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Diss Factsheets
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EC number: 216-760-3 | CAS number: 1658-56-6
- 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 skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The following data were obtained for the Similar Substance 01. It is expected that the Target Substance will present similar skin sensitising profile. Justification for Read Across is given in Section 13 of IUCLID.
In order to evaluate the skin allergenic potential of the test item, a Local Lymph Node Assay (LLNA) was performed according to the OECD Guideline No. 429 (2002). Three dose levels from 2.5 to 100 % of test item in the vehicle (ethanol/water (50/50, v/v)) and the vehicle alone as negative control were administered to sixteen female CBA/J allocated to four groups of four animals each.
The calculated Stimulation Index were 1.1 at the two low doses and 1.59 at the high dose. Thus, the test item should not be considered as a skin sensitizer under the experimental conditions and according to the followed OECD Guideline No. 429.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
SKIN SENSITISATION
In the CLP Regulation (EC) No 1272/2008 a skin sensitizer is defined as “a substance that will lead to an allergic response following skin contact”. A substance classified as skin sensitiser (Category 1) may be allocated to one of the two sub-categories 1A or 1B in accordance with the criteria given in Annex I, Part 3, Table 3.4.2.
In case of animal tests, for the LLNA (OECD TG 429) the skin sensitisation potency is measured as a function of the derived EC3-values. The EC3-value is the amount of test chemical (% concentration, molar value or dose per unit area) required to elicit a stimulation index of 3 in the standard LLNA (Kimber et al. 2003). Further details are given in the corresponding OECD Test Guideline: the decision process regards a result as positive when stimulation index ≥ 3, together with consideration of dose response and where appropriate, statistical significance.
Based on the available experimental results obtained in LLNA test performed, the stimulation index values were in all dose groups < 3. Considering the aforementioned, no classification for skin sensitization is warranted under the CLP Regulation (EC) No 1272/2008.
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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