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EC number: 260-398-9 | CAS number: 56836-93-2
- 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
Skin sensitisation (OECD TG 429): not 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:
- 26 September 2016 - 8 November 2016
- 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)
- Version / remarks:
- July 22, 2010
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- Regulation (EC) No. 440/2008
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- mouse
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo RMS B.V., Inc., Horst, The Netherlands
- Females nulliparous and non-pregnant: yes
- Age at study initiation:
- Weight at study initiation:8 to 10 weeks old
- Housing: suspended solid floor polypropylene cages furnished with softwood woodflakes
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0% (vehicle control), 10%, 30% and 100% (test item)
- No. of animals per dose:
- 5
- Details on study design:
- PRE-SCREEN TESTS:
A preliminary screening test with one animal is performed with undiluted test material observed for local skin Irritation, clinal oberservations and ear thickness measurements were done.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
TREATMENT PREPARATION AND ADMINISTRATION:
Test item was used undiluted, and freshly prepared as a solution (10, 30% v/v/) in acetone/olive oil 4:1. Four groups of five mice were treated with 25 µL per ear 0, 10, 30 and 100% v/v concentrations in acetone/olive oil 4;1 of testing material for 3 consecutive days (Days 1, 2, 3). On day 6, all 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): a total of 20 µCi to each mouse. All animals were observed twice daily on Days 1, 2 and 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. The body weight of each mouse was recorded on Day 1 (prior to dosing) and Day 6 (prior to termination). At termination, for each individual the draining auricular lymph nodes were excised and processed, and a single cell suspension was prepared (individual animal approach). The radioactive disintegrations per minute per lymph node and the stimulation index are determined using the Beckman LS6500 scintillation system.
EVALUATION
The disintegrations per minute (dpm) value was determined for each test group. This information was used to calculate the Stimulation Index (SI) for each of the test groups (disintegrations per minute of treatment group / disintegrations per minute of control group). A positive response is indicated when one or more test groups shows a SI of 3. The EC3 value is the concentration at which a 3-fold increase of
lymph node proliferation is observed. Interpolation is used to determine the EC3 value between two test concentrations - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Individual and group mean disintegrations per minute values were assessed for dose response relationships.
- Positive control results:
- A current positive control study was performed (study number SK71FG, 8 April 2016 to 14 April 2016). Three groups, each of five animals, were treated with 50 μL (25 μL per ear) of α-Hexylcinnamaldehyde, tech., 85% as a solution in acetone/olive oil 4:1 at concentrations of 5%, 10% or 25% (v/v). A further group of five animals was treated with acetone/olive oil 4:1 alone and served as the vehicle control group. The concentration of α-Hexylcinnamaldehyde, tech., 85% expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 20%. α-Hexylcinnamaldehyde, tech., 85% was considered to be a sensitizer under the conditions of the test.
- Key result
- Parameter:
- EC3
- Test group / Remarks:
- All test groups
- Remarks on result:
- not determinable
- Remarks:
- All SI < 3
- Parameter:
- SI
- Value:
- 0.85
- Test group / Remarks:
- 10% (v/v)
- Parameter:
- SI
- Value:
- 1.14
- Test group / Remarks:
- 30% (v/v)
- Parameter:
- SI
- Value:
- 1.12
- Test group / Remarks:
- 100% (v/v)
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
Mean DPM with standard deviation:
- Vehicle control group: 3862.88 (±2115.84)
- 10% (v/v): 3282.69 (±1089.26)
- 30% (v/v): 4406.17 (±730.15)
- 100% (v/v): 4335.68 (±1474.10)
DETAILS ON STIMULATION INDEX CALCULATION
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group.
- 10% (v/v): 0.85
- 30% (v/v): 1.14
- 100% (v/v): 1.12
EC3 CALCULATION
The test item was considered to be a non-sensitizer under the conditions of the test.
CLINICAL OBSERVATIONS
There were no deaths. No signs of systemic toxicity were noted in the test or control animals during the test.
BODY WEIGHTS
Body weight change of the test animals between Day 1 and Day 6 was comparable to that observed in the corresponding control group animals over the same period. - Interpretation of results:
- other: not classified
- Remarks:
- based on CLP criteria
- Conclusions:
- Under the conditions of this test, the test substance did not induce a Stimulation Index (SI) above 3 and therefore an EC3 value could not be calculated. Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
- Executive summary:
The Local Lymph Node Assay (according to OECD 429) was conducted to determine the sensitising potential of Muguesia in mice. Lymph node proliferation was determined after exposure to 0%, 10%, 30% or 100% test substance in vehicle (Acetone/Olive oil (4:1 v/v)), using radioactivity counts (DPM). A pooled approach (per test group) was used. Stimulation indices were calculated. Measured disintegrations per node/minute (pooled) were 3863, 3283, 4406 and 4336 for the 0%, 10%, 30% and 100% dosing groups, respectively. Corresponding stimulation indices (SI) were calculated to be 0.85, 1.14 and 1.12 for the 10%, 30% and 100% concentration, respectively. Under the conditions of this test, the test substance did not induce a Stimulation Index (SI) above 3 and therefore an EC3 value could not be calculated. Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
Reference
In the preliminary screening test there were no signs of systemic toxicity or visual local skin irritation noted. No irritation was indicated by an equal to or greater than 25% increase in mean ear thickness. Based on this information the undiluted test item and the test item at concentrations of 30% and 10% v/vinacetone/olive oil 4:1 were selected for the main test.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The key study for this endpoint is a Local Lymph Node Assay (according to OECD 429) was conducted to determine the sensitising potential of Muguesia in mice. Lymph node proliferation was determined after exposure to 0%, 10%, 30% or 100% test substance in vehicle (Acetone/Olive oil (4:1 v/v)), using radioactivity counts (DPM). A pooled approach (per test group) was used. Stimulation indices were calculated. Measured disintegrations per node/minute (pooled) were 3863, 3283, 4406 and 4336 for the 0%, 10%, 30% and 100% dosing groups, respectively. Corresponding stimulation indices (SI) were calculated to be 0.85, 1.14 and 1.12 for the 10%, 30% and 100% concentration, respectively. Under the conditions of this test, the test substance did not induce a Stimulation Index (SI) above 3 and therefore an EC3 value could not be calculated. Based on these results, the substance is considered not to be a sensitiser and does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
Justification for classification or non-classification
Based on the negative results found in the key study, the substance does not need to be classified for skin sensitisation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
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