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EC number: 274-581-6 | CAS number: 70356-09-1
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Comparable to guideline study with deficiencies in reporting.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- : no grading but only sensitisation-positive animals were reported.
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed in 1982.
Test material
- Reference substance name:
- 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione
- EC Number:
- 274-581-6
- EC Name:
- 1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione
- Cas Number:
- 70356-09-1
- Molecular formula:
- C20H22O3
- IUPAC Name:
- 1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione
- Test material form:
- solid
- Details on test material:
- - Name of test material : BMDBM
- Substance type: organic
- Physical state: solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Institute of biological research, Fuellingsdorf, Switzerland
- Weight at study initiation: 300 - 450 g
- Housing: Type 3 wire mesh cages
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2 °C
- Humidity (%): 45 ± 10 %
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Induction
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: 2-phenylethanol
- Concentration / amount:
- Induction:
day 0: 5 % in FCA
day 8: 20 % in 2-phenylethanol
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 2-phenylethanol
- Concentration / amount:
- Challenge:
day 21: 20 % and 6 % in 2-phenylethanol
- No. of animals per dose:
- Experimantal group: 20 animals
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
On day 0, each of the 20 animals received 2 intradermal injections of either the test item, FCA, or FCA + test item. On day 8, occlusive topical application of the test item for 2 days was performed.
- Site: neck
B. CHALLENGE EXPOSURE
On day 21, an occlusive patch with the test item (20 % and 6 %) in 2-phenylethanol was applied for 24 h.
- Site: flank
- Evaluation: 24 and 48 h after removing the patch - Positive control substance(s):
- no
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- other: mean of two readings after 24 and 48h
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 6 % and 20 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Reading:
- 1st reading
- Group:
- negative control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The occlusive challenge with BMDBM, 20 % and 6 % in 2-phenylethanol 3 weeks after the initial injections does not elicit allergic reactions in guinea pigs. As the number of positive results is 0 in a group of 20 treated animals, no classification as skin sensitiser is needed.
- Executive summary:
The occlusive challenge with BMDBM, 20 % and 6 % in 2-phenylethanol 3 weeks after the initial injections does not elicit allergic reactions in guinea pigs.
As the the number of positive results is 0 in a group of 20 treated animals, no classification as skin sensitising according to GHS and CLP is needed.
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