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Diss Factsheets
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EC number: 917-830-2 | CAS number: 1186514-91-9
- 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
non-sensitising
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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Guideline study under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- The animals were housed individually in plastic cages suspended on stainless steel racks, in a room equipped with central air-conditioning. The room temperature was within the range of 22 ±2°C, relative humidity was within the range of 55 ±10 %(1).The light regimen was set to a 12-hour light / 12-hour dark cycle.The sanitation was performed according to standard operation procedures.
Laboratory food Altromin was given ad libitum.
Water was provided ad libitum. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 100, 50 and 25%
- No. of animals per dose:
- 5 females –control (vehicle)
5 females –positive control
15 females –test substance
6 females -pre-screen test plus spare animals - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- 25% HCA resulted in a stimulation index of 6.23. This is within the historical control values for this laboratory and the positive control is considered valid.
- Key result
- Parameter:
- SI
- Value:
- >= 1.965 - <= 2.661
- Test group / Remarks:
- 25-100%
- Remarks on result:
- other: valid LLNA result: negative
- Remarks:
- Not sensitising
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was tested in the LLNA using the OECD 429 guideline, and found to be a non-sensitiser under the conditions of this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guideline LLNA test was performed prior to amendments of Regulation EC No. 1907/2006 discouraging in vivo testing for skin sensitisation. In the LLNA, the stimulation index (SI) of the highest dose administered (100%, undiluted) did not meet or exceed the sensitisation threshold (SI) of 3. Therefore, the substance is considered a non-sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The test substance was tested in the LLNA using the OECD 429 guideline, prior to the passage of amendments to Regulation EC No. 1907/2006 requiring non-animal testing as an initial approach. The LLNA clearly showed that the substance is evaluated to be a non-sensitiser. The criteria for classification as a dermal sensitiser according to Regulation EC No. 1272/2008 are not met. There is no indication that the substance is a respiratory sensitiser.
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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