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EC number: 471-170-5 | 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 (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 2, 2004 to February 2, 2005
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The study was conducted in accordance with the “Principles of Biological Safety Evaluation of Medical Devices (Pharmaceutical and.Food Safety Bureau, Japanese Ministry of Health, Labour and Welfare, Notification lyakushinhatsu No.0213001,Feb. 13,2003), and Memorandum Iryokiki-shinsa No. 36,March 19, 2003.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Existing study
Test material
- Test material form:
- liquid
In vivo test system
Test animals
- Species:
- other: Guinea pig: Hartley, (Std: Hartley, clean)
- Strain:
- Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:Japan SLC
- Age at study initiation: 4 weeks old
- Weight at study initiation:374--435g
- Housing:The animals were housed in metal hanging cages with a metal, mesh bottom(260W× 380D× 200 H mm).Three or two animals were
housed in cach cage during the quarantine period and then individually from the day of grouping.
- Diet (e.g. ad libitum):pellet feed(RC4,Oriental Yeast)
- Water (e.g. ad libitum): drinking water(Hadano city water)ad libitum.
- Acclimation period: # days not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C):21.O to 25.O C
- Humidity (%): 45-75%
- Air changes (per hr): 15 ACH
- Photoperiod (hrs dark / hrs light):12-hour light/12-hour dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: acetone
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
10% w/v FM0411M olive oil
Concentration of test material and vehicle used for each challenge:
10%, 1%, 0.1%, 0.01% and 0.l00% w/v FM0411M acetone solutio
n
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: acetone
- Concentration / amount:
- Concentration of test material and vehicle used at induction:
10% w/v FM0411M olive oil
Concentration of test material and vehicle used for each challenge:
10%, 1%, 0.1%, 0.01% and 0.l00% w/v FM0411M acetone solutio
n
- No. of animals per dose:
- Number of animals in test group: 10
Number of animals in negative control group: 5 - Details on study design:
- maximization test- 1st induction phase (day 1) Freund complete adjuvant and 10 w/v% of test substance olive oil solution injected intradermally at the interscapular region. On day 9, 2nd induction phase, 10 w/w % sodium lauryl sulfate (SLS) was topically applied without covering in interscapular region. On day 10, 10 w/v% of test substance in polive oil was topically applied in same region for 48 hours, occlusive covering. For challenge phase, the test concentration of the test substance in acetone solution and acetone were topically applied for 24 hours with occlusive dressings ( day 22). The challenge sites were observed for 24 and 48 hours after removal of the patches an dressing and their appearence was evaluated using the classification system in Draize's method.
- Positive control substance(s):
- yes
- Remarks:
- Chloro-2,4-dinitrobenzene[DNCB]
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- .1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: .1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- .1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: .1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 %. No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Maximum concentration not causing irritating effects in preliminary test: 10 %
Signs of irritation during induction:
There were no signs of irritation.
Evidence of sensitisation of each challenge concentration:
There was no evidence of any sensitisation reaction at any
of the concentrations tested. No eythema or oedema was
observed at 24 and 48 hours after removal of the dressing
and patches. In addition, the same animals did not show any
reaction to the vehicle control challenge.
All animals in the positive control showed evidence of a
sensitisation reaction to the positive control substance
when challenged at 0.1% and 0.01%.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- The test substance exhibited no skin senstization potency in guinea pigs under conditions of this study.
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