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EC number: 302-766-4 | CAS number: 94134-01-7
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 29 November 2018 - 11 January 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- see 'Principles of method if other than guideline'
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Deviations:
- yes
- Remarks:
- see 'Principles of method if other than guideline'
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- see 'Principles of method if other than guideline'
- Principles of method if other than guideline:
- The following deviations from study plan occurred:
Due to a typographical error, the Study Plan states that the animals would be housed in polypropylene cages; however, the animals were housed in polycarbonate cages.
On each day of dosing, additional clinical observations were recorded that were not specified in the Study Plan.
These deviations were considered to have not affected the integrity or validity of the study. - GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)
- EC Number:
- 302-766-4
- EC Name:
- N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)
- Cas Number:
- 94134-01-7
- Molecular formula:
- C6H9NO6.3C2H7NO
- IUPAC Name:
- 2-[bis(carboxymethyl)amino]acetic acid; tris(2-aminoethan-1-ol)
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS (UK) Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: approximately 8-12 weeks
- Weight at study initiation: range from 153 to 177g
- Fasting period before study: overnight and four hours prior to and after dosing
- Housing: limited access rodent facility in solid bottomed polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): free access to a standard rodent diet (Teklad 2014C Diet), except for the above mentioned fasting period
- Water (e.g. ad libitum): Potable-water freely available
- Acclimation period: Minimum: five days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 40-70
- Air changes (per hr): Periodic checks made
- Photoperiod (hrs dark / hrs light): 12 hrs light/12hrs dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage):10 mL/kg body weight
- Justification for choice of vehicle:none
- Purity: determination not undertaken as part of this study - Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: All surviving animals were observed for 14 days after dosing.
- Frequency of observations and weighing:observed after dosing and at frequent intervals at least 0.5, 1, 2 and 4 hours after dosing) on Day 1. The weight of each rat was recorded on Days 1, 8 and 15 or at death.
- Necropsy of survivors performed: yes
- Other examinations performed: Macroscopic Pathology, Body weight
Results and discussion
- Preliminary study:
- In the absence of data regarding the toxicity of the test item, 300 mg/kg was chosen as the starting dose.
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- In the main study the rats deaths occured between 40 minutes and 5 hours for rats administered with a dose of 2000 mg/kg.
- Clinical signs:
- other: Clinical signs prior to death were underactivity, both eyelids partially closed, convulsions, fast breathing, tremors and reduced body temperature in both animals. Flat posture was also seen.
- Gross pathology:
- No abnormalities were noted in any surviving animal at the macroscopic examination at study termination on Day 15.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity of N, N’- bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) was evaluated. It was concluded that the LD50 of the substance was between 300 and 2,000 mg/kg bw. The substance meets the criteria for classification as Acute Tox 4; H302 according to Regulation 1272/2008.
- Executive summary:
An experiment was performed to assess the acute oral toxicity of N, N’- bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3), in accordance with the OECD Testing Guideline 420. The study was GLP-compliant.
Fasted female rats received a single oral gavage dose of the test item, formulated in purified water. Sighting investigations found no morbidities at 300 and 2000 mg/kg, based on these results a further four fasted females were dosed at 2000 mg/kg in the main study. Due to the number of deaths in the main study at 2000 mg/kg body weight, a further four fasted females were similarly dosed at 300 mg/kg body weight to complete the study. During the study, clinical condition, body weight and macropathology investigations were undertaken.
Two female animals treated at 2,000 mg/kg bw died as a result of the exposure to the test substance. Clinical signs at this dose level included underactivity, chin rubbing, unsteady gait, repetitive movements, tremors and both eyelids partially closed.
At 300 mg/kg bw, there was no death and no clinical signs were observed.
In accordance with the flow chart associated to the OECD TG 420, the LD50 of N,N’-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) shall be considered as to be between 300 and 2,000 mg/kg body weight.
Therefore the substance meets the criteria for classification as Acute Tox 4; H302 according to Regulation 1272/2008.
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