Registration Dossier
Registration Dossier
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EC number: 240-457-5 | CAS number: 16409-43-1
- 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 (Bühler equivalent to OECD TG 406): not skin sensitizing (RIFM 1993)
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In the chosen key study, a Buehler test equivalent to OECD guideline 406 was conducted with male and female Hartley guinea pigs. For induction, a 0.3 ml aliquot of 50% rose oxide in diethyl phthalate (DEP) was placed under occlusion to the clipped left shoulder for 6 hours. This procedure was repeated at the same site, once a week for the next 2 weeks, until a total of 3 exposures were applied. After a 2-week rest period, 0.5, 1.5, and 5% test substance in DEP were applied to previously untreated sites for 6 hours under occlusion. No skin sensitization was observed for rose oxide under the chosen testing conditions (RIFM 1993).
Three studies with human volunteers from secondary sources with limited information are available. In an RIPT, 9 dermal applications for induction and 1 challenge application of 1.25 % rose oxide in ethanol resulted in 0/40 sensitization reactions (IFF 1964). Ten dermal induction applications followed by a single dermal challenge application of 5% rose oxide in dimthylphtalate resulted in dermal reactions in 5/51 volunteers (Givaudan 1965). The relevance of the observed skin reactions for skin sensitization cannot be assessed. In a human maximization test, application of 2% rose oxide in petrolatum did not result in skin sensitization reactions in 25 volunteers (Kligman 1978).
Overall, based on the key study (Bühler test in guinea pigs) and the majority of scarcly reported human test data, rose oxide is found to show no skin sensitization potential.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
no data available
Justification for classification or non-classification
The present data on dermal sensitization do not fulfill the criteria laid down in 67/548/EEC and CLP, and therefore, a non-classification is warranted.
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