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Diss Factsheets
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EC number: 700-636-5 | CAS number: 5413-49-0
- 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
Endpoint summary
Administrative data
Description of key information
non-skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The evaluation of the skin sensitisation potential of the substance was done by considering data on a similar substance due to the absence of available data on the substance itself. Justification for Read Across is given in Section 13 of IUCLID.
The study was performed to determine the sensitizing potential of the topically applied test substance according to the OECD guideline 429 and EPA OPPTS 870.2600 in compliance with GLP. The test substance concentrations used in the main LLNA study were chosen such that the maximum concentration tested was the highest achievable solution of the test substance in the vehicle, while avoiding both overt systemic toxicity and excessive local dermal-irritation. Concentrations of 25, 50 and 100 % (v/v) were chosen. Five animals per group were treated by topical application of the test substance concentrations, vehicle or positive control in the same manner as in the screen. A naive group of five animals was sham-treated. DMF was chosen as the vehicle, based on solubility.
Topical application of the test substances a 25 and 50 %(v/v) in the DMF vehicle, and at 100 % (v/v), resulted in SI values less than 3 (SI < 3.0). Therefore, the test substance is not a skin sensitizer in the LLNA.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC) No.1272/2008, Annex I: 3.4.2.2.3.2.the following categories for skin sensitisation classification apply:
Category 1
Substances shall be classified as skin sensitizers in category 1 where data are not sufficient for sub-categorisation in accordance with the following criteria:
(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or
(b) if there are positive results from an appropriate animal test.
Sub-category 1A
Substances showing a high frequency of occurrence in humans and/or a high potency in animals can be presumed to have the potential to produce significant sensitisation in humans. Severity of reaction may also be considered.
Specific criteria:
Local lymph node assay-EC3 value ≤ 2 %
Guinea pig maximisation test-≥ 30 % responding at ≤ 0.1 % intradermal induction dose or ≥ 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose
Buehler assay - ≥ 15 % responding at ≤ 0,2 % topical induction dose or ≥ 60 % responding at > 0.2 % to ≤ 20 % topical induction dose
Sub-category 1B
Substances showing a low to moderate frequency of occurrence in humans and/or a low to moderate potency in animals can be presumed to have the potential to produce sensitisation in humans. Severity of reaction may also be considered.
Local lymph node assay - EC3 value > 2 %
Guinea pig maximisation test- ≥ 30 % to < 60 % responding at > 0.1 % to ≤ 1 % intradermal induction dose or ≥ 30 % responding at > 1 % intradermal induction dose.
Buehler assay - ≥ 15 % to < 60 % responding at > 0.2 % to ≤ 20 % topical induction dose or ≥ 15 % responding at > 20 % topical induction dose.
The topical application of the test substances at 25 and 50 %(v/v) and at 100 % (v/v), resulted in SI values less than 3 (SI < 3.0); no EC3 was therefore determined. Based on the afore-mentioned criteria, the substance is not classified for skin sensitisation.
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