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EC number: 602-791-3 | CAS number: 122584-18-3
- 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:
- 2005-10-24 to 2005-11-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- limited information on test item, test animals and test conditions
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test Method 595.13.
- 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:
- N-[(2-bromo-5-hydroxy-4-methoxyphenyl)methyl]-N-[2-(4-hydroxyphenyl)ethyl]formamide
- Cas Number:
- 122584-18-3
- Molecular formula:
- C17H18BrNO4
- IUPAC Name:
- N-[(2-bromo-5-hydroxy-4-methoxyphenyl)methyl]-N-[2-(4-hydroxyphenyl)ethyl]formamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): JNJ-28645409-AAA (T002078)
- Physical state: solid (powder)
- Appearance: White, brown grey powder
Constituent 1
- Specific details on test material used for the study:
- 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
- Weight at study initiation: 18-23 grams
ENVIRONMENTAL CONDITIONS: no data
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- as a solution in dimethyl sulphoxide at concentrations of 50%, 25% and 10% w/w
A further group of four animals was treated with dimethyl sulphoxide alone. - No. of animals per dose:
- four/dose group
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: no data
- Irritation: no data
- Lymph node proliferation response: no data
- Systemic toxicity: Following a preliminary sighting test, no signs of systemic toxicity were observed at a concentration of 50% w/w in dimethyl sulphoxide.
- Ear thickness measurements: no data
- Erythema scores: no data
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Criteria used to consider a positive response: Test-to-control ratio greater than 3.0 indicates a positive result.
TREATMENT PREPARATION AND ADMINISTRATION:
- 50 uL (25 uL per ear) of the test substance as a solution in dimethyl sulphoxide at concentrations of 50%, 25% and 10% w/w was applied to the dorsal surface of the ear.
- A further group of four animals was treated with dimethyl sulphoxide alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS): 1%, 10%, 20% v/v in 1% pluronic L92 in distilled water
- Statistics:
- no data
Results and discussion
- Positive control results:
- see 'Any other information on results incl. tables'
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.31
- Test group / Remarks:
- 10% (w/w) in dimethyl sulphoxide
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 25% (w/w) in dimethyl sulphoxide
- Parameter:
- SI
- Value:
- 1.15
- Test group / Remarks:
- 50% (w/w) in dimethyl sulphoxide
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DPM/node obtained by dividing the DPM value by 8 (total number of lymph nodes)
vehicle: 1248.42
10% (w/w) group: 1440.78
25% (w/w) group: 1377.83
50% (w/w) group: 1632.01
DETAILS ON STIMULATION INDEX CALCULATION
The Stimulation Index (SI) was expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group
EC3 CALCULATION
Not applicable (SI < 3.0)
CLINICAL OBSERVATIONS:
no signs of systemic toxicity
BODY WEIGHTS
The mean body weight gain shown by the animals over the study period was considered to be normal.
Any other information on results incl. tables
Positive Control Local Lymph Node Assay in the Mouse (2005)
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
04/03/2005 |
10/03/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
acetone/olive oil 4:1 |
2.76, 3.34, 8.91 |
Positive |
20/04/2005 |
26/04/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
ethanol/distilled water |
2.64, 8.36, 12.94 |
Positive |
14/07/2005 |
20/07/2005 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
1% pluronic L92 in distilled water |
0.86, 1.50, 6.17 |
Positive |
14/07/2005 |
20/07/2005 |
2,4 Dinitrobenzene sulphonic acid, sodium salt (DNBS) |
1%, 10%, 20% v/v |
1% pluronic L92 in distilled water |
1.16, 9.59, 20.71 |
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:
- GHS criteria not met
- Conclusions:
- The test item was considered to be a non-sensitiser to the skin under the conditions of the test.
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