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Description of key information

Xanthan lyase, batch PPE55581 was tested for skin irritation potential using the EpiDerm™ Skin Irritation Test (SIT) according to the OECD Test Guideline 439.


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


Moreover, Xanthan lyase, batch PPE55581 was tested for eye irritation potential using the Bovine Corneal Opacity and Permeability (BCOP) test method according to the OECD TG 437. 


In this study and under the experimental conditions reported, Xanthan lyase, batch PPE55581 was given No Category classification under the conditions of the test.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
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
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 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
Vehicle:
other:
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 101.2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03 September 2020 - 15 October 2020
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
26 June 2020
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
cattle
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): As supplied
Duration of treatment / exposure:
The exposure period was 10 min.
Duration of post- treatment incubation (in vitro):
120 minutes
Number of animals or in vitro replicates:
Three tissue replicates.
Details on study design:
NUMBER OF REPLICATES: 3

NEGATIVE CONTROL USED: sodium chloride 0.9% w/v

POSITIVE CONTROL USED: ethanol

APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL applied, and corneas were exposed for 10 minutes.

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 4 times
- POST-EXPOSURE INCUBATION: 120 minutes

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: light transmission through the cornea
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)

SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: As indicated in the TG was used.
Irritation parameter:
fluorescein leakage
Value:
ca. 0.015
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Value:
ca. 0.6
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
cornea opacity score
Value:
ca. 0.3
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
According to UN GHS Classification, the test item Xanthan lyase, batch PPE55581 was given No Category classification under the conditions of the test.
Executive summary:

The Bovine Corneal Opacity and Permeability (BCOP) test method was used to evaluate, if Xanthan lyase, batch PPE55581 could induce serious eye damage.


In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability.


The test was performed according to GLP and in accordance with OECD TG 437.


The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).


The In Vitro Irritancy Score of Xanthan lyase, batch PPE55581 was 0.6. 


It was concluded that according to UN GHS Classification, Xanthan lyase, batch PPE55581 was given 'No Category' classification under the conditions of the test.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the results of both the skin and eye irritation tests, xanthan lyase cannot be classified.