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EC number: 947-453-9 | CAS number: -
- 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:
- other: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- study performed on the analogue substance; the read across justification is detailed in section 13. The Reliability of the Source Study is 2.
- Justification for type of information:
- Justification for read-across is detailed at section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Real Decreto 363/1995 of 10 March
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Real Decreto 1078/93 of 2 July
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Similar Substance 01
- IUPAC Name:
- Similar Substance 01
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Housing: Tecniplast inox cages.
- Diet: 150 g per day standard diet.
- Water: tap water; ad libitum.
- Acclimation period: 7 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2°C
- Humidity: 55 ± 25 %
- Air changes: 15 ACH
- Photoperiod: 12 hours dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.1 g fine powder.
- Observation period (in vivo):
- at 1, 24, 48 and 72 hours and at 7, 14 and 21 day after application.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM:
Cornea
Opacity: degree of density
No ulceration or opacity........................................................................................... 0
Scattered or diffuse areas of opacity .................................................................... 1
Easily discernible translucent area, details of iris slightly obscured........................2
Nacrous area, no details of iris visible, size of pupil barely discernible.................. 3
Opaque cornea, iris not discernible through the opacity..........................................4
Iris
Normal...................................................................................................................... 0
Markedly deepened rugae, congestión, swelling ................................................... 1
No reaction to light, hemorrhage, gross destructlon (any or all of these) ...............2
Conjunctivae - redness
Blood vessels normal ...............................................................................................0
Some blood vessels definitely hyperemic (injected) ................................................1
Diffuse, crimson color, individual vessels not easily discernible............................. 2
Diffuse beefy red......................................................................................................3
Conjunctivae - chemosis
No swelling............................................................................................................... 0
Any swelling above normal (includes nictitating membranes)..................................1
Obvious swelling with partial eversión of lids.......................................................... 2
Swelling with lids about half closed .........................................................................3
Swelling with lids more than half-closed...................................................................4
TOOL USED TO ASSESS SCORE: hand-slit lamp.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- other: 3/3 animals
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- other: 3/3 animals
- Time point:
- 24/48/72 h
- Score:
- < 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- other: 2/3 animals
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- not fully reversible within: 21 days
- Remarks:
- At rabbit #2 and #3, on 21th day, was given a conjunctival redness score of 1.
- Irritation parameter:
- chemosis score
- Basis:
- other: 2/3 animals
- Time point:
- 24/48/72 h
- Score:
- >= 2
- Reversibility:
- fully reversible
Any other information on results incl. tables
Mean values for cornea, iris, conjunctiva at 24, 48 and 72 hours.
Rabbit #1 | Rabbit #2 | Rabbit #3 | Mean | |
Corneal opacity | 1 | 1 | 1 | 1 |
Iritis | 0 | 0.67 | 1 | 0.55 |
Conjunctival redness | 2 | 2.67 | 3 | 2.55 |
Conjunctival oedema | 0.67 | 3 | 3.67 | 2.44 |
Individual findings - Rabbit #1 | |||||||
1 h | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | 21 days | |
Corneal opacity | - | 1 | 1 | 1 | 0 | 0 | 0 |
Iritis | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
Conjunctival redness | 3 | 2 | 2 | 2 | 2 | 1 | 0 |
Conjunctival oedema | 2 | 1 | 1 | 0 | 0 | 0 | 0 |
Individual findings - Rabbit #2 | |||||||
1 h | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | 21 days | |
Corneal opacity | 0 | 1 | 1 | 1 | 0 | 0 | 0 |
Iritis | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Conjunctival redness | 0 | 3 | 3 | 2 | 2 | 2 | 1 |
Conjunctival oedema | 3 | 4 | 3 | 2 | 1 | 0 | 0 |
Individual findings - Rabbit #2 | |||||||
1 h | 24 hrs | 48 hrs | 72 hrs | 7 days | 14 days | 21 days | |
Corneal opacity | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
Iritis | 0 | 1 | 1 | 1 | 1 | 0 | 0 |
Conjunctival redness | 0 | 3 | 3 | 3 | 2 | 2 | 1 |
Conjunctival oedema | 3 | 4 | 4 | 3 | 2 | 1 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified as Eye Irrit. 2 according to the CLP Regulation (EC 1272/2008).
- Conclusions:
- The substance is classified as Eye Irrit. 2 under the Regulation EC 1272/2008 (CLP).
- Executive summary:
The test was performed according to the Real Decreto 363/1995.
The eye irritation potential was investigated by instillation of the equivalent of 0.1 g/animal of the test substance. The scores of each animal at the reading times of 24, 48 and 72 hours was used in calculating the respective mean values for each type of lesion, as stated by the Regulation EC 1272/2008 (CLP).
Scores for corneal opacity and iritis were lower than the threshold value of 1 for 3/3 rabbits.
Scores for conjunctival redness and oedema were higher than the threshold value of 2 in 2/3 rabbits.
Every type of lesion was fully reversible within 21 days except the conjunctival redness response, which was identified in 2/3 rabbits on the 21th day of the test (graded as 1 according to the used scoring system).
From the present results the substance should be classified as corrosive to the eyes because the produced effects were not fully reversible within 21 days. However, the following considerations should be underlined.
Since the study did foresee the rising of eyes after the application of the test item in its solid form, the results of the test can be considered as an overestimation of the true irritating effects strictly related to the substance chemical/toxicological properties. Indeed, due to the intrinsic irritating nature of dusty materials, this overestimation is true especially for the conjunctival redness response and the fact that this lesion was not fully reversible within 21 days can be attributed to the lack of eye rinsing. Moreover, from the individual scoring of each animal, it can be observed a progressive reduction of this lesion, suggesting that the effect will most likely not be persistent.
For the above mentioned reason, the substance does not meet the criteria for classification as Eye Damage 1. Instead, a classification as Eye Irrit 2, under the Regulation EC 1272/2008 (CLP), is warranted.
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