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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

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:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to OECD guideline 414 with acceptable restrictions. 1. There were not 20 female animals with implantation sites at necropsy in each dose group as described in OECD414. 2. Dosing was carried out from day 6-18, OECD 414 recommends from day 5-28 (the day prior to caesarean section) 3. No data on assessment of gravid uteri.
- 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’.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
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)
- Version / remarks:
- 1. There were not 20 female animals with implantation sites at necropsy in each dose group as described in OECD414. 2. Dosing was carried out from day 6-18, OECD 414 recommends from day 5-28 (the day prior to caesarean section) 3. No data on assessment of gravid uteri.
- Deviations:
- yes
- Remarks:
- See remarks
- 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:
- Na5P3O10 H5-xP3O10Nax (where x is approximately 5) 6H2O.Na5P3O10
- IUPAC Name:
- Pentasodium triphosphate
- 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
ENVIRONMENT
- The animals were housed in temperature and humidty controlled rooms.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- Not applicable.
- Details on mating procedure:
- - On day 0 the doe's pretreated with human chorionic gonadotrophin were, 3h later, artificially inseminated with sperm from proven buck.
- Duration of treatment / exposure:
- On day 6 and continuing through to day 18 the females were dosed with the test material.
- Frequency of treatment:
- Daily through treatment period.
- Duration of test:
- 13 days of treatment.
- No. of animals per sex per dose:
- 15 - sham treated control; 13 - positive control; 16 - 2.5 mg/kg; 15 - 11.6 mg/kg; 16 - 54 mg/kg; 13 - 250 mg/kg.
- Control animals:
- yes, concurrent vehicle
- other: Positive control fed 2.5 mg/kg of 6-aminonicotinamide, dosed on day 9
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes, for appearance and behaviour.
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Days 0, 6, 12, 18 and 29 of gestation
POST-MORTEM EXAMINATIONS: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
Food consumption was monitored to rule out abnormalities as a result of anorexic effects. - Ovaries and uterine content:
- The urogenital tract of each animal was examined.
(and included:)
- Gravid uterus weight: No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of resorptions: Yes - Fetal examinations:
- - External examinations: Yes: gross examination - all per litter
- Pup survival - Following caesarean section the pups were placed in an incubator for 24 hours to assess neonatal survival.
The pups were then sacrificed and examined as follows:
- visceral exminations.
- Soft tissue examinations: Yes: all per litter
- Skeletal examinations: Yes: all per litter
- Head examinations: No data
- Bodyweight of live pups also recorded. - Statistics:
- No data
- Indices:
- No data.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects. Remark: please see below.
Details on maternal toxic effects:
Cage-side observations and periodic recording of bodyweight suggested no signs of toxicity. There were no discernible effects on nidation.
Effect levels (maternal animals)
- Dose descriptor:
- NOEC
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: no effects observed
Maternal abnormalities
- Abnormalities:
- no effects observed
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
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No effects observed
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Table 1 - 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
Table 2 - 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:
- Under the conditions of the study, the test material administered to pregnant rabbits for 13 days up to a dose level of 250 mg/kg bw showed no maternal or developmental toxicity. The NOAEL for both maternal and fetoxicity is > 250 mg/kg bw. 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.
This study is considered to be of adequate reliability and relevance to be submitted as the key study for this endpoint.
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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