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EC number: 304-038-1 | CAS number: 94233-08-6
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From December 17 to 20, 2018
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The batch tested is a commercial product
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 2002
- GLP compliance:
- yes
Test material
- Reference substance name:
- Cobalt diammonium EDTA
- IUPAC Name:
- Cobalt diammonium EDTA
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy (breeder: Harlan France S.A.R.L., Z.I. Le Malcourlet - R.N.9, 03800 Gannat, France)
- Age at study initiation: 9 to 11 weeks old
- Weight at study initiation: 1.87 to 2.34 kilograms
- Housing: grid-bottomed metal cages suspended over trays measuring 45x51x69 cm
- Diet (e.g. ad libitum): STANRAB (P) SQC, Special Diets Services, Witham, Essex CM8 3AD, UK ad libitum troughout the study
- Water (e.g. ad libitum): drinking water supplied to each cage via a water bottle ad libitum
- Acclimation period: at least 10 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr): approximately 15 to 20 air changes per hour
- Photoperiod (hrs dark / hrs light): artifcial (fluorescent tubes), daily light/dark cycle of 12112 hours
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml - Duration of treatment / exposure:
- few seconds
- Observation period (in vivo):
- at allocation; approximately 1, 24, 48 and 72 hours alter treatment.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure:
SCORING SYSTEM:
Con junctivae Value
1) Reddening of the palpebra) and bulbar conjunctivae
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected) 1
Diffuse, crimson colour, individuai vessels not easily discernible 2
Diffuse, beefy red 3
2) Chemosis of the lids andlor nictitating membrane
No swelling 0
Any swelling above normal (including nictitating membranes) 1
Obvious swelling with partial eversion of the lids 2
Swelling with lids about half closed 3
Swelling with lids more than half closed 4
3) Discharge (Lachrymation)
No discharge 0
Any amount different from normal (does not include small amount observed in
inner canthus of normal animals) 1
Discharge with moistening of the lids and hair just adjacent to the lids 2
Discharge with moistening of the lids and hair for a considerable area around the
eye 3
Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of
these or combination of any thereof, iris stili
reacting to light (sluggish reaction is positive) 1
No reaction to light, haemorrhage, gross destruction (any or all of these) 2
Cornea
1) Degree of opacity (area most dense taken for reading)
No ulceration or opacity 0
Scattered or diffuse area of opacity (other than slight dulling of normal lustre),
details of iris clearly visible 1
Easily discernible translucent area, details of iris slightly obscured 2
Nacreous area, no details of iris visible, size of pupi) barely discernible 3
Opaque cornea, iris not discernible through the opacity 4
2)Area of cornea involved
One quarter (or less) but not zero 1
Greater than one quarter, but less than half 2
Greater than half, but less than three quarters 3
Greater than three quarters, up to whole area 4
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein
not specified
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- Not eye irritant
- Executive summary:
Method
The acute eye irritation of the test item was investigated in rabbits, according to the OECD guideline 405.
A 0.1 ml aliquot of the test item was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed 1, 24, 48, and 72 hours after dosing.
Results
No irritation at either the conjunctivae, iris or cornea (score of O) was recorded in any treated animai during the whole observation period (72 h). There was no indication of a systemic effect of treatment.Changes in body weight were not remarkable.
Conclusion
These results indicate that the test item has no effect on the eye of the rabbit.
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