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EC number: 254-337-5 | CAS number: 39186-58-8
- 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 sensitization
In a Local Lymph Node Assay (LLNA) in mice (CBA/Ca strain) according to OECD Guideline 429, the substance is observed to be non-sensitising to the skin (Sanders, 2004). An in vitro or in chemico skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study (intiated before October 11th, 2016) is available.
Respiratory sensitization
No study is available to assess the potential for respiratory sensitisation.
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:
- from 2004-02-23 to 2004-03-10
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: SPL Standard Test Method 595.12
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- This 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:
- No further details available
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Vehicle:
- dimethylformamide
- Concentration:
- 0 (vehicle alone), 5, 10, and 25 % w/w
- No. of animals per dose:
- 4 animals per dose group
- Details on study design:
- RANGE FINDING TESTS: Preliminary sighting tests were performed at concentrations of 25 and 50 % w/w. No details on the results were provided in the study report.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay - The assay determined the level of lymphocyte proliferation in lymph nodes draining the application site of the test substance. Determination of lymphocyte proliferations was quantified by measuring the incorporation of radiolabelled thymidine in the dividing lymph node cells. The proliferations 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)
- Criteria used to consider a positive response: Stimulation Index (test substance to control ratio) of greater than 3.0 indicated a positive response.
TREATMENT PREPARATION AND ADMINISTRATION: Following preliminary sighting tests, three groups, each of 4 animals, were treated with 50 µl of the test substance (25 µL per ear) as a solution in dimethyl formamide. A further group was treated with the vehicle 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
- Positive control results:
- See field 'Any other information on results incl. tables'
- Parameter:
- SI
- Value:
- 1.35
- Test group / Remarks:
- 5% w/w (based on a group of 4 animals)
- Parameter:
- SI
- Value:
- 1.23
- Test group / Remarks:
- 10% w/w group (based on a group of 4 animals)
- Parameter:
- SI
- Value:
- 1.11
- Test group / Remarks:
- 25% w/w group (based on a group of 4 animals)
- Cellular proliferation data / Observations:
- No further details available.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was considered to be a non-sensitiser under the conditions of the test up to a concentration of 25 % (w/w).
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Referenceopen allclose all
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)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Sanders (2004) investigated the skin sensitization potential of T000625 following topical application to the dorsal surface of the ear of CBA/Ca mice. Primary lymphocyte proliferation was assessed during the sensitizing (induction) phase of the response. Following a preliminary sighting test at which there were no signs of systemic toxicity at a concentration of 50%, three groups, each of four animals, were treated with 50 µL of the test item (25 µL per ear) as a solution in dimethyl sulphoxide at concentrations of 10%, 25% and 50% w/w in in dimethyl
formamide. A further group of four animals was treated with dimethyl formide alone. The following stimulation index (SI) values were observed: at 5% concentration: 1.35 (negative result), at 10% concentration: 1.23 (negative result), and at 25%: 1.11 (negative result).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitization
The test item was considered to be non-sensitizing under the conditions of the test, up to a concentration of 25% (w/w). The substance does not have to be classified as a skin sensitizer, according to the criteria laid down in the CLP Regulation No 1272/2008.
Respiratory sensitization
No data were available to decide on the classification for respiratory sensitization.
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.
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