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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
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 August 2017 to 7 November 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Ambiant temperature (25.6°C) were outside of the expected ranges (19-25°C). There is a minor deviation
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Saccharomyces cerevisiae, lysate
- EC Number:
- 305-230-8
- EC Name:
- Saccharomyces cerevisiae, lysate
- Cas Number:
- 94350-12-6
- IUPAC Name:
- Saccharomyces cerevisiae, lysate
- Test material form:
- solid: particulate/powder
- Remarks:
- light beige
- Details on test material:
- - Source and lot/batch No.of test material:
supplied by the sponsor, batch no. AC17F00560
- Expiration date of the lot/batch: February 2019
- Purity test date: 30 June 2017
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Autolysat D100 batch AC17F00560
- Expiration date of the lot/batch: 02/ 2019
- Purity test date:30 June 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (15-25°C, =<70% relative humidity)
- Stability under test conditions: not applicable
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was freshly formulated of 200 mg/mL in the vehicle on the day of administration. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.
FORM AS APPLIED IN THE TEST (if different from that of starting material)
In formulation with ditilled water
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 or 13 days
- Weight at study initiation: 186-222g
- Fasting period before study: not specified
- Housing: Type II Propylene/polycarbonate
- Diet (e.g. ad libitum): ssniff® SM R/M "Autoclavable complete diet for rats and mice, ad libitum
- Water (e.g. ad libitum): tap water from the municipal supply, as for human consumption from a 500 ml bottle, ad libitum.
- Acclimation period: 9 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.6-25.6°C
- Humidity (%): 35-69% Relative Humidity
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/ 12 hours dark
IN-LIFE DATES: From: 3 August 2017 To: 30 August 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL of test item in vehicle
- Amount of vehicle (if gavage): 10mL/kg
- Justification for choice of vehicle: not specified
- Lot/batch no. (if required): 63352Y25-2 (B. Braun Pharmaceuticals SA)
- Purity: not specified
MAXIMUM DOSE VOLUME APPLIED: 10mL/kg
DOSAGE PREPARATION (if unusual): The test item was freshly formulated at a concentration of 200 mg/mL in the vehicle. The formulation container was magnetic stirred continuously up to the end of dose administration procedures.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected to be the starting dose. - Doses:
- 2000 mg/kg bw.
- No. of animals per sex per dose:
- 3 per group, 2 groups were used
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs : Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter.
Body weight : The body weight was recorded on the day before treatment (Day -1), on the day of the treatment (Day 0), weekly thereafter and at necropsy (Day 14).
- Necropsy of survivors performed: yes
- Other examinations performed: . Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Saccharomyces cerevisiae, lysate did not cause mortality at a dose level of 2000 mg/kg bw in any animal.
- Clinical signs:
- other: other: All animals were symptom-free during the observation period at a dose level of 2000 mg/kg bw.
- Gross pathology:
- There was no evidence of the macroscopic changes at a dose level of 2000 mg/kg bw in any animal.
Any other information on results incl. tables
CLINICAL OBSERVATIONS
DOSELEVEL:2000mg/kg bw, TreatmentonDay0 SEX:FEMALE
Cage No. |
Animal Number |
Observations |
Observation days |
Frequency |
||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
|||||||||
30' |
1h |
2h |
3h |
4h |
6h |
|||||||||||
1 |
386 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
387 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
388 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
2 |
389 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
390 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
391 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
Remarks +=present
h=hours
‘ = minutes
Frequency of observation = number of occurrence of observation / total number of observations
BODY WEIGHT DATA
DOSELEVEL:2000mg/kg bw, TreatmentonDay0 SEX:FEMALE
Cage No. |
AnimalNumber |
Body weight (g) Days |
Body Weight Gain (g) |
||||||
-1 |
0 |
7 |
14 |
-1-0 |
0-7 |
7- 14 |
-1 - 14 |
||
1 |
386 |
230 232 228 |
215 222 213 |
245 258 245 |
266 285 250 |
-15 -10 -15 |
30 36 32 |
21 27 5 |
36 53 22 |
387 |
|||||||||
388 |
|||||||||
2 |
389 |
200 229 223 |
186 222 212 |
210 242 241 |
221 248 259 |
-14 -7 -11 |
24 20 29 |
11 6 18 |
21 19 36 |
390 |
|||||||||
391 |
|||||||||
Mean: |
223.7 |
211.7 |
240.2 |
254.8 |
-12.0 |
28.5 |
14.7 |
31.2 |
|
Standarddeviation: |
12.0 |
13.3 |
16.0 |
21.3 |
3.2 |
5.7 |
8.8 |
13.1 |
NECROPSY FINDINGS
DOSELEVEL: 2000mg/kg bw, TreatmentonDay0 SEX:FEMALE
Cage No. |
Animal Number |
Necropsy Date/ Necropsy Day |
External Observations |
Internal Observations |
Organ/Tissue |
1 |
386 |
29 August 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
387 |
29 August 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
388 |
29 August 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
2 |
389 |
30 August 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
390 |
30 August 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
|
391 |
30 August 2017 Day 14 |
No external observations recorded |
No internal observations recorded |
Not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study, the acute oral LD50 value of the test item Saccharomyces cerevisiae, lysate was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
According the GHS and the GHS-EU (CLP) criteria, classification of Saccharomyces cerevisiae, lysate can be ranked as "Not classified" for acute oral exposure. - Executive summary:
This GLP compliant study was performed according to OECD guideline 423 (Acute Toxic Class Method) in order to determine the acute toxicity after oral gavage on rats of the registered substance Saccharomyces cerevisiae.
Two groups of three female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg body weight (bw) (Group 1 and Group 2).
A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered at the dose level of 2000 mg/kg bw.
Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group.
Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 7 and before necropsy (Day 14). All animals were subjected to a necropsy and a macroscopic examination.
Saccharomyces cerevisiae, lysate did not cause mortality at a dose level of 2000 mg/kg bw.
All animals were symptom-free during the observation period at a dose level of 2000 mg/kg bw.
There were no treatment related body weight changes. Body weights were within the range commonly recorded for this strain and age.
There was no evidence of the macroscopic changes at a dose level of 2000 mg/kg bw.
Under the conditions of this study, the acute oral LD50 value of the test item Saccharomyces cerevisiae, lysate was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats.
According the GHS and the GHS-EU (CLP) criteria, classification of Saccharomyces cerevisiae, lysate can be ranked as "Not classified" for acute oral exposure.
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