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EC number: 260-125-3 | CAS number: 56358-10-2
- 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
Local Lymph Node Assay (LLNA): sensitising
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
- Study period:
- March 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK
- Age at study initiation: Young adults
- Housing: 4 per cage.
- Diet (e.g. ad libitum): R&M No 1 supplied by Special Siet Services Ltd, Witham, Essex UK
- Water (e.g. ad libitum): Mains water
- Acclimation period: 5 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 minimum
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark - Vehicle:
- other:
- Remarks:
- Acetone
- Concentration:
- 1%, 3% and 10% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- TREATMENT PREPARATION AND ADMINISTRATION:
Approximately 25µL of a 1%, 3% of 10% w/v preparation of the test substance in acetone was applied,using a variable volume micropipette, to the dorsal surface of each ear. A vehicle control group was similarly treated using acetone alone. The procedure was repeated daily for 3 consecutive days.
Three days after the third application, the animals were held in a hot box at 37°C for 5-10 mins prior to injection via the tail vain with approx 250µL of phosphate buffered saline (PBS) containing approximately 20µCi of a 2.0Ci/mmol specific activity 3H-methyl thymidine. Approximately 5 hours later the animals were humanely killed. The draining auricular lymph nodes were removed from each animal and together with the nodes from the other animals in the group were place 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 3 times by centrifugation with approx. 10mls of PBS. Approximately 3ml of 5% w/v trichloracetic 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 1ml of TCA.
The lymph node suspensions were transferred to scintillation vials and 10ml of scintillant was added prior to Beta-scintillation counting using a Packard Tri-Carb Liquid Scintillation counter.
CLINICAL OBSERVATIONS:
Animals were checked at least once per day for signs of systemic toxicity.
POSTIVE CONTROL STUDY:
The sensitisation potential of the control (Hexylcinnamaldehyde) was assessed using the same method and concentrations (25µL of 1%, 3% and 10% preparations. A vehicle control group was similarly tested using acetone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- The application of hexylcinnamaldehyde at contrations of 1%, 3% and 10% w/v in acetone resulted in a greater than 3-fold increase in isotope incorporation at concentrations of 3% and 10%. Therefore hexylcinnamaldehyde was shown to be a skin sensitiser, confirming the validity of the protocol used for the study.
- Key result
- Parameter:
- SI
- Value:
- 1.68
- Test group / Remarks:
- 1% concentration
- Key result
- Parameter:
- SI
- Value:
- 2.81
- Test group / Remarks:
- 3% concentration
- Key result
- Parameter:
- SI
- Value:
- 5.97
- Test group / Remarks:
- 10% concentration
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance is a skin sensitiser under the conditions of this test and should be classified as skin sensitier Cat 1B according to EU CLP criteria.
- Executive summary:
The test substance was assessed for its skin sensitisation potential using the Local Lymph Node Assay. It was applied at concentrations in acetone of 1%, 3% and 10% to the surface of the ear of male mice for 3 consecutive days.
Primary proliferation of lymphocytes in the lymph node draining the site of application was evaluated using radioactive labelling of proliferating cells. The ratio of the proliferation in treated groups to that in vehicular controls, termed the Stimulation Index, was determined.
The positive control substance Hexylcinnamaldehyde (concentration 1%, 3% and 10% (w/v) elicited a reaction pattern at 3% and 10% confirming the validity of the protocol used.
Comparison of Stimulation Indexes between the treated groups and control vehicle group revealed that the test substance caused a dose dependent increase in radioisotope incorporation into the DNA of dividing lymphocytes. The Stimulation Index of the highest treated group (10% w/v) was 5.97. In accordance with OECD 429, and SI value of >3 in the LLNA test should be regarded as a skin sensitiser. The test substance therefore has the capacity to cause sensitisation and should be classified as a skin sensitiser Cat 1B.
Reference
The application of the test substance at concentrations of 1%, 3%, 10% w/v in acetone resulted in an increase in isotope incorporation which was greater than 3-fold at the 10% w/v concentration. The test substance is therefore a potential skin sensitiser. The full results are tabulated below:
Concentration of test substance |
Number of lymph nodes assayed |
Counts per minute |
Cpm per lymph node (x10-2) |
Test:control ratio |
Naïve control |
8 |
665 |
0.83 |
N/A |
0 (Vehicle only) |
8 |
1212 |
1.52 |
N/A |
1% |
8 |
2040 |
2.55 |
1.68 |
3% |
8 |
3414 |
4.27 |
2.81 |
10% |
8 |
7259 |
9.07 |
5.97 |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The test substance was assessed for its skin sensitisation potential using the Local Lymph Node Assay. It was applied at concentrations in acetone of 1%, 3% and 10% to the surface of the ear of male mice for 3 consecutive days.
Primary proliferation of lymphocytes in the lymph node draining the site of application was evaluated using radioactive labelling of proliferating cells. The ratio of the proliferation in treated groups to that in vehicular controls, termed the Stimulation Index, was determined.
The positive control substance Hexylcinnamaldehyde (concentration 1%, 3% and 10% (w/v) elicited a reaction pattern at 3% and 10% confirming the validity of the protocol used.
Comparison of Stimulation Indexes between the treated groups and control vehicle group revealed that the test substance caused a dose dependent increase in radioisotope incorporation into the DNA of dividing lymphocytes. The Stimulation Index of the highest treated group (10% w/v) was 5.97. In accordance with OECD 429, and SI value of >3 in the LLNA test should be regarded as a skin sensitiser. The test substance therefore has the capacity to cause sensitisation and should be classified as a skin sensitiser Cat 1B.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does require classification with respect to skin sensitisation,Category 1B (H317; May cause an allergic skin reaction).
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