Toxicity Studies

Basic pharmacological profile testing was performed on two concentrations of the original water-based Ordenone Formula #987-260 by North American Science Associates, Inc. to determine the safety of the product with respect to:

  1. Toxicity following oral administration
  2. Primary skin irritation.
  3. Ocular irritation.
  4. Dermal toxicity.
  5. Inhalation toxicity.
The product was evaluated at 100% concentration and was also evaluated at a 10% concentration in water.  Although subsequent formulas have minimal variations from #987-260, we believe that these results would be the same for all other Ordenone water-based formulations.  The results of the studies are as follows:
                                                                                                                  

ACUTE ORAL TOXICITY
 

100% Concentration:  Under the conditions of the study, the product would be considered orally non-toxic to the rat. The LD 50 was greater than 5g / KG body weight.

10% Concentration in Water: Under the conditions of the study the product would be considered orally non-toxic to rats at a 10% concentration in water.  The LD 50 was greater than 5g / Kg body weight. 
 
 

PRIMARY SKIN IRRITATION

100% Concentration: Under the conditions of this test, the product would not be considered a primary irritant to the skin. The primary irritant index was calculated to be 4.88.  However the product would be considered moderately irritating at 100% concentration.

10% Concentration in Water: Under the conditions of this test, the product would not be considered a primary irritant to the skin at a 10% concentration in water.  The primary irritation index was calculated to be 0.25.

 

ACUTE DERMAL TOXICITY STUDY

100% Concentration:  Under the conditions of the study, the product would be considered non-toxic to rabbits.  The LD 50 was greater than 2.0g / KG of body weight.

10% Concentration in Water:  Under the conditions of this study, the product would be considered to be non-toxic to rabbits at a 10% concentration in water.  The LD 50 was greater than 2.0g / KG of body weight.
  
 

OCULAR IRRITATION

100% Concentration: 
Under the conditions of this test, the product was considered an irritant to the ocular tissue of rabbits.

10% Concentration in Water:  Under the conditions of this test the product was considered a non-irritant to the ocular tissue of rabbits at a 10% concentration in water.
 
 

ACUTE INHALATION TOXICITY

100% Concentration:  (In rats) LD50  > 207mg/1.

Dose Level Mg/1 - 207
Sex - 5M 5F
No. Dead/No. Dosed M:F - 0/5
Mortality - 0%
This test product is non-toxic to rats by inhalation under conditions of the test.

The above tests were performed prior to the EU effective dates that have since restricted or banned animal testing of products.  No further animal testing has been done by Belle-Aire since the above test results were received.  All subsequent testing following this paragraph was done with human test volunteers.  The results of that testing is shown below. 


BACTERIAL REVERSE MUTATION ASSAY

Consumer Product Testing Company evaluated Ordenone for mutagenicity in August 2006.  Concentrations of 0.5% and 2.0% were tested with the following results.

"Under the test conditions, there was no detectable genotoxic activity associated with the single concentration (2% and 0.5%) of the test sample (Ordenone #64350) either in the presence or absence of S9 enzyme activation." 


DERMAL IRRITATION OR SENSITIZATION


Consumer Product Testing Company evaluated Ordenone for the above conditions from August to October 2006 with the following results.

“Under the conditions of this study, test material, ORDENONE #64350 (LEAVE ON) Lot #S00042, did not indicate a clinically significant potential for dermal irritation or allergic contact sensitization.