Registration Dossier
Registration Dossier
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EC number: 305-230-8 | CAS number: 94350-12-6
Endpoint summary
Administrative data
Description of key information
Based on the two available key studies (Appl, OECD TG 423 and 402, Klimisch 1, 2017), the test substance was not classified for acute oral and dermal hazard according to CLP criteria.
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:
- From 10 August 2017 to 7 November 2017
- 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:
- 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
- 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 - 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 - 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. - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Klimisch 1, OECD 423 study, GLP
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, lystae” which is estimated to be 4.60 x 10-2 Pa at 20°C and with a mass median aerodynamic diameter of 185.075 µm with less than 1% 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
- 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
- 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
- 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.
- 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 - 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 - 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.
- 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.
Reference
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 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- OECD 402 study, GLP, Klimisch 1
Additional information
Two available key studies were performed in order to evaluate acute oral and dermal hazard of the test substance:
This first key study was performed according to OECD guideline 423 in order to determine the acute toxicity after oral gavage on rats of the registered substance Saccharomyces cerevisiae, lysate (Appl, 2017, Klimisch 1, OECD 423, GLP). Two groups of three female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg body weight by oral gavage. 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. No clinical signs or alterations at necropsy was observed. 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.
The second study was to assess the potential acute dermal toxicity of the registered substance Saccharomyces cerevisiae, lysate on rats (Appl, 2017, Klimisch 1, OECD 402, GLP). 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 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. 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.
Justification for classification or non-classification
Based on the two available key studies (Appl, OECD TG 423 and 402, Klimisch 1, 2017), the test substance was not classified for acute oral and dermal hazard according to CLP criteria. The test substance did not induce mortality, clinical signs when applied in single dose through oral and skin route at 2000 mg/kg bw. Hence, the LD50 value for rats, and through oral route was defined to be 2000 mg/kg bw and through skin route the LD50 was considered to be 2000 mg/kg bw.
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