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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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-10-22 to 2007-11-15
- 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 406 (Skin Sensitisation)
- Version / remarks:
- reported April 29, 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted: 24th April 2002
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Version / remarks:
- March 2003
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
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
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/Ca01aHSD
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelman GmbH, D-33178 Borchen
- Females nulliparous and non-pregnant: not specified
- Microbiological status of animals, when known: SPF
- Age at study initiation: 8 - 12 weeks old
- Weight at study initiation: 18 - 22 g
- Housing: Macrolon cages on Altromin saw fiber bedding
- Diet (ad libitum): Altromin 1324 maintanenance diet for rats and mice, specific pathogen-free
- Water (ad libitum): tap water
- Acclimation period: at least 5 days
- Indication of any skin lesions: not specified
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): at least 10
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25%, 50%, 100%
- No. of animals per dose:
- 5 animals per dose
- Details on study design:
- PRE-SCREEN TESTS
with 50% and 100%
- Compound solubility: yes
- Irritation: none at 50%, hair loss at 100%
- Systemic toxicity: none at 50%,
- Ear thickness measurements: below 30%
- Erythema scores: none
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Criteria used to consider a positive response: stimulation index equal to or greater than 3.0.
TREATMENT PREPARATION AND ADMINISTRATION:
Topical application of 25 µL of the test item was performed once daily over three consecutive days. - Statistics:
- EC3 value calculation was performed according to OECD 429.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- EC3
- Value:
- > 76
- Test group / Remarks:
- test item
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 25%
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- 50%
- Parameter:
- SI
- Value:
- 4.2
- Test group / Remarks:
- 100%
- Cellular proliferation data / Observations:
- CLINICAL OBSERVATIONS:
Please refer to "signs of toxicity". No other clinical signs were recorded in any of the animals.
BODY WEIGHTS
Weight development of all animals was within the expected range, which includes a weight loss of up to 2 g throughout the study. As the weight loss was observed in dosed animals only, test item relation cannot be excluded.
SIGNS OF TOXICITY
Animals treated with 100% of the test item showed hair los and clotted hair.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test item was concluded to be a skin sensitizer. A stimulation index (SI) of > 3 was recorded for a test item concentration of 100%, the EC3 value (derived by linear interpolation) was calculated to be at least 76%.
- Executive summary:
The test item was assayed for skin sensitizing properties in the Local Lymph Node Assay (LLNA) according to OECD 429. Based on the results of a preliminary study, test item concentrations of 25%, 50% and 100% were used. The vehicle was Acetone/Olive Oil (AOO).
Each mouse was treated by topical application of the prepared test item to the entire dorsal surface of each ear daily over three consecutive days.
Five days after the first topical application, all mice were injected intravenously with [3]H-methyl thymidine. Approximately 5 hours after the injection, all mice were sacrificied. The draining "auricular lymphnodes nodes" were excised.
A single cell suspension of the lymph nodes for each animal was prepared. The [3]H-methyl thymidine-incorporation was measured in a beta-counter and expressed as the number of disintgrations per minute (DPM). Determination of radioactivity was performed individually for each animal.
The proliferative response of lymph nodes was calculated as the ratio of [3]H-methyl thymidine- incorporation into lymph node cells of test group animals. A stimulation index (SI) of the test item/ negative control was calculated for each concentrtation.
Weight development of all animals was within the expected range, which includes a weight loss of up to 2 g throughout the study.
All animals tested with the 100% concentration showed hair loss and clotted hair. No other visible clinical symptoms were recorded at the daily clinical observation in any the animals.
SI-values of 2.1, 1.7 and 4.2 were calculated for 25%, 50% and 100% of the test item. The EC3 value (derived by linear interpolation) was calculated to be at least 76%.
The test item was concluded to be a skin sensitizer.
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