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Safe and Harmless SELFEEL

SELFEEL is completely inorganic, thus non-toxic and harmless to the human body.  SELFEEL has been used in public facilities, such as schools, medical facilities, restaurants and public buildings.  SELFEEL's safety features make it an excellent choice for home use especially homes with infants.
SELFEEL - ensuring comfortable surroundings.


Experimental Data

Acute oral toxicity test
Acute oral toxicity test
Test organization:Japan Food Research Laboratories
Test No.:#104074025-002
Test animals
5-weeks-old female rats (BrlHan:WIST strain@Jcl) were purchased from CLEA Japan, Inc..  The rats were observed and verified that their general physical states are normal, and then the animals were used for the test.  The animals were kept in polycarbonate-cages (5 rats in a cage) at room temperature of 23}2, 12 hour-lighting a day.  Foods (solid mouse/rat food; Labo MR Stock made by Nosan Corporation) and water (from the tap) were given freely.
Experimental methods
Two groups of each 5 rats were provided, a test group to give 2,000 mg/kg of the test material (SELFEEL) and the other control group to give injection solvent.  Before administration, the test animals were starved for about 17 hours.  After weighing individual body weight, an amount of 20 mL/kg of the test solution and control solvent was orally administrated once to the test group and the control group by stomach sonde, respectively.  The observation took place over 14 days, once a day, except for several times of observation on the day of administration.  Body weight was measured on the 7th day and 14th day after administration, and the data of the two groups were statistically compared by t-test with significant level of 5%.  All animals were sacrificed for anatomical inspection at the end of observation period.
Discussion and Results
Acute toxicity test by oral administration using female rats (limit test) of test material (SELFEEL) was performed.  The test material was orally administrated once at a dose of 2,000 mg/kg, and it was not any abnormality and death during the observation period.  Therefore, LD50 value of the test material for female rats by single oral administration is considered to be more than 2,000 mg/kg.


Primary rabbit skin irritation test
Primary rabbit skin irritation test
@ Test organization:Japan Food Research Laboratories
Test No.:#104074025-001
Test animals
Male rabbits (Japan white strain) were purchased from KITAYAMA LABES Co., Ltd..  The rabbits were observed and verified that their general physical states are normal, and then three rabbits were used for the test.  Each rabbit was kept in FRP-cages (5 rats a cage) at room temperature of 22}2, 12 hour-lighting a day.  Foods (solid rabbit/guinea pig food; LRC4 made by Oriental Yeast Co., Ltd.) were given under restriction, and water (tap water) was given freely.
Experimental methods
Hairs on the back of test rabbits were shaved off approx.  24 hours prior to the test, and 4 shaved areas (each approx. 6 cm2) were provided on the back of each animal.  There of 2 areas were scratched in #-shape at the cornified layer not reaching as deep as dermis with an 18-gauge injection needle (hereafter called "scratched skin") and the other two areas were left as they were (hereafter called "scratch-less skin").  0.5 mL of the test material (SELFEEL) was applied evenly on a gauze patch cut into a size of approx.  2cm x 3cm.  Each one patch was applied to the scratched skin and the scratch-less skin respectively, and fixed by bandage (Japanese Pharmacopoeia).  Further, the patches were supported with Blendarm surgical tape (product of 3M Healthcare), so that firm contact between the patch and the skin could be maintained.  And the rest of each one scratched skin and non-scratch skin areas were left over as control areas.

After 4 hours of exposure, each patch was removed and the areas were cleaned with purified water.  After 1, 24, 48 and 72 hours, observation was done, and the reaction of irritation was scored.  Also, in accordance with the Federal Register (1972), the total score of after 1, 24 and 48 hours was divided with 6, and then an average score of each test animal was calculated to have the primary irritation index (P.I.I.) to evaluate irritation characteristic of the test material based upon the ISO 10993-10 standard.  Body weight of the test animals was measured at the start and the end of the test.
Results
For the test material, the primary irritation test to the skin in rabbits was performed according to the OECD Guidelines for The Testing of Chemicals 404 (1992).  As a result, although sign of erythema was slightly detected in all cases (3 rabbits) at 1 hour after taking off of the patch, the sign was disappeared in 2 cases after 24 hours and in the last one after 48 hours.  The primary irritation index (P.I.I.) was calculated to be 0.3 based upon the Federal Register (1972). Consequently, it is evaluated that the test material (SELFEEL) is "non-irritation" by the test of primary irritation to the skin in rabbits.


Mutagenicity test
Mutagenicity test
Test organization:Japan Food Research Laboratories
Test No.:#205090546-001
Methods and Results
Mutagenicity of Air-Catalyst "SELFEEL" was assayed according to the method of Notification # 77 (Sept. 1, 1988) of the Ministry of Labor.  The reverse mutation test was performed using 4 strains of Escherichia coli WP2uvrA and Salmonella typhimurium TA strain including the method of metabolic activation at the doses of 100-500L of the test material (SELFEEL) per plate.
As a result, increase of mutation colony number was not observed in all cases.  Accordingly, it was concluded that the mutagenicity of the test material was negative.


Skin sensitization test on guinea pig by the maximization method
Skin sensitization test on guinea pig by the maximization method
Test organization:Japan Food Research Laboratories
Test No.:#205090546-002
Methods and Results
Skin sensitization of Air-Catalyst "SELFEEL" was assayed by the maximization method using guinea pig.  As an induction of sensitization, 10 test animals were intradermally injected with the test material (SELFEEL), and after 1 week of the induction of sensitization, the filter paper applied with the test material or 10 w/v% injection solution as a negative control was closely pasted at the i.d. injection point for 48 hours in order to induce skin sensitization.  As a result, after 48 and 72 hours of the closed patch, the skin reaction was not observed in all test animals.  Consequently, it was concluded that the test material has no skin sensitization in guinea pig.


Primary irritation test on human skin by the 24 hours closed patch test
Primary irritation test on human skin by the 24 hours closed patch test
Test organization:Koei Chemicals Co., Ltd. and Face Survey Center for
Medical Research
Test No.:#051126
Experimental methods
To total 32 volunteers of male and female 18 years old or more who understood objective of this test, the test material (SELFEEL) was closely pasted at the back (side of spina) for 24 hours using Finn Chamber (EPITEST, Finland) on Scanpor tape (Norgesplaster, Norway) as a patch test unit.  At 30-60 minutes after removal of the patch test unit (24 hours after the pasting) and at 48 hours after the pasting, the judgment was made according to the Japanese criterion.
Results
It was concluded that primary irritation on human skin of the test material is negative by the closed patch test for 24 hours.
The same test was done by using the water for injection (defined in the Japanese Pharmacopoeia) and the white petrolatum (defined in Japanese Pharmacopoeia) as a reference substance (Test No. #051127 and #051128).  It was confirmed that results of the tests with these two reference substances were negative (no skin irritation).



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