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EC number: 416-530-4 | CAS number: 178949-82-1
- 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:
- 24 April to 11 May 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- eyes were not examined at 1 h and eye irritation was scored in accordance with Draize
- Principles of method if other than guideline:
- The study was designed to assess eye irritation potential using a procedure based on Proctor and Gamble Protocol No. C2B-E (Dated 16 March 1987). This protocol is essentially equivalent to OECD Guideline 405. Occular lesions were scored using the Draize numerical scoring system (Draize JH, 1959).
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 416-530-4
- EC Name:
- -
- Cas Number:
- 178949-82-1
- Molecular formula:
- C10H13N2Na3O8
- IUPAC Name:
- trisodium 2-({2-[(1-carboxy-2-carboxylatoethyl)amino]ethyl}amino)butanedioate
- Details on test material:
- - Name of test material (as cited in study report): trisodium EDDS (under code)
- Substance type: technical product
- Physical state: white granular powder
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: March 1990
- Storage condition of test material: "ambient"
- Other: test substance was finely ground using a pestle and mortar and then passed through a 425 micron sieve
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Smith A, Warlingham, Surrey and Froxfield Farms UK Ltd, Petersfield, Hampshire, England
- Age at study initiation: 10 to 13 weeks
- Weight at study initiation: 2.3-3.0 kg
- Housing: individually in metal cages with perforated floors
- Diet (e.g. ad libitum): SDS standard rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: "were acclimated" no further details given
ENVIRONMENTAL CONDITIONS
- Temperature (°C): approximately 19
- Humidity (%): 30-70
- Air changes (per hr): 19
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: 24 April 1989 to 11 May 1989
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mg [this is quite a low amount] - Duration of treatment / exposure:
- The treated eyes were not rinsed after instillation
- Observation period (in vivo):
- 7 d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no rinse
SCORING SYSTEM: based on the numerical scoring system of Draize (Draize JH, 1959. Appraisal of the safety of chemicals in foods, drugs and cosmetics. Assn. of Food and Drug Officials of the United States, 51). The Maximum Average Score (MAS) was defined as "the highest Primary Irritation Score recorded for any observation period". The Primary Irritation Score at each observation period for each group of animals was calculated by totalling all of the cornea, iris, and conjunctivae scores and dividing by the number of animals in the group.
TOOL USED TO ASSESS SCORE: handheld torch
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 110
- Reversibility:
- other: not applicable
- Remarks on result:
- other: No occular reactions were recorded at any of the observation time points.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No corneal damage, iridial inflammation or conjunctival reactions were seen in any of the three animals during the observation period
- Other effects:
- none reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a GLP study conducted according to a protocol similar to OECD Guideline 405, no evidence of corneal damage, iridial inflammation or conjunctival reactions were observed when 4 mg of trisodium EDDS was instilled into one eye of each of three rabbits.
- Executive summary:
In a GLP study conducted according to a protocol similar to OECD Guideline 405, the ability of trisodium EDDS to cause eye irritation and corrosion was investigated by instilling 4 mg of the undiluted material into the conjunctival sac of one eye of each of three New Zealand White rabbits. Treated eyes were not rinsed after substance application. The contralateral eye remained untreated and served as a control. Scoring of occular effects was performed at 1, 2, 3, 4 and 7 days after test substance administration.
No corneal damage, iridial inflammation or conjunctival reactions were seen in any of the three animals throughout the 7-d observation period. Under the conditions of this study, trisodium EDDS would not be classified as capable of producing serious eye damage/eye irritation according to EU CLP regulation.
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