Safety

Softcare product safety

We at Oy Soft Protector Ltd want to emphasize the most important principle of our product development: To provide high quality and safe products.

We are committed both to the science of safety and to the art of creating products that are gentle on people and the environment. Like you, we have a healthy scepticism, when it comes to the use of any chemicals – whether they are found in nature or made in a factory.

All of our ingredient choices are supported by the best available science, as well as by a team of scientists who specialize in ingredient safety. We actively monitor all of our products and their constituents, to ensure they reflect the latest science, as well as our customers’ preferences and concerns.

Softcare Textile Protectors

The ingredients used in Softcare Protectors (e.g. Softcare Textile Protector, Softcare Carpet Protector and Softcare Leather Protector) are well-defined and their efficacy and safety have been studied extensively. Softcare Protectors effectively protect the textiles, upholstery, clothing and leather. In addition, this protection extends the life cycle of the textile and enhances its aesthetics, keeping the textile looking newer for a longer time. As a result, the protected textile has a significantly reduced environmental footprint, particularly in the use and maintenance phase.

Textile protection technologies can be roughly divided into fluorinated compounds, hydrocarbons, silicones, dendrimers, wax based treatments and nanoparticle technologies.

Turvallisuus_1_2From these technologies the fluorinated textile protection technologies are the most effective protective technology for textiles, as only they provide an effective, long-lasting protection and excellent repellence against water, oil, soil and dirt. In addition, they are long lasting and more resistant to washing, light, rain, abrasion and other environmental factors to which textiles are exposed to during their life cycle.

Fluorotelomers are based on perfluorinated alkyl chain F(CF2)n-, where n is the number of the fluorinated carbons, and which can be attached to a non-fluorinated polymer backbone (e.g. acrylic polymer).

This chain length “n” of fluorotelomers is very important for the safety and biodegradability of the fluorotelomers. Long-chain (n ≥ 8) perfluorinated alkyl compounds, such as PFOA (perfluorooctanoic acid) and PFOS (perfluorooctane sulfonate) are not used in Softcare protectors.

It has been known to us that perfluorinated alkyl compounds with long-chain (n ≥ 8) are questionable both in regards of user safety and environmental safety. For this reason our Softcare protectors only utilize so-called short-chain C6 (n ≤ 6) perfluorinated alkyl acrylate polymer technology.

This has been a conscious design and development choice Oy Soft Protector Ltd has made as a part of our company’s values and responsible product development. We do not use PFOS, PFOA or other long-chain (n ≥ 8) based perfluorinated compounds. Therefore Oy Soft Protector Ltd has during its responsible product development made this decision well before the authorities in different countries began to evaluate the long-chain (n ≥ 8) perfluorinated substances according to newer scientific studies.

It should be noted also that the environmental authorities in Finland have concluded that PFOS-related compounds have not been prepared in Finland, and since 2000, Finnish companies have introduced only two such compound containing product. PFOS and PFOA compounds have been used, for example, at civil and military airports in firefighting foams. Oy Soft Protector Ltd has never manufactured or imported such products – any kind of firefighting foam has never been in Softcare product portfolio.

PFOS and other long-chain perfluorinated alkyl compounds

As stated previously, the Softcare Protectors do not contain or make use of long-chain perfluorinated alkyl compounds (e.g. PFOA or PFOS, which have n = 8).

Long-chain perfluorinated alkyl compounds are at the present under scientific and regulatory reviews, and have restrictions and/or prohibitions of use in e.g.

  • European Union
  • Norway
  • Germany
  • United States
  • Canada
  • Australia
  • Japan

Softcare protectors do not contain any such compounds which have restrictions and/or prohibitions. Amongst other things, the US Environmental Protection Agency EPA (Environmental Protection Agency) has stated the following: “PFAC chemicals with fewer than C8 carbons, such as Perfluorohexanoic Acid (PFHxA), are not considered long chain chemicals. These shorter-chain PFAC are not part of this action plan, because data in non-human primates indicate that they have substantially shorter half-lives in these animals than PFOA and are less toxic than long-chain PFAC chemicals.”

Additionally, in the European Union, PFOA (n = 8) compounds are listed on the European Chemicals Agency ECHA’s list of “Substances of Very High Concern” (SVHC) list and their use is also limited, for example, in Norway.

It is important to emphasize that despite the similar sounding names, not all perfluorinated compounds can be stereotypically grouped into one single category, because particularly the chain length (n) of the fluorotelomer and the attachment to the polymer backbone have significant impact on both physicochemical and toxicological properties.

 

Softcare Protectors are based on C6 fluorotelomer chemistry

Turvallisuus_1Softcare protectors are based on C6 (n = 6) fluorotelomer chemistry. These short-chain fluorotelomers (n ≤ 6) cannot degrade to longer chain-length compounds, such as PFOA or PFOS compounds.

In addition, these short-chain fluorotelomers in Softcare protectors are attached to a polymer backbone during manufacturing process, thus Softcare protectors do not contain freely available fluorotelomers.

Since these polymers in Softcare protectors are quite large, with molecular weight well over 1000 Daltons, the polymer of this size is generally too large to penetrate cell membranes and does not bioaccumulate, that is, does not accumulate in the human body.

C6 based perfluorinated compounds (n = 6) are short-chain, for example, 6:2 FTOH, 6:2 FTAC and – at least theoretically possible – a breakdown product perfluorohexanoic acid (PFHxA). The toxicity to humans, mammals and animals has been extensively studied and reported in scientific literature.
C6 (n = 6) based perfluorinated compound toxicity, for example acute and chronic toxicity, neurotoxicological effects, the effect on reproduction, the effect on the fetus, the effect of pregnant mammals, etc. have been extensively studied. Studies have demonstrated C6 based perfluorinated substances to be safe in normal and reasonably foreseeable use of and exposure to Softcare protectors. C6 perfluorinated compounds – and their theoretically potential degradation products such as perfluorohexanoic acid – have harmless effect levels (NOAEL, BDL10) at least a magnitude higher than the long-chain perfluorinated compounds.

 

Exposure to Softcare Protectors

Based on our empirical experience, one (1) kilogram of Softcare protector is generally enough for treating about ten (10) square meters of typical textile.

The amount of Softcare protector remaining on one (1) square meter after treatment, under normal and reasonably foreseeable conditions, is estimated to be about 1.4 grams of a textile protective agent per one (1) square meter of treated fabric.
When this estimated concentration of 1.4 g per m2 per standard toxicological calculation methods taking into account in example body weight, systemic exposure and duration of exposure is calculated, the systemic exposure dose (SED) expressed in mg/kg body weight/day remains low.

This systemic exposure dose (SED) is then compared to established no adverse effect levels (NOAEL) – that is, to the dose levels at which no adverse effects have been found in toxicological in vivo testing.

The Margin of Safety of the C6 perfluorinated compounds and their theoretically possible degradation products present in Softcare protectors are calculated by comparing these no adverse effect levels to systemic exposure dose.

In practice this means that under normal conditions and in normal amounts, Softcare Textile Protectors are many times safer to use than even the levels of harmless effect levels shown through research. The products have now caused any health risks to the user.

 

Softcare Protectors in waste treatment

Scientific studies have been conducted to understand the effects of perfluorinated alkyl compound treated textiles in municipal waste such as waste incineration plants.

Studies have shown that such textiles treated protectant did not cause any significant release of perfluorinated compounds into the environment.
Sources and scientific publications

  • S.S. ANAND et al., “Toxicological assessment of tridecafluorohexylethyl methacrylate (6:2 FTMAC)”, Toxicology 292 (2012) 42–52
  • J.C. O’CONNOR et al., “Evaluation of the reproductive and developmental toxicity of 6:2 fluorotelomer alcohol in rats”, Toxicology 317 (2014) 6–16
  • T. SEREX et al., “Toxicological evaluation of 6:2 fluorotelomer alcohol”, Toxicology 319 (2014) 1–9
  • T. YAMADA et al., “Thermal degradation of fluorotelomer treated articles and related materials”, Chemosphere 61 (2005) 974–984
  • M. SCHERINGER et al., “Helsingør Statement on poly- and perfluorinated alkyl substances (PFASs)”, Chemosphere 114 (2014) 337–339
  • C.P. HIGGINS et al., “Treatment of poly- and perfluoroalkyl substances in U.S. full-scale water treatment systems”, Water Research 51 (2014) 246-255
  • R.A. HOKE et al., “Comparative acute freshwater hazard assessment and preliminary PNEC development for eight fluorinated acids”, Chemosphere 87 (2012) 725–733
  • D. HERZKE et al., “Perfluoroalkyl and polyfluoroalkyl substances (PFASs) in consumer products in Norway – A pilot study”, Chemosphere 88 (2012) 980–987
  • L. ZHAO et al., “6:2 Fluorotelomer alcohol aerobic biotransformation in activated sludge from two domestic wastewater treatment plants”, Chemosphere 92 (2013) 464–470
  • M.H. RUSSELL et al., “Elimination kinetics of perfluorohexanoic acid in humans and comparison with mouse, rat and monkey”, Chemosphere 93 (2013) 2419–2425
  • M.H. RUSSELL et al., “Inhalation and oral toxicokinetics of 6:2 FTOH and its metabolites in mammals”, Chemosphere 120 (2015) 328–335
  • M. FILIPOVIC et al., “Historical usage of aqueous film forming foam: A case study of the widespread distribution of perfluoroalkyl acids from a military airport to groundwater, lakes, soils and fish”, Article in Press, Chemosphere xxx (2014) xxx–xxx
  • Z. XU et al., “Human exposure to fluorotelomer alcohols, perfluorooctane sulfonate and perfluorooctanoate via house dust in Bavaria, Germany”, Science of the Total Environment 443 (2013) 485–490
  • C.P. CHENGELIS et al., “A 90-day repeated dose oral (gavage) toxicity study of perfluorohexanoic acid (PFHxA) in rats (with functional observational battery and motor activity determinations)”, Reproductive Toxicology 27 (2009) 342–351
  • R.J. MITCHELL et al., “Toxicity of fluorotelomer carboxylic acids to the algae Pseudokirchneriella subcapitata and Chlorella vulgaris, and the amphipod Hyalella azteca”, Ecotoxicology and Environmental Safety 74 (2011) 2260–2267
  • Z. WANG et al., “Global emission inventories for C4–C14 perfluoroalkyl carboxylic acid (PFCA) homologues from 1951 to 2030, Part I: production and emissions from quantifiable sources”, Environment International 70 (2014) 62-75
  • Z. WANG et al., “Global emission inventories for C4–C14 perfluoroalkyl carboxylic acid (PFCA) homologues from 1951 to 2030, part II: The remaining pieces of the puzzle”, Environment International 69 (2014) 166–176
  • K. KLESZCZYNSKI et al., “Analysis of structure–cytotoxicity in vitro relationship (SAR) for perfluorinated carboxylic acids”, Toxicology in Vitro 21 (2007) 1206–1211
  • K.T. ERIKSEN et al, “Genotoxic potential of the perfluorinated chemicals PFOA, PFOS, PFBS, PFNA and PFHxA in human HepG2 cells”, Mutation Research 700 (2010) 39–43
  • N. WANG et al., “6:2 Fluorotelomer sulfonate aerobic biotransformation in activated sludge of waste water treatment plants”, Chemosphere Volume 82, Issue 6, (2011) 853–858
  • R.C. BUCK et al., “Perfluoroalkyl and Polyfluoroalkyl Substances in the Environment: Terminology, Classification, and Origins”, Integrated Environmental Assessment and Management — Volume 7, Number 4 (2011) 513–541
  • A. PISTOCCI and R. LOOS, “A Map of European Emissions and Concentrations of PFOS and PFOA”, Environ. Sci. Technol. 2009 43, 9237–9244
  • H. NILSSON et al., “Biotransformation of fluorotelomer compound to perfluorocarboxylates in humans”, Environment International 51 (2013) 8–12
  • J. MALM et al., “Inclusion of Substances of Very High Concern in the Candidate List”, ECHA – European Chemicals Agency ED/69/2013
  • X. LIU et al., “Determination of fluorotelomer alcohols in selected consumer products and preliminary investigation of their fate in the indoor environment”, Chemosphere (2014)
  • W. A. GEBBINK et al., “Estimating human exposure to PFOS isomers and PFCA homologues: The relative importance of direct and indirect (precursor) exposure”, Environment International 74 (2015) 160-169
  • P. GUERRA, M. KIM, L. KINSMAN, T. NG, M. ALAEE, S.A. SMYTH, “Parameters affecting the formation of perfluoroalkyl acids during wastewater treatment”, Journal of Hazardous Materials 272 (2014) 148-154
  • “Long-Chain Perfluorinated Chemicals (LCPFCs) Used in Carpets”, Contract # EP-W-08-010, Office of Pollution, Prevention, and Toxics U.S. Environmental Protection Agency, USA
  • ENVIRON International, “Assessment of POP Criteria for Specific Short-Chain Perfluorinated Alkyl Substances”, FluoroCouncil, Project 0134304A
  • Anon., “Perfluorioktaanisulfonaatti PFOS”, Available at www.ymparisto.fi, Accessed on 26th November 2014
  • J. STEINHILBER, “Industry Perspective on Alternatives to Long-Chain PFCs”, FluoroCouncil (2014)
  • W. KNAUP, “REGULATORY AFFAIRS – The Challenge PFOA Free”, R&D Fluoropolymers, Archroma (2013)
  • M. SCHERINGER, “The Helsingør Statement on Poly- and Perfluorinated Alkyl Substances – Where Are We Going with Fluorinated Alternatives?”, Science and Policy Symposium, Madrid, 2014
  • COWI A/S, “Inventory of PFOS and PFOS-related substances in fire-fighting foams in Norway”, Norwegian Pollution Control Authority, TA-2961/2012
  • R.W. RICKARD, Ph.D., D.A.B.T., “Toxicology – Perfluorocarboxylates”, October 2009, Presented to EPA Office of Water, USA