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EC number: 441-420-8 | CAS number: 113889-23-9
- 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: no skin sensitiser based on testing in OECD TG 406
Respiratory sensitisation: the substance is not considered a respiratory sensitiser in absence of human data and in absence of skin sensitisation in animals.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In addition to the GPMT test also a HRIPT test is available showing absence of effects at 100%.
A Guinea Pig Maximisation Test (GPMT) was performed according to OECD guideline 406 to determine the sensitisation potential of the substance. Intradermal induction was performed with 5% Cyclobutanate in arachis oil BP, epicutaneous induction with 100% test material and epicutaneous challenge with 100 and 75% concentrations.
After induction injection discrete/patchy moderate and confluent erythema was noted at the intradermal induction sites of test and control group animals. Discrete or patchy erythema was also noted after topical induction of test group animals on the induction sites. Bleeding from intradermal injection sites was noted in 9 test group animals after 1 hour. The control animals showed discrete or patchy erythema at topical induction site.
At challenge, 8 and 0 out of 20 test group animals (100% Cyclobutanate) showed a positive skin reaction at the 24 and 48 hour reading. For the control group, this was 1 and 0 out of 10. In the 75% Cyclobutanate group, 6 and 0 out of 20 animals responded positive. In the control group 2 and 0 positive skin reactions were observed.
Under the conditions of this study, a positive skin reaction was seen in 8 out of 20 guinea pigs 24 hours after challenge. These reactions were not considered sensitising, as they were not apparent after 48 hours (sensitisation rate: 0%).
Based on these results, Cyclobutanate is considered to be non-sensitising to the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Respiratory sensitisation can be assessed using human data such as indicated in R7.3.5.2 of the ECHA guidance (2017) 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. 7.3-4, 2017), which says that if the substance is not a skin sensitiser, it is unlikely to be a respiratory sensitiser.
Justification for classification or non-classification
The substance is not a skin sensitizer in the Guinea Pig Maximisation Test (OECD guideline 406) and therefore does not need to be classified for skin sensitisation according to EU CLP (EC No. 1272/2008 and its amendments). Consequently, Cyclobutanate is unlikely to be a respiratory sensitiser and it does not have to be classified as such.
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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