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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 of people around the world as well as trust from the Japanese market. 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.

Human

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

Human

Patch test

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

Human

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

Eye irritation tests of a cytotoxicity-based in vitro assay

We have two alternative methods of testing with corneal epithelium cells without using laboratory animals. STE test (OECD Test Guideline 491) using SIRC cells is highly reproduceble and reasonable at low cost, since cells are cultured in a monolayer. RhCE test (OEDC test guideline 492) can evaluate sparingly soluble substances by using 3 dimensionally reconstructed human corneal epithelium model.
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 tested in STE method 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

Phototoxicity of cosmetics ingredients to the skin under sunlight is evaluated using a Reactive Oxygen Species (ROS) assay. This test is recommended as a reliable with low false negative rate compared to 3T3-NRU test*. ROS assay is highly reproduceble and reasonable at low cost.
A test substance is irradiated by a solar-simulator (290-800nm) and the generation of ROS (1O2 and O2-) is evaluated 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 : Cosmetics ingredients including essential oil, fragrance, plant extracts, 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, order form, sample confirmation form.

Fill the order form and sample confirmation form, and email us their PDF files which shall be deemed as a definitive formal order.

Ship 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.
The test substance will be discarded after the test, or if the test is not possible for technical reason by Saticine Medical.

Upon checking of physical properties of test substance, we will conduct the test .
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, order form, sample confirmation form.

Order

Fill the order form and sample confirmation form, and email us their PDF files which shall be deemed as a definitive formal order.

Shipment

Ship 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 paid by the client.
The test substance will be discarded by Saticine Medical after the test, or if the test is not possible for technical reason.

Conduct of the test

Upon checking of physical properties of test substance.
If the test is not possible for technical reason, the test substance will be discarded by Saticine Medical.

Report

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, or any actions based on test results.
Confidentiality
We keep all confidential strictly in information such as contents of request and test result.

Application / Enquiry Form