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Diss Factsheets
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EC number: 946-134-1 | CAS number: 164651-56-3
- 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 sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No studies on "Skin Sensitisation" are available for the substance in itself nevertheless, studies were conducted with an analogue molecule (Similar Substance 01). Further information are reported in the Read Across justification attached to section 13.
The potential of the test material to provoke delayed skin sensitization reactions was tested in a study conducted following the maximisation test described in the OECD guideline 406, EU method B.6 (Skin sensitisation).
The test was performed on 5 male and 5 female guinea pigs in the test group and 5 male guinea pigs in the control group.
Test article was first tested by intradermal injection in a pretest phase at 5 % in physiological saline; then several epidermal applications where performed using different concentrations of the substance on separate animals: 5, 10, 20, 30, 40 and 50 % in physiological saline were tested. 50 % was the highest possible concentration of the test article in physiological saline. The tested concentrations did not induce erythema reactions.
5 % and 50 % were the concentrations selected for the intradermal application and epidermal application respectively. After the first challenge application, reaction were observed in 40 % of the animals of the control group, therefore a second challenge, using a lower test article concentration and a new control group, was performed. 10 % was the new concentration of test article tested. After the second challenge test none of the control group animals showed skin reactions 24 and 48 hours after removing the dressing. In the test group 50 % and 70 % of the animals showed skin reactions after 24 and 48 hours after removing the dressing, respectively.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to CLP Regulation (EC 1272/2008), a substance has to be classified as Skin sensitiser Sub-category 1B if during a Guinea pig maximisation test the animals with a positive response are:
≥ 30 % to < 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose or
≥ 30 % responding at > 1 % intradermal induction dose
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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