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Diss Factsheets
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EC number: 247-019-2 | CAS number: 25481-21-4
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data is from peer reviewed journals
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of EDTA and its salts
- Author:
- Cosmetic Ingredient Review Expert Panel
- Year:
- 2 002
- Bibliographic source:
- International Journal of Toxicology,2002
- Reference Type:
- publication
- Title:
- The Classification of Skin Irritants by Human Patch Test
- Author:
- D. A. BASKETTER et.al
- Year:
- 1 997
- Bibliographic source:
- Food and Chemical Toxicology, 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Human patch test
- Principles of method if other than guideline:
- Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Disodium dihydrogen ethylenediaminetetraacetate
- EC Number:
- 205-358-3
- EC Name:
- Disodium dihydrogen ethylenediaminetetraacetate
- Cas Number:
- 139-33-3
- Molecular formula:
- C10-H16-N2-O8.2Na
- IUPAC Name:
- 2-[2-[bis(carboxymethyl)amino]ethyl-(carboxymethyl)amino]acetic acid
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Disodium dihydrogen ethylenediaminetetraacetate
- Molecular formula: C10H14N2Na2O8
- Molecular weight: 336.208 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- other: humans
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- no data available
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact skin
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- 0.2 g solid moistened
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 24, 48 and 72 hours
- Number of animals:
- 26
- Details on study design:
- TEST SITE
- Area of exposure: upper outer arm
- % coverage: 25 mm Plain Hill Top Chamber
- Type of wrap if used:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: after exposure
SCORING SYSTEM: Treatment sites were assessed for the presence of irritation using a four point scale.
Grading of response
0 - No reaction
+ - Weakly positive reaction (usually characterized by mild erythema or dryness across most of the treatment site)
++ - Moderately positive reaction (usually distinct erythema possibly spreading beyond the treatment site)
+ + + - Strongly positive reaction (strong, often spreading erythema with oedema)
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritatng
- Conclusions:
- No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”. - Executive summary:
Patch tests were performed oh human volunteers to assess the dermal irritation potential of the test chemical. 0.2 g of the test chemical on a 25 mm Plain Hill Top Chambers containing a Webril pad (moistened for solid test materials) to the skin of the upper outer arm of 26 human volunteers for up to 4 hours. To avoid the production of unacceptably high reactions, test materials are applied progressively from 15 and 30 min through 1, 2, 3 and 4 hours.
Treatment sites are assessed for the presence of irritation using a four point scaleat 24, 48 and 72hours after patch removal. 0.2 ml of20% Sodium dodecycl sulphate was used as a positive control.
No signs of dermal irritation were observed in the 26 volunteers treated with the test chemical as compared to the 21 of 26 volunteers treated with SDS.
Hence the test chemical was considered to be not irritating to human skin and it can be classified under the category “Not Classified”.
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