Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 12 September 2017 to 8 December 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute 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: supplied by the sponsor, Batch/Lot Number: 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°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
The test item was administered as supplied in a single dose. Sufficient water was used to dampen the test material to ensure good contact with the skin.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI Wistar rats
- Sex:
- male/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: Young adult rats
- Weight at study initiation: Between 216 g and 239 g
- Fasting period before study: not specified
- Housing: Type II. polypropylene/polycarbonate
- Diet (e.g. ad libitum): Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice – breeding and maintenance" produced by ssniff Spezialdiäten, 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: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9–24.8°C
- Humidity (%): 30–66%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours light (6.00 a.m. to 6.00 p.m.)
IN-LIFE DATES: From: 14 September 2017 To: 3 October 2017
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5cm x 5cm (25cm²) on the back on the animals
- % coverage: approximately 10% area (and not less) of the total body surface
- Type of wrap if used: semi occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes
- Time after start of exposure: At the end of the exposure period, (after 24 hours of exposure period), the treated area of skin with the test item was washed with water at body temperature.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Concentration (if solution): not appliclble
- Constant volume or concentration used: no, adjusted to animal body weight
- For solids, paste formed: yes
VEHICLE
No vehicle was used. Only sufficient water was used to dampen the test material to ensure good contact with the skin - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals per sex per condition was used
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were performed on the day of treatment at 1 and 5 hours after application of the test item and once each day for 14 days thereafter. Observations included the skin and fur, eyes and mucous membranes, the 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.
Adverse skin reactions at the site of application were recorded daily following the removal of the dressing.
The body weights were recorded on Day 0 (before the test item administration) and on Days 7 and 14 (before necropsy).
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- The test item did not cause mortality at the dose level of 2000 mg/kg bw.
- Clinical signs:
- other: other: There were no systemic clinical signs noted in any animal throughout the study. No adverse local dermal signs were observed after treatment with the test item or during the 14 days observation period.
- Gross pathology:
- There was no evidence of any gross macroscopic changes at a dose level of 2000 mg/kg bw.
Any other information on results incl. tables
TABLE1: ClinicalObservations
DOSE LEVEL: 2000mg/kgbw SEX:MALE
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
1 |
1047 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
2 |
1048 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
3 |
1049 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
4 |
1050 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
5 |
1051 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
DOSE LEVEL: 2000mg/kgbw SEX: FEMALE
Cage No. |
Animal No. |
Observations |
Observation days |
Frequency |
|||||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|||||
1h |
5h |
||||||||||||||||||
6 |
1052 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
7 |
1053 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
8 |
1054 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
9 |
1055 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
10 |
1056 |
Symptom Free |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
+ |
16/16 |
Remarks:
+ = present h = hour (s)
Treatment day = Day 0
Frequency of observation = number of occurrence of observation / total number of observations
TABLE2: Body WeightData
|
DOSELEVEL: 2000mg/kgbw - SEX: FEMALE
Cage No. |
Animal No. |
Body weight (g) Days |
Body Weight Gain (g) |
||||
0 |
7 |
14 |
0-7 |
7-14 |
0-14 |
||
6 |
1052 |
232 |
235 |
250 |
3 |
15 |
18 |
7 |
1053 |
216 |
229 |
242 |
13 |
13 |
26 |
8 |
1054 |
226 |
239 |
243 |
13 |
4 |
17 |
9 |
1055 |
234 |
247 |
258 |
13 |
11 |
24 |
10 |
1056 |
223 |
240 |
253 |
17 |
13 |
30 |
Mean: |
226.2 |
238.0 |
249.2 |
11.8 |
11.2 |
23.0 |
|
Standard deviation: |
7.2 |
6.6 |
6.8 |
5.2 |
4.3 |
5.5 |
TABLE3: MacroscopicFindings
DOSELEVEL: 2000mg/kgbw -SEX:MALE
Cage No. |
Animal No. |
Necropsy Date / Necropsy Day |
External Observations |
Internal Observations |
Organ/ Tissue |
1 |
1047 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
2 |
1048 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
3 |
1049 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
4 |
1050 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
5 |
1051 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
DOSELEVEL: 2000mg/kgbw -SEX:FEMALE
Cage No. |
Animal No. |
Necropsy Date / Necropsy Day |
External Observations |
Internal Observations |
Organ/ Tissue |
6 |
1052 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
7 |
1053 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
8 |
1054 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
9 |
1055 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
10 |
1056 |
03 October 2017 Day 14 |
No external observations |
No internal observations |
Not applicable |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item Saccharomyces cerevisiae, lysate was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats.
According the GHS and the GHS-EU (CLP) criteria, classification of Saccharomyces cerevisiae, lysate can be ranked as "Not classified" for acute dermal exposure. - Executive summary:
The purpose of this GLP compliant study was to assess the potentiel acute dermal toxicity of the regiestered substance Saccharomyces cerevisiae, lysate on rats. This study was performed according to the OECD 402 guideline, limit dose test.
This study was performed with the test item Saccharomyces cerevisiae, lysate in male and female Crl:WI Wistar rats. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as a single dermal 24-hour exposure followed by a 14-day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured on Day 0 (prior to dosing) and on Days 7 and 14 (before necropsy). Gross macroscopic examination was performed on all animals at necropsy at the end of the 2-week observation period (Day 14).
Test item did not cause mortality at the dose level of 2000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. No adverse local dermal signs were observed after treatment with the test item or during the 14 days observation period. There were no treatment related effects on body weight or body weight gain during the observation period. There was no evidence of any macroscopic changes at a dose level of 2000 mg/kg bw.
The acute dermal median lethal dose (LD50) of the test item Saccharomyces cerevisiae, lysate was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats.
According the GHS and the GHS-EU (CLP) criteria, classification of Saccharomyces cerevisiae, lysate can be ranked as "Not classified" for acute dermal exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.