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Diss Factsheets
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EC number: 205-355-7 | CAS number: 139-13-9
- 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
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Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Early, but well documented, profound study meeting today standards. A higher dose level may have been selected for detection of a reproductive potential, but seems sufficient for risk assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 971
Materials and methods
- Principles of method if other than guideline:
- Method: Procter & Gamble (USA)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Trisodium nitrilotriacetate
- EC Number:
- 225-768-6
- EC Name:
- Trisodium nitrilotriacetate
- Cas Number:
- 5064-31-3
- IUPAC Name:
- trisodium 2,2',2''-nitrilotriacetate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River CD
Administration / exposure
- Route of administration:
- oral: feed
- Details on exposure:
- Two levels of Na3NTA, 0-1 and 0-5 % of the diet, were chosen for the rat studies on the basis of information from the subacute and long-term studies of Nixon (1971) and Nixon, Buehler & Niewenhuis (1971) . The lower level was without effect in these studies, while the 0-5 % level produced some mild toxicity.
Na3NTA was mixed into ground Purina Chow at the appropriate levels and the two diets were fed to groups of 20 male and 20 female Charles River CD rats continuously through two generations, or to groups of 20 female rats only during each period of organogenesis (days 6-15 of pregnancy). A similar group of 20 males and 20 females fed ground Purina Chow served as the control. - Details on mating procedure:
- The weanling rats from both F, and F1b generations were distributed into groups on the basis of body weight and litter mates, except that animals selected for the second-generation breeders were chosen only from their own respective groups. The rats were randomly caged individually in a carefully controlled environment and were fed and watered ad lib. For each generation, records of individual weekly feed consumption and body-weight gain were kept during the first 8 wk from weaning. Afterwards, the parent rats were weighed at the beginning of each mating phase and no records of feed consumption were kept.
The original parent rats (F0) were bred three times while the second-generation parents (F1b) were bred twice. The first litters of both generations (F1a and F2a were discarded at weaning while the second litters of the first generation (F1b) were kept and used as second generation breeders. The third litters of the first generation (F1c) and the second ones of the second generation (F2b) were used for teratological studies. The day of conception (day 0) was determined by vaginal smears and one-half of each group of dams was sacrificed on day 13 and the other half on day 21 of pregnancy.
All live-born litters were counted at birth and again 4 days later, when the pups were weighed and their sex determined. Each litter was reduced to 8 pups, divided as evenly as possible between the sexes. This was done to equalize, as much as possible, the stress of lactation on the groups of dams. The pups were weaned and weighed 21 days after birth. - Duration of treatment / exposure:
- 10 d
- Frequency of treatment:
- continuous from day 6 through 15 of pregnancy
- Duration of test:
- day 6 - 15 of pregnancy
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.1 and 0.5 % [= 50-75 and 250-375 mg/(kg bw *d)]
Basis:
nominal conc.
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- Sex: female
Duration of test: for two generations
Examinations
- Maternal examinations:
- The numbers of corpora lutea, implantations and resorptions were recorded in dams sacrificed on day 13 of gestation to assess early embryo mortality and, to some extent, dominant lethal effects in the groups where the males were also given Na3NTA.
- Fetal examinations:
- The foetuses removed from dams sacrificed at day 21 of gestation were dried of amniotic fluids and weighed, and their sex was determined. They were inspected for gross abnormalities and sacrificed by means of excessive ether. One-third of each litter was cleared in KOH and stained with Alizarin Red S (Staples & Schnell, 1964) for the determination of skeletal defects, while the remaining foetuses were fixed in Bouin's solution and razor-blade sectioned (Wilson, 1965) to be examined for soft-tissue defects. Representative sections of the vital organs and tissues were taken from five rats of each sex from each group at the end of each teratological phase and at 8 wk after weaning, in second-generation rats. These were fixed in Bouin's solution, embedded in paraffin, and stained with haematoxylin and eosin for histopathological examination.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- >= 250 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
- Dose descriptor:
- NOAEL
- 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
Na3.NTA.H20 was neither embryo- or maternally toxic nor
teratogenic at either dietary levels. All of the defects
were in the soft tissues and predominantly in the urinary
tract: hydroureter and/or hydronephrosis comprised most of
the anomalies observed. As there was no substance-related
context, authors assumed that it could have been caused by
some virus.
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.
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