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EC number: 607-384-4 | CAS number: 244768-32-9
- 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
Endpoint summary
Administrative data
Description of key information
The skin sensitization potential of T002488 was determined with a Local
Lymph Node Assay in the mouse, performed according to the SPL Standard
Test Method 595.12. The test substance was deterimined to be not
sensitising to the skin under the conditions of the test.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-11-01 to 2004-12-07
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted following SPL Standard Test method 595.12.
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test Method 595.12
- Principles of method if other than guideline:
- The assay determines the level of lymphocyte proliferation in lymph nodes draining the application site of the test material. Determination of lymphocyte proliferation is quantified by measuring the incorporation of radiolabeled thymidine in the dividing lymph node cells. The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
- 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 had not been audited by the QA Unit. No formal claim of GLP compliance was made for the study.
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Janssen Pharmaceutica N.V.
- Expiration date of the lot/batch: No data
- Purity test date: No data
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: No data
- Stability under test conditions: No data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No data. - 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: 15 to 22 grams
- 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 - Vehicle:
- dimethylformamide
- Concentration:
- vehicle alone, 2.5%, 5% and 10% w/w
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Following a preliminary sighting test, no signs of systemic toxicity were observed at a concentration of 10% w/w.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA
- Criteria used to consider a positive response: a stimulation index of greater than 3.0
TREATMENT PREPARATION AND ADMINISTRATION:
- Three groups, each of four animals were treated with 50 µL (25µuL per ear) of the test substance as a solution in dimethyl formamide at concentrations of 2.5%, 5% and 10% w/w. A further group of four animals was treated with dimethyl formamide alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- other: 2,4 Dinitrobenzenesulfonic acid, sodium salt at 1%, 10%, 20% v/v in 1% pluronic F-68 in distilled water
- Statistics:
- No statistical analysis was used.
- Positive control results:
- see tables below
- Parameter:
- SI
- Value:
- 1.81
- Test group / Remarks:
- 4 animals in 2.5% w/w in DMF group
- Parameter:
- SI
- Value:
- 2.25
- Test group / Remarks:
- 4 animals in 5% w/w in DMF group
- Parameter:
- SI
- Value:
- 1.91
- Test group / Remarks:
- 4 animals in 10% w/w in DMF group
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
DPM:
- 2.5% = 11089.82 (1386.23/node)
- 5% = 13787.05 (1723.38/node)
- 10% = 11719.21 (1464.90/node)
- Vehicle Only = 6129.19 (766.15/node)
EC3 CALCULATION
- Not applicable
CLINICAL OBSERVATIONS:
-No mortality or clinical observations were observed.
BODY WEIGHTS:
- No unusualy changes in body weight were observed. - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be a non-sensitiser under the conditions of the test.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Positive Control Local Lymph Node Assay in the Mouse (2004)
Start Date |
Finish Date |
Test Material |
Concentration |
Vehicle |
Stimulation Indexa |
Classificationb |
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 |
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 |
14/10/2004 |
26/10/2004 |
α‑Hexylcinnamaldehyde, tech., 85% |
5%, 10%, 25% v/v |
tetrahydrofuran |
1.97, 3.71, 7.82 |
Positive |
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 |
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)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Following a preliminary sighting test, at which there were no signs of systemic toxicity at a concentration of 10% w/w, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl formamide at concentrations of 2.5%, 5% and 10% w/w. A further group of four animals was treated with dimethyl formamide alone.
The maximal simulation index (2.25) was obtained for the intermediate concentration tested on mice, equaling 5% w/w in dimethyl formamide.
Given these results, the substance T002488 was not considered to be a skin sensitiser under the conditions of the test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the skin sensitisation test and the criteria given in the CLP regulation, the test item should not be classified as skin sensitiser.
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