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EC number: - | 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:
- September 4 to November 6, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Details on test material:
- - Analytical purity: 99%
- Lot No.: 08-018
- Storage condition of test material: room temperature (permissible range: 10-30°C, actual values: 18.1-25.3°C ) in light-shielded and air-tight container)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc.
- Age at study initiation: 8 weeks
- Weight at study initiation: 19.6-23.2g (av.21.3g)
- Housing: polycarbonate cages (W220*D325*H130)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.3-22.0
- Humidity (%): 55.5-61.3
- Air changes (per hr): 6-20 times
- Photoperiod (hrs dark / hrs light): 12 hours/12 hours
IN-LIFE DATES: From: September 10, 2008 To: September 22, 2008
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 1, 5 and 20 w/v%
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: maximum 20 w/v% suspension
- Irritation: not observed
- Lymph node proliferation response:
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method:
- Criteria used to consider a positive response: Stimulation Index Value (Sample group Mean Value/Vehicle group Mean Value) >3
TREATMENT PREPARATION AND ADMINISTRATION:
Auricular application
-Dose volume: 25μL per ear (total 50 μL)/day
-Treatment: application to dorsum of each ear with a micropipette
-Frequency: once daily for 3 consecutive days
Radioisotope
-Dose volume: 250 μL/body (radioactivity level: 0.74MBq)
-Treatment: injection into the caudal vein at a rate of approx. 100 μL/sec. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- SI = 7.38
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 0.94
- Test group / Remarks:
- 1% (w/v)
- Parameter:
- SI
- Value:
- 1.05
- Test group / Remarks:
- 5% (w/v)
- Parameter:
- SI
- Value:
- 0.77
- Test group / Remarks:
- 20% (w/v)
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Negative control (vehicle): 968.2 Test substance 1 w/v %: 911.0 Test substance 5 w/v %: 1013.3 Test substance 20 w/v %: 750.0 Positive control (HCA): 7148.0
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Conclusions:
- Under the conditions of the test, the test substance was not considered to be sensitising
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.

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