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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | 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
Skin corrosion:
A K1, GLP-compliant in vitro skin corrosion study was performed according to OECD guideline 431 and EU Method B.40 (K1, Warren, 2014b). The substance was considered not to be classified for skin corrosion.
Skin irritation
A K1, GLP-compliant in vitro skin irritation study was performed according to OECD guideline 439 and EU Method B.46 (K1, Warren, 2014a). The substance was considered not to be classified for skin irritation.
Eye irritation:
A K1, GLP-compliant eye irritation study was performed according to OECD guideline 437 (K1, Warren, 2015). The substance was considered not irritant to eyes and should not be classified for eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In vitro skin irritation:
Warren (2014a) studied skin irritation using the EPISKIN TM reconstructed human epidermis model in a K1, GLP compliant study. The substance was applied topically to triplicate tissues for an exposure period of 15 minutes. 10 µl (26.3 µl/cm²) of the test item (undiluted) was applied to the epidermis surface. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT to a soluble, coloured, formazan product. The prediction model uses the percentage viability values (compared to negative control viability) to identify irritant and non-irritant substances. The relative mean viability of the test item treated tissues was 90.4% after a 15-minute exposure period and 42 hours post-exposure incubation period. The substance is considered not to be classified for skin irritation.
In vitro skin corrosion:
Warren (2014b) studied skin corrosion using the EPISKINTM reconstructed human epidermis model. Duplicate tissues were treated with the substance for exposure periods of 3, 60 and 240 minutes. 50 µl of the test item was applied topically. The cell viability was determined by mitochondrial dehydrogenase activity, assessed by the reduction of MTT to a soluble, coloured, formazan product. The optical density was measured (quantitative viability analysis) at 562 nm (without a reference filter). The corrosivity potential of the test item was predicted form the relative mean tissue viabilities obtained after the 3, 60 and 240 -minute exposure periods, compared to the mean of the negative control tissues treated with 0.9% w/v sodium chloride solution. The relative mean viabilities of the test item treated tissues were:
- 240 minutes exposure: 108.1%;
- 60 minutes exposure: 143.9%;
- 3 minutes exposure: 129.1%.
The substance is considered not to be classified for skin corrosion.
Eye irritation:
Warren (2015) investigated eye irritation by an in vitro bovine corneal opacity-permeability (BCOP) assay (K1, GLP). 0.75 ml of the substance (as supplied) was applied for 10 minutes followed by an incubation period of 120 minutes. Both opacity and permeability were measured and the resulting objective values were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The corneas treated with the test item were clear post treatment and post incubation. An in vitro irritancy score of 0.9 was calculated. Based on the results (IVIS < 3), the substance is considered not irritant to eyes and should not be classified for eye irritation.
In vivo skin irritation
A key study is available for acute dermal toxicity. LD50 was determined in this study to be >2000 mg/kg bw (based on active ingredient). According to the REACH Regulation, no in vivo skin irritation study needs to be conducted if the key acute dermal toxicity study does not indicate skin irritation up to the limit dose level (2000 mg/kg bw) (column 2, annex VIII, section 8.1.1). In addition, the results of the in vitro skin irritation test (K1, GLP, Warren, 2014) showed a relative mean viability of test item treated tissues of 90.4% after 15 min exposure period and 42 h post-exposure incubation period. Therefore, it is not necessary to perform an in vivo skin irritation study with the substance.
In vivo eye irritation
A key in vitro eye irritation study (BCOP) is available. The test item is considered not to be classified (IVIS score < 3) for eye irritation. Based on the OECD TG 437 guideline, no in vivo eye irritation study is required for the substance.
Justification for selection of skin irritation / corrosion endpoint:
Reliable skin irritation study
Justification for selection of eye irritation endpoint:
Only one reliable study is available.
Justification for classification or non-classification
Based on the results of the skin irritation/corrosion and eye irritation studies and according to the criteria of the CLP Regulation, the substance should not be classified for skin irritation/corrosion and eye irritation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.