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EC number: 696-577-7 | CAS number: 34335-10-9
- 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:
- key study
- Study period:
- 22 December 2008 to 15 January 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study undertaken at GLP accredited laboratory to internationally recognised guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- ECOPROMOTE
- IUPAC Name:
- ECOPROMOTE
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report):ECOPROMOTE
- Substance type: inorganic
- Physical state: powder
- Analytical purity: 99%
- Lot/batch No.: 7279
- Storage condition of test material: Room temperature and dark storage
- Other: date of receipt December 09 2008.
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 4 weeks
- Weight at study initiation: 278 to 292 g
- Housing: Stainless steel cages
- Diet (e.g. ad libitum): The animals could freely access pellet food RC4 (Lot No. 081I1I, Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): Tap water supplied by the local government was filtered through a 5-1J.Dl cartridge filter and was offered ad libitum from the automatic watering system.
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21.4 to 24.2°C
- Humidity: 43.6 to 62.6%
- Air changes: 17 air changes / hr
- Photoperiod (hrs dark / hrs light): Artificial lighting, with a sequence of 12 hours on (between 6:00 a.m. and 6:00 p.m.) and 12 hours off
IN-LIFE DATES: From: 22 December 2008 To: 14 January 2009
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction;
for intradermal induction of sensitization, 0.1 mL each of the following formulations were injected to 2 sites in the neck of each animal: A, an emulsion of equal volumes of Freund's complete adjuvant (PCA) and physiological saline; B, a 0.3 w/v% test substance formulation (vehicle: liquid paraffin); C, an emulsion of equal volumes of a 0.6 w/v% test substance formulation (vehicle: FCA) and physiological saline.
For induction of sensitization by direct contact, a 2 x 4-cm piece of lint impregnated with 0.2 mL of a 40 w/v% the test substance formulation (vehicle: liquid paraffin) was applied to the intradermal injection sites on Day 7 and close contact was maintained for 48 hours.
For challenge, on Day 21 after the start of induction of sensitization, the cloth of an adhesive tape for patch tests impregnated with 0.1 mL of 40, 10, 3, 1, 0.3 or' 0.1 w/v% test substance formulation. (vehicle: liquid paraffin) was applied directly to the lateral . abdominal region ofeach animal and close con.tact was maintained for 24 hours.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- Induction;
for intradermal induction of sensitization, 0.1 mL each of the following formulations were injected to 2 sites in the neck of each animal: A, an emulsion of equal volumes of Freund's complete adjuvant (PCA) and physiological saline; B, a 0.3 w/v% test substance formulation (vehicle: liquid paraffin); C, an emulsion of equal volumes of a 0.6 w/v% test substance formulation (vehicle: FCA) and physiological saline.
For induction of sensitization by direct contact, a 2 x 4-cm piece of lint impregnated with 0.2 mL of a 40 w/v% the test substance formulation (vehicle: liquid paraffin) was applied to the intradermal injection sites on Day 7 and close contact was maintained for 48 hours.
For challenge, on Day 21 after the start of induction of sensitization, the cloth of an adhesive tape for patch tests impregnated with 0.1 mL of 40, 10, 3, 1, 0.3 or' 0.1 w/v% test substance formulation. (vehicle: liquid paraffin) was applied directly to the lateral . abdominal region ofeach animal and close con.tact was maintained for 24 hours.
- No. of animals per dose:
- A total of 15 animals were used. The test groups consisted ofthe sensitization induction group receiving the test substance (10 animals) and its control group (5 animals).
- Details on study design:
- RANGE FINDING TESTS: this test substance was shown to be non-irritating when applied directly and close contact was maintained
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 21 days
- Test groups: 1
- Control group: 1
- Site: neck
- Frequency of applications: 1
- Duration: 21 days
- Concentrations: 0.3 to 0.6 % w/v
B. CHALLENGE EXPOSURE
- No. of exposures: 6
- Day(s) of challenge: 21d
- Exposure period: 1 day
- Test groups: 1
- Control group: 1
- Site: abdomen
- Concentrations: 40, 10, 3, 1, 0.3 or 0.1 w/v%
- Evaluation (hr after challenge): 24 and 48 hours - Challenge controls:
- For challenge, on Day 21 after the start of induction of sensitization, the cloth of an adhesive tape for patch tests impregnated with 0.1 mL of 40, 10, 3, 1, 0.3 or' 0.1 w/v% test substance formulation. (vehicle: liquid paraffin) was applied directly to the lateral . abdominal region ofeach animal and close con.tact was maintained for 24 hours. Skin reactions were evaluated 24 and 48 hours after removal of the patches applied for
challenge. - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3 to 0.6 % w/v
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 to 0.6 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 40, 10, 3, 1, 0.3 or' 0.1 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40, 10, 3, 1, 0.3 or' 0.1 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 40, 10, 3, 1, 0.3 or' 0.1 w/v%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40, 10, 3, 1, 0.3 or' 0.1 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, it was concluded that this test substance had no sensitization potential.
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