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Contract Research Services For Cosmetics Product Safety

What’s new
January 31, 2017

Start exporting services of safety testing

November 5 through 6, 2016

An accreditation for allergy patch testing has been granted to a Saticine’s technical staff who has completed a technical training course held by The Japanese Society for Dermatoallergology and Contact Dermatitis, November 5 through 6th, 2016 in Tokyo,

July 13, 2016

Start contract services for safety testing

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Japan Quality

Japanese consumers have a great interest in the safety of cosmetic products. Certification according to Japanese safety standards will help to build trust in the Japanese cosmetic brand globally. Saticine Medical, as a leading Japanese cosmetic manufacturer and the only Contract Research Organization (CRO) in Japan, examines the safety of cosmetics and their ingredients using methods recommended in the OECD. We provide the following in vitro, non-animal tests with high standards qualified by Japanese consumers.

Our services

We provide safety evaluation studies for the cosmetic industry on a contract basis.

In vivo

Stinging tests

This test evaluates temporary stinging sensation with volunteers with sensitive skin. Product which pass this test will be allowed to claim as the product “Passed Stinging test on Sensitive Skin Volunteers” in the Japanese market.
Delivery :Approx. one month from receipt of the test order to completion and release of the report.
Test substance category :Ingredients of cosmetics and final products for skin care, makeup, hair care and body care.

Primary skin irritation

In vivo

patch tests

This test evaluates whether or not a cosmetic product may lead to irritation of the human skin in vivo. Skin reactions arising from occluded test substance will be scored after a 24-hour exposure. Products which pass this test are allowed to claim that they have “Passed Patch Tests” in the Japanese market.
Delivery : Approx. one month from receipt of the test order to completion and release of the report.
Test substance category : Ingredients of cosmetics and final products for skin care, makeup, hair care and body care.

  • Primary skin irritation-In vivo patch tests
  • Primary skin irritation-In vivo patch tests
  • Primary skin irritation-In vivo patch tests
  • Primary skin irritation-In vivo patch tests
  • Primary skin irritation-In vivo patch tests

In vivo

Patch test on subjects with sensitive skin

This test is carried out as an in vivo patch test with volunteers with sensitive skin. Products which pass this test will be allowed to claim that the product “Passed Patch Tests on Sensitive Skin Volunteers” in the Japanese market.
Delivery : Approx. one month from receipt of the test order to completion and release of the report.
Test substance category : Ingredients of cosmetics and final products for skin care, makeup, hair care and body care.

In vitro

Primary irritation test with in vitro three-dimensional tissue culture models

This test evaluates the potential for a substance to irritate the skin using a human skin model. The test substance is applied to a three-dimensionally reconstituted human epidermis model. The cell viability is evaluated quantitatively according to the enzymatic conversion of the MTT into a blue formazan salt in viable cells. Thus, the irritability of the test substance is estimated. This test is recommended in OECD test guideline No. 439* as an alternative to animal tests.
* OECD Test Guideline No. 439 as latest version: In vitro Skin Irritation: Reconstructed Human Epidermis Test Method.
Delivery : Approx. 2.5 months from receipt of the test order to completion and release of the report.
Test substance category : Ingredients of cosmetics.

Eye irritation

In vitro

Cytotoxicity test using SIRC cells

This test evaluates the potential for eye irritation of a substance using a cytotoxicity-based in vitro assay performed on a confluent monolayer of Statens Seruminstitut Rabbit Cornea (SIRC) cells. SIRC cells are exposed to test samples and the cell viability is evaluated quantitatively based on the enzymatic conversion of the vital dye MTT into a blue formazan salt in viable cells. This test is employed as stated in the OECD test guideline*.
* OECD Test Guideline No. 491: Short Time Exposure In vitro Test Method for identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage.
Delivery : Approx. 1.5 months from receipt of the test order to completion and release of the report.
Test substance category :

Ingredients of cosmetics. Please note that some samples cannot be properly tested due to technical reasons.
  • Eye irritation-In vitro Cytotoxicity test using SIRC cells
  • Eye irritation-In vitro Cytotoxicity test using SIRC cells
  • Eye irritation-In vitro Cytotoxicity test using SIRC cells
  • Eye irritation-In vitro Cytotoxicity test using SIRC cells
  • Eye irritation-In vitro Cytotoxicity test using SIRC cells

Photo toxicity

In vitro

ROS assay

Photo-reactive potential of a chemical substance when it comes in to contact with skin in the presence of sunlight is evaluated using a Reactive Oxygen Species (ROS) assay. This test is recommended as a reliable test method with low false negative rate in the Japanese official guideline*.
A test substance solution is irradiated with sunlight at a wavelength of 290-800nm emitted from a solar-simulator and the generation of Reactive Oxygen Species (ROS) as a result of excitation by sunlight is evaluated quantitatively as an indicator of phototoxicity potential.
* Photosafety Evaluation of Pharmaceuticals, Yakushokushinsa No. 0521, the Ministry of Health, Labour and Welfare of Japan (MHLW), May 21st, 2014 which is Japanese endorsement of ICH Harmonised Tripartite Guideline.
Delivery : Approx. one month from receipt of the test order to completion and release of the report.
Test substance category : Ingredients of cosmetics including powders.

Single dose toxicity

In vitro

Cytotoxicity test using SIRC cells

Intentional or accidental ingestion of a chemical substance may cause acute toxicity. At Saticine Medical, an in vitro cytotoxicity assay of the test substance on SIRC cells is provided as a preliminary prediction of such systemic toxicity.
Delivery : Approx. 1.5 months from the time of the test to release of the report.
Test substance category : Ingredients of cosmetics.
Please note that some samples could not be properly tested for technical reasons.

How to order

Fill the application form on the web.

We will email a quotation accordingly to the application form.

Fill the purchase order form attached by the email and email us its’ PDF file which shall be deemed as a definitive formal order.

Consign the test substance to the following address.

Safety Evaluation Team, Research Department Saticine Medical Co., Ltd. 3F Haseman Bldg., 11-6 Tomioka 2-chome, Koto-ku, Tokyo 135-0047 JAPAN

Freight and custom charges shall be borne by the client.

Upon checking of physical properties of test substance, we will issue an invoice. Remittance shall be made to with bank transfer.
If the test is not possible for technical reason, the test substance will be discarded by Saticine Medical.

The requested study will be conducted at our Tokyo Laboratory.
Test results will be emailed in a PDF file, followed by the shipment of reports.

Application

Fill the application form on the web.

Quotation

We will email a quotation accordingly to the application form.

Order

Fill the purchase order form attached by the email and email us its’ PDF file which shall be deemed as a definitive formal order.

Shipment

Consign the test substance to the following address.

Safety Evaluation Team, Research Department Saticine Medical Co., Ltd. 3F Haseman Bldg., 11-6 Tomioka 2-chome, Koto-ku, Tokyo 135-0047 JAPAN

Freight and custom charges shall be borne by the client.

Payment

Upon checking of physical properties of test substance, we will issue an invoice. Remittance shall be made to with bank transfer.
If the test is not possible for technical reason, the test substance will be discarded by Saticine Medical.

Conduct of the study

The requested study will be conducted at our Tokyo Laboratory.
Test results will be emailed in a PDF file, followed by the shipment of reports.

Responsibility
Saticine Medical is not responsible for any losses arising from the use of test results submitted by Saticine Medical in a report format, and the client shall be solely responsible for the acts based on the information provided by Saticine Medical.
Confidentiality
The facts pertaining to the conduct of study and its outcomes shall be kept confidential and not be disclosed or provided to any third party.

Application / Enquiry Form