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EC number: 413-330-9 | CAS number: 134724-55-3
- 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:
- 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- None
Test material
- Reference substance name:
- 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione
- EC Number:
- 413-330-9
- EC Name:
- 3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione
- Cas Number:
- 134724-55-3
- Molecular formula:
- C27H20O6
- IUPAC Name:
- 6-{4-[(oxolan-2-yl)methoxy]phenyl}-12-phenyl-4,10-dioxatricyclo[7.3.0.0^{3,7}]dodeca-1(12),2,6,8-tetraene-5,11-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- None
Constituent 1
- Specific details on test material used for the study:
- None
In vitro test system
- Details on the study design:
- None
In chemico test system
- Details on the study design:
- None
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS- Source: Charles river, Japan- Weight at study initiation: 306 - 420 g- Housing:aluminium cages- Diet (e.g. ad libitum): (GC-4, oriental Yeast Co.) ad libitum- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: 12 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 24 +- 2°C- Humidity (%): 55+-15%- Air changes (per hr): 10 times per hour- Photoperiod (hrs dark / hrs light): 12 hours light/dark cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction: a) 0,5 g of the test substance was added to small amounts of corn oil.Concentration of test material and vehicle used for each challenge: a) 0,5 g of the test substance was added to small amounts of corn oil
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- maize oil
- Concentration / amount:
- Concentration of test material and vehicle used at induction: a) 0,5 g of the test substance was added to small amounts of corn oil.Concentration of test material and vehicle used for each challenge: a) 0,5 g of the test substance was added to small amounts of corn oil
- No. of animals per dose:
- Number of animals in test group: 10Number of animals in negative control group: 10
- Details on study design:
- None
- Challenge controls:
- 0.5% DNCB in acetone- control animals were treated with acetone similarly
- Positive control substance(s):
- yes
- Remarks:
- 2,4 -dinitrochlorobenzene.
Results and discussion
- Positive control results:
- None
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- 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: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100%. No with. + reactions: 0.0. Total no. in groups: 10.0.
In vivo (LLNA)
- Cellular proliferation data / Observations:
- None
Any other information on results incl. tables
No skin reactions were observed in any D-523 treated animals during the induction period. 24 and 48 hours after the challenge application with D-523, any skin reactions were observed neither in the sensitised animals with D-523 nor in the D-523 control animals.
In the DNCB sensitised group, slight to moderate erythema and slight sweeling were observed in all animals after the second induction. Moderate erythema and slight to moderate swelling were observed in all animals after the third induction. 24 hours after the challenge application with DNCB, slight to moderate erythema and slight swelling were observed in all animals. Slight erythema was observed in all animals and slight swelling was observed in 3 animals 48 hours after challenge. No skin reactions were observed in the DNCB control group 24 and 48 hours after the challenge with DNCB. Thus, it was shown that DNCB was a definite skin sensitizer and that the test systems worked properly.
From the results, it was concluded that D-523 is not a skin sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance FAT 40554 is non sensitiser in animals.
- Executive summary:
A study was performed to determine the skin sensitisation potential of FAT 40554 in guinea pigs according to EU Method B.6 (Skin Sensitisation). Skin sensitisation test with D-523 was conducted in male guinea pigs by using Buehler's method.
A dose of 0.5g of the test material was topically applied for induction to the flank of each animal with a lint patch once a week, 3 times in total with the time interval of 1 week. 2 weeks after the last treatment, the animals were challenged with the test material in the same manner as the induction treatment. Any allergic reactions were not observed 24 and 48 hours after the challenge in the animals sensitised with the test material.
On the other hand, well defined skin reactions such as erythema and swelling were observed in the animals treated with a positive control, 2,4 -dinitrochlorobenzene.
Based on the above findings, it was concluded that D-523 is not a skin sensitiser.
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