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EC number: 207-993-1 | CAS number: 504-53-0
- 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
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
- Justification for type of information:
- For in vitro tests, the test item is insoluble in all solvent indicated by the respective OECD guidelines at the required concentrations. Under these circumstances, in vitro skin sensitization testing of Stearone in accordance with OECD 442C, OECD 442D and OECD 422E was not possible. Other validated in vitro tests on skin sensitization are not available at present.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA/Ca
- Details on test animals and environmental conditions:
- Age at First Dose 10-11 weeks, female animals were non-pregnant and nulliparous were used
Animal Health The health condition of animals was examined by a veterinarian
before initiation of the study. Animals were healthy, without visible signs of disease.
Acclimation The animals were acclimated in identical conditions as during the experiment for 6 days prior to the start of treatment. The acclimati on was according to standard operation procedures.
Housing Condition The animals were housed in IVC polycarbonate cages (5 animals per cage) suspended on stainless steel racks, in a room equippe d with central air-conditioning. The room temperature was within the range of 22 ± 3 °C, relative humidity was within the range of 5 0 - 60 %. The light regimen was set to a 12-hour light / 12-hour dark cycle. The sanitation was performed according to standard op eration procedures.
Diet A laboratory food ssniff (ssniff Spezialdiäten GmbH, Germany) was served ad libitum, each day approximately at the same time. Th e certificate of analysis is included in the raw data.
Water The animals received tap water for human consumption. Supply of drinking water was unlimited. The quality of drinking water is pe riodically monitored (including microbiological control) and recorded; certificate of analysis is included in raw data.
Bedding Lignocel S3/4, Lufa - ITL GmbH, Germany
Animals Identification Each animal was marked with permanent pen on the tail. Each cage was affixed with a cage card containing pertinent animal and s tudy information.
Justification for
the Choice of Species The CBA/Ca mice are the standard experimental rodent of choice and recommended by OECD Guideline No. 429. - Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- The doses were selected from the concentration series 100 %, 50 %, 25 %, 10 %, 5 %, 2.5 % etc. according to OECD Guideline No. 429.
The starting concentration was determined according to pre-screen test result.
Based on the observations recorded in the preliminary test, the concentrations of 100, 50 and 25 % were selected for the main test. - No. of animals per dose:
- 5 females – negative control (vehicle)
5 females – positive control
15 females – test item
4 females - pre-screen test, plus spare animals - Details on study design:
- Day 1:
Each animal was identified and the body weight was recorded. To the dorsum of each ear 25 µL of the appropriate dilution of the test item, or the vehicle alone was applied.
Days 2 and 3:
The application procedure carried out on day 1 was repeated.
Days 4 and 5: No treatment.
Day 6:
The body weight of each animal was recorded. 250 µL of sterile phosphate-buffered saline (PBS) containing 2 µCi (7.4 x 104 Bq) of 125I-iododeoxyuridine and 10-5M fluorodeoxyuridine was injected into all test and control mice via the tail vein.
Five hours later, the animals were euthanizedsacrificed. The draining auricular lymph nodes from each ear were excised and pooled in PBS for each experimental group (pooled treatment group approach). - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- Lymph node Number of
weight (g) lymph nodes DPM SI EC3 (%)
Control 0.0324 10 1333 - -
Positive Control 0.0642 10 9776 6.63 - Key result
- Parameter:
- SI
- Value:
- 1.06
- Test group / Remarks:
- Stearone 100%
- Key result
- Parameter:
- SI
- Value:
- 0.96
- Test group / Remarks:
- Stearone 50%
- Key result
- Parameter:
- SI
- Value:
- 0.87
- Test group / Remarks:
- Stearone 25%
- Cellular proliferation data / Observations:
- Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance as a sensitizer. Therefore, it was not possible to calculate an EC3 value.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin sensitization potential of Stearone was evaluated by LLNA method, which basic underlying principle is that sensitizers induce a primary proliferation of lymphocytes in the auricular lymph nodes draining the site of chemical application.
In the present study, the test item was applied to the dorsum of each ear of five female mice (CBA/Ca) per group over three consecutive days, at three concentrations. All animals survived throughout the test period without showing any clinical signs of toxicity. Calculated SI values in treated groups remained under the value of 3, which is the threshold to consider the substance as a sensitizer. Therefore, it was not possible to calculate an EC3 value.
The skin sensitizing potential of Stearone was assessed using the murine local lymph node assay.
Based on the results of this study, Stearone is not considered a skin sensitizer under the condition of this LLNA study. - Executive summary:
The sensitization potential of Stearonewas evaluated using the Local Lymph Node Assay (LLNA). The LLNA has been developed to determine the allergic contact sensitization potential of chemicals.
Based on the recommendations of the OECD Guideline 429, the test item was suspended in Acetone/Olive Oil, 4:1 (v/v). The positive control (a-Hexylcinnamic aldehyde) (25 %) was dissolved in the same vehicle.
ThePre-screen test was performed using the dose of 100 %. Based on the observations recorded in the Pre-screen tests, the concentration of 100 % was selected as top dose for the main test.
Five female mice (CBA/Ca) per group were topically exposed (dorsum of both ears) to the test item at concentrations of 25 %, 50 % and 100 %, to the positive control and to the vehicle only. Lymphocyte proliferation was measured using incorporation of radioactive125I-iododeoxyuridine and 10-5M fluorodeoxyuridinein the draining lymph nodes. The radioactive incorporation was expressed as disintegrations per minute (DPM)/pooled treatment group and compared with DPM value from the vehicle control group and expressed as the Stimulation Index (SI).
After application of the test itemat three concentrations (25 %, 50 % and 100 % w/v) the animals did not show visible clinical symptomsof either local irritation or systemic toxicity.
In this study the Stimulation Indices (SI) of0.87, 0.96 and 1.06 were determined with the test item at concentrations of 25 %, 50 %, and 100 % inAcetone/Olive Oil 4:1, respectively. The EC3 value could not be calculated, since none of the tested concentrations induced a SI greater than the threshold value of 3.
The test item Stearoneis not considered a skin sensitizer under the test conditions of this study.
Reference
In comparison with the control group, a minor increase of the pooled lymph node weights was observed at concentration of 100 %. The pooled lymph node weights of treated groups were 0.0293 g for 25 % concentration, 0.0302 g for 50 % concentration and 0.0336 g for 100 % concentration of test item. The lymph node weight of control group and positive control group were 0.0324 g and 0.0642g, respectively. The DPM values for the three treated groups were 1157 (25 %), 1275 (50 %) and 1413 (100 %), respectively. The SI values for the three treated groups were 0.87 (25 %), 0.96 (50 %) and 1.06 (100 %), respectively. The EC3 value could not be calculated, since none of the tested concentrations induced a S.I. was not greater than the threshold value of 3.
The Lymph node weights, DPM and SI values are shown in Table 6.
Table 6.The Lymph node weight, DPM, SI, EC3 values.
|
Lymph node |
Number of |
|
|
|
|
|
weight (g) |
lymph nodes |
DPM |
SI |
EC3 (%) |
|
Control |
0.0324 |
10 |
1333 |
- |
-
|
|
Positive Control |
0.0642 |
10 |
9776 |
6.63* |
||
Stearone |
25% |
0.0293 |
10 |
1157 |
0.87 |
|
Stearone |
50% |
0.0302 |
10 |
1275 |
0.96 |
|
Stearone |
100% |
0.0336 |
10 |
1413 |
1.06 |
*Calculated with corresponding control value of 1475 DPM (Appendix 2)
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For in vitro tests, the test item is insoluble in all solvent indicated by the respective OECD guidelines at the required concentrations. Under these circumstances, in vitro skin sensitization testing of Stearone in accordance with OECD 442C, OECD 442D and OECD 422E was not possible. Other validated in vitro tests on skin sensitization are not available at present.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The skin sensitizing potential of Stearone was assessed using the murine local lymph node assay.
Based on the results of this study, Stearone is not considered a skin sensitizer under the condition of this LLNA study.
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