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EC number: 232-800-2 | CAS number: 9025-57-4
The skin and eye irritation potential of xylanase has been tested and no dermal or eye irritation was observed.
TABLE 1: INDIVIDUAL BODY WEIGHTS
TABLE 2: INDIVIDUAL SKIN IRRITATION SCORES (ERYTHEMA/EDEMA)
Time After Patch Removal
Immediately after patch removal
TABLE 3: SUMMARY OF MEAN SCORES FOR DERMAL RESPONSES
Calculated from the 24-, 48-, and 72-hour dermal responses (EEC/GHS)
A primary skin irritation test was conducted with rabbits to determine the local skin irritant effect of the test substance. This study was conducted according to the method recommended in the OECD Guideline No. 404, April 2002.
Approximately 24 hours prior to application, all animals were prepared by clipping the dorsal area and the trunk. 0.5mL was applied to one 6 cm2 intact dose site and covered with 1 inch x 1 inch, 4-ply gauze pad. The pad and entire trunk of each animal were then wrapped with semi-occlusive tape. Collars were placed on each rabbit. After 4 hours of exposure, the pads and collars were removed and the test sites were cleansed of any residual test substance. The grade of skin reaction was scored according to the Draize’s scoring system immediately following patch removal and at 30-60 minutes, 24, 48 and 72 hours after patch removal. This study was conducted in a stepwise manner. Initially, 0.5mL of the test substance was applied to the skin of one rabbit for 4 hours. Since no dermal irritation was noted in this rabbit, a confirmatory test was completed with two additional healthy rabbits. No dermal irritation was observed at any dose site during the study.
TABLE 1: INDIVIDUAL BODY WEIGHTS
Body Weight (g)
TABLE 2: INDIVIDUAL SCORES FOR OCULAR IRRITATION
TABLE 3: MEAN SCORES FOR INDIVIDUAL RABBITS
Calculated from the 24-, 48-, and 72-hour scores (EEC/GHS).
The objective of this study was to assess the ocular irritation potential of the test substance. This study was conducted according to the method recommended in the OECD Guideline No. 405, 24 April 2002.
The study was conducted in a stepwise fashion. Initially, 0.1mL of the test substance was instilled into the conjunctival sac of the right eye of one rabbit. The left eye remained untreated and served as control. The grade of ocular reaction was recorded at 1, 24, 48 and 72 hours post instillation and evaluated by the method of Draize et al. At the 24-hour reading, fluorescein was instilled and then rinsed with 0.9% NaCl. The eye was then examined with an UV-light to detect corneal damage. Since there was no significant ocular irritation noted in this rabbit, the test was repeated on two additional rabbits by the same procedure. No ocular irritation was noted in all three rabbits.
The skin and eye irritation potential of xylanase has been tested according to OECD guidelines, in compliance with GLP. No dermal or eye irritation was observed at any dose site during the studies. The conclusion was that xylanase is neither a skin nor an eye irritant.
The skin and eye irritation potential of xylanase has been tested according to OECD guidelines and in compliance with GLP. The conclusion was that xylanase did not exert any skin and eye irritation and therfore xylanase should not be classifed.
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