|
In numerous studies, N-Duopropenide has demonstrated
very low toxicity when it is used at the recommended
concentrations.
Systemic
toxicity:
1. Acute Toxicity:
The
test was carried out in Wistar rats and
following the methodology of Directive 79/831,
annex VIII part B, B2. Results showed that N-Duopropenide is
a harmful substance when administered orally,
but it is not toxic, as it has a DL50 between
200 and 2000 µl/kg.
Oral acute toxicity has also been tested according to the following method: OECD-402 and Directive 92/69/CEE, Annex, Part B, Method B.3. Results concluted that N-Duopropenide, when administered via dermal patch to Sprague-Dawley rats, presents a LD50 higher than 2000 mg/Kg.
Moreover, N-Duopropenide is not volatile
(diffusion power 1 x10EXP-10) and therefore
the possibility of contact with the respiratory
tract is remote
.
2.
Subchronic Toxicity:
The
subchronic toxicity study (carried out at
Salamanca University) shows that the continuous
oral administration of N-Duopropenide does
not modify the general state or the biochemical
parameters of the treated animals (Wistar
rats).
3.
Chronic Toxicity:
The
chronic toxicity studies (Salamanca University)
in Wistar rats were carried out under extreme
conditions (intraperitoneal administration)
and in comparison with another classic quaternary
ammonium compound (Benzalkonium Chloride).
In this test, the animals were subjected
to four dosage levels (1, 2, 4, 16-mg/day)
of both disinfectants, keeping a control
group.
Animals treated with N-Duopropenide
showed a much greater survival rate than
those that were treated with Benzalconium
Chloride. With a 2-mg/day dose of N-Duopropenide
the animals survived the test period, while
with the same dose of Benzalconium Chloride,
only one animal survived.
Irritant
Effects:
N-Duopropenide
does not irritate the skin or mucous membranes,
nor does it produce allergy. Irritant effects were not found during hand disinfection tests performed on healthy volunteers.
The Draize
test shows that N-Duopropenide, at a 0,4%
concentration, is slightly irritating to
the eyes when they are in direct contact
with the substance.
Hypersensitivity:
The
delayed hypersensitivity study in guinea
pigs was carried out following the methodology
described in Directive 79/831, Annex VIII
part B, B2.
The results showed that after 28 days the
NDP, at a 1/10 concentration, did not produce
delayed hypersensitivity by contact in guinea
pigs.
Mutagenicity:
N-Duopropenide
has shown lack of mutagenic power
in the following tests:
|
-
-
- |
|
Ames Test.
In vitro chromosomal aberrations test
carried out in mammal cells according
to guideline OECD 473.
In vivo Mammalian erythrocyte micronucleus
test according to guideline OECD 474.
|
Comparative
with other disinfectants
| Disinfectant
|
Toxicity |
Corrosiveness
|
Irritability
|
Observations
|
|
NDP
|
Low
|
Low
|
Low
|
Stable.
Easy
manipulation
Not
inactivated by organic material.
|
|
Environmental
Disinfection |
|
Hydrogen
peroxide
|
Low
|
High
|
Moderate
|
Unstable.
Inactivated
by organic material.
Very reactive. |
|
Benzalkonium
chloride
|
Low
|
Low
|
Moderate
|
Unsuitable
for surface disinfection.
|
|
Silver
by-products
|
High
|
Incompatible
with Cl2, Na, I2,
proteins |
High
|
High
cost |
|
Phenols
|
High
|
Absorbed
by rubber |
High
|
Protect
from light |
|
Hospital
Disinfection |
|
Peracetic
acid |
Low
|
High
|
Moderate
|
Harmful
for skin and mucous membranes |
|
Alcaline
glutaraldehyde
|
High
|
Low
|
High
|
Require
protection for patients and personnel
|
|
Phenolate
Glutaraldehyde
|
High
|
Moderate
|
High
|
|
Persulphate
|
Low
|
High
|
Low
in solution
High
in dust |
Do
not inhale dust |
Sources:
Pharmaceutical Microbiology, W.B. Hugo and
A.D. Russell
Antiseptics and disinfectants, Department
of Health and Social Security, Generalitat
of Catalonia
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