Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Description of key information
Skin sensitisation:
In a K2 local lymph node assay in the mouse according to SPL Standard Test Method 595.13, the substance is observed to be not sensitising to the skin (Sanders, 2005).
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:
- 2005-10-24 to 2005-11-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- 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)
- Specific details on test material used for the study:
- no data
- 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
- 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
- Positive control results:
- see 'Any other information on results incl. tables'
- 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. - 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.
- 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 (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)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In order to assess the cutaneous allergenic potential of the substance, a local lymph node assay in the mouse was performed. Following a preliminary sighting test, at which there were no signs of systemic toxicity at a concentration of 50% w/w in dimethyl sulphoxide, three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in dimethyl sulphoxide at concentrations of 50%, 25% and 10% w/w. Clinical signs and mortality were observed during 6 days after administration of the substance with observations pre-dosing and 1 hour postdosing on days 1, 2 and 3. Individual body weights were measured on days 1 and 6 and body weight changes were calculated.
The stimulation index, calculated based on the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control groups, was lower than 3 at each test concentration which means no positive results have been observed. Therefore, T002078 was considered to be a non-sensitiser to the skin under the conditions of the test. In addition, no signs of systemic toxicity have been observed.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation:
Based on the study results and the criteria of the CLP Regulation, the test item is not regarded as a potential skin sensitiser.
Respiratory sensitisation:
No data were available to decide on the classification for respiratory sensitisation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.