentasodium triphosphate
- Cas Number:
- 7758-29-4
- Molecular formula:
- H5O10P3.5Na
- IUPAC Name:
- pentasodium bis(phosphonatooxy)phosphinate
- Details on test material:
- - Name of test material (as cited in study report): Sodium tripolyphosphate
- Substance type: Anhydrous granular
- Physical state: solid
- Lot/batch No.: Lots 3561210 Lot D, Lot #195001-8 and Lot #5071018
- Stability under test conditions: Stable under test conditions
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Rochester Strain (Ex-Wistar 1923)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 60 g
- Diet: e.g. ad libitum
- Water :e.g. ad libitum
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Exposure took place for 100 days prior to mating, 21 days of gestation and during lactation. For the F1, F2, F3-generations, offspring were weaned and exposed during an interim period of 10 days and then during a mating period of 7 days. Dams were exposed continually during gestation and lactation. Offspring of the second litter were again mated for 7 days after a 10 day interim period following weaning. The first litters (F1a, F2a, F3a) were sacrificed at 30 days of age. The second litters (F1b, F2b, F3b) were used to produce the succeeding generation.
- Details on mating procedure:
- Each male was caged with two females for 7 days until conception occurred.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Exposure took place for 100 days prior to mating, 21 days of gestation and during lactation. For the F1, F2, F3-generations, offspring were weaned and exposed during an interim period of 10 days and then during a mating period of 7 days. Dams were exposed continually during gestation and lactation. Offspring of the second litter were again mated for 7 days after a 10 day interim period following weaning. The first litters (F1a, F2a, F3a) were sacrificed at 30 days of age. The second litters (F1b, F2b, F3b) were used to produce the succeeding generation.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5% in diet
Basis:
nominal in diet
- No. of animals per sex per dose:
- P1, F1, F2, F3: 16 females and 8 males
- Control animals:
- yes, concurrent vehicle
Examinations
- Sperm parameters (parental animals):
- Not evaluated
- Litter observations:
- number of pups, stillbirths, live births, weight gain per litter
Not Evaluated: sex of pups, presence of gross anomalies
physical or behavioural abnormalities, , no individual pup body weights - Postmortem examinations (offspring):
- F3b generation groups of male (8/group) and female (16/group) rats were fed control diet or diet with 0.5% test material for 100 days (P1) generation. Body weights were measured weekly during the 100 day pre-mating exposure for each generation. Each male was caged with two females for 7 days until conception occurred. Pregnancy rates were determined. The first litter born of the parental animals was designated as the F1a litter. Upon delivery, offspring were counted and average litter weights determined. On day 5 pups were culled to 10 per litter. Body weights per litter were determined on day 21. Pup survival was determined on days 1-5 and days 6-21. The F1a litter was sacrificed at 30 days postnatally. Parental animals were mated again 10 days after the sacrifice of the F1a litter. Mating took place for 7 days. A second litter (F1b) was born after approximately 21 days of gestation. Upon delivery, offspring were counted and the average litter weights determined. On day 5 pups were culled to 10 per litter. Body weights per litter were determined on day 21. Pup survival was determined on days 1-5 and days 6-21. Following weaning of the F1b litter, 8 males and 16 females for the control group and the treated group were fed their respective diets for 100 days. Again two litters (F2a and F2b) were produced. Parental animals were mated for 7 days following 10 days after the sacrifice of the F2a litter (pups were 30 days old). Following birth of the F2b litter the same offspring and parental parameters were measured. Eight males and 16 females of the F2b litter were designated for continual exposure for another 100 days. Upon completion of the exposure of the F2b litter, animals were mated again to produce the F3a and F3b litters in the same manner described above. The ten males and ten females from final litter, the F3b litter, were evaluated for body weight, histopathology (liver, kidneys, gonads, lungs, brain, stomach, heart, spleen, adrenal, stomach, large and small intestines, bladder, nodes, marrow, pancreas) and organ weights (liver, kidneys, testes, lungs, brain, stomach, heart, spleen). Individual animal data were collected and recorded throughout the study.
Organ weights:
liver, kidneys, gonads, lungs, brain, stomach, heart, spleen on F2b offspring.
Not evaluated: Uterus, ovaries, epididymides (total and cauda), prostate, seminal vesicles, pituitary, thyroid, adrenal glands
Histopathology:
Kidneys, heart, brain, spleen, lungs, ovaries, testes, adrenal, bladder, lymph nodes, gut, bone marrow, pancreas on F3b animals.
Not Evaluated: Vagina, uterus with cervix, epididymis, seminal vesicle, prostate coagulating gland
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Dose descriptor:
- NOEC
- Effect level:
- 0.5 other: %
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
This study included only one dose level of the test material, 0.5% in the diet. There were occasional fluctuations in the fertility index. The lower fertility index in the F2a, F3a and F3b litters is considered spurious and not treatment-related. The fertility indices of the treated group were greater than the control group for some litters (F1a, F2b); the same as the control group for the F1b litter, and less than the control group for other litters (F2a, F3a, F3b). These variations are not considered to show a treatment-related effect on fertility. The duration of pregnancy, live birth index, litter size, litter weights, survival index, viability index and lactation index were all comparable between control and treated groups. Organ weights were similar between control and treated groups. There were no treatment-related histopathological findings.
Parameter |
Control |
High dose |
||||
Generation |
M |
F |
M |
F |
||
Mortality |
Incidence |
P |
0 |
0 |
0 |
0 |
F1 |
0 |
0 |
0 |
0 |
||
F2 |
0 |
0 |
0 |
0 |
||
F3 |
0 |
0 |
0 |
0 |
||
Food consumption |
% of control |
NA |
NA |
NA |
NA |
|
Body weight gain |
% of control |
100 |
100 |
100 |
100 |
|
Clinical Observations specify effects |
Incidence |
NA |
NA |
NA |
NA |
|
Organ weights (F3b) |
% of control |
95 -103 |
95 -103 |
95 -103 |
95 -103 |
|
Pathology |
||||||
Histopathologic examination: F3b Immature testes Renal cyst Parasites in intestine Focal pulmonary hemorrhage Parasites in renal pelvis |
Incidence |
10 - - - - |
- - 1 1 - |
10 1 1 1 - |
- - - - 2 |
|
Reproductive Performance |
||||||
Mating index: P |
- |
NA |
NA |
|||
F1 |
- |
NA |
- |
NA |
||
F2 |
- |
NA |
- |
NA |
||
F3 |
- |
NA |
- |
NA |
||
Fertility index: P, la |
- |
87.5 |
- |
93.8 |
||
F1b |
- |
75 |
- |
75 |
||
F2a |
- |
82.3 |
- |
68.8 |
||
F2b |
- |
76.5 |
- |
81.3 |
||
F3a |
81.3 |
- |
68.8 |
|||
F3b |
80 |
- |
62.5 |
|||
Number of implantation sites |
Mean |
- |
NA |
- |
NA |
|
Duration of pregnancy: P, 1a |
Mean days |
24.7 |
24.06 |
|||
F1b |
25.1 |
- |
25.25 |
|||
F2a |
23.36 |
- |
24.91 |
|||
F2b |
25 |
- |
24.4 |
|||
F3a |
25.8 |
- |
25.1 |
|||
F3b |
25.2 |
- |
25 |
|||
Birth index |
||||||
Live birth index: P, 1a |
- |
93.8 |
- |
100 |
||
F1b |
93.8 |
- |
100 |
|||
F2a |
100 |
- |
100 |
|||
F2b |
100 |
- |
93.8 |
|||
F3a |
93.8 |
- |
100 |
|||
F3b |
100 |
87.5 |
||||
Gestation index |
||||||
Litter size: P, 1a |
Mean |
- |
8.9 |
- |
9.2 |
|
F1b |
11 |
- |
13 |
|||
F2a |
9.2 |
- |
9.5 |
|||
F2b |
10.7 |
- |
10.2 |
|||
F3a |
10.4 |
- |
10.2 |
|||
F3b |
8.4 |
- |
10.5 |
|||
Litter weight: P, 1a |
Mean, day 21, g |
- |
307 |
- |
283 |
|
F1b |
348 |
- |
392 |
|||
F2a |
279 |
- |
341 |
|||
F2b |
379 |
- |
325 |
|||
F3a |
270 |
349 |
||||
F3b |
319 |
- |
388 |
|||
Pup weight, 1a |
Mean: day 21, g |
36.8 |
- |
37.8 |
||
F1b |
42.2 |
- |
40.5 |
|||
F2a |
42.9 |
- |
42.1 |
|||
F2b |
40.3 |
- |
41.5 |
|||
F3a |
41.4 |
- |
43.7 |
|||
F3b |
45.6 |
- |
41.9 |
|||
Sex ratio |
Male/female |
NA |
NA |
|||
Survival index: P, 1a |
Day 5 |
91.4 |
- |
95.6 |
||
F1b |
91.6 |
- |
97.4 |
|||
F2a |
93.3 |
- |
88.6 |
|||
F2b |
96.7 |
- |
93.4 |
|||
F3a |
82.4 |
- |
85.2 |
|||
F3b |
74.8 |
- |
98.8 |
|||
Viability index: P, 1a |
Day 21 |
- |
86.2 |
- |
81.1 |
|
F1b |
75 |
- |
74.3 |
|||
F2a |
74.2 |
- |
84.8 |
|||
F2b |
85 |
- |
77 |
|||
F3a |
72.8 |
- |
72 |
|||
F3b |
76.2 |
- |
88 |
|||
Lactation index: P, 1a |
Day 21 |
86.2 |
- |
81.1 |
||
F1b |
75 |
- |
74.3 |
|||
F2a |
74.2 |
- |
84.8 |
|||
F2b |
85 |
- |
77 |
|||
F3a |
72.8 |
- |
72 |
|||
F3b |
76.2 |
- |
88 |
|||
Sperm characterization |
NA |
NA |
||||
Number |
% of control |
NA |
NA |
|||
Deformations |
% of control |
NA |
NA |
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.