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Diss Factsheets
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EC number: - | CAS number: -
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Avena Sativa leaf/stem extract
- IUPAC Name:
- Avena Sativa leaf/stem extract
Constituent 1
In vivo test system
Study design: in vivo (LLNA)
- Vehicle:
- other: purified water (Citoxlab Scantox A/S) and Pluronic® PE9200
- Details on study design:
- The methods used in this study were based on the OECD guideline 429 ”Skin Sensitisation: Local Lymph Node Assay” adopted on 22 July 2010. The CBA/Ca mouse was selected as the test model, according to this guideline.
As EXT. AQ. CONC. PLANTULE AVOINE is a hydrophilic substance, 1% Pluronic® PE9200 was added to dose formulations to ensure maximum exposure in the animals.
Prior to the conduction of the main study (LLNA) a sighting study (irritation/toxicity screen) was performed, to determine the highest dose concentration tolerated in the animals.
The maximum dose for the sighting study was determined based on the OECD guideline 429 which recommends dosage at 100%, if possible. The low dose was set at 25%.
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 5.1
- Test group / Remarks:
- 100% Avena Sativa leaf/stem extract
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 75% Avena Sativa leaf/steam extract
- Key result
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- 50% Avena Sativa leaf/steam extract
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- It cannot be concluded whether the hair loss observed in the 75% and 100% dose groups was not caused by excessive grooming due to discomfort, though no skin irritation was observed. Dilutions of 50% v/v and 75% v/v EXT. AQ. CONC. PLANTULE AVOINE were shown to have no sensitization potential in this Local Lymph Node Assay in Mice. They are thus characterised as non-sensitizing. A dilution of 100% v/v of EXT. AQ. CONC. PLANTULE AVOINE was shown to have sensitization potential in the Local Lymph Node Assay in Mice and is thus characterised as a sensitizer.
- Executive summary:
The objective of this study was to determine the skin sensitisation potential of pure and dilutedEXT. AQ. CONC. PLANTULE AVOINE, administered daily by dermal application on the dorsal surface of the pinna of both ears to mice for 3 days. The test item is an industrial chemical.
The methods used in this study were based on the OECD guideline 429 ”Skin Sensitisation: Local Lymph Node Assay” adopted on 22 July 2010. The CBA/Ca mouse was selected as the test model, according to this guideline.
The dose levels ofEXT. AQ. CONC. PLANTULE AVOINEfor the Local Lymph Node Assay in Mice were determined based on an irritation/toxicity screen (sighting study) whichincluded the following parameters:Ear thickness measurements and ear biopsy weights.
AsEXT. AQ. CONC. PLANTULE AVOINEisa hydrophilic substance, 1% Pluronic® PE9200 was added to dose formulations to ensure maximum exposure in the animals.
In the Local Lymph Node Assay (main study), mice were topically dosed with 3 concentrations of the test item on the dorsal surface of the pinna of both ears for three days, applying a total dose volume of 50 µL/animal/day. Lymphoproliferation was measured as incorporation of tritiated methyl thymidine (3HTdR) into the DNA of dividing lymphocytes on the 6thday of the main study.
The study was performed in 7-8 week old female CBA/CaOlaHsd brown mice.
The animals in the sighting study were treated as follows:
Group
Days of dosing
Test item
Animal Nos
Colour code
Female
1
1-3
Purified water with 1% v/vPluronic®PE 9200 (Vehicle control)
1-2
White
2
1-3
25% v/v of Plantule Avoine
3-4
Cyan
3
3-5
100% v/v of Plantule Avoine
5-6
Green
Dose escalation was performed as no adverse clinical signs and no excessive irritation at the application sites were observed on Days 1-3.
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