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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-11-12 to 2007-11-20
- 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:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 24th April, 2022
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 2004
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- New Zealand White Hsd If:NZW
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Age at study initiation: not specified
- Weight at study initiation: 2.1 - 3.4 kg
- Fasting period before study: overnight, after administration of the test item the food was withheld for for further 3- 4 h
- 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
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Remarks:
- 24 hours before the test, fur was removed from the dorsal area of the trunk by clipping.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h after patch removal
120 h after patch removal if symptoms present after 72 h - Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm2
- Type of wrap: gauze patch, held in place with non-irritating tape and fixed with semi-occlusive dressing.
REMOVAL OF TEST SUBSTANCE: not specified. It was stated that the test item was stuck to the application site
OBSERVATION TIME POINTS: 1, 24, 38 nd 72 h
SCORING SYSTEM: according to Draize (1944)
1. Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) ..................................................................................1
Well defined erythema ................................................................................................................ 2
Moderate to severe erythema .................................................................................................... 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema ........ 4
Maximum possible: 4
2. 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 mm) .......................................................................3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) ...............4
Maximum possible: 4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 120 h
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- Reversibility of any observed effect: changes fully reversible within 5 days
- Other effects:
- The test item showed slightly irritant, but no corrosive effects on the intact skin of 3 rabbits after a contact time of 4 h.
The scores for animals 1, 2 and 3 were (0.67, 1, 0.67) for erythema and (0, 0, 0) for edema.
Animals No. 1 and 3: All symptoms were fully reversible within 72 hours after removing the patch.
Animal No. 2: All syptoms were fully reversible within 120 hours after removing the patch.
There were no significant body weight changes during the contact and 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 showed slightly irritant effects, which were fully reversible.
- Executive summary:
The skin irritation potential of the test item was assayed in an in vivo skin irritation study according to OECD 404 in three New Zealand rabbits. 0.5 mL of the test item was applied per test side (dorsal area of the trunk), the untreated side served as control. The exposure period was 4 h. A semiocclusive dressing was used. The test sides were observed 1, 24, 48 and 72 h after patch removal for erythema and oedema.
The test item showed slightly irritant, but no corrosive effects on the intact skin of 3 rabbits after a contact time of 4 h. The scores for erythema and edema were (0.67, 0) for animal 1, (1, 0) for animal 2 and (0.67, 0) for animal 3.
Animals No. 1 and 3: All symptoms were fully reversible within 72 hours after removing the patch.
Animal No. 2: All symptoms were fully reversible within 120 hours after removing the patch.
There were no significant body weight changes during the contact and observation period.
The test item was concluded to be slightly irritant, with full reversibility.
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