Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
skin irritation / corrosion, other
Type of information:
experimental study
Adequacy of study:
key study
Study period:
9 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 430 (In Vitro Skin Corrosion: Transcutaneous Electrical Resistance Test Method (TER))
Deviations:
no
GLP compliance:
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

In vitro test system

Test system:
isolated skin discs
Source species:
rat
Cell type:
other: Skin Discs
Cell source:
other: Sacrificed rat skin discs
Source strain:
Wistar
Vehicle:
water
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Duration of treatment / exposure:
24 hours
Number of replicates:
3

Test animals

Species:
rat

Test system

Type of coverage:
occlusive
Preparation of test site:
clipped
Vehicle:
water

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
transcutaneous electrical resistance (in kΩ)
Value:
>= 6.34 - <= 6.34
Vehicle controls validity:
not valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non-Corrosion

Applicant's summary and conclusion

Interpretation of results:
other: Non-Corrosive
Conclusions:
The InVitro study of Bacillus Coagulans was found to be Non-Corrosive by Transcutaneous Electrical Resistance (TER) method.