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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
Endpoint summary
Administrative data
Description of key information
Based on the available key study (SIMON, OECD TG 423, GLP, 2020, Klimisch 1), 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 rats (no mortality, no clinical signs, no effects on body weights, no macroscopic changes at necropsy). Hence, according to the CLP criteria, the test substance was not classified for acute oral toxicity
Acute inhalation toxicity study was waived because exposure of humans via inhalation is unlikely taking into account the very low vapour pressure of “Saccharomyces cerevisiae cell wall, extracted” which is estimated to be ≤ 4.60 x 10-2 Pa at 20°C and with a mass median aerodynamic diameter of 60.62 µM with less than 1.2% of particles having a size <= 10 µM.
Acute dermal toxicity study was waived based on the results of the acute oral toxicity study in the rat which demonstrated that Saccharomyces cerevisiae cell wall, extracted is not an acute oral toxic and is not classified as STOT SE (no mortality, no clinical sign, no effects on body weights, no macroscopic changes at necropsy; LD50 > 2000 mg/kg bw).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- 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
- 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 - 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 - 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 - 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.
- 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.
Reference
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 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- Reliability 1 study (GLP compliant and guideline study).
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
Exposure of humans via inhalation is unlikely taking into account the very low vapour pressure of “Saccharomyces cerevisiae cell wall, extracted” which is estimated to be ≤ 4.60 x 10-2 Pa at 20°C and with a mass median aerodynamic diameter of 60.62 µM with less than 1.2% of particles having a size <= 10 µM.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and, in the absence of an in vivo study by the oral route, no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read across, QSAR studies)
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
The acute dermal toxicity study was waived based on the results of an acute oral toxicity study.
An OECD 423 TG test (acute toxic class method) was performed with the target substance Saccharomyces cerevisiae cell wall, extracted in femate rats. Initially, three females were treated at dose level of 2000 mg/kgbw. As no mortality was observed, a confirmatory group was treated at the same dose level. No mortality was observed in this group; therefore, no further testing was required. Results from this test showed that no mortality occurred and all animals were symptom-free up to the 14-day observation period. Also, there were no test item related body weight changes and there was no evidence of macroscopic changes at necropsy. Hence, it can be concluded that the acute oral LD50 value of Saccharomyces cerevisiae cell wall, extracted was above 2000 mg/kg bw in female rats and the substance is not classified according to the CLP criteria for acute oral toxicity endpoint.
As Saccharomyces cerevisiae cell wall, extracted does not meet the criteria for classification as an acute toxic or STOT SE by the oral route, an acute dermal toxicity study does not need to be conducted. - Clinical signs:
- other: other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
One key study is available for assessment (SIMON, OECD TG 423, GLP, 2020, Klimisch 1):
An OECD 423 TG test (acute toxic class method) was performed with the target substance Saccharomyces cerevisiae cell wall, extracted in femate rats. Initially, three females were treated at dose level of 2000 mg/kgbw. As no mortality was observed, a confirmatory group was treated at the same dose level. No mortality was observed in this group; therefore, no further testing was required. Results from this test showed that no mortality occurred and all animals were symptom-free up to the 14-day observation period. Also, there were no test item related body weight changes and there was no evidence of macroscopic changes at necropsy. Hence, it can be concluded that the acute oral LD50 value of Saccharomyces cerevisiae cell wall, extracted was above 2000 mg/kg bw in female rats and the substance is not classified according to the CLP criteria for acute oral toxicity endpoint.
Justification for classification or non-classification
Based on the available key 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. Hence, the substance Saccharomyces cerevisiae cell wall, extracted does not require classification for acute oral toxicity according to the CLP criteria.
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