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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 August 2020 - 26 October 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 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Active enzyme protein of Xanthan Lyase (CAS 113573-69-6, EC name: Xanthan lyase, Enzyme class no 4.2.2.12)
Molecular formula:
n.a.
IUPAC Name:
Active enzyme protein of Xanthan Lyase (CAS 113573-69-6, EC name: Xanthan lyase, Enzyme class no 4.2.2.12)
Constituent 2
Reference substance name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Protein as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 3
Reference substance name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 4
Reference substance name:
Carbohydrates as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Carbohydrates as a constituent of enzyme deriving from the fermentation or extraction process
Constituent 5
Reference substance name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Molecular formula:
Not available. See remarks.
IUPAC Name:
Lipids as a constituent of enzyme deriving from the fermentation or extraction process
Test material form:
liquid
Details on test material:
- Lot/batch No.: PPE55581
- Expiration date of the lot/batch: 18 June 2028

In vitro test system

Test system:
human skin model
Source species:
human
Details on test system:
RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EPIDERM™ Reconstructed Human Epidermis Model Kit
- Tissue batch number(s): 30885
- Date of initiation of testing: 10 August 2020

TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37 degrees Celcius
- Temperature of post-treatment incubation (if applicable): 37 degrees Celcius

REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: Filling and emptying each tissue insert 15 times

MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1 ml/mL MTT solution
- Incubation time: 3 hours
- Spectrophotometer: Labtech LT-4500 microplate reader
- Wavelength: 570 nm

NUMBER OF REPLICATE TISSUES: Three tissues for each treatment group

NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION:

PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- Classification of irritation potential was based upon relative mean tissue viability following the 60-Minute exposure period followed by the 42-Hour post-exposure incubation period. If Relative mean tissue viability is ≤50% = Corrosive or Irritant/If Relative mean tissue viability is >50% = Non-irritant.
Amount/concentration applied:
Test substance as is
Duration of treatment / exposure:
60 minutes
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
Triplicate tissues

Test system

Vehicle:
other:

Results and discussion

In vitro

Results
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 101.2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
In this study and under the experimental conditions reported, the test item was classified as non-irritant.
Executive summary:

The purpose of this test was to evaluate the skin irritation potential of Xanthan lyase, batch PPE55581 using the EpiDerm™ Skin Irritation Test (SIT) according to the OECD Test Guideline 439 In Vitro Skin Irritation Reconstructed Human Epidermis (RHE) and the synonymous EU B.46. test method.
The test item was applied topically for a treatment period of 60 minutes followed by a post-exposure incubation period of 42 hours.



The acceptance criteria required for acceptance of results in this test were satisfied.


The relative mean viability of the test item treated tissues was 101.2% after the 60-Minute exposure period and 42-Hours post-exposure incubation period.


In this study and under the experimental conditions reported, Xanthan lyase, batch PPE55581 was classified as non-irritant.

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