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EC number: 254-935-6 | CAS number: 40470-68-6
- 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Adopted: 22 July 2010
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- 4,4'-bis(2-methoxystyryl)-1,1'-biphenyl
- EC Number:
- 254-935-6
- EC Name:
- 4,4'-bis(2-methoxystyryl)-1,1'-biphenyl
- Cas Number:
- 40470-68-6
- Molecular formula:
- C30H26O2
- IUPAC Name:
- 4,4'-bis(2-methoxystyryl)-1,1'-biphenyl
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: 4,4'-bis(2-methoxystyryl)-1,1'-biphenyl
- IUPAC name: 1-[(E)-2-(2-methoxyphenyl)ethenyl]-4-{4-[(E)-2-(2-methoxyphenyl)ethenyl]phenyl}benzene
- Molecular formula: C30H26O2
- Molecular weight: 418.53 g/mol
- Smiles notation: COC1=CC=CC=C1/C=C/C2=CC=C(C3=CC=C(/C=C/C4=CC=CC=C4OC)C=C3)C=C2
- InChl: 1S/C30H26O2/c1-31-29-9-5-3-7-27(29)21-15-23-11-17-25(18-12-23)26-19-13-24(14-20-26)16-22-28-8-4-6-10-30(28)32-2/h3-22H,1-2H3/b21-15+,22-16+
- Substance type: Organic
- Physical state: Solid
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: AnLab, Prague, Czech Republic
- Females nulliparous and non-pregnant: yes
- Microbiological status of animals, when known:
- Age at study initiation: 10-11 weeks
- Weight at study initiation: Not available
- Housing: The animals were housed in IVC polycarbonate cages (5 animals per cage) suspended on stainless steel racks
- Diet: ad libitum
- Water: tap water, supply of drinking water was unlimited
- Acclimation period: 6 days
- Indication of any skin lesions: Animals were healthy, without visible signs of disease.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 50 - 60 %
- Air changes (per hr): Equipped with central air-conditioning
- Photoperiod (hrs dark / hrs light): 12-hour light / 12-hour dark cycle
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- the test item at three concentrations (25%, 50% and 100% w/v)
- No. of animals per dose:
- The doses were selected from the concentration series 100%, 50%, 25%, 10%, 5%, 2.5% etc. according to OECD Guideline No. 429.
The starting concentration was determined according to pre-screen test result.
Number of animals:
5 females – negative control (vehicle)
5 females – positive control
15 females – test item
4 females - pre-screen test, plus spare animals - Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: soluble
- Irritation: all mice (2 mice/group) were observed daily at the application site.
- Systemic toxicity: all mice (2 mice/group) were observed daily at the application site.
- Ear thickness measurements: measured by a calliper on Day 1 (pre-dose), Day 3 and Day 6
- Erythema scores: observed daily at the application site.
MAIN STUDY
- Name of test method: Clinical Observations, Body Weights, Lymph Node Proliferation
ANIMAL ASSIGNMENT AND TREATMENT: Criteria used to consider a positive response: excessive local skin irritation is indicated by an erythema score ≥ 3 and/or an increase in ear thickness of ≥25%.
TREATMENT PREPARATION AND ADMINISTRATION: Preparation of solutions, Dose Preparation and Dose Administration, Preparation of cell suspensions - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- For calculation of mean, S.D. and t-test values of body weights MS Excel was used.
Results and discussion
- Positive control results:
- body weight: 20.39 to 20.81 (from Initial body weight to Terminal body weight);
The daily clinical observation of the animals did not show visible clinical signs of toxicity;
SI values: 6.63* (*Calculated with corresponding control value of 1475 DPM);
The lymph node weight: 0.0642g.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.81
- Test group / Remarks:
- 100 % (w/v) test substance / test item
- Key result
- Parameter:
- SI
- Value:
- 0.91
- Test group / Remarks:
- 50 % (w/v) test substance / test item
- Key result
- Parameter:
- SI
- Value:
- 0.71
- Test group / Remarks:
- 25 % (w/v) test substance / test item
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
: The DPM values for the three treated groups were 742 (25%), 944 (50%) and 914 (100%), respectively.
DETAILS ON STIMULATION INDEX CALCULATION : The SI values for the three treated groups were 0.71 (25%), 0.91 (50%) and 0.81 (100%), respectively.
EC3 CALCULATION : The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. was not greater than the threshold value of 3.
CLINICAL OBSERVATIONS: The daily clinical observation of the animals did not show visible clinical signs of toxicity.
BODY WEIGHTS: The mean body weight of the negative control group, positive control group and the three test item treated groups are shown in below:
20.42 to 20.37 (negative control: from Initial body weight to Terminal body weight)
20.39 to 20.81 (positive control: from Initial body weight to Terminal body weight)
22.44 to 22.58 (25%: from Initial body weight to Terminal body weight)
20.37 to 20.39 (50%: from Initial body weight to Terminal body weight)
19.56 to 19.63 (100%: from Initial body weight to Terminal body weight)
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item 4,4´-bis(2-methoxystyryl)-1,1´-biphenyl is not considered a skin sensitizer under the test conditions of this study.
- Executive summary:
The sensitization potential of4,4´-bis(2-methoxystyryl)-1,1´-biphenylwas evaluated using the Local Lymph Node Assay (LLNA). The LLNA has been developed to determine the allergic contact sensitization potential of chemicals.
Based on the recommendations of the OECD Guideline 429, the test item was suspended in Acetone/Olive Oil, 4:1 (v/v). The positive control (a-Hexylcinnamic aldehyde) (25%) was dissolved in the same vehicle.
The Pre-screen testwas performed using the dose of 100 %. Based on the observations recorded in the Pre-screen tests, the concentration of 100 % was selected as top dose for the main test.
Five female mice (CBA/Ca) per group were topically exposed (dorsum of both ears) to the test item at concentrations of 25%, 50% and 100%, to the positive control and to the vehicle only. Lymphocyte proliferation was measured using incorporation of radioactive125I-iododeoxyuridine and 10-5M fluorodeoxyuridinein the draining lymph nodes. The radioactive incorporation was expressed as disintegrations per minute (DPM)/pooled treatment group and compared with DPM value from the vehicle control group and expressed as the Stimulation Index (SI).
After application of the test itemat three concentrations (25%, 50% and 100% w/v) the animals did not show visible clinical symptomsof either local irritation or systemic toxicity.
In this study the Stimulation Indices (SI) of0.71, 0.91 and 0.81 were determined with the test item at concentrations of 25%, 50%, and 100% inAcetone/Olive Oil 4:1, respectively. The EC3 value could not be calculated, since none of the tested concentrations induced a SI greater than the threshold value of 3.
The test item4,4´-bis(2-methoxystyryl)-1,1´-biphenylis not considered a skin sensitizer under the test conditions of this study.
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