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EC number: 258-649-2 | CAS number: 53585-53-8
- 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:
- 1994-11-08 to 1994-12-30
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Test was performed before REACH was inforce.
Test material
- Reference substance name:
- Dibenzylbenzene, ar-methyl derivative
- EC Number:
- 258-649-2
- EC Name:
- Dibenzylbenzene, ar-methyl derivative
- Cas Number:
- 53585-53-8
- Molecular formula:
- C21H20
- IUPAC Name:
- dibenzylbenzene, ar-methyl derivative
- Test material form:
- liquid
- Details on test material:
- Test was performed with dibenzyltoluene, new name: dibenzylbenzene, ar-methyl derivative
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Borchen, Germany
- Age at study initiation: young adults, no further details mentioned
- Weight at study initiation: 379 g (mean value)
- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage)
- Diet (e.g. ad libitum): Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 1994-11-08 To: 1994-11-11 (preliminary study)
From: 1994-11-29 To: 1994-12-30 (main study)
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- induction: 100 %
challenge: 100 %
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- induction: 100 %
challenge: 100 %
- No. of animals per dose:
- test animals: 20 (main experiment), 2 (pilot study), 3 (determination of challenge concentration)
control animals: 10 - Details on study design:
- RANGE FINDING TESTS:
Determination of the non-irritant concentration of the test substance on 2 animals with occlusive epicutaneous applications for 6 hours of test substance 5 %, 25 %, 50 % in maize germ oil and undiluted. Readings at 30 and 54 hours after application. In 3 additional animals the challenge concentration was determined with dermal application of test substance 5 %, 25 %, 50% in maize germ oil and undiluted.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: occlusive dermal applications for 6 hours, scoring at 30 hours after application
- Test group: receiving test substance (0.3 cm³/patch)
- Control group: receiving vehicle (0.3 cm³/patch)
- Site: left flanks
- Frequency of applications: induction on days 0, 7 and 14
- Duration: 3 weeks
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28
- Exposure period: occlusive dermal application for 6 hours
- Test groups: receiving test substance and vehicle (0.3 cm³/patch each)
- Control group: receiving test substance and vehicle (0.3 cm³/patch each)
- Site: right flanks (front: vehicle, back: test substance)
- Concentrations: 100 %
- Evaluation (hr after challenge): 30 and 54 hours after application
OTHER: none - Challenge controls:
- same treatment as test group animals
- Positive control substance(s):
- yes
- Remarks:
- 2-Mercaptobenzothiazole
Results and discussion
- Positive control results:
- To test the responsiveness of the used guinea-pig strain to 2-Mercaptobenzothiazole 20 test and 10 control animals were used. Any reactions, especially erythema and edema were 24, 48 and 72 hours evaluated after challenge. The highest concentration for application was 50% in vaseline. No positive control substance related systemic effects or changes in body weight gains were observed. The dermal treatments of the three induction phasesshowed no dermal irritations 30 hours p.a.. The challenge application resulted in erythema and edema in 4 test animals 30 hours p.a. at the application area of the positive control substance. A fifth animal showed dermal reactions 54 hours p.a.. In toto showed 25% of the test animals positive skin reactions, therefore the test strain was jugded to be sensitive in the Buehler test.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 30.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 54.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 30
- 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: 30.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 54
- 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: 54.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
RESULTS OF PILOT STUDY:
None of the test substance formulation did cause any skin irritations on the three animals in the preliminary test 30 and 54 hours after administration. The determination of the challenge concentration in the 4th week of the test on three untreated animals of the same age led to no signs of dermal irritation after administration of the 5, 25, 50 and 100 % test substance. On the basis of these results the undiluted test substance was specified for the induction phases and the challenge treatment in the main test.
RESULTS OF TEST
Sensitization reaction: no sensitising effects observed
Clinical signs: no systemic effects and no impairment of body weight gain due to the test substance were observed in the test and control animals
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In a standard guinea pig skin sensitisation assay according to Buehler no skin sensitisation was observed.
- Executive summary:
The skin sensitisation potential of Dibenzylbenzene, ar-methyl derivative was evaluated in an OECD guideline study according to Buehler. Under the conditions of the study the material is not a skin sensitizer.
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