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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
75 Days
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

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:
Bacillus Ferment Filtrate Extract
EC Number:
924-436-4
Cas Number:
68038-65-3
Molecular formula:
Not Available
IUPAC Name:
Bacillus Ferment Filtrate Extract
Test material form:
liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

Route of administration:
oral: feed
Vehicle:
water
Doses:
Initial Dose 300 mg/kg body weight and Final Dose 2000 mg/kg body weight.
No. of animals per sex per dose:
3 female rates
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 2 000 - <= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 values greater than 2000 mg/kg with cut-off value at 5000 mg/kg
Mortality:
No

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
The LD50 values greater than 2000 mg/kg with cut-off value at 5000 mg/kg for Bacillus Coagulans.