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EC number: 244-742-5 | CAS number: 22036-77-7
- 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:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other: Study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
- Principles of method if other than guideline:
- SImilar to OECD test guidelines
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt
- EC Number:
- 244-742-5
- EC Name:
- [ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt
- Cas Number:
- 22036-77-7
- Molecular formula:
- C6H20N2O12P4.xNa
- IUPAC Name:
- x sodium (8-x) hydrogen {ethane-1,2-diylbis[nitrilobis(methylene)]}tetrakis(phosphonate)
- Details on test material:
- 34.7% (w/w) as the free acid form of Dequest 2041 Phosphonate and 9.31% (w/w) sodium in an aqueous solution, pH 7 corresponding to Dequest 2046.
Unique identification nr - NB81635800
Molecular weight = 436 (in acid form)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
ADMINISTRATION / EXPOSURE
Doses: 0, 0.5, 1.0, 2 g/(free acid form)/ kg (bw) /day administered as an aqueous solution.
Test substance mixed with water, administered at 8 ml/kg/d.
Control group treated with 8 ml/animal 0.9% (w/v) saline.
Volume adjusted based on most recent bwt data.- Frequency of treatment:
- Daily between gestation day 6 (implantation day) to gestation day 19 inclusive
- Duration of test:
- 13 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
The doses used (calculated on the free acid form) were as follows 2g (free acid form)/kg (bw)/day, 1 g (free acid form)/kg (bw)/day, 0.5 g (free acid form)/kg,Control (0.9% (w/v) sodium chloride.
Basis:
other: Animals were dose by gavage on gestation days 6 through to 19 with doses for all groups corresponding to 8 ml dose volume/kg (bw)/day. The body weights used for dose calculation were the most recent body weights measured on gestation days 6, 8, 10 and 13.
- No. of animals per sex per dose:
- 25 animals were assigned to each treatment or control group.
- Control animals:
- yes
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 0.5
- Based on:
- other: Free acid
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- Effect level:
- > 2
- Based on:
- other: free acid
- Basis for effect level:
- other: fetotoxicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
MATERNAL TOXIC EFFECTS BY DOSE LEVEL AND BY SEX
Effects with dose level: 0, 0.5,
1.0, 2 g/(free acid form)/ kg (bw) /day administered as an aqueous
solution
Mortality
- no treatment related deaths during the study.
Body weight
- Significantly lower body weights for pregnant females compared
to control values (ca 9% lower) in the 2g/kg dose levels beginning on
gestation day 13 - day 20.
- Analysis of body weight change between day 6 – day 20 indicated
significantly lower body weight gains for the 1 g/kg and 2 g/kg females
compared to control values.
Clinical observations, physical signs
- The occurrence of light brown loose faeces in the high dose
animals was noted. This appeared on GD 14 and generally persisted until
sacrifice.
Necropsy findings
- No lesions which exhibited a pattern indicative of a
treatment-related response.
Reproductive parameters
- pregnancy rate comparable between groups, no
treatment-related changes recorded.
- The increases in resorption per dam and number of dams with post
implantation loss in the 1 g and 2 g/kg dose levels were not
significantly significant. Similarly the lower mean corpora lutea/dam in
the 1 g/kg dose level group was also not statistically significant.
FETAL DATA
The difference in the mean foetal weight of male and female
foetuses was considerably lower in the high dose group compared to the
controls, but it was not statistically significant.
Because there were indications of maternal toxicity at the 2 g/kg dose level any effects on post implantation loss or foetal weights could be secondary to maternal toxic effects. No significant detectable embryonic or fetotoxic effects occurred at either the 0.5 g/kg or 1 g/kg dose levels.It was also concluded that the skeletal malformations observed were secondary effects related to maternal toxicity. This was supported by comparison of the individual maternal body weight gains and skeletal malformations in the 2 g/kg dose group. Of the five females with lowest body weight gain, four females had foetuses with vertebral anomalies, indicating some correlation between individual susceptibility of the dam to treatment and induction of the vertebral effects.
Applicant's summary and conclusion
- Conclusions:
- Maternal toxicity NOAEL = 0.5 g/Kg (bw), foetal toxicity > 2 g/kg (bw) based on active acid.
- Executive summary:
Mated female Sprague Dawley rats were dosed by gavage at levels of 0.5g, 1g and 2g/kg (bw) of Dequest 2046 (neutral sodium salt) from gestation day 6 through to day 19 inclusive. Based on indications of maternal toxicity at 1 g/kg and 2 g/kg dose levels, the NOAEL for maternal toxicity is 2 g/kg (bw). Because there were indications of maternal toxicity at the 2 g/kg dose level, any effects on post implantation loss or foetal weights were viewed as being secondary to maternal toxic effects. No significant detectable embryonic or fetotoxic effects occurred at either the 0.5 g/kg or 1 g/kg dose levels. It was also concluded that the skeletal malformations observed in the high dose group were secondary effects related to maternal toxicity. On the basis of the results the NOAEL for developmental effects is > 2 g/ kg (bw).
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