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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2000-08-17 to 2000-08-25
- 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 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive No. 92/69/EEC, B.5, 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 3.0 ± 0.1 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
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg - Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- The eyes were examined approximately 1 hour, 24, 48 and 72 hours after administration of the test substance.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM:
Conjunctival lesions and discharge:
Chemosis (lids and/or nictitating membranes):
- no swelling: 0
- any swelling above normal (includes nictitating membranes): 1
- obvious swelling with partial eversion of lids: 2
- swelling with lids about half-closed: 3
- swelling with lids more than half-closed: 4
Redness (refers to palpebral and bulbar conjunctivae, cornea and iris):
- blood vessels normal: 0
- a number of blood vessels definitely hyperemic (injected): 1
- diffuse, crimson colour, individual vessels not easily discernible: 2
- diffuse, beefy red: 3
Discharge
- absence of discharge: 0
- slight discharge (does not include small amounts normally found in inner canthus): 1
- discharge with moistening of lids and hairs adjacent to lids: 2
- discharge with moistening of lids and hairs on wide area around the eye: 3
Iris lesions
- normal: 0
- markedly deepened rugae, congestion, swelling, moderate circum-comeal hyperemia, or injection, any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive): 1
- no reaction to light, haemorrhage, gross destruction (any or all of these): 2
Opacity (degree of intensity: area most dense taken for reading):
- no ulceration or opacity 0
- scattered or diffuse areas of opacity (other than slight dulling or normal lustre), details of iris clearly visible: 1
- easily discernible translucent area, details of iris slightly obscured: 2
- nacrous areas, no details of iris visible, size of pupil barely discernible: 3
- opaque cornea, iris not discernible through the opacity: 4
Area of opacity:
- one quarter (or less) but not zero: 1
- greater than one quarter but less than a half: 2
- greater than one half but less than three quarters: 3
- greater than three quarters up to whole area: 4
TOOL USED TO ASSESS SCORE: not reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- based on 3 animals
- Time point:
- other: mean value of the scores at each reading (24, 48 and 72h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no opacity observed
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- based on 3 animals
- Time point:
- other: mean value of the scores at each reading (24, 48 and 72h)
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: no lesions observed
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- based on 3 animals
- Time point:
- other: mean value of the scores at each reading (24, 48 and 72h)
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: redness and discharge
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean value of the scores at each reading (24, 48 and 72h)
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean value of the scores at each reading (24, 48 and 72h)
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean value of the scores at each reading (24, 48 and 72h)
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 24 hours
- Irritant / corrosive response data:
- Slight conjunctival reactions were observed in all animals on day 1: a very slight or slight chemosis (grade 1 or 2), a very slight redness of the conjunctiva (grade 1) and a clear discharge were noted.
A very slight chemosis (grade 1) persisted in 2/3 animals on day 2 and in 1/3 animals on day 3. No other ocular reactions were noted during the study.
Mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.3 and 0.0 for chemosis, 0.0, 0.0 and 0.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. - Other effects:
- No other effects were noted
Any other information on results incl. tables
Table 1: Individual ocular examinations and mean values of the scores recorded at each reading (24, 48 and 72 hours) for each animal
Rabbit number | Region of eye | Description of ocular reactions | Scores | Mean irritation score (1) | Interpretation | |||
lh | 24h | 48h | 72h | |||||
Dl | D2 | D3 | D4 | (-) (+) | ||||
753 | Conjunctivae | Chemosis | 1 | 1 | I | 0 | 0.7 | (-) |
Redness | 1 | 0 | 0 | 0 | 0.0 | (-) | ||
Discharge | 0 | 0 | 0 | 0 | 0.0 | |||
Iris | 0 | 0 | 0 | 0 | 0.0 | (-) | ||
Corneal opacity | Intensity | 0 | 0 | 0 | 0 | 0.0 | (-) | |
Area | 0 | 0 | 0 | 0 | 0.0 | |||
Other | * | * | * | * | ||||
Fluorescein | / | U | / | / | ||||
769 | Conjunctivae | Chemosis | 2 | 1 | 0 | 0 | 0.3 | (-) |
Redness | 1 | 0 | 0 | 0 | 0.0 | (-) | ||
Discharge | 2 | 0 | 0 | 0 | 0.0 | |||
Iris | 0 | 0 | 0 | 0 | 0.0 | (-) | ||
Corneal opacity | Intensity | 0 | 0 | 0 | 0 | 0.0 | (-) | |
Area | 0 | 0 | 0 | 0 | 0.0 | |||
Other | * | * | * | * | ||||
Fluorescein | / | U | / | / | ||||
770 | Conjunctivae | Chemosis | 1 | 0 | 0 | 0 | 0.0 | (-) |
Redness | 1 | 0 | 0 | 0 | 0.0 | (-) | ||
Discharge | 1 | 0 | 0 | 0 | 0.0 | |||
Iris | 0 | 0 | 0 | 0 | 0.0 | (-) | ||
Corneal opacity | Intensity | 0 | 0 | 0 | 0 | 0.0 | (-) | |
Area | 0 | 0 | 0 | 0 | 0.0 | |||
Other | * | * | * | * | ||||
Fluorescein | / | U | / | / | ||||
(1) mean of scores on days 2, 3 and 4 | ||||||||
h = hour | ||||||||
D = day | ||||||||
(+) = irritant according to E.E.C. criteria | ||||||||
(-) = non-irritant according to E.E.C. criteria | ||||||||
* = None | ||||||||
U = Fluorescein batch No. C079 | ||||||||
/ = Fluorescein not used |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the test substance Fe3KEDDHSA is non-irritant when administered by ocular route to rabbits.
- Executive summary:
The potential of the test substance Fe3KEDDHSA to induce ocular irritation was evaluated in New Zealand White rabbits according to OECD TG 405. A single dose of 100 mg of the test substance in its original form was introduced into the left conjunctival sac of three animals. The right eye was not treated and served as control. Ocular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration. The mean values of the scores for chemosis, redness of the conjunctiva, iris lesions and corneal opacity were calculated for each animal. The interpretation of results was carried out according to the classification criteria laid down in the Regulation (EC) No. 1272/2008 (CLP).
Slight conjunctival reactions (very slight or slight chemosis, very slight redness of the conjunctiva and clear discharge) were observed in all animals on day 1 (day of application). A very slight chemosis persisted in 2/3 animals on day 2 (24 -hour reading) and in 1/3 animals on day 3 (48 -hour reading). No lesions were observed on day 3 (72 -hour reading). No other ocular reactions were noted during the study. Mean scores calculated for each animal over 24, 48 and 72 hours were 0.7, 0.3 and 0.0 for chemosis, 0.0, 0.0 and 0.0 for redness of the conjunctiva, 0.0, 0.0 and 0.0 for iris lesions and 0.0, 0.0 and 0.0 for corneal opacity. The mean scores for 2 out of 3 animals do not exceed trigger values for classification and labelling defined in the CLP. The test substance Fe3KEDDHSA is considered to be not irritating to eyes.
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