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EC number: 828-365-9
CAS number: 113573-69-6
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.
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.
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.
Based on the results of both the skin and eye irritation tests, xanthan lyase cannot be classified.
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