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EC number: 281-682-9 | CAS number: 84012-38-4 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Ruscus aculeatus, Liliaceae.
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: Draize, J.H. Dermal Toxicity. Appraisal of Safety of Chemicals in Foods, Drugs and Cosmetics. 46-59; 1959
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Buehler, E.V. Delayed contact hypertensensitivity in the guinea pigs. Arch. Dermat. 91:171-175; 1965
- Deviations:
- not specified
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was performed in 1980
Test material
- Reference substance name:
- Ruscus aculeatus, ext.
- EC Number:
- 281-682-9
- EC Name:
- Ruscus aculeatus, ext.
- Cas Number:
- 84012-38-4
- Molecular formula:
- not applicable
- IUPAC Name:
- Ruscus aculeatus, ext.
- Test material form:
- solid
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, open
- Vehicle:
- water
- Concentration / amount:
- 50% (w/v)
- Day(s)/duration:
- 24
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #10
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- water
- Concentration / amount:
- 50% (w/v)
- Day(s)/duration:
- 2
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Positive control substance(s):
- yes
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50% (w/v)
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.15% (w/v)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.15% (w/v)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Clinical observations.
No deaths occurred and all animals appeared normal throughout the study
Dermal responses
Individual dermal responses at 24 and 48 hours after administration of the challenge dose. For both group of animals treated with Rusco (induction plus challenge application and challenge application only) no erythema or edema was noted at 24 and 48 hours after administration of the challenge dose. Among the ten animals received the challenge dose of DNCB (1-chloro-2,4-dinitrobenzene Lot N° D9A, very slight erythema was noted in one animal at 24 hours while no dermal reaction were seen at 48 hours postdose. Among the ten animals exposed to both the induction and challenge doses of DNCB, very slight to well defined erythema was noted in all animals at 48 hours and in all but one animal at 48 hours following application of the challenge dose. No edema was noted in any animals exposed to DNCB. Because no delayed hypersensitization was noted in the animals exposed to Rusco, the test material was not considered a sensitizing agent in guinea pigs.
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