Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
The Quality & Regulatory Information Sheets (QRIS) are documents prepared to meet
the regulatory requirements associated with the sale of products into the personal care
market, and the QRIS are the intellectual property of Dow Silicones Corporation (“Dow
Chemical”). The QRIS are not intended for general circulation, however, Dow Chemical
authorizes you to distribute the QRIS to the regulatory or safety group within your
company. In the event that your company uses a third party consultant for product
safety assessments, Dow Chemical hereby authorizes your company to distribute to
such third party the QRIS solely for their internal use in conducting the product safety
assessment on behalf of your company. Except as expressly stated herein, no license
is granted under Dow Chemical intellectual property rights to use the QRIS.
Distribution of this document should be limited to customers or potential customers upon specific request for the information for
Health or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your
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Template Version 6.1 Revision Date: June 10, 2016
This version supersedes all previous versions
Previous Revision Date: September 13, 2013
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Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
1. Introduction
The purpose of this document is to provide key quality and regulatory information frequently requested by our
customers on the above-named product. The information contained herein is offered in good faith and is
believed to be accurate. However, because conditions and methods of use of our products are beyond our
control, this information should not be used in substitution for customers’ tests to ensure that Dow Chemical’s
products are safe, effective, and fully satisfactory for the intended end use. For further information, please
see our website, www.consumer.dow.com, or contact your local Dow Chemical representative.
2. Identity
INCI Name Cyclopentasiloxane (and) Dimethicone Crosspolymer
Chemical Name or Silicone
Description
Supplier/Manufacturer Dow Silicones Corporation
Country of Manufacture USA
Manufacturing Process This material is produced by reacting raw materials under appropriate
mixing conditions, filtering, and packaging.
Manufacturing Quality Dow Chemical has a global management system that integrates
System Environment, Health, Safety, Security and Quality requirements and that
supports Dow Chemical commitment to Sustainability, Responsible Care®,
and Customer Satisfaction. Dow Chemical holds global ISO9001 and
ISO14001 certifications that include most manufacturing and commercial
sites. The sites that are part of the global ISO9001 and ISO14001
certifications are listed on our certificates. The certificates of registration
can be found on www.consumer.dow.com, under About Dow Chemical /
Quality & Six Sigma.
3. Chemical Inventory Status
The information provided within this section is intended to address chemical inventory status for various
geographies. It is not intended to be a comprehensive regulatory assessment. Formulators are reminded of
their responsibilities to ensure the suitability of raw materials selected and of the final cosmetic formulation.
US - TSCA All chemical substances in this material are included on or exempted from
TSCA.
Europe – EINECS All ingredients listed in EINECS or exempt.
Please note that compliance with Regulation (EC) No 1907/2006 (REACH) is required to import substances
(pure, in mixtures or in articles) to the European Economic Area (i.e. EU member states + Iceland, Liechtenstein,
Norway). The EINECS status of a substance is no longer appropriate to give evidence if import of a substance to
the EEA is permissible or not. Additional information is available from our REACH Resource Center on
http://www.consumer.dow.com/content/about/REACH_Resource_Center.aspx in the document
http://www.consumer.dow.com/content/publishedlit/REACh_Position_Statement_English_September12.pdf
Australia - AICS All ingredients listed or exempt.
Canada - DSL All ingredients listed or exempt.
China - IECSC All ingredients listed or exempt.
Japan – ENCS/ISHL All components are listed on ENCS/ISHL or its exempt rule.
Korea - ECL All ingredients listed, exempt or notified.
Philippines- PICCS All ingredients listed or exempt.
Distribution of this document should be limited to customers or potential customers upon specific request for the information for Health
or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your technical Dow
Chemical contact person or our technical information center (tech.info@dow.com)
Template Version 6.1 Revision Date: June 10, 2016
This version supersedes all previous versions
Previous Revision Date: September 13, 2013
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Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
4. Specific Regulatory Information
The information is intended to address specific product-based regulations in various geographies. It is not
intended to be comprehensive regulatory assessment. The information in this section is accurate to the best
of our knowledge. Information is based on Dow Chemical’s product and process knowledge as well as
information provided by our suppliers. Formulators are reminded of their responsibilities to ensure the
suitability of raw material components and of the final cosmetic formulation.
European Union
Substances included in Annex II of the Cosmetic Regulation 1223/2009:
Not expected to contain substances restricted by Annex II of EU Regulation N°1223/2009 at
>0.1%.
Substances included in Annex III of the Cosmetic Regulation 1223/2009:
Not expected to contain substances restricted by Annex III of EU Regulation N°1223/2009
at >0.1%.
Substances restricted by Annex III of EU Regulation N°1223/2009 on cosmetic product
include the allergens listed in 7th amendment of European Directive 76/768 for
cosmetic products (Directive 2003/15/EC of 27 February 2003):
Not expected to contain allergenic substances restricted by Annex III of EU Regulation
N°1223/2009.
Substances classified CMR pursuant to annex VI of EU Regulation 1272/2008:
Not expected to contain substances classified CMR category 1A pursuant to Annex VI of
EU Regulation 1272/2008 at >0.1%.
Not expected to contain substances classified CMR category 1B pursuant to Annex VI of
EU Regulation 1272/2008 at >0.1%.
Not expected to contain substances classified CMR category 2 pursuant to Annex VI of EU
Regulation 1272/2008 at >0.1% with the exception of
Cyclotetrasiloxane at <=1%
Japan
Cosmetic Labelling, JCIA:
All ingredients are registered in JCIA
Quasi-drug Status:
One or more ingredients are not registered in JSQI
5. Composition, including Preservatives & Antioxidants
Note: Impurities Information is in section 10
The composition shown below is intended to illustrate the typical composition of this product and should not
be interpreted as a formulation specification.
European Typical
Registration CAS INCI Name Chemical Name Concen- Function Origin
Number tration
208-764-9
541-02-6 Cyclopentasiloxane Decamethylcyclopentasiloxane 80-90% Key Synthetic
(EINECS)
Dimethyl MethylHydrogen
Exempted as Dimethicone
213629-14-2 Siloxane Reaction Prodcuts 10-15% Key Synthetic
polymer Crosspolymer
with 1,5-Hexadiene
Distribution of this document should be limited to customers or potential customers upon specific request for the information for Health
or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your technical Dow
Chemical contact person or our technical information center (tech.info@dow.com)
Template Version 6.1 Revision Date: June 10, 2016
This version supersedes all previous versions
Previous Revision Date: September 13, 2013
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Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
Dimethylcyclosiloxanes, D6 or
None None None 1-5% Impurity Synthetic
greater
209-136-7
556-67-2 Cyclotetrasiloxane Octamethylcyclotetrasiloxane <=1% Impurity Synthetic
(EINECS)
This list may not be an exhaustive chemical description of this product’s composition, but it shows the quantitative
composition of each ingredient mentioned in the INCI name. Please refer to the applicable country (or geographical area)
safety data sheet (example: Japan or Europe) for any other ingredient that would require regulatory classification.
6. Product Characteristics
Odor
Slight
Nanomaterial Status
Based on the EU Cosmetics Regulation (1223/2009/EC) and on the European Commission
Recommendation on the Definition of Nanomaterial (2011/696/EU), Dow Chemical does not expect this
product to be classified as a nanomaterial. This information is based on our knowledge available at this
time.
7. Biologics Information
Material Status
Genetically Modified This product is solely synthetic and is not expected to contain genetically
Organisms (GMOs) modified organisms.
Animal Derived This product does not contain ingredients of animal origin.
Natural Rubber/Latex This product is not formulated with latex derived from the rubber tree, Hevea
Brasiliensis.
8. Additives
Material Present
Phthalates Not intentionally added.
Colorants Not intentionally added.
Bleaching agents Not intentionally added.
9. Heavy Metals
These values are not intended for use in preparing specifications. They are indicative information. Since we
do not regularly analyse for presence of those substances, we cannot guarantee specific limits. When
present in the Dow Chemical product, these metals are impurities. Given the manufacturing process, it is
not possible to completely remove these substances from the Dow Chemical product.
Element Concentration
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or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your technical Dow
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Template Version 6.1 Revision Date: June 10, 2016
This version supersedes all previous versions
Previous Revision Date: September 13, 2013
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Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
Arsenic (As) Tested, found to be less than 1 ppm.*
Bismuth (Bi) Tested, found to be less than 1 ppm.*
Cadmium (Cd) Tested, found to be less than 1 ppm.*
Cerium (Ce) Tested, found to be less than 1 ppm.*
Cobalt (Co) Tested, found to be less than 1 ppm.*
Chromium (Cr) Tested, found to be less than 1 ppm.*
Copper (Cu) Tested, found to be less than 1 ppm.*
Mercury (Hg) Tested, found to be less than 1 ppm.*
Lead (Pb) Tested, found to be less than 1 ppm.*
Nickel (Ni) Tested, found to be less than 1 ppm.*
Antimony (Sb) Tested, found to be less than 1 ppm.*
Strontium (Sr) Tested, found to be less than 1 ppm.*
Zinc (Zn) Tested, found to be less than 1 ppm.*
* Value generated via ICP standard method.
Number of samples tested was: 1
Date of analysis was: March 2014
Element Concentration
JSQI General Heavy Metals Test Tested, total found to be is less than 20 ppm
JSQI Test for Arsenic Tested, found to be less than 2 ppm
10. Potential Impurities
The information below is accurate to the best of our knowledge, with the information provided as indicated
in the table, as of the issuing date. This is not an exhaustive list of potential impurities and may not include
impurities referenced elsewhere within this document. These values are not intended for use in preparing
specifications. They are indicative information. Since we do not regularly analyse for the presence of those
substances, we cannot guarantee specific limits. Given the manufacturing process, it is not possible to
completely remove these substances from the Dow Chemical product.
Component CAS #
National Formulary Class 1 & 2 71-43-2; Benzene, non-detect, based on internal analytical
Solvents 108-88-3 data (detection limit is 2 ppm); Toluene, non-detect,
based on internal analytical data (detection limit is
2 ppm)
Amidoamine Not tested, none expected
Triethanolamine 102-71-6 Not tested, none expected
Diethanolamine 111-42-2 Not tested, none expected
Dimethylnitrosoamine; 62-75-9; Not tested, none expected
Nitrosodipropylamine; 621-64-7;
2,2’-(Nitrosoimino)bisethanol 1116-54-7
Diethylene glycol 111-46-6 Not tested, none expected
1,4-Dioxane 123-91-1 Not tested, none expected
Ethylene Oxide 75-21-8 Not tested, none expected
Propylene Oxide 75-56-9 Not tested, none expected
Distribution of this document should be limited to customers or potential customers upon specific request for the information for Health
or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your technical Dow
Chemical contact person or our technical information center (tech.info@dow.com)
Template Version 6.1 Revision Date: June 10, 2016
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Previous Revision Date: September 13, 2013
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Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
Formaldehyde 50-00-0 Not tested, none expected
Free Amines Not tested, none expected
11. Microbiological Data
This product has a water activity (AW) level of less than 0.6. It is generally accepted that an Aw less than
0.6 will not support microbial growth. Therefore, Dow Chemical does not routinely test this material for
microbial contamination and there is not a microbial specification associated with this product. While this
product does not contain sufficient available water for microbial growth, it is not antimicrobial in nature.
Therefore, please use normal precautionary measures for handling cosmetic grade materials while using
these raw materials.
12. Toxicological Data
A summary of health data or an opinion letter is available on request for this material, its components, or
similar materials. This material has been assessed by Dow Chemical’s product toxicology department for use
in the personal care application(s) listed below. Sufficient information exists at this time to support these
intended commercial activities. Supported Personal Care Application(s) (this list may not be exhaustive):
• Cosmetic Additive
• Hair Care, Shampoos
• Antiperspirants/Deodorants
This assessment is based upon currently available information and is the opinion of Dow Chemical for its
product(s). This is a general assessment; the safety and the efficacy of the end use application are the
customer’s responsibility. Nothing herein should be constructed as a finished product certificate and Dow
Chemical disclaims any expressed or implied warranty of fitness for a particular purpose or merchant ability
and any liability of incidental or consequential damages.
Animal Test Status:
The above referenced product has been tested on animals by or on behalf of Dow Chemical, with the latest
test date being 2008. This product has not been tested for cosmetic purposes. Additional information on
animal test status is available on request.
For the purpose of this document, animal testing is defined as testing performed on non-human mammals,
in vivo. In providing this information to you at this time, Dow Chemical does not undertake to monitor
further developments or update this information if the testing status changes. Health hazard testing,
including base set tests for product registration, industrial worker safety evaluation testing, and the
industry-sponsored Siloxane Research Program (SRP) studies, are not considered to be for cosmetic
purposes. This information represents only Dow Chemical's conduct with respect to the use/commissioning
of animal tests.
13. Environmental Data
See this product’s Safety Data Sheet for specific safety and environmental information. Information on
degradation of polydimethylsiloxanes and volatile siloxanes in the environment is available on request.
European Environmental Hazard Classification: refer to European Safety Data Sheet.
Distribution of this document should be limited to customers or potential customers upon specific request for the information for Health
or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your technical Dow
Chemical contact person or our technical information center (tech.info@dow.com)
Template Version 6.1 Revision Date: June 10, 2016
This version supersedes all previous versions
Previous Revision Date: September 13, 2013
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Summary of Quality and Regulatory Information for Beauty Care
DOWSIL™ 9040 Silicone Elastomer Blend
14. Sustainability
The connection between sand, one of nature’s abundant resources, and our silicon-based products
provides the foundation on which Dow Chemical is based, and aligns with our dedication to building a
sustainable future for you and each of us. As we bring to life our Guiding Principles, we continually strive to
be one of the most respected companies in the chemical industry for environmental, health, and safety
performance. We have used the American Chemistry Council's Responsible Care® program as the
framework to assure environment, health, and safety practices are well established within the
company. These management systems guide our actions and enable us to responsibly develop, produce,
and provide products to enhance lives and be a positive force working for our collective future. To
effectively work toward this goal, we rely on the commitment and involvement of our employees around the
world. Do not hesitate to request Dow Chemical’s latest Sustainability Summary Report. To support
customers in the product safety needs, Dow Chemical has an extensive Product Stewardship organization
and a team of Product Safety and Regulatory Compliance (PS&RC) specialists available in each area. For
additional information, please see our website,
http://www.consumer.dow.com/content/about/aboutehs/default.aspx or contact your Dow Chemical
representative.
Important Legal Information
2013 © Dow Silicones Corporation. All rights reserved. No part of this work may be reproduced or
transmitted in any form by any means, electronic or mechanical, including but not limited to photocopying or
recording, or by any information storage or retrieval system without permission in writing from Dow
Silicones Corporation.
While Dow Chemical believes the information to be accurate at the time it is provided, DOW CHEMICAL
DOES NOT MAKE ANY WARRANTY OR REPRESENTATION, EXPRESS OR IMPLIED, WITH RESPECT
TO THE ACCURACY, COMPLETENESS OR UTILITY OF THE INFORMATION CONTAINED IN THIS
DOCUMENT OR OTHERWISE FURNISHED.
In providing this information to you at this time, Dow Chemical does not undertake to do further testing, to
monitor further developments in the field or to provide further information to you.
Dow Chemical provides this document solely for your internal use and any submissions to governmental
agencies by you. Except for reliance upon these data by a governmental agency, such as for product (or
chemical substance) registration purposes, third parties may not use it or rely upon it. No third party obtains
any right of any kind from this Agreement, the Report or your use of it. TO THE FULL EXTENT
PERMITTED BY LAW, DOW CHEMICAL DISCLAIMS ANY AND ALL LIABILITY WITH RESPECT TO
YOUR USE OF, OR RELIANCE UPON, ANY INFORMATION, PROCEDURE, CONCLUSIONS OR
OPINION CONTAINED IN THIS DOCUMENT OR OTHERWISE FURNISHED.
This document is not intended as, nor should it be relied upon as, legal advice, either generally or with
respect to your specific situation. For advice about specific facts and legal issues, you should consult your
own legal counsel.
Distribution of this document should be limited to customers or potential customers upon specific request for the information for Health
or Safety assessment or Regulatory purpose. For any question concerning the content of this document please ask your technical Dow
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Template Version 6.1 Revision Date: June 10, 2016
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Previous Revision Date: September 13, 2013
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