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EC number: 201-344-6 | CAS number: 81-33-4
- 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
Skin sensitization: not sensitizing in LLNA, according OECD TG 429, GLP-compliant, 3 %, 10 %, 30 % test substance in polypropylene glycol, mouse, 1999, K1
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:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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)
- Specific details on test material used for the study:
- - Physical state: solid/powder
- Analytical purity: 98.9% - Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK, Blackthorne, Bicester, Oxon, UK
- Age at study initiation: young adults
- Housing: cages suitable for animals of this strain and weight range (max. of 4 mice per cage)
- Diet (e.g. ad libitum): R&M No.1 (Special Diet Services Limited, Witham, Essex, UK), ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: The animals were housed under the experimental conditions for at least 5 days, prior to the start of the study .
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr): A minimum of 15
- Photoperiod (hrs dark / hrs light): 12 / 12 - Vehicle:
- propylene glycol
- Concentration:
- the test substance was applied as 3%, 10% or 30% w/v preparations in propylene glycol
- No. of animals per dose:
- 4
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four male mice were used for this study. Approximately 25μ1 of a 3%, 10% or 30% w/v preparation of the test substance in propylene glycol was applied, using a variable volume micro-pipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using propylene glycol alone. The procedure was repeated daily for 3 consecutive days. A concurrent naïve control group was not treated with the test substance or the vehicle .
Three days after the third application, all the animals were injected, via the tail vein, with approximately 250 μl of phosphate buffered saline (PBS) containing approximately 20 μCi of a 2.OCi/mmol specific activity 3H-methyl thymidine . Approximately 5 hours later, the animals were humanely killed by inhalation of halothane vapour followed by cervical dislocation. The draining auricular lymph nodes were removed from each animal and, together with the nodes from the other animals in the group, were placed in a container of PBS .
A single cell suspension was prepared by mechanical disaggregation of lymph nodes through a 200-mesh stainless steel gauze . The cell suspensions were then washed three times by centrifugation with approximately 10 ml of PBS. Approximately 3 ml of 5% w/v trichloroacetic acid (TCA) was added and after overnight precipitation at 4°C, the samples were pelleted by centrifugation and the supernatant was discarded. The cells were then resuspended in approximately 1 ml of TCA .
The lymph node suspensions were transferred to scintillation vials and 10 mL of scintillant (Optiphase) was added prior to ß-scintillation counting using a Packard Tri-Carb 2500TR Liquid Scintillation Counter.
CLINICAL OBSERVATIONS:
Animals were checked at least once daily for signs of systemic toxicity.
CRITERIA USED TO CONSIDER A POSITIVE RESPONSE:
The criterion for a positive response is that one or more concentrations of the test substance should elicit a 3-fold or greater increase in isotope incorporation relative to the vehicle control group. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The application of hexylcinnamaldehyde at concentrations of 1%, 3% and 10% w/v in acetone resulted in a greater than 3-fold increase in isotope incorporation at the 10% w/v concentration. Therefore, hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
- Parameter:
- SI
- Value:
- 1.16
- Test group / Remarks:
- 3%
- Parameter:
- SI
- Value:
- 1.61
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 1.31
- Test group / Remarks:
- 30%
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- >= 2 322 - <= 3 216
- Remarks on result:
- other: naïve control: 2301 0 (vehicle only): 1989 3% w/v: 2322 10% w/v: 3216 30% w/v: 2613
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions chosen, the test substance did not show any skin sensitizing potential and thus, was concluded not to be a skin sensitizer.
- Executive summary:
In a GLP-compliant LLNA study conducted according to OECD guideline 429, groups of four male CBA/Ca mice per dose level were treated with a 3%, 10% or 30% w/v preparation in propylene glycol or with the vehicle alone. Each test animal was applied with 25 µL of the test substance preparation to the dorsum of both ears for three consecutive days. Three days after the last application the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the proliferative capacity of the prepared lymph node cells. The application of the test substance at concentrations of 3%, 10% and 30% w/v in propylene glycol resulted in an increase in isotope incorporation which was less than 3-fold at all three concentrations (SI indices were: 1.16 (3%); 1.61 (10%); 1.31 (30%)). Therefore, the test substance is considered to be not sensitizing.
Reference
The application of the test substance at concentrations of 3%, 10% and 30% w/v in propylene glycol resulted in an increase in isotope incorporation which was less than 3-fold at all three concentrations. Consequently, the test substance is designated as unlikely to be a moderate or strong sensitiser under the conditions of the test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
In a GLP-compliant LLNA study conducted according to OECD guideline 429, groups of four male CBA/Ca mice per dose level were treated with a 3%, 10% or 30% w/v preparation in propylene glycol or with the vehicle alone (CTL, 1999). Each test animal was applied with 25 µL of the test substance preparation to the dorsum of both ears for three consecutive days. Three days after the last application the mice were sacrificed and the auricular lymph nodes were removed. Lymph node response was evaluated by measuring the proliferative capacity of the prepared lymph node cells. The application of the test substance at concentrations of 3%, 10% and 30% w/v in propylene glycol resulted in an increase in isotope incorporation which was less than 3-fold at all three concentrations (SI indices were: 1.16 (3%); 1.61 (10%); 1.31 (30%)). Therefore, the test substance is considered to be not sensitizing.
Further toxicological data of category members:
This finding was supported by the data obtained for additional members of the same substance category. In three LLNA assays conducted according to OECD guideline 429 and in compliance with GLP, three additional members of the same category were analyzed for their sensitization potential. None of the tests gave a positive response, therefore all tested substances were considered as not sensitizing.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No increase in the stimulation index was observed in the LLNA (OECD 429). Therefore, the substance does not require classification as a skin sensitizer under Regulation (EC) No. 1272/2008, as amended for the fourteenth time in Regulation (EC) No. 2020/217.
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