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EC number: 439-840-1 | CAS number: 20846-91-7
- 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:
- 20 December 2001 to 17 January 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 439-840-1
- EC Name:
- -
- Cas Number:
- 20846-91-7
- Molecular formula:
- C10H16N2O8
- IUPAC Name:
- (2S)-2-[(2-{[(1S)-1,2-dicarboxyethyl]amino}ethyl)amino]butanedioic acid
- Details on test material:
- - Name of test material (as cited in study report): EDDS acid (under code)
- Substance type: technical product
- Physical state: solid
- Storage condition of test material: room temperature in the dark
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: at least 200 g
- Fasting period before study: overnight
- Housing: in groups of three by sex in solid-floor polypropylene cages furnished with woodflakes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: the oral route was predicted to be the most likely route of exposure
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: as recommended by OECD Guideline 423 - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 1/2, 1, 2 and 4 hr after dosing, then daily
- Frequency of weighing: once prior to dosing, then every 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathological examination following necropsy - Statistics:
- not applicable
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: CL not applicable
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study carried out according to OECD Guideline 423 (and EU Method B.1), the acute oral LD50 for EDDS acid was determined to be greater than 2 g/kg bw in male and female rats.
- Executive summary:
In a GLP study carried out according to OECD Guideline 423 (and EU Method B.1), three male and three female Sprage-Dawley rats were given a single dose of 2 g/kg bw EDDS acid via oral gavage. Rats were observed for overt signs of toxicity ½, 1, 2 and 4 hr following dosing, then once daily for fourteen days. Body weight was recorded prior to dosing (day 0), then on days 7 and 14. All animals were sacrificed after 14 days, and were subject to external and internal gross pathological examination. The occurrence of any macroscopic abnormalities was recorded.
No deaths or overt signs of systemic toxicity were observed throughout the experiment. Following sacrifice and examination of major organs on day 14, no macroscopic abnormalities were observed. All animals gained weight over the study period as expected.
In conclusion, the acute oral LD50 for EDDS acid was determined to be greater than 2 g/kg bw in male and female rats.
According to EU CLP and DSD regulations, EDDS acid would not be classified as acutely toxic by the oral route under the conditions of this test.
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