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EC number: 915-335-6 | CAS number: -
- 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
Not reactive in DPRA (OECD TG 442C, GLP)
Negative in KeratinoSens (OECD TG 442D, GLP)
Non sensitising up to 25% in LLNA (OECD TG 429, GLP)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In vitro: DPRA
An OECD guideline 442C study, Direct Peptide Reactivity Assay (DPRA), following GLP was used to assess the reactivity and sensitizing potential of the test substance. Solutions of the test substance were successfully analyzed by the validated DPRA analytical method in both the Cysteine and Lysine containing synthetic peptides. There was no to minimal reactivity of both peptides in the presence of the test substance. With an overall depletion of peptide of 0.370% (0.74% and -0.0280% for cysteine and lysine, respectively), the reactivity of the test substance is henceforth classified as “no or minimal” therefore the DPRA prediction is negative.
In vitro: KeratinoSens
An in vitro KeratinoSens (ARE-Nrf2 luciferase reporter) assay was performed in accordance with OECD guideline 442D, following GLP, to assess the skin sensitising potential of the test substance. Two independent experiments were performed. Test concentrations ranged from 0.98 to 2000 μM. Cinnamic aldehyde was used as a positive control. The Imax for the test substance was 1.19 in test 1 and 1.15 in test 2. The Imax for both tests was <1.5 fold compared to the DMSO control and therefore the EC1.5 could not be calculated. The IC30 value was 168.73 μM in test 1 and 153.68 μM in test 2 and the IC50 values were 193.79 μM and 183.52 μM in tests 1 and 2, respectively. Graphs showed no overall dose-response for luciferase induction. All acceptance criteria for the positive control, cinnamic aldehyde, were met. It was concluded that the test substance gave a negative response in the KeratinoSens.
Both of the performed in vitro/in chemico tests (DPRA and KeratinoSens) were negative. Based on the negative results in the two tests, the overall conclusion of the in vitro/in chemico tests is that the test substance has no skin sensitizing potential in accordance with Bauch et al., (2012).
Animals
In a local lymph node assay, performed according to OECD Guideline 429 and GLP, four groups of 4 CBA/Ca female mice were treated on the dorsal surface of both ears once per day for 3 days with 0.5, 1, 2.5, 10, or 25% (w/v) of the test substance or the vehicle alone (ethanol/diethylphthalate in a ratio of 1:3). Exposure to the test substance at 0.5, 1, 2.5, 10 and 25% (w/v) resulted in stimulation indices of 0.9, 0.8, 0.8, 0.9, and 1.4. Therefore, the test material is considered to be a non-sensitiser up to 25% under the conditions of the test.
Human
In four studies with human volunteers in which concentrations were tested of 4 to 10%, no sensitising effects were observed.
Overall conclusion
The negative DPRA and KeratinoSENS lead to the conclusion that Dimyrcetol is negative for sensitisation. This is supported with an LLNA up to 25% not showing skin sensitisation, despite not tested up to 100%,
Reference
Bauch, C., Kolle, S.N., Ramirez, T., Eltze, T., Fabian E., Mehling, A., Teubner, W., van Ravenzwaay, B., Landsiedel, R., 2012, Putting the parts together: Combining in vitro methods to test for skin sensitizing potentials, Regul. Toxicol. Pharmacol., 63, 489–504.
Justification for classification or non-classification
The substance is not a skin sensitiser and therefore it does not need to be classified for skin sensitisation according to EU CLP (EC 1272/2008 and its amendments).
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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