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EC number: 248-742-6 | CAS number: 27939-60-2
- 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 sensitisation: The substance is a skin sensitizer 1B, though an EC3 could not exactly be derived; NOEC was derived of 5% in an LLNA (OECD TG 429)
Skin sensitisation in an HRIPT test: At 1% non-sensitising
Respiratory sensitisation: No adverse effects observed
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The available data on skin sensitisation on Vertoliff is summarized below.
Vertoliff: OECD TG 429 (LLNA)
The skin sensitisation potential of the test substance has been tested using the Local Lymph Node Assay (LLNA) according to OECD TG 429, EPA OPPTS 870.2600 and GLP. The application of the test substance at concentrations of 1, 2.5, 5, 10 and 25% (v/v) in ETOH/DEP (1:3) resulted in SI indexes of 2.1, 2.0, 2.9, 4.2 and 2.7, respectively. At 10% the SI is > 3 and therefore the substance is considered a skin sensitizer. An EC3 is difficult to estimate because of the absence of a dose response when tested up to 25%. The 25% result, however, may be confounded due to skin irritation. A NOEC can be derived, which is set at 5% (SI 2.9).
Vertoliff: HRIPT
An HRIPT test was performed with 1% test substance. 106 volunteers finished the study and they were exposed to 0.2 mL solution at 25 mm under occlusive conditions. The subjects removed the bandages 24 hours after application. The basic schedule was kept in the induction phase every Monday, Wednesday and Friday till 9 applications had been made. The test patch was applied to the same site each time, unless reaction to sample rendered this inadvisable, in which case the test patch was applied to a distant site. After two weeks a challenge patch was applied to a site not previously exposed and removed after 24 hours. Reactions to the challenge were assessed after 24, 72 and 96 hours. None of the 106 subjects tested was sensitized by the sample. In addition, for one subject who showed a mild and transient response, a re-challenge was performed 6 weeks after the study. From occlusive, semi-occlusive and open application it was concluded that the substance is not associated with an allergic dermatitis response. Under the conditions of the test 1% test substance was not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
This endpoint can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2015) that indicate respiratory reactions e. g. from consumer experience or occupational exposure. In case no such data are available, the respiratory sensitisation can be assessed using the integrated evaluation strategy for respiratory sensitisation data in the ECHA guidance (R7A, Fig. 7.3-2, 2015). Based on this strategy, Vertoliff is not a respiratory sensitizer, because it is not a di-isocyanate, it does not have any other structural alerts (like acid anhydride or platinum salt, etc.) and there are no other reasons to suppose potential respiratory sensitization hazard of Vertoliff.
Justification for classification or non-classification
According to EU CLP (EC No. 1272/2008 and its amendments), the substance is classified as a skin sensitiser category 1B (May cause an allergic skin reaction, H317). The substance is not a respiratory sensitiser in absence of human data indicating such effects which is according to EU CLP (EC No. 1272/2008 and its amendments) and following the ECHA guidance.
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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