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n Chemicals Sales group

phone: +81-3-3347-9617(Tokyo)

phone: +81-6-6365-3046(Osaka)

Safety

ST-gel is adhesive and has good electric conductivity, but produces very little skin irritation, and is safe for skin.

The safety of gels of different grades

Our unique polymerization technology has enabled us to create of a highly safe network of polymers, minimizing the unreacted substances (residual monomers) in the gel. All ingredients have been confirmed for safety to ensure the safety of the product.

Test item	Objective	CR, SR	HIT	AG
Residual monomers (ppm)	Indicator for rashes and skin lesions	Not more than 50	Not more than 50	Not more than 50
Acute oral toxicity test	Toxicity and risk upon accidental swallowing	LD50>2000 mg/kg	No data	LD50>10 ml/kg (Gel extracts)
Cytotoxicity test	Biological toxicity	2 (mild)*	0	No data

* Since the gel contains electrolytes, the measurement result depends on the concentration of the electrolytes.

(The data shown is an example of the measurements obtained at the Safe Pharm Lab. and Japan Food Research Laboratories.)

Low skin irritation

n Skin irritation of gels of different grades

Test item	Objective	CR, SR series gel	HIT series gel	AG series gel
Primary skin irritation test	Skin contact irritation	P.I.I. 0.0*	P.I.I. 0.0*	P.I.I. 0.0*
Skin sensitization test	Degree of allergenicity	Non-sensitizer	Non-sensitizer	Non-sensitizer

* Means that the result of primary skin irritation test is "Non Irritation."

n Evaluation of human skin irritation

<24-Hour open patch test>
(Test method)
1.	The patch was applied to the inner side of the upper arm of 20 subjects.
2.	After the patch has been attached for 24 hours, the application site was observed and the replica specimens were collected from the site. No macroscopic abnormality was found.
3.	The entire field of the replica specimens was observed at 50X magnification.
4.	The specimens were observed and classified into four levels from A Stage to D Stage according to the severity of irritation.

Kawai's "24-hour open patch test"3B-0C-OD

Criteria of judgment in the patch test by microscopical observation

Method of judgmen	Microscopical judgment						Macrography
Morphological changes of skin surface	Round ridges	Depressed skin grooves				Shallow furrows Vanishing furrows Irregular ridges furrows creased ridges Lamellar scales	Erythema Edema Papule
Rank of irritant	A-Stage	B-Stage				C-Stage	D-Stage
Criteria of judgment	-	(Irritant index test substance) - (Irritant index of Control)				More than one case	More than one case
Criteria of judgment	-	≤ 0	1 - 2	3	≥ 4	More than one case	More than one case
			Almost negative	Almost Positive	Positive	Positive	Positive


Epidermal replica image		A-Stage		B-Stage		C-Stage

n Safety of the pack material grades of gels

Test name	Protocol	Test result
Skin sensitization test	OECD 406	Non-sensitizer
Primary skin irritation test	OECD 404	Non-irritant
Primary eye irritation test	OECD 405	Substantially non-irritant
14-Day repeated dose skin irritation test	OECD 404	Non-irritant

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