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EC number: 257-573-7 | CAS number: 51981-21-6
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- in-life part February -March 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
- Objective of study:
- other: absorption and excretion
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: ICH M3 (R2): Note for guidance on non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals, December 2009
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- GLDA-Na4
- IUPAC Name:
- GLDA-Na4
- Reference substance name:
- Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate
- EC Number:
- 257-573-7
- EC Name:
- Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate
- Cas Number:
- 51981-21-6
- Molecular formula:
- C9H9NO8Na4
- IUPAC Name:
- tetrasodium 2-[bis(carboxylatomethyl)amino]pentanedioate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: GLDA-Na4
Chemical Name: Tetrasodium-N,N-bis(carboxylatomethyl)-L-glutamate
Molecular formula: C9H9NO8.4Na
Molecular weight: 351.163
CAS Number: 51981-21-6
Description: White powder
Batch: FC-C 10943
Purity: 87.3wt% as GLDA-Na4
Test substance storage: at room temperature in the dark
Stability under storage conditions: Stable
Expiry date: 19 April 2015
Hygroscopic: Yes, store in well-sealed container
Volatile: No, vapour pressure: 0.08 KPa at 20C
Reactivity: Reactive to moisture
Specific Gravity / Density: 1.466 (relative density)
pH: 11.5 at concentration of 1%
Stability at higher temperatures: Yes, maximum temperature: 120 degr. C
Maximum duration: 2 hours
Constituent 1
Constituent 2
- Radiolabelling:
- no
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Randomization:
By computer-generated random algorithm according to body weight, with all animals within ± 20% of the sex mean.
Acclimatisation period:
At least 5 days under laboratory conditions.
Conditions:
Environmental controls for the animal room were set to maintain 18 to 24°C(actual range 19.0-20.3°C), a relative humidity of 40 to 70% (actual
range 30-51%), approximately 15 room air changes/hour, and a 12-hour light/12-hour dark cycle. Any variations to these conditions were recorded in the raw data and were considered not to have had any effect on the outcome of the study.
Accommodation:
Before dosing animals were group housed 4 animals per sex per cage. Housed in labeled Macrolon cages (type IV; height 18 cm.) with sterilized
sawdust as bedding material (Litalabo, S.P.P.S., Argenteuil, France) and paper as cage-enrichment (Enviro-dri, Wm. Lilico & Son (Wonham Mill Ltd), Surrey, United Kingdom). Group1: The day prior to dosing and following administration, the rats were individually housed in stainless steel metabolism cages (LxWxH = 18.5x19x20 cm) with a grid. Groups 2-6: on the day of dosing and following administration, the rats were individually housed in stainless steel metabolism cages (LxWxH = 18.5x19x20 cm) with a grid. The urine and feces collection assembly of the metabolism cage was cooled using dry ice.
Diet:
Free access to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
Water: Free access to tap-water.
Administration / exposure
- Route of administration:
- other: gavage or intraperitineal injection
- Vehicle:
- water
- Details on exposure:
- Group 1, 2 and 5: Oral gavage, using a plastic feeding tube.
Group 3, 4 and 6: Intraperitoneal injection.
The animals were not deprived of food overnight. - Duration and frequency of treatment / exposure:
- Frequency: once on Day 1.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Dose Level Oral: 100, 300 and 1000 mg/kg
Intraperitoneal: 5, 15 and 50 mg/kg
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- other: urine and feces were also sampled from animals from group 1 prior to dosing (control values)
- Positive control reference chemical:
- No
- Details on study design:
- Single dose on day 1.
Duration of follow-up 72 hours. - Details on dosing and sampling:
- Single dose on day 1. Dose Volume: 5 mL/kg
Actual dose volumes were based on the latest individual body weights.
For urine and feces collection the rats were individually housed in stainless steel metabolism cages (LxWxH = 18.5x19x20 cm) with a grid. The urine and feces collection assembly of the metabolism cage was cooled using dry ice.
Urine and feces were collected over the following intervals:
Predose once, only for Group 1: -24 to 0 hr
0-24 hr
24-48 hr
48-72 hr
Urine and feces samples were weighed and stored in labeled polypropylene tubes (Greiner Bio-One GmbH, Frickenhausen, Germany) at approximately ≤ -75°C until dispatch on dry-ice to the test site for bioanalysis. Samples were sent to Akzo Nobel NV, Arnhem, The Netherlands, on 11 March
2013. - Statistics:
- Not applicable
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- <5% following oral administration
- Type:
- excretion
- Results:
- GLDA-Na4 is excreted unmetabolized and when a limited amount of GLDA-Na4 is being absorbed, on average >85% is rapidly (first 24 hours) excreted via urine/faeces
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- In samples from animals subjected to single oral administration (groups 1, 2 and 5), the test substance was largely detected in faeces (92.7 – 99.1%). Only a small part was detected in urine (0.9 – 7.3%), while the overall recovery of GLDA-Na4 in orally dosed animals (PO) ranged from 95.8 – 103.0%. For the samples from animals subjected to intraperitoneal administration (IP) (groups 3, 4 and 6), the results were less clear. In 2 out of 12 animals (both sexes) higher levels of GLDA-Na4 were found in the faeces compared to the urine. Nevertheless, after IP dosing, the test substance was mainly detected in urine (in 83% of the animals), with an overall recovery of GLDA-Na4 in the IP dosed animals ranging from 74.6 – 103.3% (see tables attached).
Applicant's summary and conclusion
- Conclusions:
- In the orally dosed rats, most GLDA-Na4 was found in the faeces. This indicates that only a limited amount of GLDA-Na4 is being absorbed, i.e. <5% on average, when GLDA-Na4 is dosed orally. In the IP dosed rats, GLDA-Na4 was mainly detected in urine (83% of the animals). This indicates that (a) GLDA-Na4 is excreted unmetabolized and (b) when a limited amount of GLDA-Na4 is being absorbed, on average >85% is rapidly (first 24 hours) excreted via urine/faeces by the animal.
- Executive summary:
In the present study, rats were dosed with GLDA-Na4 either orally or via intraperitoneal administration. In the orally dosed rats, most GLDA-Na4 was found in the faeces with an overall recovery ranging from 95.8 – 103.0%.This indicates that only a limited amount of GLDA-Na4 is being absorbed, i.e. <5% on average, when GLDA-Na4 is dosed orally. In the IP dosed rats, GLDA-Na4 was mainly detected in urine (83% of the animals), with an overall
recovery ranging from 74.6 – 103.3%. This indicates that (a) GLDA-Na4 is excreted unmetabolized and (b) when a limited amount of GLDA-Na4 is being absorbed, on average >85% is rapidly (first 24 hours) excreted via urine/faeces by the animal.
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