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EC number: 215-958-7 | CAS number: 1461-22-9
- 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
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Endpoint summary
Administrative data
Description of key information
The test material was considered to be a sensitiser under the conditions of the test.
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:
- 14 June 2010 to 13 July 2010
- 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:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of OECD 429.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Female CBA/Ca (CBA/CaOlaHsd) strain mice were used. The animals were nulliparous and non pregnant.
- Age at study initiation: eight to twelve weeks old.
- Weight at study initiation: 15 to 23 g
- Housing: The animals were individually housed in suspended solid floor polypropylene cages furnished with softwood woodflakes.
- Diet: Food was allowed throughout the study.
- Water: Free access to mains tap water was allowed throughout the study.
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature: 19 to 25 °C
- Humidity: 30 to 70 %
- Air changes: rate of air exchange was approximately fifteen changes per hour
- Photoperiod: lighting was controlled by a time switch to give twelve hours continuous light (06.00 to 18.00) and twelve hours darkness. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- Groups of four mice were treated with the test material at concentrations of 0.5, 0.25 or 0.10 % v/v in acetone/olive oil 4:1.
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
- Compound solubility: For the purpose of the study, the test material was freshly prepared as a solution in acetone/olive oil 4:1. This vehicle was chosen as it produced the highest concentration that was suitable for dosing. The test material was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
- Irritation: no data
- Lymph node proliferation response:
The animals treated with the test material at concentrations of 50, 10 or 1 % v/v in acetone/olive oil 4:1 were humanely killed on Day 2 or Day 3, due to the occurrence of clinical signs of toxicity that approached the moderate severity limit set forth in the UK Home Office Project Licence. Signs of systemic toxicity noted were hunched posture, lethargy, ataxia, decreased or increased respiratory rate, laboured respiration, ptosis, pilo-erection, hypothermia and splayed gait. Bodyweight loss was noted in the animals treated with the test material at concentrations of 50 or 1 % v/v in acetone/olive oil 4:1.
No signs of systemic toxicity were noted in the animal treated with the test material at a concentration of 0.5 % v/v in acetone/olive oil 4:1.
Based on this information the dose levels selected for the main test were 0.5, 0.25 and 0.10 % v/v in acetone/olive oil 4:1.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: 3H-Methyl Thymidine Administration
- Criteria used to consider a positive response:
The proliferation response of lymph node cells was expressed as the number of radioactive disintegrations per minute per lymph node (disintegrations per minute/node) and as the ratio of 3HTdR incorporation into lymph node cells of test nodes relative to that recorded for the control nodes (Stimulation Index).
The test material will be regarded as a sensitiser if at least one concentration of the test material results in a threefold or greater increase in 3HTdR incorporation compared to control values. Any test material failing to produce a threefold or greater increase in 3HTdR incorporation will be classified as a "non sensitiser".
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated with the test material at concentrations of 0.5, 0.25 or 0.10 % v/v in acetone/olive oil 4:1. The preliminary screening test suggested that the test material would not produce systemic toxicity or excessive local irritation at the highest suitable concentration. The mice were treated by daily application of 25 µl of the appropriate concentration of the test material to the dorsal surface of each ear for two consecutive days (Days 1, 2). The surviving mice were similarly treated on the following day (Day 3). The test material formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the vehicle alone in the same manner.
Five days following the first topical application of the test material or vehicle (Day 6) all surviving mice were injected via the tail vein with 250 µL of phosphate buffered saline (PBS) containing 3H methyl thymidine (3HTdR: 80 µCi/mL, specific activity 2.0 Ci/mmol, ARC UK Ltd) giving a total of 20 µCi to each mouse.
OBSERVATIONS:
Clinical observations: All animals were observed twice daily on Day 1 and 2 and pre-dose on Day 3. The surviving mice were observed post dose on Day 3 and on a daily basis on Days 4, 5 and 6. Any signs of toxicity or signs of ill health during the test were recorded.
Bodyweights: The bodyweight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination). The bodyweight of the mouse that was humanely killed was recorded immediately prior to termination. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- no data
- Positive control results:
- The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
Concentration (% v/v) in acetone/olive oil 4:1: 15
Stimulation Index: 3.12
Result: Positive
α Hexylcinnamaldehyde, tech., 85 % was considered to be a sensitiser under the conditions of the test. - Key result
- Parameter:
- SI
- Value:
- 5.8
- Test group / Remarks:
- 0.10 % (v/v)
- Remarks on result:
- other: Positive
- Key result
- Parameter:
- SI
- Value:
- 13.39
- Test group / Remarks:
- 0.25 % (v/v)
- Remarks on result:
- other: Positive
- Key result
- Parameter:
- SI
- Value:
- 14.87
- Test group / Remarks:
- 0.5 % (v/v)
- Remarks on result:
- other: Positive
- Cellular proliferation data / Observations:
- One animal treated with the test material at a concentration of 0.5 % v/v in acetone/olive oil 4:1 was humanely killed, pre dose on Day 3, due to the occurrence of clinical signs of toxicity that approached the moderate severity limit set forth in the UK Home Office Project Licence. Signs of systemic toxicity noted in this animal were hunched posture, lethargy and ptosis. Mild redness to the ears was also noted in this animal.
No signs of systemic toxicity were noted in the surviving test or control animals during the test. Mild redness to the ears and neck was noted on Days 4 and 5 in surviving animals treated with the test material at a concentration of 0.5 % v/v in acetone/olive oil 4:1.
Bodyweight changes of the surviving test animals between Day 1 and Day 6 were comparable to those observed in the corresponding control group animals over the same period. - Interpretation of results:
- other: EU Criteria: H317: May cause an allergic skin reaction
- Conclusions:
- The test material was considered to be a sensitiser under the conditions of the test.
- Executive summary:
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 0.5% v/v in acetone/olive oil 4:1, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µl (25 µl per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 0.5%, 0.25% or 0.10% v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (% v/v) in acetone/olive oil 4:1 Stimulation Index Result 0.1 5.8 Positive 0.25 13.39 Positive 0.5 14.87 Positive The test material was considered to be a sensitiser under the conditions of the test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The key study for skin sensitisation was conducted according to OECD 429 and EU method B.42. The study was conducted in line with GLP. A reliability rating of 1 according to the criteria of Klimisch, 1997.
A study was performed to assess the skin sensitisation potential of the test material in the CBA/Ca strain mouse following topical application to the dorsal surface of the ear. The method was designed to meet the requirements of the following:
OECD Guideline for the Testing of Chemicals No. 429 "Skin Sensitisation: Local Lymph Node Assay" (adopted 24 April 2002)
Method B42 Skin Sensitisation (Local Lymph Node Assay) of Commission Regulation (EC) No. 440/2008
Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 0.5 % v/v in acetone/olive oil 4:1, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Three groups, each of four animals, were treated with 50 µL (25 µL per ear) of the test material as a solution in acetone/olive oil 4:1 at concentrations of 0.5, 0.25 or 0.10 % v/v. A further group of four animals was treated with acetone/olive oil 4:1 alone.
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (% v/v) in acetone/olive oil 4:1 Stimulation Index Result
0.1 5.8 Positive
0.25 13.39 Positive
0.5 14.87 Positive
The test material was considered to be a sensitiser under the conditions of the test.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Regulation (EC) no 1272/2008 the test substance would be classified as a Category 1 Sensitiser; H317: May cause an allergic skin reaction, accompanied with the signal word 'warning'.
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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