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EC number: 283-042-4 | CAS number: 84539-54-8
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-08-08 to 2000-08-13
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive No. 92/69/EEC, B.4, 31st July 1992.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): EDDHAS Fe, sel de K
- Molecular formula (if other than submission substance): C18H14FeN2O12S2(3K)
- Molecular weight (if other than submission substance): 687.3
- Smiles notation (if other than submission substance): O=C(O)C(NCCNC(C(=O)O)c1cc(ccc1(O))S(=O)(=O)O)c2cc(ccc2(O))S(=O)(=O)O
- InChl (if other than submission substance): InChI=1S/C18H20N2O12S2/c21-13-3-1-9(33(27,28)29)7-11(13)15(17(23)24)19-5-6-20-16(18(25)26)12-8-10(34(30,31)32)2-4-14(12)22/h1-4,7-8,15-16,19-22H,5-6H2,(H,23,24)(H,25,26)(H,27,28,29)(H,30,31,32)
- Substance type: Fe chelate
- Physical state: brownish/red powder
- Analytical purity: 55±2%
- Impurities (identity and concentrations): none
- Purity test date: 2000-10-24
- Expiration date of the lot/batch: 2001-01-24
- Stability under test conditions: at least 6 months from receipt (date of receipt: 24 July 2000)
- Storage condition of test material: at room temperature and protected from humidity
- Other:
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Elevage Cunicole de Val de Selle, 80160 Prouzel, France
- Age at study initiation: not reported
- Weight at study initiation: mean body weight of 3 animals 2.6 ± 0.2 kg
- Housing: individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm). Each cage was equipped with a food container and a water bottle.
- Diet (e.g. ad libitum): ad libitum. 110 pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France).
- Water (e.g. ad libitum): Drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ±3
- Humidity (%): 30 to 70
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped using electric clippers
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The untreated skin served as control
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg of the test substance were placed on a moistened gauze pad. Purified water (prepared at CIT by reverse osmosis) was used in order to moisten the test substance and ensure a good contact with the skin. - Duration of treatment / exposure:
- 3 min and 4 hours
- Observation period:
- The skin was examined approximately 1 hour, 24, 48 and 72 hours after removal of the dressing.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: back
- % coverage: 6%
- Type of wrap if used: The test substance and the gauze pad were held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test substance was wiped off by means of a moistened gauze pad.
- Time after start of exposure: 3 min and 4 hours
SCORING SYSTEM:
Erythema and eschar formation:
- no erythema: 0
- very slight erythema (barely perceptible): 1
- well-defined erythema: 2
- moderate to severe erythema: 3
- severe erythema (beet redness) to slight eschar formation (injuries in depth): 4
Oedema formation
- no oedema: 0
- very slight oedema (barely perceptible): 1
- slight oedema (edges of area well-defined by definite raising): 2
- moderate oedema (raised approximately 1 millimetre): 3
- severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4
Any other lesions were noted.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean scores after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no cutaneous reactions
- Remarks on result:
- other: A brown coloration of the skin, which could have masked a possible very slight erythema (grade 1), was noted at the 1-hour scoring only
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean scores after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no cutaneous reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean scores after 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: a very slight or well-defined erythema (grade 1 or 2)
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean scores after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no cutaneous reactions
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean scores after 24, 48 and 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hors
- Remarks on result:
- other: a very slight or well-defined erythema (grade 1 or 2)
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean scores after 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no cutaneous reactions
- Irritant / corrosive response data:
- After a 3-minute exposure (one animal):
No cutaneous reactions were observed. A brown coloration of the skin, which could have masked a possible very slight erythema (grade 1), was noted at the 1-hour scoring only.
After a 4-hour exposure (three animals):
No cutaneous reactions were observed in 1/3 animals; a brown coloration of the skin, which could have masked a possible very slight erythema (grade 1), was noted at the 1-hour scoring only.
In both remaining animals, a very slight or well-defined erythema (grade 1 or 2) was noted from day 1 up to day 3.
Mean scores over 24, 48 and 72 hours for each animal were 0.0, 1.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for oedema.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information according to the Regulation (EC) No. 1272/2008 Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions, the test substance EDDHAS Fe 3K is slightly irritant when applied topically to rabbits. However, the average scores calculated for each of the three animals for three consecutive days (24, 48 and 72 hours) do not exceed cut-off-values defined in the CLP.
- Executive summary:
The potential of the test substance Fe3KEDDHSA to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (92/69/EEC, B.4, 31st July 1992) guidelines. The test substance was applied for periods of 3 minutes and 4 hours to a single male New Zealand White rabbit. Since the test substance was not irritant on this first animal, it was then applied for 4 hours to two other animals. A single dose of 500 mg of the test substance in its original form was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal. After a 3-minute exposure no cutaneous reactions were observed in the first animal. A brown coloration of the skin, which could have masked a possible very slight erythema, was noted at the 1-hour scoring only. After a 4-hour exposure no cutaneous reactions were observed in 1/3 animals; a brown coloration of the skin, which could have masked a possible very slight erythema, was noted at the 1 -hour scoring only. In both remaining animals, a very slight or well-defined erythema was noted from day 1 up to day 3. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 1.0 and 1.0 for erythema and 0.0, 0.0 and 0.0 for oedema. Under the experimental conditions, the test substance Fe3KEDDHSA is slightly irritant when applied topically to rabbits.
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.
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