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EC number: 949-711-6 | CAS number: -
- 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:
- 14 July 2020 to 30 November 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Saccharomyces cerevisiae cell wall, extracted
- EC Number:
- 949-711-6
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Saccharomyces cerevisiae cell wall, extracted
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch number of test material: AD19K01750
- Expiration date of the lot/batch: 27 July 2021
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germany GmbH
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 8 weeks
- Weight at study initiation: 186-200 g
- Fasting period before study: no
- Housing: Group caging (3 animals/cage): Type II. or III. polycarbonate cages - Wood bedding and nest building material
- 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 (ad libitum)
- Acclimation period: at least 5 days
- Method of randomisation in assigning animals to test and control groups : no control group
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.1 – 24.7°C
- Humidity (%): 37 - 64%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily
IN-LIFE DATES: From: 21 July 2020 To: 06 August 2020
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 100 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: Preliminar trials allowed to obtain homogenous formulations. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2 groups of 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
* Mortality/ Moribundity: Animals were inspected for signs of morbidity and mortality twice daily (at the beginning and end of each working day).
* Clinical observations: Any clinical sign noted during dosing or at any other occasions was recorded at the time seen.
- Body weights: Recorded on Days -1 (prior to removal of food), 0 (prior to administration), 7 and 14.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred in the study during the 14-day observation period at dose level of 2000 mg/kg bw.
- Clinical signs:
- other: other: All animals were symptom-free during the 14-day observation period.
- Gross pathology:
- here was no evidence of the macroscopic changes at dose level of 2000 mg/kg bw at necropsy.
- Other findings:
- No other findings.
Any other information on results incl. tables
TABLE 1: INDIVIDUAL CLINICAL OBSERVATIONS
DOSE LEVEL: 2000 mg/kg bw, Treatment on Day 0 |
|
|
|
|
|
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 |
5573 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
5574 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
5575 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
2 |
5576 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
5577 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
5578 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
20/20 |
|
Standard Footnotes: |
+ = present |
- = absent |
||||||||||||||
h = hour (s) |
' = minute |
|||||||||||||||
# = Found dead |
M = Moribund |
|||||||||||||||
Frequency of observation = number of occurrence of observation / total number of observations |
||||||||||||||||
Occurrent severities: |
Sl = Slight/Small/Few/Small amount |
|||||||||||||||
Mo = Moderate/Several/Moderate amount |
||||||||||||||||
Ex = Severe/Large/Many/Large/Extreme amount |
TABLE 2: INDIVIDUAL BODY WEIGHT AND BODY WEIGHT GAIN
|
Body weights (g) |
Absolute weight gain (g) |
||||||
Days / Period |
-1 |
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
|
5573 |
200 |
186 |
212 |
226 |
26 |
14 |
40 |
|
5574 |
217 |
198 |
222 |
236 |
24 |
14 |
38 |
|
5575 |
212 |
200 |
210 |
211 |
10 |
1 |
11 |
|
5576 |
199 |
192 |
219 |
228 |
27 |
9 |
36 |
|
5577 |
204 |
195 |
231 |
239 |
36 |
8 |
44 |
|
5578 |
207 |
189 |
232 |
245 |
43 |
13 |
56 |
|
Mean |
206.5 |
193.3 |
221.0 |
230.8 |
27.7 |
9.8 |
37.5 |
|
SD |
7.0 |
5.4 |
9.3 |
12.0 |
11.3 |
5.0 |
14.8 |
|
Max |
217 |
200 |
232 |
245 |
43 |
14 |
56 |
|
Min |
199 |
186 |
210 |
211 |
10 |
1 |
11 |
|
N |
6 |
6 |
6 |
6 |
6 |
6 |
6 |
|
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 cell wall, extracted was found to be above 2000 mg/kg bw in female Crl:WI rats. According to the CLP criteria, Saccharomyces cerevisiae cell wall, extracted can be ranked as "No category" for acute oral exposure. According to the GHS criteria, Saccharomyces cerevisiae cell wall, extracted can be ranked as "Unclassified" for acute oral exposure.
- Executive summary:
The acute oral toxicity study of Saccharomyces cerevisiae cell wall, extracted in rats was tested according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in Crl:WI Wistar rats. Two groups of three female Crl:WI rats were treated with the test item at 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. The test item was administered at the dose level of 2000 mg/kgbw, with water as vehicle.
Initially, three females (Group 1) were treated at dose level of 2000 mg/kgbw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in this group; therefore, no further testing was required according to OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris. Animals were observed during 14psot-treatment for clinical observations, body weight and then necropsied.
The results of the study were:
No mortality occurred in the study during the 14-day observation period at dose level of 2000 mg/kg bw.
All animals were symptom-free during the 14-day observation period.
There were no test item 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 dose level of 2000 mg/kg bwat necropsy.
Conclusion:
Under the conditions of this study, the acute oral LD50value of the test item Saccharomyces cerevisiae cell wall, extracted was found to be above 2000 mg/kg bw in female Crl:WI rats. According to the CLP criteria, Saccharomyces cerevisiae cell wall, extracted can be ranked as "No category" for acute oral exposure.
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