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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
- Study period:
- From 11 April 2022 to 9 May 2022
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
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:
- Heavy wax residue fraction, waste plastic derived, hydrothermal conversion
- Molecular formula:
- Not applicable - UVCB
- IUPAC Name:
- Heavy wax residue fraction, waste plastic derived, hydrothermal conversion
- Test material form:
- other: solid - lumps
- Details on test material:
- - Stability: stable under storage conditions
- Storage: room temperature (20 ± 5 °C)
- Appearance: large, brown, solid lumps
- Purity: not applicable, UVCB
- Homogeneity: homogeneous
- EC no.: 950-445-8
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- - Source: Anlab, Praha, Czech Republic
- Females (if applicable) nulliparous and non-pregnant: yes, 32 animals
- Age at study initiation: 9 weeks for Pre-screen test, 11 weeks for main study
- Housing conditions: The animals were housed in TECNIPLAST cages from the Tecniplast Company, in Conventional animal room No. B2-609. Maximum six females were housed per cage. The room temperature was within the range of 20-24 oC, relative humidity was within the range of 40-60 %. The animals were subjected to a 12-hour light/ 12-hour dark cycle
- Diet (e.g. ad libitum): A laboratory food Teklad Global 16% Protein Rodent Diet was served ad libitum
- Water (e.g. ad libitum): The animals received tap water for human consumption ad libitum. The water from the local mains was monitored for quality by testing for the microbiological and chemical quality by Waterworks Bratislava quarterly. Bottles were exchanged and cleaned once a week. The quality of drinking water is periodical monitored (including microbiological control) and recorded
- Acclimation period: 5 days
- Animal Health: The health condition of animals and skin integrity was examined by a veterinarian before initiation of the study (Pre-screen test and Main study). Animals were healthy, without visible symptoms of disease.
Study design: in vivo (LLNA)
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 25 %, 10 % and 5 % (w/v) based on solubility and pre-screen test results.
- No. of animals per dose:
- 5 animals per treatment group for main study
- Details on study design:
- Preliminary laboratory tests showed that test item is partially soluble in acetone/olive oil (AOO, 4:1 v/v) and methyl ethyl ketone and creates non-homogenous suspension. Selection of the doses was limited by suspensibility of the test item in recommended vehicles. The Pre-screen test was performed using the concentrations of 25 %, 10 % and 5 % (w/v). Based on absence of clinical symptoms, either of local irritation at the application site or systemic toxicity in the Pre-screen test, the same concentrations of 5 % (w/v), 10 % (w/v) and 25 % (w/v) were selected for the Main study.
Day 1: Each animal was identified, and the body weight was recorded. To the dorsum of each ear 25 µL of the appropriate dilution of the test item, positive control, or the vehicle alone was applied.
Days 2 and 3: The application procedure carried out on day 1 was repeated.
Days 4 and 5: No treatment.
Day 6: The body weight of each animal was recorded. 250 μL of sterile phosphate-buffered saline (PBS) containing 20 μCi (7.4×105 Bq) of tritiated (3H)-methyl thymidine was injected into all test and control mice via the tail vein.
Five hours later, the animals were sacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- Stimulation index SI = 7.82 for positive control was in the middle of the range of historical positive controls
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.51
- Test group / Remarks:
- 5 % test item
- Key result
- Parameter:
- SI
- Value:
- 1.16
- Test group / Remarks:
- 10 % test item
- Key result
- Parameter:
- SI
- Value:
- 0.66
- Test group / Remarks:
- 25 % test item
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, HEAVY WAX RESIDUE FRACTION, WASTE PLASTIC DERIVED, HYDROTHERMAL CONVERSION is not considered a skin sensitizer under the conditions of this LLNA study.
- Executive summary:
The sensitization potential of HEAVY WAX RESIDUE FRACTION, WASTE PLASTIC DERIVED, HYDROTHERMAL CONVERSION was evaluated using Local Lymph Node Assay (LLNA). The LLNA has been developed to determine the allergic contact sensitization potential of chemicals.
Based on the recommendations of the OECD Guideline No. 429, the test item was dissolved in acetone/olive oil (AOO, 4:1 v/v). The positive control (a-Hexylcinnamic aldehyde) was dissolved in AOO. Selection of the doses was limited by suspensibility of the test item in recommended vehicles. The Pre-screen test was performed using the concentrations of 25 %, 10 % and 5 % (w/v). Based on absence of clinical symptoms, either of local irritation at the application site or systemic toxicity in the Pre-screen test, the same concentrations of 5 % (w/v), 10 % (w/v) and 25 % (w/v) were selected for the Main study.
In the Main study, five female mice (CBA/CaOlaHsd) per group were topically exposed (dorsum of both ears) to the test item at concentrations of 5 % (w/v), 10 % (w/v) and 25 % (w/v) in AOO. Positive control was exposed to the 25 % solution of a-Hexylcinnamic aldehyde in AOO and negative control to the vehicle (AOO), only. Lymphocyte proliferation was measured using incorporation of radioactive 3H-methyl-thymidine in the draining lymph nodes. The radioactive incorporation was measured as disintegrations per minute (DPM). Results were expressed as Stimulation Index (SI) calculated as DPM/pooled treatment group divided by DPM/vehicle control group.
Regardless of the dose applied, daily clinical observation of animals did not show visible clinical signs of systemic toxicity in all HEAVY WAX RESIDUE FRACTION, WASTE PLASTIC DERIVED, HYDROTHERMAL CONVERSION treated mice. No signs of significant local irritation were observed in test item treated groups.
In this study, the Stimulation Indices (SI) of 0.51, 1.16 and 0.66 were determined with the test item at concentrations of 5 % (w/v), 10 % (w/v) and 25 % (w/v) HEAVY WAX RESIDUE FRACTION, WASTE PLASTIC DERIVED, HYDROTHERMAL CONVERSION in AOO, respectively. The EC3 value could not be calculated since none of the tested concentrations induced a SI greater than the threshold value of 3.
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