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Diss Factsheets
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EC number: 605-047-6 | CAS number: 156157-97-0
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-study according to OECD guideline 429 (Skin sensitisation: Local Lymph Node Assay)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- yes
- Remarks:
- one dead animal in the vehicle group on theday of preparation
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- The pure active substance was used.
Purity: 99%
Batch number: Catena-08-183
Production date: 16.05.2008
Expiry date: 05.2009
Storage: Closed vessel at room temperature in the dark
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- Test system: Mice, CBA/CaOlaHsd
Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
Age: 8 - 12 weeks (beginning of treatment)
Body weight: 18.8 - 23.6 g
Identification: Single caging. The animals were distributed into the test groups at random and identified by cage number.
Acclimatisation: At least 5 days prior to the start of dosing under test conditions after health examination. Only animals without any visible
signs of illness were used for the study.
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:deionised water (7+3)
- Concentration:
- 10, 25, 50%
- No. of animals per dose:
- 5
- Details on study design:
- Number of animals for the pre-test: 2 females
Number of animals for the main study: 20 females
Number of animals per group: 5 females (nulliparous and non-pregnant)
Number of test groups: 3
Number of control (vehicle) groups: 1 - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- The mean values and standard deviations were calculated for the body weight in the groups.
Results and discussion
- Positive control results:
- concentration SI
5% 1.78
10% 1.84
25% 4.87
EC3: 15.7%
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: Test substance 10%: 1.05 Test substance 25%: 0.85 Test substance 50%: 0.74
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Background I: 23 Background II: 24 Control group: 3243 Test substance 10%: 4244 Test substance 25%: 3462 Test substance 50%: 3003
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The substance is not a skin sensitiser.
- Executive summary:
In the study the test substance dissolved in ethanol:deionised water (7+3) was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 10, 25, and 50 %.
The animals did not show any clinical signs during the course of the study and no cases of local irritation or test item related mortality were observed. One animal of the vehicle control group (animal 1) was found dead on the day of preparation.
In this study Stimulation Indices (S.I.) of 1.05, 0.85, and 0.74 were determined with the test item at concentrations of 10, 25, and 50 % in ethanol:deionised water (7+3), respectively.
The test item TEAP was not a skin sensitiser in this assay.
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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