Toxicological information
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A total absence of irritation to the skin or eyes, and no toxicity upon oral or intraperitoneal administration
Amoéba's Green biocide (Biomeba) has undergone all the toxicological tests, listed below. Results obtained in three animal models – rat, rabbit and Guinea pig – are reported below.
At the bottom of those results, classification and label elements of the active substance Willaertia magna C2c Maky and of the Green Biocide BIOMEBA according to Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures (CLP) are:
Classification of the substance / mixture:
Physical Hazards : Substance / Preparation is not classified.
Health Hazards : Substance / Preparation is not classified.
Environmental Hazards : Substance / Preparation is not classified.
Label elements
Hazard pictograms (CLP) : None.
Signal word (CLP) : None.
Hazard statements (CLP) : None.
Precautionary statements (CLP) : None.
Other hazards
None.
No skin irritation – Acute skin irritation study in rabbits (OECD 404), Study No. 20100231TLC
Under the experimental conditions adopted, Willaertia magna was found to be non-irritant for rabbit skin.
No eye irritation – Acute eye irritation study in rabbits (OECD 405), Study No. 20100232TLC
Under the experimental conditions adopted, Willaertia magna C2c Maky was found to be non-irritant for rabbit eyes.
Non-sensitizing for the skin – Skin sensitization study in Guinea pigs (Magnusson and Kligman maximization test method) (OECD 406), Study No. 20100233TCOC
Under the experimental conditions adopted, the test item Willaertia magna C2c Maky was found to have no sensitizing effect in Guinea pigs.
No acute oral toxicity – Acute oral toxicity study in rats: acute toxic class method (OECD 423), Study No. 20100234TRC
Under the experimental conditions adopted, the oral administration of Willaertia magna C2c Maky caused no mortality and did not induce clinical symptoms at 2000 mg/kg over a 14-day period, in female Sprague-Dawley rats. Therefore, the maximum tolerated dose in female rats exceeds 2000 mg/kg.
No mortality and no clinical symptoms upon oral uptake – Biodistribution and Acute toxicity study in rats by the oral route (EPA Microbial Pesticide Test Guideline OPPTS 885.3050), Study No. 20110134TRC
In the experimental conditions applied, oral administration of Willaertia magna caused no mortality and did not induce any clinical symptoms in male or female Sprague-Dawley rats. Assessment of biodistribution showed that the test item was not present in any of the organs investigated in the study, but was present in the feces in very small amounts (less than 0.0001%) or at undetectable levels. The presence of Willaertia magna in feces could be due to free-living amoeba naturally present in the microflora of the animals' digestive tracts.
No toxicity by the intraperitoneal route – Acute toxicity study in rats by intraperitoneal exposure (EPA Microbial Pesticide Test Guideline OPPTS 885.3200), Study No. 20110135TRC
In the experimental conditions tested, intraperitoneal administration of Willaertia Magna C2c Maky caused no mortality and did not induce any clinical symptoms in male or female Sprague-Dawley rats.
Microbial Pesticide Test Guidelines: OPPTS 885.3150 Acute Pulmonary Toxicity/Pathogenicity Study No. 20130134TRC
Results: Under the experimental conditions adopted, the single nasal administration of Willaertia Magna C2c Maky caused no mortality and no toxicological effect in male and female Sprague-Dawley rats. The biodistribution assessment showed that the test item was not present in all the organs considered in the study and was present on the treatment site (nasal cavity and turbinate) 1 and 4 days after treatment.
Microbial Pesticide Test Guidelines: OPPTS 885.3100 Acute Dermal Toxicity/Pathology Study No. 20100135TLC
Results: Under the experimental conditions adopted, a single application of Willaertia Magna at 2 mL/kg of body weight had no effect on the skin of males or females New Zealand White rabbit.