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EC number: 253-649-9 | CAS number: 37743-18-3
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-10-28 to 2003-11-10
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test method 595.12
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was conducted in a facility operating to Good Laboratory Practice within the UK national GLP monitoring programme but the study report has not been audited by the QA unit. No formal claim of GLP compliance is made for this study.
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- EC Number:
- 253-649-9
- EC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Cas Number:
- 37743-18-3
- Molecular formula:
- C18H20NO.Br
- IUPAC Name:
- (dihydro-3,3-diphenyl-3H-furan-2-ylidene)dimethylammonium bromide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: no data
- Expiration date of the lot/batch: no data
- Purity test date: no data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING: No data
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol/distilled water 4:1
- Concentration:
- 5%, 10%, 25% w/w
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no systemic toxicity in a preliminary sightings test at 25%
- Lymph node proliferation response: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: SPL Standard Test Method 595.12
- Criteria used to consider a positive response: Test to control ratio greater than 3.0 indicates a positive result
TREATMENT PREPARATION AND ADMINISTRATION:
-3 groups of 4 animals were treated with 50 uL test material (25 uL per ear), in a solution of ethanol/distilled water 4:1, at 5, 10 and 25 %.
- Another group was treated with ethanol/distilled water 4:1 alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 2,4-dinitrobenzenesulfonic acid, sodium salt 1%, 10%, 20% v/v in 1% pluronic F-68 in distilled water
- Statistics:
- no data
Results and discussion
- Positive control results:
- see section Any other information on results incl. tables
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 2.21
- Test group / Remarks:
- 5 (% w/w)
- Remarks on result:
- other: Negative
- Parameter:
- SI
- Value:
- 6.15
- Test group / Remarks:
- 10 (% w/w)
- Remarks on result:
- other: Positive
- Parameter:
- SI
- Value:
- 11.01
- Test group / Remarks:
- 25 (% w/w)
- Remarks on result:
- other: Positive
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA: no data
DETAILS ON STIMULATION INDEX CALCULATION: see above
EC3 CALCULATION : 6%
CLINICAL OBSERVATIONS: no data
BODY WEIGHTS: no data
Any other information on results incl. tables
Positive Control Local Lymph Node Assay in the Mouse (2004)
Project Number |
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
039/687· |
29/04/2004 |
05/05/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
1.40, 2.23, 6.09 |
Positive |
039/688* |
29/04/2004 |
05/05/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
1.74, 2.20, 8.89 |
Positive |
039/719* |
14/10/2004 |
26/10/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
tetrahydrofuran |
1.97, 3.71, 7.82 |
Positive |
039/720* |
29/09/2004 |
05/10/2004 |
2,4‑Dinitrobenzenesulfonic acid, sodium salt |
1%, 10%, 20% v/v |
1% pluronic F-68 in distilled water |
1.03, 4.41, 13.55 |
Positive |
039/723* |
27/10/2004 |
02/11/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
10%, 25%, 50% v/v |
cottonseed oil |
1.52, 2.63, 5.07 |
Positive |
a= Ratio of test to control lymphocyte proliferation
b= Stimulation index greater than 3.0 indicates a positive result
* = Standard Test Method 595 (Pooled nodes)
·= Standard Test Method 599 (Individual nodes)
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- Based upon the data generated, an EC3 value of 6% was calculated. Therefore, the test substance was considered to be a sensitizer under the conditions of the test. The test substance is classified as category 1 based on criteria of CLP Regulation.
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