Safety
data of CRABYON
Acute Toxicity
Test (Chitin)
LD 50(lethal dose 50): Over 3,000mg/Kg
The term lethal dose 50 is defined as the dose
of a substance which is fatal to 50% of the
test animals. More specifically. Lethal dose
50 means that if chitin is orally administred
to mice on the basis of 3,000mg/Kg (mouse weight),
50% of them die.
Mutagenicity
Test (Chitin)
Mutagenicity Test: Negative
This
test is conducted to determine whether or not
the test animals undergo an abrupt change in
the genotype of organ.
Positive: Mutagenic
Negative: not Mutagenic
Skin irritation Patch Test *
Patch Test: 1B (almost negative)
To be in compliance with JAFET (Japanese Association
for the Functional Evaluation of Textile), the
fabric in question has to be at least almost
negative.
* A test in which material is applied and
left in contact with skin surfaces for 48
hours to check tissue sensivity.
Clinical tests of whether
"CRABYON underwear" will improve
patients of atopic dernatitis.
Purpose
The objective is to determine whether CRABYON,
with many characteristics can alleviate the
symptom of atopic dermatitis.
Tester of CRABYON underwear
A doctor of medicine who runs a pediatrics
in Osaka, Japan.
Test Specimen
Half-sleeved underwear of blended fabric (30%
Crabyon / 70% cotton).
Testees (patients)
The doctor selected 11 patients from among
his outpatients, whose symptoms are relatively
stable and whom he can be reach easily for
consultation.
a. Test period: January to March, 1996
b. The number of testees: 11 patients
c. Age: Children of 2 year 3 month to 11 years
3 month old.
Test Method
All 11 testees wore CRABYON underwear after
obtaining their parents consent. Three pieces
of underwear were goven to each testees who
wore them one after another and were washed
after each use. The doctor and parents saw
each testee every two weeks. After eight weeks,
he evaluated whether or not the CRABYON underwear
improved patients of atopic dermatitis.
Efficacy Evaluation
|
| Category |
|
|
5
|
Improved
considerably |
|
4
|
Improved |
|
3
|
Improved
a little |
|
2
|
Remain
unchanged |
|
1
|
Aggravated |
|
a. Doctor'sComments
He recorded the skin conditions such as itch,
dryness and scratches every two weeks and classified
them into five categories: |
| Category |
|
|
5
|
Very effective |
|
4
|
Effective |
|
3
|
Somewhat
effective |
|
2
|
Not effective |
|
1
|
Unknown |
|
b. Overall Evaluation
Considering the skin conditions, use of medicine
and food, he classified the underwear's effectiveness
into five categories: |
| Test Results
|
|
2-3 years old
|
3 persons |
|
3-4
|
2 |
|
4-5
|
1 |
|
5-6
|
1 |
|
6-7
|
2 |
|
7-8
|
- |
|
8-9
|
1 |
|
9-10
|
- |
|
10-
|
1 |
|
|
11
persons |
|
a. Testees Age
Group |
| Category |
|
|
5 (improved considerably)
|
"0"
persons |
|
4 (improved)
|
2 |
|
3 (somewhat improved)
|
5 |
|
2 (remain unchanged)
|
4 |
|
1 (aggravated)
|
0 |
|
b. Test results
He classified the testees skin conditions as
follows: |
He classified the effectiveness of CRABYON underwear
as follows: |
| Category |
|
|
5 (very effective)
|
1
person(s) |
|
4 (effective)
|
1 |
|
3 (somewhat effective)
|
4 |
|
2 (not effective)
|
3 |
|
1 (unknown)
|
2 |
|
c.
Side effects
All 11 testees experienced no side effects of
CRABYON at the end of two month-long wear test.
At the end of the test, it is considered that
the CRABYON underwear is safe. |
|
d. Time dependent change of skin conditions
Table 1 and Fig. 9 show how skin conditions
changed over time. (Weighted average of five
categories)
|
Table1
-
Time dependent change of skin conditions
|
|
|
Itch
|
Scrach
|
Dryness
|
Softness
|
Ovall
evalution
|
|
1 day
|
3.82
|
4.09
|
3.91
|
4.36
|
3.00
|
|
4
week
|
4.36
|
4.64
|
4.27
|
n.d
|
n.d
|
|
8
week
|
4.45
|
4.64
|
4.36
|
4.36
|
4.00
|
|
 Fig.
9 |
|
|
