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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 irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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 guideline
- 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:
- no
- GLP compliance:
- not specified
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
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 200, 2000, 5000 mg/kg
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 14 days
- Number of animals:
- 2 males and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: 10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: 10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: 10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 7/10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: 7/10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: 7/10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- edema score
- Basis:
- animal #4
- Time point:
- other: 7/10/14 d
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 d
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Method.
Upon receipt, the six rabbits of each sex were assigned to the following groups by computerized randomization process. The rabbits were acclimated to laboratory conditions for approximately two weeks prior to initiation of tretment.
Group1: 2 males and 2 females Dosage levels 200 mg/kg
Group2: 2 males and 2 females Dosage levels 2000 mg/kg
Group3: 2 males and 2 females Dosage levels 5000 mg/kg
Compound Administration.
Prior to initiation, the hair was closely clipped from the abdomen of each rabbit (area approximately 10% of the total body surface). Just prior to compound application, the skin of one-half of the animals in each group was abraded with minor incision which were sufficiently deep to penetrate the stratum corneum, but not deep enough to disturb the derma or to produce bleeding. The skin of the remaining rabbits was left intact. The skin was premoistened with physiological saline, and the appropriate amount of the test material was applied to the skin of each rabbit. The test material was held in contact with the skin for 24 hours by means of a nonabsorbent binder composed of polyethylene tubing and Coban elastic bandage. 24 hours following application, the binders were removed, the residual amount of the test material was estimated, and the exposure sites were wiped with gauze to preclude further exposure of the animals to the test material. The test material was administered dermally because potential human exposure is by dermal route.
Observations and records.
All of the rabbits were observed twice daily for mortality and signs of toxic and pharmacologic effects for 14 days.
Dermal responses were graded and scored on days 1, 3, 7, and 14 according to the system of Draize ( 1959).
Individual body weights were recorded prior to treatment, on day 7 and at termination.
Sacrifice and gross pathology.
At termination (Day 14) all surviving rabbits were sacrificed with T- Euthanasia Solution (Taylor Pharmacal Company, Decatur, Illinois) and necropsied; observations were recorded.
Applicant's summary and conclusion
- Interpretation of results:
- other: No classified
- Conclusions:
- Most of the test material applied to the exposure sites of each animal was found in situ at 24 hours postapplication. Very slight to well defined erythema was noted in all animals on Days 1, 3 and 7, while very slight edema was noted in all animals on Days 1 and 3. Compound adhering to the skin was observed on all animals on Days 1 and 3; blanching was noted in one male dosed at 5000 mg/kg on Days 1 and 3, and male dosed at 200 mg/kg on Day 3. Thickening of the skin was seen in one male dosed at 2000 mg/kg on Day 3. All animals in Days 7, one male and two females dosed at 2000 mg/kg and one animal of each sex dosed at 5000 mg/kg on Day 10, two females dosed at 2000 mg/kg and one animal of each sex dosed at 5000 mg/kg on Day 14 were noted to have epidermal scaling.
No gross pathology was observed in any of the test animals.
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