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EC number: 828-365-9
CAS number: 113573-69-6
Xanthan lyase was not tested for acute toxicity, but two closely-related enzymes, pectate lyase and pectin lyase, were tested for acute toxicity.
The acute toxicity of pectate lyase and pectin lyase was tested by administration by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days. No signs of toxicity were observed among the rats treated with a single oral dose of pectate lyase corresponding 2447 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1526 mg aep/kg bodyweight) or a single dose of pectin lyase corresponding to 2218 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1428 mg aep/kg bodyweight).
Based on the similarity of the tested enzymes with xanthan lyase - all belonging to the same enzyme sub-subclass - it can be concluded that similar results are expected for xanthan lyase.
The objective of the study was to assess the acute toxicity of pectate lyase when administered by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days.
The study was conducted in accordance with the OECD Guideline No 401, 1987 “Acute Oral Toxicity”. The limit test was used. The test item was supplied as a brown liquid ready to use. The dose volume administered was 2x12 mL/kg bodyweight of the undiluted test material.
No clinical signs were observed and the overall body weight gain during the study was considered to be normal. The post-mortem inspection revealed no abnormalities.
In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2447 mg enzyme concentrate dry matter/kg bodyweight (corresponding to 1526 mg aep/kg bodyweight).
The study was performed to assess the acute oral toxicity of pectin lyase, batch PPJ34366 to the rat. A group of three fasted female rats received a single oral gavage dose of the test substance, ‘as supplied’ at a dose level of 2218 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1428 mg aep/kg bodyweight). As results at this dose level indicated the acute lethal oral dose of the test substance to be greater than 2218 mg enzyme concentrate dry matter/kg bodyweight, in compliance with the study guidelines, a further group of three fasted females was similarly dosed at 2218 mg enzyme concentrate dry matter/kg bodyweight to complete the study.
There were no deaths during the study. There were no clinical signs of reaction to treatment throughout the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
The acute median lethal oral dose (LD50) to rats of pectin lyase, batch PPJ34366 was therefore demonstrated to be greater than 2218 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1428 mg aep/kg bodyweight).
Based on the results from the two acute toxicity tests with pectate lyase and pectin lyase, xanthan lyase is not classified.
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