Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 200-449-4 | CAS number: 60-00-4
- 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- other: literature review
- Adequacy of study:
- key study
- Study period:
- 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Data prepared by European Chemical Bureau.
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- European Union Risk Assessment Report CAS 60-00-4 EC 200-449-4 edetic acid (EDTA)
- Author:
- Europen Chemical Bureau Institute of Health and Consumer Protection
- Year:
- 2 004
- Bibliographic source:
- Europen Chemical Bureau Institute of Health and Consumer Protection
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: patch test
- GLP compliance:
- not specified
- Type of study:
- patch test
Test material
- Reference substance name:
- Edetic acid
- EC Number:
- 200-449-4
- EC Name:
- Edetic acid
- Cas Number:
- 60-00-4
- Molecular formula:
- C10H16N2O8
- IUPAC Name:
- 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetic acid
- Reference substance name:
- EDTA
- IUPAC Name:
- EDTA
- Details on test material:
- patch test concentration 1%
concentration of 1% in either petrolatum or water or 10% concentration in petrolatum
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- human
Results and discussion
Any other information on results incl. tables
Three out of 50 subjects showed a positive reaction to EDTA (patch test concentration 1%, Raymond and Gross, 1969). In another study after patch testing with a 1% EDTA concentration (Rudner, 1977), an incidence of 0.9% (positive responses of 215 subjects) was reported by the North American Contact Dermatitis Group without data on exposure to EDTA or other tested substances. Positive incidences of 1.7-2.8% (13/743 or 10/345 patients) were reported by Pevny and Schäfer (1980) and by Pevny et al. (1981). However the usual test concentration of 1% in either petrolatum or water (de Groot, 1986) was not used but a 10% concentration in petrolatum. Therefore, these data may not only suggest a contact allergy but also an irritating response. In 529 patients with eczematous dermatitis 2 (0.4%) showed a positive reaction to EDTA. It was not mentioned if the patients were exposed to EDTA (Angelini et al., 1985). According to Fisher (1986) not a single positive reaction in hundreds of patients who were tested with EDTA was observed. He concludes that EDTA is not a sensitiser and also does not crossreact with ethylenediamine hydrochloride.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- EDTA is not a sensitiser.
- Executive summary:
Based on reports on humans studies and on the fact that the substance is being used in industry and consumer products for many decades in high quantities the incidences of positive responses is too low to warrant a labelling with H317 May cause an allergic skin reaction.
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.
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