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EC number: 477-470-2 | 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-11-20 to 2007-11-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- April 2002
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 477-470-2
- EC Name:
- -
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Reaction product of tetraethylsilicate, ethylpolysilicate, dioctyltinoxide, methanol and benzoic acid
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- New Zealand White Hsd If:NZW
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: not specified
- Weight at study initiation: 2.6 - 2.7 kg
- Housing: ABS-plastic rabbit cages, floor 4200 cm2
- Diet (ad libitum): Altromin 2123 maintanenance diet for rabbits, specific pathogen-free
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Microbiological status: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL
- Duration of treatment / exposure:
- not applicable, no washing;
lids were gently hold together for 1 sec - Observation period (in vivo):
- 72 h
- Number of animals or in vitro replicates:
- 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: no
SCORING SYSTEM: according to Draize (1944)
Endpoint Description Range
Cornea degree opacity and ulcerations 0–4
Iris swelling, hyperaemia 0–2
Conjunctivae redness, vessel discernibility 0–3
Chemosis swelling, lids closed/open 0–4
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Animal No. 1 showed redness (grade 1), discharge (grade 2) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness and chemosis (grade 1) were observed. After 48 h, redness (grade 1) was observed. After 72 h, no symptoms were obseved. Thus, the changes were fully reversible within 72 hours post instillation.
Animals No. 2 and 3 showed redness (grade 1) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness (grade 1) was observed. After 48 h, no symptoms were obseved. Thus, the changes were fully reversible within 48 hours post instillation.
The scores were (conjuctivae, chemosis, cornea opacitiy, iris):
Animal 1: (0.67; 0.33; 0; 0)
Animal 2: (0.33; 0 ;0; 0)
Animal 3: (0.33; 0 ;0; 0) - Other effects:
- There were no significant body weight changes during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Considering the reported data of this irritation study, it can be stated that the test item produced slightly irritating, but no corrosive effects in the eyes of rabbits. All signs of irritation were fully reversible.
- Executive summary:
The skin irritation potential of the test item was assayed in an in vivo eye irritation study according to OECD 405 in three female New Zealand White rabbits (HsdIf:NZW). 0.1 mL of the test item was instilled in the lower conjuctival sac of one eye of each animal, the untreated contralateral eye served as control. The animals were observed for 72 h for ocular lesions in the cornea, iris and conjuctivae.
Observations were scored and compared to the control eyes 1, 24, 48 and 72 h post-dose. The test item showed slightly irritant, but no corrosive effects on the eyesof 3 rabbits.
Animal No. 1 showed redness (grade 1), discharge (grade 2) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness and chemosis (grade 1) were observed. After 48 h, redness (grade 1) was observed. After 72 h, no symptoms were obseved. Thus, the changes were fully reversible within 72 hours post instillation.
Animals No. 2 and 3 showed redness (grade 1) as well as chemosis of the conjuctivae (grade 1) 1 h after instillation of the test item. 24 h post-treatment redness (grade 1) was observed. After 48 h, no symptoms were obseved. Thus, the changes were fully reversible within 48 hours post instillation.
The scores were (conjuctivae, chemosis, cornea opacitiy, iris): (0.67; 0.33; 0; 0) for animal 1, (0.33; 0 ;0; 0) for animal 2 and (0.33; 0 ;0; 0) for animal 3.
There were no significant body weight changes during the observation period. Further, no corneal lesions were found in any animal at the final reading.
The test item was concluded to be slightly irritant to the eye, with full reversibility.
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