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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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- NOAEL
- 11 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- other: no data
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- open
- Vehicle:
- water
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- on each working day (20 days)
- Remarks:
- Doses / Concentrations:
2.5% aqueous solution (50 mg/kg) as Na3NTA
Basis:
nominal per unit body weight - No. of animals per sex per dose:
- 6 animals in total, of which 3 treated and 3 not tretaed
- Control animals:
- yes, concurrent no treatment
- Dose descriptor:
- NOAEL
- Effect level:
- 37 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: Effect level expressed as the acid
- Critical effects observed:
- not specified
Reference
No local or systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 37 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- other: no data
- GLP compliance:
- not specified
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- open
- Vehicle:
- water
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- on each working day (20 days)
- Remarks:
- Doses / Concentrations:
2.5% aqueous solution (50 mg/kg) as Na3NTA
Basis:
nominal per unit body weight - No. of animals per sex per dose:
- 6 animals in total, of which 3 treated and 3 not tretaed
- Control animals:
- yes, concurrent no treatment
- Dose descriptor:
- NOAEL
- Effect level:
- 37 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: Effect level expressed as the acid
- Critical effects observed:
- not specified
Reference
No local or systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
There are a number of subchronic and chronic oral dose studies available in the rat, mouse and dog. The two most reliable chronic studies (2 years in rat) have been taken up as endpoints. The other studies can be found in the attached IUCLID4 dossier in section 13.
There is one subchronic (28 days) and one chronic (91 days) dermal dose study available, both in rabbits and with the same result (no local or systemic effects). The subchronic study has been taken up as endpoint as the chronic study has a very low reliability. The other study can be found in the attached IUCLID4 dossier in secion 13.
The IARC monograph on nitrilotriacetic acid (volume 73, chapter 19) from 1999, which is attached in section 13, summarizes these toxic effects as follows:
Renal tubular cells show evidence of toxicity in rats and mice given high doses of
nitrilotriacetic acid or its sodium salt corresponding to the doses that produce renal-cell
tumours in these species. Regenerative proliferation ensues. The toxicity correlates with
plasma and urinary accumulation of Zn++, considered to occur secondary to the chelating
properties of nitrilotriacetic acid. Administration of zinc nitrilotriacetic acid or co-administration
of zinc salts with nitrilotriacetic acid accentuates this effect (Anderson et al.,
1985).
The urothelial effects of nitrilotriacetic acid and its sodium salt occur in rats but not
in mice, and sex differences are seen, depending on the experimental treatment. Urothelial
tumours (renal pelvis, ureters, bladder) occur in animals of each sex. In contrast
to the effect in renal tubules, the urothelial effects are not due to accumulation of zinc
but rather appear to be related to depletion of calcium. This occurs at doses higher than
those required for the nephrotoxicity produced by nitrilotriacetic acid, and the doses
correspond to those that produce urothelial toxicity and regenerative hyperplasia.
Although nitrilotriacetic acid-containing microcrystalluria occurs, this was not considered
to be a sufficient explanation for the urothelial toxic and regenerative effects
(Anderson et al., 1985).
Nitrilotriacetic acid did not mediate efficient oxidative production of single- and
double-strand breaks in DNA in vitro in supercoiled plasmid pZ189 (Toyokuni &
Sagripanti, 1993).
It increased the incidence of liver-cell nodules but not carcinomas in female rats
(IARC, 1990).
Repeated dose toxicity: via oral route - systemic effects (target organ) urogenital: kidneys
Justification for classification or non-classification
At the effect levels found there is no requirement for an additional classification according to CLP for STOT RE
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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