Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 to 27 December 2001
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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: white solid
- Stability under test conditions: no data
- Storage condition of test material: room temperature, in darkness
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2-3.5 kg
- Housing:individually in suspended metal cages
- Diet (e.g. ad libitum): conventional, ad libitum
- Water (e.g. ad libitum): mains drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 20 December 2001 To: 27 December 2001
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL (about 55 mg) - Duration of treatment / exposure:
- the test substance was not washed out of the eye during the 72-h observation period
- Observation period (in vivo):
- 1, 24, 48 and 72 h
- Number of animals or in vitro replicates:
- Initially 1, then 2 more tested
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
SCORING SYSTEM: using the Draize scale (Draize, 1977):
Score for conjunctiva = (redness + chemosis + discharge) X 2
Score for iris = degree of effects X 5
Score for cornea = (degree of opacity X area involved) X 5
Ocular irritancy potential was classified according to a modified version of the method of Kay and Calandra (1962). The scores for cornea, iris and conjunctiva for each time point were added together for each rabbit and the group mean calculated. The highest of these group means, together with the persistence of the reactions was used to classify the irritancy potential.
TOOL USED TO ASSESS SCORE: ophthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- ca. 4.2
- Max. score:
- 110
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- other: not applicable
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1, 24, 48 and 72 h
- Score:
- ca. 4.2
- Max. score:
- 20
- Reversibility:
- fully reversible within: 48 h
- Irritant / corrosive response data:
- No effects were seen on the cornea or iris in any of the three rabbits. Moderate conjunctival irritation was noted in all of the rabbits after 1 h, which was minimal at 24 h and had fully reversed by 48 h.
- Other effects:
- There was an initial pain reaction of 2 (slight pain; rabbit blinks and tries to open eye, but reflex closes it)
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study conducted according to OECD Guideline 405, EDDS acid (when applied to the right eye of three rabbits) produced moderate irritation of the conjunctivae after 1 h, which had completely reversed by 48 h. No effects on the cornea or iris were evident.
- Executive summary:
In a GLP study conducted according to OECD Guideline 405, EDDS acid was tested for its ability to cause eye irritation in rabbits. The test substance (0.1 mL) was placed in the conjunctival sac of the right eye of three New Zealand White rabbits and the eyelids held together for about one second (no washing). The left eye was left untreated and acted as the control. Assessment of ocular irritation was made at 1, 24, 48 and 72 h using the scoring method of Kay and Calandra (1962) and an ophthalmoscope.
No effects on the cornea or iris were evident. Moderate irritation of the conjunctivae was seen with scores of 2 each for redness, chemosis and discharge at 1 h, which had receded to a score of 1 (at the most) for each parameter by 24 h. The eyes of all three rabbits appeared normal at 48 and 72 h. In conclusion, under the conditions of this test, EDDS was considered to be non-irritating when applied to the rabbit eye (mean scores at 24, 48 and 72 h) according to the EU CLP and DSD regulations.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.