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Diss Factsheets

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:
2020
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

Constituent 1
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
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.