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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
Key value for chemical safety assessment
Effects on fertility
Link to relevant study records
- Endpoint:
- two-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1971
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- other: Procter & Gamble (USA)
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Charles River CD
- Sex:
- male/female
- Route of administration:
- oral: feed
- Duration of treatment / exposure:
- pre-mating exposure period: 8 weeks for male and female
exposure period during pregnancy: from day 6 through day 15 - Frequency of treatment:
- continuous
- Remarks:
- Doses / Concentrations:
0.1% and 0.5% (50 and 250 mg/kg bw per day as Na3NTA.H2O
Basis:
nominal in diet - No. of animals per sex per dose:
- 20 animals per dose per sex
20 animals per sex for control - Control animals:
- yes, concurrent no treatment
- Dose descriptor:
- NOAEL
- Effect level:
- > 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level expressed as the acid
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- > 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level expressed as the acid
- Dose descriptor:
- NOAEL
- Generation:
- F2
- Effect level:
- > 175 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Effect level expressed as the acid
- Reproductive effects observed:
- not specified
Reference
F1+F2: There were no effects on number of corpora lutea, resorptions and implantations (on day 13); conception, live and dead foetuses, weight of
foetuses, gross and microscopic inspection of organs for abnormalities (day 21).
Conception varied from 86% (F2) to 97% (F1), with control 92-95%.
See for further details the in section 13 attached IUCLID4 data set.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 175 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The IARC monograph on nitrilotriacetic acid (volume 73, section 19) from 1999, which is atteched in section 13, summarizes the toxicity to reproduction as follows. The two most relevant studies have been taken up in the IUCLID5 dossier. All studies can be found in IUCLID4 data set which is attached in section 13.
The developmental and reproductive effects of nitrilotriacetic acid have been reviewed (Anderson et al., 1985). No significant maternal, embryonic or fetal effects were reported in rats exposed to up to 0.5% in the diet, rabbits exposed by oral gavage to up to 250 mg/kg bw per day or in mice exposed via the drinking-water at 0.2%. Addition of heavy metals such as mercury and cadmium did not change the response. Similarly, studies of reproductive toxicity did not indicate an effect on neonatal development. Nitrilotriacetic acid was used to assess the predictive value of two assays for mammalian teratogenesis in vitro: an assay for inhibition of the growth of embryonic palatal mesenchymal cells, which evaluates effects on proliferative potential, and an assay for inhibition of the attachment of mouse ascites tumour cells to concanavalin A-coated surfaces. The concentrations of nitrilotriacetic acid that inhibited growth or attachment by 50% were > 1 mmol/L in both assays, and the authors considered the results to be negative (Steele et al., 1988). Exposure of developing Drosophila larvae to nitrilotriacetic acid caused a dose-related increase in gross wing defects and extra bristles in adults, but the authors did not consider these effects predictive of developmental toxicity in mammals (Lynch et al., 1991). Nitrilotriacetic acid was evaluated for effects on amphibian embryogenesis in the frog embryo teratogenesis assay Xenopus laevis (FETAX) assay. The concentration that caused the deaths of 50% of the embryos was reported to be 540 mg/L, the concentration that induced terata in 50% of the surviving embryos was 530 mg/mL, and the teratogenic index was 1.0 mg/mL. The authors considered the effects to be due to disruption and osmoregulation and not to teratogenic potential (Dawson et al., 1989).
Nitrilotriacetic acid does not induce developmental toxicity in rats, rabbits or mice
exposed during gestation and gave negative results in short-term assays to screen for
teratogenesis in two cellular assays in Drosophila larvae and frog embryos.
Effect levels are expressed as the acid
Effects on developmental toxicity
Link to relevant study records
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1972
- Reliability:
- 2 (reliable with restrictions)
- Guideline:
- other: no data
- GLP compliance:
- not specified
- Species:
- mouse
- Strain:
- NMRI
- Route of administration:
- oral: drinking water
- Duration of treatment / exposure:
- from day 6 to day 18 of gestation
- Frequency of treatment:
- continuous
- Duration of test:
- 18 days
- Remarks:
- Doses / Concentrations:
0.2% (300 mg/kg bw per day) as the acid
Basis:
nominal in water - Control animals:
- yes, concurrent no treatment
- Details on embryotoxic / teratogenic effects:
- Details on embryotoxic / teratogenic effects:
Teratogenic investigations were combined with a series of distribution experiments to follow nitrilotriacetic acid (NTA) within dam and fetus by
means of radio labelled NTA. NTA exerted no embryotoxic effect and produced no malformations though there was appreciable placental passage of radioactivity onto the fetus. - Dose descriptor:
- NOAEL
- Effect level:
- > 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: teratogenicity
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Conclusions:
- Substance is NOT a potential developmental toxicant
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 300 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance showed no untoward effects and thus a classification is not required.
Additional information
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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