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EC number: 227-105-6 | CAS number: 5657-17-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: EU method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline no. 439: In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Ethylenediamine-N,N'-di(acetic acid)
- EC Number:
- 227-105-6
- EC Name:
- Ethylenediamine-N,N'-di(acetic acid)
- Cas Number:
- 5657-17-0
- Molecular formula:
- C6H12N2O4
- IUPAC Name:
- 2-({2-[(carboxymethyl)amino]ethyl}amino)acetic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- Chemical name: Ethylenediaminediacetic acid (ED2A-H2)
Batch/lot No.: FC-C 12874
Appearance: Yellow powder (visual)
Assay: 99.2% (HPLC)
pH: 4.7 (saturated solution)
Solubility in water: soluble in water at 1.0 g/L
Constituent 1
- Specific details on test material used for the study:
- Purity: 99.2%
Test system
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 14.27 to 27.95 mg, moistened with 5 µl water
NEGATIVE CONTOL:
- Amount(s) applied (volume or weight with unit): 25 µl Phosphate buffered saline
POSITIVE CONTROL
- Amount(s) applied (volume or weight with unit): 25 µl
- Concentration (if solution): 5% (aq) Sodium dodecyl sulphate - Duration of treatment / exposure:
- Exposure:15 minutes
Post incubation period: 42 hours - Details on study design:
- TEST SITE
- Area of exposure: human epidermis model
- % coverage: 0.38 cm2
REMOVAL OF TEST SUBSTANCE
- Washing (if done): phosphate buffered saline
- Time after start of exposure: 15 minutes
POST INCUBATION PERIOD
- 42 hours
SCORING SYSTEM:
- After a 42 hour incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues.
Results and discussion
In vitro
Results
- Irritation / corrosion parameter:
- other: other: percentage viability
- Value:
- 129
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: percentage of control; time point: 15 minutes
Any other information on results incl. tables
Mean tissue viability +/- SD (%):
negative control: 100 +/- 6.8
positive control: 5.7 +/- 2.1
test item: 129 +/- 29
The standard deviation of the viability of the test item treated tissues was 29% which is above acceptance criteria. Since all individual viabilities were >50% and each of the individual viabilities was higher than each of the negative control viabilities, the test outcome was considered valid.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vitro skin irritation test was conducted according to OECD 439 guideline and GLP principles.
It is concluded that this test is valid and that ED2A-H2 is non-irritant in the in vitro skin irritation test. - Executive summary:
The objective of this study was to evaluate ED2A-H2 for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SMTM)). The possible skin irritation potential of ED2A-H2 was tested through topical application for 15 minutes.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
Batch FC-C 12874 of the test item was a yellow powder. Skin tissue was moistened with 5 µl of Milli-Q water and at least 10 mg of the test item was applied directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT at the end of the treatment.
Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with ED2A-H2 compared to the negative control tissues was 129%. Since the mean relative tissue viability for ED2A-H2 was above 50% after 15 ± 0.5 minutes treatment ED2A-H2 is considered to be non-irritant.
The positive control had a mean cell viability of 5.7% after 15 ± 0.5 minutes exposure. The absolute mean OD570(optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was < 7% for the negative and positive control, indicating that the test system functioned properly.
In conclusion, ED2A-H2 is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report andshould not be classified according to the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) of the United Nations.
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