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EC number: 305-230-8 | CAS number: 94350-12-6
- 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
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- Endpoint summary
- Stability
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- 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
Based on the available key study (Appl, OECD TG 429, GLP, 2018), the test substance Saccharomyces Cerevisiae, lysate did not induce skin sensitisation. Hence, according to CLP criteria, the test substance was not classified for skin sensitisation.
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:
- From 6 September 2017 to 13 November 2017
- 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:
- Due to technical reasons, temperature values (maximum of 25.3°C) outside the expected ranges of 19-25°C and relative humidity values (minimum of 26% and maximum of 78%) outside the expected range of 30-70% were recorded occasionally during the study.
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA)
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: AC17F00560
- Expiration date of the lot/batch: February 2019
- Purity test date: 30 June 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (15-25°CC, ≤70 RH%**)
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: soluble at the high dose
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was weighed and formulations prepared daily on a weight:volume basis (as % (w/v)) - Species:
- mouse
- Strain:
- CBA/Ca
- Remarks:
- CBA/CaOlaHsd mice
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Envigo
- Females (if applicable) nulliparous and non-pregnant: yes
- Microbiological status of animals, when known: SPF (Specific Pathogen Free)
- Age at study initiation: 11 weeks old (age-matched, within one week)
- Weight at study initiation: 20.2 – 21.7 grams
- Housing: Type II. polypropylene / polycarbonate
- Diet (e.g. ad libitum): Animals received ssniff® SM Rat/Mouse – Breeding and Maintenance, “Complete feed for Rats and Mice – Breeding and Maintenance" and Gel diet Transport, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply from 500 mL bottles, ad libitum. - Acclimation period: 34 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.0 – 25.3°C
- Humidity (%): 26 - 78 % relative humidity
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark, light from 6.00 a.m. to 6.00 p.m.
- IN-LIFE DATES: From: 6 September 2017 To: 19 September 2017 - Vehicle:
- other: 1 % Pluronic in distilled water
- Concentration:
- 0, 5, 10, 25% in vehicle
- No. of animals per dose:
- 4 animales were used per condition
- Details on study design:
- PRE-SCREEN TESTS:
- Compound solubility: The solubility of the test item was examined in a short Preliminary Compatibility Test. The following standard OECD vehicles were assessed: Acetone: Olive oil 4:1 (v/v) mixture, N,N- dimethylformamide, Methyl ethyl ketone, Propylene glycol (1 % Pluronic), Dimethyl sulfoxide and 1 % aqueous Pluronic® PE9200. The best vehicle taking into account the test item characteristics, its usage and the requirements of the relevant OECD guideline was considered to be 1 % Pluronic. The highest achievable concentration based on the regulatory requirements of the OECD guideline and the physical characteristics of the test item was 25% (w/v). The formulations appeared to be suspensions by visual examination.
- Irritation: In the Preliminary Irritation / Toxicity Test, all mice were observed daily for any clinical signs of systemic toxicity or local irritation at the application site. Both ears of each mouse were observed for erythema and scored.
During the Preliminary Irritation / Toxicity Test, no mortality or signs of systemic toxicity were observed. No amount of test item precipitation was observed on the ears of the animals. There were no indications of any irritancy at the site of application
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local Lymph Node Assay
- Randomisation: The animals were randomised and allocated to the experimental groups. The randomisation was checked by computer software using the body weight to verify the homogeneity and variability between the groups
- Criteria used to consider a positive response:
The test item is regarded as a sensitizer if both of the following criteria are fulfilled:
- That exposure to at least one concentration of the test item resulted in an incorporation of 3HTdR at least 3-fold or greater than recorded in control mice, as indicated by the stimulation index.
- The data are compatible with a conventional dose response, although allowance must be made (especially at high topical concentrations) for either local toxicity or immunological suppression.
TREATMENT PREPARATION AND ADMINISTRATION:
During the study, animals were topically dosed with 25 µL of the appropriate formulation using a pipette on the dorsal surface of each ear. Each animal was dosed once a day for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6.
On Day 6, animals were taken to the radioactive suite and each mouse was intravenously injected via the tail vein with 250 µL of sterile PBS (phosphate buffered saline) containing approximately 20 µCi of 3HTdR using a gauge 25G x 1" hypodermic needle with 1 mL sterile syringe. Once injected, the mice were left for 5 hours (± 30 minutes).
Five hours (± 30 minutes) after intravenous injection the mice were euthanized by asphyxiation with ascending doses of carbon dioxide.
The draining auricular lymph nodes were excised. The carcasses were discarded after cervical dislocation or after cutting through major cervical blood vessels.
Once removed, the nodes of mice from each test group was pooled and collected in separate Petri dishes containing a small amount (1-2 mL) of PBS to keep the nodes wet before processing.
A single cell suspension (SCS) of pooled lymph node cells (LNCs) was prepared and collected.After the washing step, supernatants were removed. Pellets were gently agitated resuspended and 3 mL of 5 % (w/v) TCA solution was added to the tubes for precipitation of macromolecules.
After overnight (approximately 18 hours) incubation at 2-8 °C, precipitates were centrifuged (approximately 190 x g for 10 minutes at 4oC), and supernatants were removed. Pellets were resuspended in 1 mL of 5 % (w/v) TCA solution and dispersed by using an ultrasonic bath. Samples were transferred into a suitable sized scintillation vial filled with 10 mL of scintillation liquid and thoroughly mixed. The vials were loaded into a β-scintillation counter and 3HTdR incorporation was measured (10-minute measurement).
The β-counter expresses the 3HTdR incorporation as the number of radioactive disintegrations per minute (DPM). Background level was also measured in duplicates by adding 1 mL of 5 % (w/v) TCA solution into a scintillation vial filled with 10 mL of scintillation liquid. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Positive control results:
- No mortality, cutaneous reactions or signs of toxicity were observed for the positive control substance in the study. A lymphoproliferative response in line with historical positive control data (stimulation index value of 5.2) was noted for HCA in the main experiment. This value was considered to confirm the appropriate performance of the assay.
- Key result
- Parameter:
- SI
- Value:
- 1
- Test group / Remarks:
- Vehicle control
- Key result
- Parameter:
- SI
- Value:
- 2.1
- Test group / Remarks:
- 25% Test item
- Key result
- Parameter:
- SI
- Value:
- 2.9
- Test group / Remarks:
- 10% Test item
- Key result
- Parameter:
- SI
- Value:
- 1.3
- Test group / Remarks:
- 5% Test item
- Cellular proliferation data / Observations:
- CELLULAR PROLIFERATION DATA
The appearance of the lymph nodes was normal in the negative control group and in the 25, 10 and 5 % (w/v) test item treated dose groups. Larger than normal lymph nodes were observed in the positive control group.
DETAILS ON STIMULATION INDEX CALCULATION
Stimulation index (SI = DPN value of a treated group divided by the DPN value of the negative control group) for each treatment group was also calculated. A stimulation index of 3 or greater is an indication of a positive result.
EC3 CALCULATION
No EC3 calculation was performed in this study.
CLINICAL OBSERVATIONS:
No mortality or signs of systemic toxicity were observed during the study. No amount of test item precipitation was observed on the ears of the animals.
BODY WEIGHTS
No marked body weight losses (≥5%) were observed on the mean body weight changes in any groups; however, the body weight loss was ≥5% for 1 out of 4 animals in the Negative control group. These changes were considered incidental - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present assay, Saccharomyces cerevisiae, lysate, tested in a suitable vehicle, did not show a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
No classification/labelling is triggered according to CLP criteria. - Executive summary:
This GLP compliant study was performed according to OECD 429 guideline (Local Lymph Node Assay) in order to assess the potential sensitisation effect of the registered item, Saccharamyces Cerevisiae lysates, through skin application in mice.
Based on the results of the Preliminary Compatibility Test, the test item characteristics, its usage and on the recommendations of the OECD Guideline, the best vehicle for the test item was 1 % Pluronic. The 25 % (w/v) formulation was the highest concentration which was suitable for the test. The formulations appeared to be suspensions by visual examination.
The Preliminary Irritation/Toxicity Test was performed in CBA/CaOlaHsd mice using two doses (2 animals/dose): 25 and 10 % (w/v) in 1 % Pluronic. Based on the observations recorded in the preliminary test, 25 % (w/v) was selected as top dose for the main test.
In the main assay, twenty female CBA/CaOlaHsd mice were allocated to five groups of four animals each:
- three groups received Saccharomyces cerevisiae, lysate (formulated in 1 % Pluronic) at 25, 10 and 5 % (w/v) concentrations respectively,
- the negative control group received the vehicle (1 % Pluronic) only,
- the positive control group received 25 % (w/v) HCA (dissolved in 1 % Pluronic).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4,
5 and 6. The cell proliferation in the local lymph nodes was assessed by measuring disintegrations per minutes after incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI) in comparison with the control group.
No mortality or signs of systemic toxicity were observed during the study. No amount of test item precipitation was observed on the ears of the animals. No marked body weight losses (≥5%) was observed on the mean body weight changes in any groups; however, the body weight loss was ≥5% for 1 out of 4 animals in the Negative control group.
The stimulation index values were 2.1, 2.9 and 1.3 at concentrations of 25, 10 and 5 % (w/v), respectively.
Under the conditions of the present assay, Saccharomyces cerevisiae, lysate, tested in a suitable vehicle, did not show a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
No classification/labelling is triggered according to CLP criteria.
Reference
Table 1:Individual Body Weights for all Animals with Group Means
Animal Number |
Identity Number |
Test Group Name |
Initial Body Weight (g) |
Terminal Body Weight* (g) |
Change#(%) |
4602 |
1 |
Negative (vehicle) control |
21.5 |
19.8 |
-7.9 |
4606 |
2 |
in 1 %Pluronic |
21.6 |
22.0 |
1.9 |
4612 |
3 |
|
20.3 |
20.4 |
0.5 |
4617 |
4 |
|
20.4 |
21.4 |
4.9 |
|
|
Mean |
21.0 |
20.9 |
-0.2 |
4603 |
5 |
Saccharomyces cerevisiae, lysate |
21.2 |
21.9 |
3.3 |
4620 |
6 |
25% (w/v) |
21.7 |
23.5 |
8.3 |
4618 |
7 |
in 1 %Pluronic |
20.9 |
21.6 |
3.3 |
4607 |
8 |
|
20.4 |
21.5 |
5.4 |
|
|
Mean |
21.1 |
22.1 |
5.1 |
4616 |
9 |
Saccharomyces cerevisiae, lysate |
21.3 |
22.7 |
6.6 |
4601 |
10 |
10 % (w/v) |
21.7 |
22.1 |
1.8 |
4611 |
11 |
in 1 %Pluronic |
20.7 |
22.2 |
7.2 |
4608 |
12 |
|
20.3 |
20.5 |
1.0 |
|
|
Mean |
21.0 |
21.9 |
4.2 |
4605 |
13 |
Saccharomyces cerevisiae, lysate |
21.2 |
20.7 |
-2.4 |
4613 |
14 |
5 % (w/v) |
21.5 |
21.2 |
-1.4 |
4615 |
15 |
in 1 %Pluronic |
20.8 |
21.3 |
2.4 |
4609 |
16 |
|
20.5 |
21.6 |
5.4 |
|
|
Mean |
21.0 |
21.2 |
1.0 |
4610 |
17 |
Positive control |
21.2 |
21.7 |
2.4 |
4614 |
18 |
25 % (w/v) HCA |
21.7 |
21.4 |
-1.4 |
4619 |
19 |
in 1 %Pluronic |
20.8 |
23.9 |
14.9 |
4604 |
20 |
|
20.2 |
21.0 |
4.0 |
|
|
Mean |
21.0 |
22.0 |
4.9 |
Notes:
*: Terminal body weights were measured on Day 6.
#: = (Terminal Body Weight – Initial Body Weight) / Initial Body Weight x 100
Table 2:DPM, DPN and Stimulation Index Values for all Groups
Test Group Name |
Measured DPM / group |
DPM |
Number of lymph nodes |
DPN |
Stimulation Index |
Background (5 %(w/v)TCA) |
34 |
- |
- |
- |
- |
Negative control (1 %Pluronic) |
2999 |
2965.0 |
8 |
370.6 |
1.0 |
Saccharomyces cerevisiae, lysate 25 %(w/v)in 1 %Pluronic |
6252 |
6218.0 |
8 |
777.3 |
2.1 |
Saccharomyces cerevisiae, lysate 10 %(w/v)in 1 %Pluronic |
8608 |
8574.0 |
8 |
1071.8 |
2.9 |
Saccharomyces cerevisiae, lysate 5 % (w/v) in 1 %Pluronic |
3922 |
3888.0 |
8 |
486.0 |
1.3 |
Positive control (25 % (w/v) HCA in 1 %Pluronic) |
15382 |
15348.0 |
8 |
1918.5 |
5.2 |
The stimulation index values were 2.1, 2.9 and 1.3 at concentrations of 25, 10 and 5% (w/v), respectively.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
One key study is available for assessment (Appl, Klimisch 1, OECD TG 429, GLP, 2018):
A Local Lymph Node Assay was performed on mice. A preliminary Irritation/Toxicity Test was performed in CBA/CaOlaHsd mice using two doses (2 animals/dose): 25 and 10 % (w/v) in 1 % Pluronic. Based on the observations recorded in the preliminary test, 25 % (w/v) was selected as top dose for the main LLNA test.
In the main assay, twenty female CBA/CaOlaHsd mice were allocated to five groups of four animals each:
- three groups received Saccharomyces cerevisiae, lysate (formulated in 1 % Pluronic) at 25, 10 and 5 % (w/v) concentrations respectively,
- the negative control group received the vehicle (1 % Pluronic) only,
- the positive control group received 25 % (w/v) HCA (dissolved in 1 % Pluronic).
The test item solutions were applied on the dorsal surface of ears of experimental animals (25 µL/ear) for three consecutive days (Days 1, 2 and 3). There was no treatment on Days 4, 5 and 6. The cell proliferation in the local lymph nodes was assessed by measuring disintegrations per minutes after incorporation of tritiated methyl thymidine (3HTdR) and the values obtained were used to calculate stimulation indices (SI) in comparison with the control group.
No mortality or signs of systemic toxicity were observed during the study. No amount of test item precipitation was observed on the ears of the animals. No marked body weight losses (≥5%) was observed on the mean body weight changes in any groups; however, the body weight loss was ≥5% for 1 out of 4 animals in the Negative control group. The stimulation index values were 2.1, 2.9 and 1.3 at concentrations of 25, 10 and 5 % (w/v), respectively.
Under the conditions of the present assay, Saccharomyces cerevisiae, lysate, tested in a suitable vehicle, did not show a sensitisation potential (non-sensitizer) in the Local Lymph Node Assay.
No classification/labelling is triggered according to CLP criteria.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available key study, the test substance Sacharomyces Cerevisiae, lysate was negative in the Local Lymph Node Assay. Hence, the test item does not require classification for skin sensitisation according to CLP criteria.
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