Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-773-6 | CAS number: 1009-93-4
- 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 2016-01-27 to 2016-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Although the study was terminated, it was conducted according to an appropriate OECD test guideline, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- Preliminary study
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- An LLNA study was not performed because the test method is not considered to be suitable for substances that contain silicon. Please refer to the attached document for further details.
Test material
- Test material form:
- liquid
- Details on test material:
- - State of aggregation:
- Particle size distribution:
- Mass median aerodynamic diameter (MMAD):
- Geometric standard deviation (GSD):
- Shape of particles:
- Surface area of particles:
- Crystal structure:
- Coating:
- Surface properties:
- Density:
- Moisture content:
- Residual solvent:
- Activation:
- Stabilisation:
- Other:
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: undergoes hydrolysis in water
- Solubility and stability of the test substance in the solvent/vehicle: soluble in acetone
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Crl: HA
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Housing: kept in groups in Terluran - cages on Altromin saw fibre bedding
- Diet: autoclaved hay and to Altromin 3122 maintenance diet for guinea pigs, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10 x / hour
- Photoperiod (hrs dark / hrs light): 12/ 12
Study design: in vivo (non-LLNA)
- No. of animals per dose:
- 25, 50, 75, 100 % : 2 animals
0.5, 1.0 %: 1 animal
2.5, 5.0 %: 1 animal - Details on study design:
- RANGE FINDING TESTS: a solubility test was performed to define the maximum concentration which is technically applicable to the animals. The substance was soluble in the vehicle, acetone, at a concentration of 75%.
Different concentrations of the test item were applied topically to the flanks of the animals for 6 hours using occlusive dressing to determine the concentration for the main study.
2 animals were treated topically with concentrations of 100% and 50% of the test item (dissolved in dried acetone) on the left flank and of 75% and 25% of the test item (dissolved in dried acetone) on the right flank for 6 hours.
1 animal was treated topically with a concentration of 1% of the test item (dissolved in dried acetone) on the left flank and with a concentration of 0.5% of the test item (dissolved in dried acetone) on the right flank for 6 hours.
1 animal was treated topically with a concentration of 5% of the test item (dissolved in dried acetone) on the left flank and with a concentration of 2.5% of the test item (dissolved in dried acetone) on the right flank for 6 hours. - Positive control substance(s):
- no
Results and discussion
Any other information on results incl. tables
Signs of systemic toxicity (tremor) and severe signs of irritation at the application sites (necrosis) were observed when 25, 50, 75 and 100% of test item were applied.
Erythema grade 2, which was unchanged 72 hours after patch removal was observed when 2.5 and 5.0% of the test item were applied. Erythema grade 1, which was fully reversible within 72 hours after patch removal was observed when 0.5 and 1.0% of test item were applied.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Systemic signs of toxicity and severe irritation (necrosis) were observed in animals treated with high doses of test substance, while grade 1 or 2 erythema was observed in animals treated with lower doses. The study was terminated due to adverse effects observed during the preliminary study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.