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EC number: 260-828-5 | CAS number: 57583-34-3
- 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
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Endpoint summary
Administrative data
Description of key information
Topical application with 5, 25 and 50 % v/v test substance elicited a stimulation index (SI) of 2.13, 7.25 and 9.05, respectively in a local lymph node assay (OECD 429), thus the material is a sensitiser.
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)
- Deviations:
- yes
- Remarks:
- , none that affected the integrity of the study
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan UK
- Age at study initiation: 11 to 12 weeks
- Weight at study initiation: 20.7 to 24.5 grams
- Housing: housed individually in solid floor standard polysulfone cages (Size: Approximately L 360 x B 205 x H 140 mm), with stainless steel top grill
- Diet (e.g. ad libitum): Ssniff mice pellet food, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days before the start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23 deg C
- Humidity (%): 57 to 66 %
- Air changes (per hr): 14.2 air changes/hr
- Photoperiod (hrs dark / hrs light): 12 hrs light/ 12 hrs dark
IN-LIFE DATES: From: 2009-08-03 To: 2009-08-18 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 5, 25, 50, 75 % in vehicle and 100 % of the test substance
- No. of animals per dose:
- 6
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: The test item was miscible at all the tested concentrations in Acetone:olive oil
- Irritation: erythema was observed at 75 and 100 % concentrations
- Lymph node proliferation response: screen looked at irritation only
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: randomly distributed to different groups by body weight stratification method.
- Criteria used to consider a positive response: Any test material that produces a SI , 3 in the LLNA is normally considered "positive" for dermal sensitisation potential
TREATMENT PREPARATION AND ADMINISTRATION:
The test substance was combined with Acetone Olive oil to obtain concentrations of 5, 25 and 50 % v/v. Test item solution was prepared daily just prior to dosing.
The application of the test item (25 µL/ear) was made on the dorsum of both ears in a manner to prevent test item loss. Six female
mice/group received vehicle (Acetone : Olive oil) or positive control (30 % α-hexylcinnamaldehyde) or 5, 25 and 50 % test substance once daily for three consecutive days. Ears were inspected prior to application on test item solution, and erythema was evaluated on days 2,3 and 6. All mice were weighed on days 1 and 6. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Means and SD were generated for body weight data (absolute and gain) and LLNA response (dpm and SI values). The body weight and dpm data
were analysed by one-way analysis of variance. When the differences are indicated by the ANOVA, a comparison of treated vs. control groups was done using a Dunnett's t-test (Ps0.05). Statistically significant differences (P≤ 0.05). - Positive control results:
- 30 % HCA in Acetone: olive oil elicited a stimulation index (SI) of 8.48, in comparison with the vehicle-treated mice
- Key result
- Parameter:
- SI
- Value:
- 2.13
- Test group / Remarks:
- 5 % v/v test substance
- Key result
- Parameter:
- SI
- Value:
- 7.25
- Test group / Remarks:
- 25 % v/v test substance
- Key result
- Parameter:
- SI
- Value:
- 9.05
- Test group / Remarks:
- 50 % v/v test substance
- Key result
- Parameter:
- EC3
- Value:
- 8.4
- Cellular proliferation data / Observations:
- DPM/Mouse:
- Vehicle (AOO): 1000.50; 378.07
- 30 % HCA in AOO: 8482.50; 2857.66
- 5 % test substance in AOO: 2131.33; 568.45
- 25 % test substance in AOO: 7251.83; 1066.03
- 50 % test substance in AOO: 9054.67; 2509.62 - Interpretation of results:
- other: Classified as a sensitiser as Category 1B in accordance with EU criteria
- Conclusions:
- Topical application with 5, 25 and 50 % v/v test substance elicited a stimulation index (SI) of 2.13, 7.25 and 9.05, respectively. The calculated EC3 value was 8.40 %
- Executive summary:
The Local Lymph Node Assay (LLNA) was conducted to evaluate the potential of the test substance to cause contact sensitization by measuring lymphocyte proliferative response from auricular lymph nodes following topical application of the test item to the female CBA/Ca mouse ear.
Screening Study: Three daily topical application of 5, 25, 50 and 75 % v/v in Acetone Olive oil and 100 % of the test substance were given to one animal at each dose level. Erythema was observed at 75 and 100 % concentration. The mice exposed to 50, 75 and 100 % concentration lost body weights. Results from this study were used to determine the dosing concentration in the LLNA study.
LLNA study: Six female CBA/Ca mice group received vehicle (Acetone Olive oil [AOO]) or 30 % α-hexylcinnarnaldehyde (HCA: positive control in AOO) or 5, 25 and 50 % of the test substance on days 1 to 3. On day 6, uptake of 3H-methyl thymidine into the auricular lymph nodes draining the site of test item application was measured five hours post administration. Proper conduct of the LLNA was confirmed via a positive response using 30 % α-hexylcinnamaldehyde, contact sensitiser, which elicited proliferation with a Stimulation Index (SI) value of 8.48, in comparison to vehicle-treated mice. The test substance did not elicit erythema. The test substance at the dose concentration of 50 % v/v decreased the body weight gain. The SI values for 5, 25 and 50 % of test substance were 2.13, 7.25 and 9.05, respectively. The EC3 value was 8.40 %.
Reference
The analysed radioactivity of 3H-TdR working solution was 83.72 uCi/mL against the nominal concentration of 80 uCi/mL.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A local lymph node assay is available for the test substance. The assay was conducted to evaluate the potential of the test substance to cause contact sensitisation by measuring lymphocyte proliferative response from auricular lymph nodes following topical application of the test item to the female CBA/Ca mouse ear.
The test substance did not elicit erythema. The test item at the dose concentration of 50 % v/v decreased the body weight gain. The SI values for 5, 25 and 50 % of test substance were 2.13, 7.25 and 9.05, respectively. The EC3 value was 8.40 %.
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 requires classification with respect to skin sensitisation as Category 1B ( H317: May cause an allergic skin reaction).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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