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Diss Factsheets
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EC number: 281-658-8 | CAS number: 84012-13-5 Extractives and their physically modified derivatives such as tinctures, concretes, absolutes, essential oils, oleoresins, terpenes, terpene-free fractions, distillates, residues, etc., obtained from Arctium lappa, Compositae.
- 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 (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21. Jan. 2004 - 2. April 2004
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP-Study. All data are given. However the tested test item contained additionally Glycerin (40%) which is used in that form in the final formulations in cosmetics.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- RCC
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Arctium lappa, ext.
- EC Number:
- 281-658-8
- EC Name:
- Arctium lappa, ext.
- Cas Number:
- 84012-13-5
- IUPAC Name:
- Arctium lappa, ext.
- Details on test material:
- - Name of test material (as cited in study report): Klettenextrakt (Sample ID: 12230)
- Physical state: Greenish liquid
- Expiration date of the lot/batch: 21-MAY-2004
- Stability under test conditions: stable under storage conditions
- Storage condition of test material: in original container at 5+-3°C, away from direct sunlight
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Herlan Netherlands, Horst, The Netherlands
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 16-24 g
- Housing: individually in Makrolon type-2 cages with standard softwood bedding
- Diet: Pellet standard Kliba 3433 rat/mouse maintenance diet, ad libitum
- Water: Community tap water, ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°C
- Humidity: 30-70%
- Air changes (per hr): 10-15
- Photoperiod: 12 hrs dark / 12 hrs light
Study design: in vivo (LLNA)
- Vehicle:
- other: ethanol:water (7:3 (v/v))
- Concentration:
- Pre-test: 5%, 10%, 25% and 50%
Main test: 1%, 5% and 25% (w/w) in ethanol:water, 7:3 (v/v)
Test item weighted and vehicle added. Dilutions prepared individually using magnetic stirrer. Test item formulations made freshly before each dosing occasion and not more than 4 hours prior to application. - No. of animals per dose:
- Pre-test: 2
Main-test: 16
Test groups: 3 (4 animals per group)
Control group: 1 (4 animals) - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations calculated for body weight.
Results and discussion
- Positive control results:
- The control substance was found to be a skin sensitizer and an EC3 value of 11.7% (w/v) was derived.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- 1% (w/w) / 4 animals per group
- Parameter:
- SI
- Value:
- 0.9
- Test group / Remarks:
- 5 % (w/w) / 4 animals per group
- Parameter:
- SI
- Value:
- 1.1
- Test group / Remarks:
- 25 % (w/w) / 4 animals per group
Any other information on results incl. tables
Incorporation of 3H-methyl Thymidine: no dose-response relation observed.
Viability/mortality: no deaths occurred
Clinical signs: no signs observed in any animals of control group, 1% and 5% concentration. In the 25% group, a slight ear erythema was observed at both dosing sites in all animals, persisting for a total of 3 days.
Body weight: in the normal range at all animals.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The tested test item contained additionally Glycerin which is used in that form in the final formulations in cosmetics. However the test should still be relevant for the REACH registration as
1. the registered substance is marketed in the formulation with 40% Glycerin only.
2. A sensitizising effect of the substance for registration can be excluded until a concentration of 15% in Ethanol:Water, 7:3 (v/v) because of the test item contained 40% Glycerin.
3. The test item is identical to the marketed mixture which is used in that way in the cosmetic industry directly.
4. No sensitizising effects were observed on humans through its use in cosmetics.
5. The relevant content of Arctiin of test item in this study is in the range of Arctiin contents of the substance for registration.
6.. The available study is sufficient to characterise the substance sensitisation potential.
The substance registered is considered not a skin sensitizer based on the results of the study according to OECD Guideline 429.
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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