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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

Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
- Report date:
- 1973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- not specified
- 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): FDA 71-46 (sodium tripolyphosphate; anhydrous)
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- Dutch
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: mesh bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: artificial insemination
- Duration of treatment / exposure:
- 12 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 2.5, 11.6, 54, 250 mg/kg
Basis:
nominal conc.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent vehicle
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 12, 18 and 29 of gestation
POST-MORTEM EXAMINATIONS: No data - Ovaries and uterine content:
- he ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: No data - Statistics:
- No data
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:not examined
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
The number of abnormalities seen in either soft or skeletal tissues of the test group did not differ from the number occurring spontaneously in the sham treated control
Effect levels (fetuses)
- Dose descriptor:
- NOEC
- Effect level:
- 250 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Reproduction data
Dose (mg/kg) |
0 |
Positive control* |
2.5 |
11.6 |
54 |
250 |
Pregnancy |
||||||
Total no |
15 |
13 |
16 |
15 |
16 |
13 |
Died or aborted |
5 |
2 |
1 |
3 |
8 |
1 |
To term |
10 |
11 |
15 |
12 |
14 |
12 |
Total corpora lutea |
216 |
166 |
227 |
242 |
263 |
200 |
Average corpora lutea |
10.8 |
9.76 |
11.4 |
12.1 |
12.0 |
9.52 |
Total live litters |
8 |
8 |
14 |
12 |
14 |
10 |
Average implant site no |
6.20 |
4.91 |
5.13 |
6.08 |
5.71 |
5.33 |
Resorptions |
||||||
Percent partial resorptions |
50.0 |
72.7 |
26.7 |
16.7 |
50.0 |
50.0 |
Percent complete resorptions |
10.0 |
27.3 |
6.67 |
- |
- |
16.7 |
Average live foetus |
4.7 |
3.73 |
4.27 |
5.42 |
5.07 |
4.42 |
Sex ratio (m/f) |
1.35 |
1.16 |
1.29 |
1.16 |
1.29 |
0.83 |
Dead foetuses |
6 |
1 |
4 |
- |
1 |
- |
Percent partial dead |
10.0 |
9.09 |
13.3 |
- |
7.14 |
- |
percent all dead |
10.0 |
- |
- |
- |
- |
- |
Average foetus weight (g) |
37.2 |
33.5 |
41.8 |
39.7 |
41.0 |
38.9 |
*2.5 mg/kg 6-aminonicotinamide dosed on day 9
Summary of skeletal findings
Dose (mg/kg) |
0 |
Positive control |
2.5 |
11.6 |
54.0 |
250 |
Sternebrae |
||||||
Incomplete oss |
- |
6/2 |
- |
- |
4/3 |
- |
Bipartite |
- |
- |
- |
- |
1/1 |
- |
Fused |
- |
10/5 |
6/3 |
1/1 |
2/2 |
1/1 |
Extra |
2/2 |
1/1 |
- |
2/2 |
3/3 |
2/1 |
missing |
- |
1/1 |
- |
- |
1/1 |
- |
Ribs |
||||||
Fused/split |
- |
13/6 |
- |
- |
- |
- |
Vertebrae |
||||||
Scrambled |
- |
16/6 |
- |
- |
- |
- |
Scoliosis |
- |
13/6 |
- |
- |
- |
- |
Tail defects |
1/1 |
35/8 |
- |
- |
1/1 |
- |
Skull |
||||||
Incomplete closure |
- |
1/1 |
- |
- |
- |
- |
(number of foetuses effected/number of litters)
Soft tissue abnormalities were only observed in the positive control group
Applicant's summary and conclusion
- Conclusions:
- The administration of up to 250 mg/kg bw/day of the test material to pregnant rabbits for 13 consecutive days had no clearly discernible effect on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham treated controls.
It is therefore concluded that sodium tripolyphosphate is not a teratogen for the rabbit
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