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EC number: 692-061-0 | CAS number: 1207435-39-9
- 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
Sensitising properties of UVCB substance were determined both on the basis of known substance composition (the amount of sensitising components) and on the basis of supporting study. The amount of formaldehyde that is classified as a skin sensitiser is above the specific concentration limit (SCL) set for formaldehyde (0.2 %) and thus triggers the classification as a skin sensitiser.
In the supporting study, the potential of fast pyrolysis bio-oil to induce delayed contact hypersensitivity was assessed using the murine Local Lymph Node Assay (LLNA). No mortality and no clinical signs were observed during the study. No cutaneous reactions and no noteworthy increase of ear thickness were observed in the animals of the treated groups. A significant lymphoproliferation (SI > 3) was noted at the tested concentrations of 5 and 10 % . According to study results, the test item should be considered as a moderate sensitizer.
Justification for selection of skin sensitisation endpoint:
The potential of fast pyrolysis bio-oil to induce delayed contact hypersensitivity was assessed in BIOTOX project in a guideline study using the murine Local Lymph Node Assay (LLNA). According to study results, the test item should be considered as a moderate sensitizer.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 01.01.2003-30.06.2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Guideline study, final study report not available. Results published in BIOTOX project (BIOTOX. 2005. An assessment of bio-oil toxicity for safe handling and transportation. Final Technical Report. Part I: Publishable Final Report. Report drafted by Blin, J. Project N°: S07.16365. Project co-ordinator: Centre de Coopération Internationale de Recherche Agronomique pour le Développement (Cirad). Partners: Aston University, Bundesforschungsanstalt für Forst- und Holzwirtschaft (BFH)).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive No. 2004/73/EC B.42
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/J
- Sex:
- female
- Vehicle:
- dimethylformamide
- Concentration:
- 0.5, 1, 2.5, 5 or 10 %
- No. of animals per dose:
- 4
- Details on study design:
- During the induction phase, bio-oil, vehicle or reference item was applied over the ears (25 μL per ear) for 3 consecutive days (days 1, 2 and 3). After 2 days of resting, the proliferation of lymphocytes in the lymph node draining the application site was measured by incorporation of 46 tritiated methyl thymidine (day 6). The obtained values were used to calculate stimulation indices (SI).The irritant potential of the test item was assessed in parallel by measurement of ear thickness on days 1, 2, 3 and 6.
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Key result
- Parameter:
- EC3
- Value:
- ca. 3.2
- Interpretation of results:
- other: moderate sensitizer
- Remarks:
- Criteria used for interpretation of results: other: Kimber I. et al 2003
- Conclusions:
- The test item should be considered as a moderate sensitizer.
- Executive summary:
The potential of fast pyrolysis bio-oil to induce delayed contact hypersensitivity was assessed in a guideline study using murine Local Lymph Node Assay (LLNA). No mortality and no clinical signs were observed during the study. No cutaneous reactions and no noteworthy increase of ear thickness were observed in the animals of the treated groups. A significant lymphoproliferation (SI > 3) was noted at the tested concentrations of 5 and 10 % .
According to study results, the test item should be considered as a moderate sensitizer.
Reference
Results of the "Evaluation of skin sensitization potential Mice Using LLNA" test
Treatment | Concentration (%) | Signs of local irritation | Stimulation Index (SI) |
Test item | 0.5 | no | 1.19 |
Test item | 1 | no | 2.48 |
Test item | 2.5 | no | 1.73 |
Test item | 5 | no | 6.35 |
Test item | 10 | no | 14.58 |
HCA | 25 | - | 3.99 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Sensitising properties of UVCB substance were determined on the basis of known substance composition and the amount of sensitising components.
No known components of fast pyrolysis bio-oil are classified as respiratory sensitisers. Thus, based on current knowledge, no classification for the substance itself is necessary.
Justification for classification or non-classification
Sensitising properties of UVCB substance were determined on the basis of known substance composition and the amount of sensitising components. The amount of formaldehyde that is classified as a skin sensitisiser is above the specific concentration limit (SCL) set for formaldehyde (0.2 %) and thus triggers the classification as a skin sensitiser.
No known components of fast pyrolysis bio-oil are classified as respiratory sensitisers. Thus, based on current knowledge, no classification for the substance itself concerning respiratory sensitisation is necessary. Classification criteria is based on CLP regulation (EC) No 1272/2008.
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