Registration Dossier
Registration Dossier
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EC number: 232-730-2 | CAS number: 9012-33-3
Skin irritation / corrosion
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:
- 2 020
- 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
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process
- 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
- 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
- Reference substance name:
- beta-N-acetylhexosaminidase, IUBMB 3.2.1.52
- Molecular formula:
- Not available
- IUPAC Name:
- beta-N-acetylhexosaminidase, IUBMB 3.2.1.52
- Test material form:
- liquid
- Details on test material:
- - Lot/batch No.: PPX69725
- Expiration date of the lot/batch: 25 February 2030
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
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. 99.6
- 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, beta-N-acetylhexosaminidase was classified as non-irritant.
- Executive summary:
The purpose of this test was to evaluate the skin irritation potential of beta-N-acetylhexosaminidase 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 99.6% after the 60-Minute exposure period and 42-Hours post-exposure incubation period.
In this study and under the experimental conditions reported, beta-N-acetylhexosaminidase was classified as non-irritant.
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