Safety AssessmentofVinylpyrrolidone Polymers as Used in
Cosmetics

Status:Release Date:
Panel Date:

Final Report
January 23, 2019
December 3-4, 2018

The 2018 Cosmetic Ingredient Review Expert Panel members are: Chair, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V.
Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.;
Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Executive Director is Bart
Heldreth, Ph.D. This report was prepared by Wilbur Johnson, Jr., M.S., Senior Scientific Analyst.

© Cosmetic Ingredient Review
1620 L Street, NW, Suite 1200 ♢ Washington, DC 20036-4702 ♢ ph 202.331.0651 ♢ fax 202.331.0088 ♢cirinfo@cir-safety.org

ABSTRACT: The Cosmetic Ingredient Review (CIR) Expert Panel (Panel) reviewed the safety of 30 vinylpyrrolidone
polymers as used in cosmetic products; most of these ingredients have the reported cosmetic function of film former incommon. The Panel reviewed data relevant to the safety of these ingredients, and determined that 27 vinylpyrrolidone
polymers are safe in cosmetics in the present practices of use and concentration described in the safety assessment. The
Panel also concluded that the available data are insufficient to make a determination that 3 vinylpyrrolidone polymers (allurethanes) are safe under the intended conditions of use in cosmetic formulations.
INTRODUCTION
The safety of the following 30 vinylpyrrolidone (VP) polymer ingredients, as used in cosmetics, is being reviewed inthis safety assessment:
VP Copolymers
Acrylic Acid/VP Crosspolymer
Maltodextrin/VP Copolymer
PVP/Decene Copolymer
PVP/VA/Itaconic Acid Copolymer
PVP/VA/Vinyl Propionate Copolymer
Styrene/VP Copolymer*
Triacontene/VP Copolymer
VP/Eicosene Copolymer
VP/Hexadecene Copolymer
VP/VA Copolymer*
VP/Vinyl Alcohol Copolymer
VP Acrylate Copolymers
Acrylates/Stearyl Methacrylate/VP Copolymer
Acrylates/VP Copolymer*
Ammonium Acryloyldimethyltaurate/VP Copolymer*
Ethylhexyl Acrylate/VP/Dimethicone Methacrylate
Copolymer
Ethylhexyl Methacrylate/Methyl Methacrylate/VP
Copolymer
Methacrylic Acid/Styrene/VP Copolymer*

Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate
Copolymer*
VP/Acrylates/Lauryl Methacrylate Copolymer
VP/Dimethylaminoethylmethacrylate Copolymer*
VP/DMAPA Acrylates Copolymer
VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer
Polyvinylpyrrolidone (PVP) and Modified PVP Polymers
Butylated PVP
PVP*
Triacontanyl PVP
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP Crosspolymer
Sodium Acryloyldimethyltaurate/VP Crosspolymer*
Urethanes
VP/Dimethiconylacrylate/Polycarbamyl/Polyglycol Ester
VP/Dimethylaminoethylmethacrylate/Polycarbamyl
Polyglycol Ester
VP/Polycarbamyl Polyglycol Ester*Previously reviewed by the CIR Expert Panel
Most of these ingredients have the reported cosmetic function of film former in common (see Table 1).1 Viscosity
increasing agent and binder are two other functions that are frequently reported. Also, all 30 ingredients named above sharein common a vinylpyrrolidone monomer. Therefore, even though 9 of these ingredients have been previously reviewed by
the Panel,.2,3,4,5,6,7,8 the collection of these ingredients in one report enables the assembly of reinforcing and complementary
test data. Consequently, the Panel determined these ingredients should be reviewed together in one document.
The Panel’s published conclusions on the 9 ingredients that were previously reviewed are stated in Table 2, and the
published reports may be found on the CIR website (https://www.cir-safety.org/ingredients.) This safety assessment includes
summaries of relevant safety test data from the published reports of the previously-reviewed vinylpyrrolidone polymers,
when available, and that information is identified using italicized text. Any available safety test data on these ingredients thathave entered the published literature since the publication of these reports are included in this report, as well.
It should be noted that some of the monomer components of these polymers are toxic, and therefore the residual
monomer content of polymers should be taken into consideration. Information relating to the CIR review status of themonomer components of vinylpyrrolidone polymers is presented in Table 3. (The published reports that contain data on themonomer components can be accessed at the CIR website, as identified above.)This safety assessment includes relevant published and unpublished data for each endpoint that is evaluated.
Published data are identified by conducting an exhaustive search of the world’s literature. A list of the typical search engines
and websites used, sources explored, and endpoints that CIR evaluates, is available on the CIR (https://www.cirsafety.org/supplementaldoc/preliminary-search-engines-and-websites; https://www.cir-safety.org/supplementaldoc/cir-reportformat-outline). Unpublished data are provided by the cosmetics industry, as well as by other interested parties.

CHEMISTRY
Definition and General Characterization
The definitions, structures, and functions of the vinylpyrrolidone polymers that are reviewed in this safetyassessment are presented in Table 1. These polymeric ingredients share in common a vinylpyrrolidone monomer (Figure 1).

Figure 1. Vinylpyrrolidone polymer ingredients (wherein –C(R)HCH2- represents at least one co-monomer residue).

Chemical and Physical Properties
The physical properties of 15 vinylpyrrolidone polymers are presented in Table 4. Maltodextrin/VP Copolymer has
an average molecular weight of 132,999 Da.9 According to one supplier, Triacontanyl PVP is another high molecular weight
polymer, and is insoluble in water, acid, or base solution.10 VP/Acrylates/Lauryl Methacrylate Copolymer is expected tohave low water solubility based on its mostly hydrophobic structure. 11 Sodium Acryloyldimethyltaurate/VP Crosspolymer is
miscible with water and VP/Dimethylaminoethylmethacrylate Copolymer has a density of 1.047 g/cm 3.12,13 Additionally, themolecular weight of PVP can range from 10,000 to 700,000 Da, and PVP with an average molecular weight of 40,000 Da iscommonly used in cosmetic formulations.8
Australia’s National Industrial Chemical Notification and Assessment Scheme (NICNAS) has determined that
Maltodextrin/VP Copolymer, VP/Acrylates/Lauryl Methacrylate Copolymer, and Sodium Acryloyldimethyltaurate/VP
Crosspolymer are polymers of low concern (PLC).12,9,11 The following statements relate to some of the NICNAS-establishedcharacteristics of a PLC: A polymer cannot be a PLC if it is designed to or can be expected to substantially degrade,
decompose, or depolymerize, including polymers that substantially degrade, decompose or depolymerize after manufactureand end use, even though they are not intended to do so. 14

VP Copolymers
VP/VA Copolymer
VP/VA Copolymer does not absorb energy over the long-wavelength ultraviolet (UVA), mid-wavelength ultraviolet(UVB), or visible light spectrum.2
Method of Manufacture
VP Copolymers
VP/VA Copolymer
VP/VA Copolymer is prepared by free radical polymerization in ethyl alcohol.2 Details about radical initiators,
propagators, chain terminators, and solvent(s) were not provided.
VP/VA Copolymer is produced by free radical copolymerization of N-vinyl-2-pyrrolidone (NVP) and vinyl acetate(VA) in an isopropanol solution, in the presence of initiators.15 The process is continuous and temperature controlled, andsodium bisulfite is added to the batch for color stability. Isopropanol is exchanged for deionized water by adding deionizedwater to the reactor and performing a solvent exchange via vacuum distillation. Sodium acetate (for pH stabilization) and a
microbiological preservative (identity not specified) are added. The batch is then heated, sampled, and adjusted for solids
content. The product is isolated as an aqueous solution/emulsion, or as a spray-dried solid. The specification for the
maximum concentration of hydrazine that is formed in the reaction mixture is included in the ‘Composition/Impurities’
section.

A cosmetic ingredient supplier reports that radical polymerization is used to make VP/VA Copolymer fromvinylpyrrolidone and vinyl acetate. 16 Details about radical initiators, propagators, chain terminators, and solvent(s), were notprovided.
PVP and Modified PVP Polymers
PVP
Two cosmetic ingredient suppliers report that radical polymerization is used to make PVP.17,18 Details about radical
initiators, propagators, chain terminators, and solvent(s) were not provided.
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP Crosspolymer
According to one manufacturer, the method of manufacture of Hydrolyzed Wheat Protein begins with a solution ofprotein, water, and enzyme.19 The pH of the mixture is adjusted and additional enzyme is added. This is accompanied byaddition of a denaturant, followed by filtration using activated carbon. Filtration is followed by purification, evaporation, andpreservation. The next step is the copolymerization of vinylpyrrolidone in the presence of an initiator, and this is followed by
pH adjustment and preservation. The reaction mixture is then diluted in accordance with established specifications, which isfollowed by filtration into packs.
Composition/Impurities
VP Copolymers
Acrylic Acid/VP Crosspolymer
Acrylic Acid/VP Crosspolymer contains ≤ 500 ppm acrylic acid (residual monomer) and ≤ 100 ppm vinylpyrrolidone (residual monomer).20 Heptane (< 0.99%) has been identified as another impurity in Acrylic Acid/VP
Crosspolymer.
Maltodextrin/VP Copolymer
Maltodextrin/VP Copolymer, a high molecular weight polymer (132,999 Da), contains an unnamed low molecularweight species that is < 1000 Da (0.8% of composition) and an unnamed low molecular weight species that is < 500 Da(0.1% of composition). 9
Styrene/VP Copolymer
Data provided by industry indicate that styrene and vinyl-type styrene copolymer trade name materials containstyrene monomer at levels of 100 ppm or less.5
Styrene/VP Copolymer contains < 0.2% styrene (residual monomer) and < 10 ppm N-vinylpyrrolidone (residual
monomer).20
VP/Eicosene Copolymer
VP/Eicosene Copolymer contains ≤ 100 ppm vinylpyrrolidone (residual monomer).20 Other impurities that havebeen detected in VP/Eicosene Copolymer include t-butanol (< 0.5%) and isopropanol (< 0.5%).
VP/Hexadecene Copolymer
VP/Hexadecene Copolymer contains ≤ 100 ppm vinylpyrrolidone (residual monomer).20 Other impurities that havebeen detected in VP/Hexadecene Copolymer include t-butanol (< 0.5%) and isopropanol (< 0.5%).
VP/VA Copolymer
VP/VA Copolymer is supplied either in 100% concentration as a powder or as a 50% solution in alcohol.2 VP/VA
Copolymers may contain the residual monomers vinyl acetate at 1.0% (max) and vinylpyrrolidone at 0.5% (max).

For VP/VA Copolymers with molecular weights of approximately 12,000 and greater, the level of vinyl acetate issmaller than or equal to 300 ppm as measured using HPLC. 3,21 Another source reported vinyl acetate levels of less than 100
ppm for copolymers of molecular weights of 12,700 to approximately 30,000, and levels of less than 1000 ppm for a
copolymer of a molecular weight of approximately 51,000.
Specifications for VP/VA Copolymer that were submitted to the European Food Safety Authority (EFSA) arepresented in Table 5. Some of the specifications relate to monomer content and impurities.15
Regarding the production process for VP/VA Copolymer, free radical copolymerization of NVP and vinyl acetate,
specifications limit the concentration of hydrazine that is formed from amines present in the reaction mixture to a maximumof 1 mg/kg.15 Furthermore, due to the method of production (radical polymerization from vinylpyrrolidone and vinyl
acetate) as described by a supplier, residual monomers may be present in VP/VA Copolymer at a maximum of 50 ppm
vinylpyrrolidone and a maximum of 100 ppm vinyl acetate.16 Data received from the cosmetics industry also indicate that
VP/VA Copolymer contains ≤ 1000 ppm vinylpyrrolidone (residual monomer) and ≤ 1000 ppm vinyl acetate (residual
monomer).20
VP Acrylate Copolymers
Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer
Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer contains < 0.1% vinylpyrrolidone (residual
monomer) and ≤ 1% vinylcaprolactam (residual monomer).20
VP Acrylates/Lauryl Methacrylate Copolymer
The residual monomer content of VP Acrylates/Lauryl Methacrylate Copolymer has been described as follows:≤ 1000 ppm lauryl methacrylate, ≤ 1000 ppm vinylpyrrolidone, and ≤ 2000 ppm acrylic acid. 20 Heptane (< 10,000 ppm) is
another impurity that has been identified in VP Acrylates/Lauryl Methacrylate Copolymer.
VP Dimethylaminoethylmethacrylate Copolymer
VP Dimethylaminoethylmethacrylate Copolymer contains ≤ 1000 ppm vinylpyrrolidone.20
VP/DMAPA Acrylates Copolymer
The residual monomer content of VP/DMAPA Acrylates Copolymer has been identified as ≤ 100 ppm vinylpyrrolidone.20
VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer
VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer contains ≤ 100 ppm vinylpyrrolidone (residual monomer)and ≤ 100 ppm vinyl caprolactam (residual monomer).20 Water is another impurity that has been identified in VP/Vinyl
Caprolactam/DMAPA Acrylates Copolymer.
PVP and Modified PVP Polymers
Butylated PVP
Butylated PVP contains ≤ 100 ppm (residual monomer).20
PVP
According to the Food Chemicals Codex, the acceptance criteria (i.e., limitations on PVP impurities) relating to theuse of PVP in food are as follows: lead (not more than 2 mg/kg), aldehydes (as acetaldehyde, not more than 0.05%), nitrogen(not less than 11.5% and not more than 12.8%), and hydrazine (not more than 1 mg/kg).22
PVP, an NVP-containing polymer, is imported into Australia for industrial uses, and the residual NVP monomer
levels in PVP were obtained from a few (number not stated) major importers of PVP.23 It was noted that it appears that there
are different grades of PVP imported into Australia, depending on the end use (i.e., pharmaceutical, cosmetic, or industrial

grade). The residual NVP monomer content in the PVP imported into Australia varies and ranges from 10 ppm to 2000
ppm. In Europe (countries not specified), NVP residues in PVP are generally below 100 ppm.
As a result of the production method described by two cosmetic-ingredient suppliers of PVP, residual monomers
may be present in PVP at a maximum of 100 ppm vinylpyrrolidone and a maximum of 100 ppm vinyl acetate. 17,18 Also,
according to one of the suppliers, other impurities that may be present are acetaldehyde at a maximization concentration of
100 ppm and heavy metals in sum (as lead) at a maximum of 10 ppm. 18 Other data received from the cosmetics industry
indicate that PVP contains ≤ 1000 ppm vinylpyrrolidone (residual monomer).20
Triacontanyl PVP
According to one source, Triacontanyl PVP has a purity of > 97% and consists of < 2% water. 10 Data received
from the cosmetics industry indicate that Triacontanyl PVP contains ≤ 20 ppm vinylpyrrolidone (residual monomer).20
Hexanol (≤ 500 ppm) is another impurity that has been detected in Triacontanyl PVP.
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP Crosspolymer
According to a chemical supplier, the main impurity in Hydrolyzed Wheat Protein/PVP Crosspolymer is ash, up to a
maximum of 2%.19 Furthermore, an internal specification of 0.2% maximum has been established for residual
N-vinylpyrrolidone monomer.
Sodium Acryloyldimethyltaurate/VP Crosspolymer
NICNAS has noted that Sodium Acryloyldimethyltaurate/VP Crosspolymer contains residual monomers and/or
impurities (identities and concentrations not stated) that are classified as hazardous according to the Globally Harmonized
System of Classification and Labeling of Chemicals (GHS), as adopted for industrial chemicals in Australia.12 “These are notpresent in the notified polymer as introduced above the cut off concentration for classification.” Sodium
polyacryloyldimethyl taurate, a chemical that is similar to a component of Sodium Acryloyldimethyltaurate/VP
Crosspolymer, is reported to contain < 2000 ppm 2-acrylamido-2-methyl-1-propane sulfonic acid and < 10 ppm acrylamide.6

USE
Cosmetic
The safety of vinylpyrrolidone polymers is evaluated based on data received from the US Food and Drug
Administration (FDA) and the cosmetics industry on the expected use of these ingredients in cosmetics. Use frequencies ofindividual ingredients in cosmetics are collected from manufacturers and reported by cosmetic product category in FDA’s
Voluntary Cosmetic Registration Program (VCRP) database.24 Use concentration data are submitted by the cosmetics
industry in response to surveys, conducted by the Council, of maximum reported use concentrations by product. 25
According to 2018 VCRP data, the greatest use frequency is reported for PVP, which is being used in 900 cosmetic
products (798 leave-on products + 101 rinse-off products + 1 product diluted for bath use). 24 The second highest use
frequency is being reported for Ammonium Acryloyldimethyltaurate/VP Copolymer (597 cosmetic products: 525 leave-on
products + 62 rinse-off products). In general, the differences in current use frequencies of vinylpyrrolidone polymers incosmetics versus those reported in previous years are unremarkable. 2,3,4,5,6,7,8,24
The results of a concentration of use survey conducted in 2017 indicate that VP/VA Copolymer is being used atconcentrations up to 44% in rinse-off products (paste masks and mud packs), which is the highest maximum ingredient use
concentration that is being reported for vinylpyrrolidone polymers.25 Notably, in 2003, the highest maximum use
concentration of VP/VA Copolymer in rinse-off products was 10%, which is 4-fold lower than the current highest maximum
use concentration in rinse-off products.3 The highest maximum ingredient use concentration of vinylpyrrolidone polymers inleave-on products is being reported for PVP, which is used at concentrations up to 35% in leg and body paints. Notably, in
2013, the highest maximum use concentration of PVP in leave-on products was lower, 12%.7 Thus, the highest maximum use
concentration of PVP in leave-on products is approximately 3-fold greater than the highest maximum use concentration ofthis ingredient in leave-on products that was reported in 2013. It should also be noted that 35% was the maximum cosmetic
use concentration that was reported in the original final report on PVP that was published in 1998. 8 Current and historicaluse frequency and concentration of use data are presented in Table 6.

According to VCRP and Council survey data, the following 9 vinylpyrrolidone polymers are not currently used incosmetic products:
Acrylates/Stearyl Methacrylate/VP Copolymer
Ethylhexyl Acrylate/VP/Dimethicone Methacrylate Copolymer
Ethylhexyl Methacrylate/Methyl Methacrylate/VP Copolymer
Methacrylic Acid/Styrene/VP Copolymer
PVP/Decene Copolymer
PVP/VA/Itaconic Acid Copolymer
PVP/VA/Vinyl Propionate Copolymer
Triacontene/VP Copolymer
VP/Vinyl Alcohol Copolymer
Cosmetic products containing vinylpyrrolidone polymers may be applied to the skin and hair or, incidentally, may
come in contact with the eyes (e.g., at maximum use concentrations up to 17.2% VP/Hexadecene Copolymer [in eye
shadows]) and mucous membranes (e.g., at maximum use concentrations up to 24.1% VP/Hexadecene Copolymer [inlipstick]). Incidental ingestion of ingredients may result from the use of lipstick products. Products containing
vinylpyrrolidone polymers may be applied as frequently as several times per day and may come in contact with the skin or
hair for variable periods following application. Daily or occasional use may extend over many years.
VP/VA Copolymer is being used in both pump hair sprays (maximum use concentrations up to 9%) and aerosol hairsprays (maximum use concentrations up to 10%), which may result in incidental inhalation exposure. These 2 concentrations
are the highest maximum cosmetic use concentrations that are being reported for vinylpyrrolidone polymers in cosmetic
products that are sprayed In practice, 95% to 99% of the droplets/particles released from cosmetic sprays have aerodynamic
equivalent diameters > 10 µm, with propellant sprays yielding a greater fraction of droplets/particles below 10 µm, comparedwith pump sprays.26,27,28,29 Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be depositedin the nasopharyngeal and bronchial regions and would not be respirable (i.e., they would not enter the lungs) to any
appreciable amount.26,27
VP/Eicosene Copolymer is being used in face powders at concentrations up to 0.5% (highest maximum use
concentration). Conservative estimates of inhalation exposures to respirable particles during the use of loose powder
cosmetic products are 400-fold to 1000-fold less than protective regulatory and guidance limits for inert airborne respirable
particles in the workplace.30,31,32
The ingredients reviewed in this safety assessment are not restricted from use in any way under the rules governing
cosmetic products in the European Union.33
Non-Cosmetic
VP Copolymers
VP/VA Copolymer
The EFSA Panel on Food Additives and Nutrient Sources added to Food has provided a scientific opinion on the useof VP/VA Copolymer in food supplements.15 This opinion addresses the safety of VP/VA Copolymer for use in foodsupplements, in tablet form as a binding/coating agent in an amount of up to 10% of weight per tablet, for a tablet weight of1000 mg. Overall, the EFSA Panel concluded that the use of VP/VA Copolymer in solid food supplements as abinding/coating agent is unlikely to be a safety concern at the proposed uses and use levels provided. The EFSA Panel also
concluded that the residual level of hydrazine, proposed at a maximum of 1.0 mg/kg in the final product, is unlikely to be ofsafety concern. However, the EFSA Panel noted that it would be prudent to lower the level of hydrazine as far as reasonably
achievable.
PVP and Modified PVP Polymers
PVP
According to the Food Chemicals Codex, PVP has the following uses: clarifying agent, separation/filtration aid,stabilizer, bodying agent, tableting aid, dispersant, and coating on fresh fruit .22

PVP is used widely in industries such as pharmaceuticals, adhesives, agriculture, and surface coating.23 It is used in
medicine and in the pharmaceutical industry as a blood plasma expander, and it is a common ingredient in drug
manufacture.34

TOXICOKINETIC STUDIES
Absorption, Distribution, Metabolism, and Excretion
PVP and Modified PVP Polymers
AnimalPVPThe absorption, distribution, metabolism, and excretion of PVP is dependent on molecular weight, amount andfrequency of dosing, and route of administration.8 Polymers with a weight < 25,000 are eliminated through the kidneys. An
oral dosing study using 0.9 mg per rat of a PVP trade name material found no significant absorption.
New data on the absorption, distribution, metabolism and excretion of PVP or other vinylpyrrolidone polymers were
not discovered in the published literature, and unpublished data were not submitted.
TOXICOLOGICAL STUDIES
Acute Toxicity Studies

AnimalDermalPVP and Modified PVP Polymers
Triacontanyl PVP
A single dose of a Triacontanyl PVP trade name material (moistened with water, dose = 2 g/kg) was applied, underan occlusive wrap, for 24 h to the backs of 10 New Zealand white rabbits. 10 The animals were observed for up to 14 days
after test substance application, and all gained weight during the study. None of the animals died, and no abnormal clinicalsigns were observed. The acute dermal LD50 was > 2 g/kg.
Oral
VP Copolymers
VP/VA Copolymer
Acute oral toxicity studies were performed with VP/VA Copolymer in formulation and in solutions of the raw
ingredient. Tests on mice and rats showed low to no toxicity on more than 76 animals. Two animals died fromadministration of a formulation containing other, unidentified ingredients. The surviving animals showed, at most, decreased
activity and ataxia at maximum doses of 5 g/kg of a solution containing 12.5% VP/VA Copolymer.2
VP Acrylate Copolymers
Ammonium Acryloyldimethyltaurate/VP Copolymer
The acute oral LD50 for Ammonium Acryloyldimethyltaurate/VP Copolymer was reported to be >2 g/kg in rats.6
VP/Acrylates/Lauryl Methacrylate Copolymer
An oral LD50 of > 5 g/kg (rats) has been reported for undiluted VP/Acrylates/Lauryl Methacrylate Copolymer.11
Dyspnea was observed in 1 animal. The number of animals tested and details relating to the test protocol and study results
were not specified.

PVP and Modified PVP Polymers
PVP
The oral LD50 of PVP (avg. MW of 40,000) is > 100 g/kg body weight for both rats and guinea pigs.8
Triacontanyl PVP
The acute oral toxicity of a Triacontanyl PVP trade name material was evaluated using 10 Sprague-Dawley rats (5males, 5 females).10 A single 5 g/kg oral dose of the test substance (ground into a powder and mixed with peanut butter andhoney) was fed to the animals. The test substance was consumed within 18 h to 24 h. Dosing was followed by a 14-day
observation period. None of the animals died and no gross organ changes were observed at necropsy. The LD 50 was > 5
g/kg.
Short-Term Toxicity Studies
DermalVP Copolymers
VP/VA Copolymer
A hair product containing 1% VP/VA Copolymer was tested in a 6-week dermal toxicity study on 50 albino rats.
Volumes of 2.0 ml/kg of the product were applied 5 days a week for 6 weeks for a total of 30 applications to the clipped skinof the animals. All rats survived, and their body weight, physical appearance, behavior, and gross and microscopic anatomy
were normal. No systemic toxic effects could be attributed to the test material.2
Oral
VP Copolymers
VP/VA Copolymer
VP/VA Copolymer was administered in the diet of 3 groups of male and female Sprague-Dawley rats (5animals/sex/group; control group: 5 animals/sex) for 28 days at doses of 0 (control), 100, 300, and 1000 mg/kg/day,
respectively.15 The control group was fed the basal diet only. All animals survived to the scheduled necropsy. There wereno clinical signs of toxicity, and there were no effects on the following: body weight gain, feed consumption, hematology
parameters, serum chemistry, and urinalyses. There also were no test substance-related effects on organ weights,
macroscopic and microscopic evaluations. The authors concluded that the no-observed-adverse-effect level (NOAEL) was
1000 mg/kg/day.
PVP and Modified PVP Polymers
PVP
The short-term oral toxicity of a PVP tradename material (5% w/v in water) was evaluated using 2 groups of 6
HanWistar rats (RccHan:WIST; 3 males, 3 females/group). 35 The test animals received oral doses (dose volume of 10
ml/kg, by gavage) daily for 28 consecutive days. The control group received water. One day after the final dose, the animals
were killed and scheduled for necropsy. The following tissues were examined microscopically: eyes, liver, kidneys, urinary
bladder, lungs, heart, thymus, sternum, upper jaw (with nares and nasal turbinates), lower jaw with skin, stomach/duodenum,
intestine (jejunum, ileum, cecum, and rectum), mesenteric lymph node, and the tongue. All hematology findings were within
the normal background range for the rat strain that was tested, and there was no induction of cytochrome P450 protein(CYP1A1/2, CYP2B1, CYP3A, and CYP4A) levels. There were no toxicologically relevant effects on body weight gain,
food consumption, or water consumption, and there were no treatment-related microscopic changes.

Inhalation
PVP and Modified PVP Polymers
PVP
In two short-term inhalation studies using rats, PVP was detected in lung samples but no inflammatory response
was noted. Mild lymphoid hyperplasia and fibroplasia were noted in the subpleural, perivascular, and peribronchial
lymphatics.8 The animals were exposed to an average PVP concentration of 118 or 146 mg/m 3 5 days per week (8 hours perday) for a total of 30 exposures.
Subchronic Toxicity Studies
Oral
VP Copolymers
VP/VA Copolymer
VP/VA Copolymer was administered in the diet of 3 groups of male and female Sprague-Dawley rats
(10 animals/sex/group; control group of 10 animals/sex) for 90 days at doses of 0 (control), 100, 300, and 1000 mg/kg/day
VP/VA Copolymer.15 The control group was fed the basal diet only. All animals survived to the scheduled necropsy. There
were no clinical signs of toxicity, and there were no effects on the following: body weight gain, feed consumption, functional
observational battery, and locomotor activity evaluations. Furthermore, there were no ophthalmic lesions indicative of
toxicity, and no test-substance-related effects on hematology parameters, serum chemistries, and urinalyses. No test
substance-related effects on organ weights, macroscopic, and microscopic evaluations were observed. The authors concluded
that the NOAEL was 1000 mg/kg/day.
Inhalation
VP Copolymers
VP/VA Copolymer
Rats and hamsters were exposed for 13 weeks to a spray containing 4.0% VP/VA Copolymer. 2 Each of three groups
comprised of 12 rats and 12 hamsters per group inhaled the spray for 4 hours per day, 5 days per week for 13 weeks at aconcentration of 5.4 mg/m3 (calculated to be the equivalent of 100 times the normal human use level of the product). No
gross or microscopic changes occurred that could be attributed to the test material. Lungs and other tissues were similar incontrol and tested animals. Subchronic inhalation of a spray formulation containing 1.72% VP/VA Copolymer for 90 days
produced no effects in rabbits. On each day of this 90-day study, the animals received one 30-second exposure each morningand afternoon and were left in the spray atmosphere for 15 minutes.
Chronic Toxicity Studies
AnimalOral
VP Copolymers
VP/VA Copolymer
Chronic (1 year) oral ingestion of a solution containing 10.2 mg/l of VP/VA Copolymer produced no effects in miceor rats.2
In a 52-week dietary study, the chronic oral toxicity of VP/VA Copolymer was evaluated using the following
groups of male and female pure-bred Beagle dogs: group 1 (4 males, 4 females: 510 mg/kg/day), group 2 (4 males, 4 females:
1518 mg/kg/day), and group 3 (6 males, 6 females: 2522 mg/kg/day). 36 The control group (6 males, 6 females) was fed adiet without the test substance. All animals were killed at the end of the dosing period, and both gross and histopathologic
examinations were performed. None of the animals died during the study and no treatment-related clinical signs wereobserved. Furthermore, the following parameters were unaffected by treatment: food consumption, ophthalmoscopic
examinations, hearing tests, electrocardiograms, and blood pressure. There were no treatment-related body weight lossesduring the study. Hematology, clinical biochemistry, and urinalysis parameters were unaffected by feeding with the test
substance; sporadic statistically significant intergroup differences were observed, but these findings were not dose-related.
There were no treatment-related or dose-related changes in organ weights or organ-to-body weight ratios. At grossexamination, the type and incidence of findings were comparable between test and control groups. At microscopic
examination, the incidence and severity of findings were comparable between test and control groups and were considered
commonly observed changes in dogs of the age and strain used in this study. No inflammatory and/or degenerative changes(i.e., necrosis, granulomas, etc.) were associated with vacuolated histiocytes that were diagnosed in the sinusoids andtrabeculae of some mesenteric lymph nodes. The NOAEL was determined to be the target dose of 2500 mg/kg/day (target
dose for highest dose group).36
The chronic oral toxicity of VP/VA Copolymer was evaluated using 3 groups of male and female Wistar rats of the
Chbb:THOM (SPF) strain (50 males, 50 females/group). 36 The 3 groups were fed the test substance (in the diet) at thefollowing doses for 24 months: group 1 (low dose: 686 mg/kg/day [males] and 691 mg/kg/day [females]), group 2 (middose: 1374 mg/kg/day [males] and 1378 mg/kg/day [females), and group 3 (high dose: 2625 mg/kg/day [males] and 2759
mg/kg/day [females]). A fourth group (control group: 50 males, 50 females) was fed a diet without the test substance for thesame duration. The test substance (same doses) was also fed to 4 satellite groups (3 -test and 1 control) for 18 months. These
4 groups were included for hematological evaluation. For all groups in the study, the animals were killed after a 16-h to 20-h
fasting period that began after the end of the dosing period. Numerous tissues were submitted for histopathologicalexamination. The mortality rates ranged from 14% in the high-dose males to 36% in the control males, and 26% in the highdose females to 30% in the control females. Data were comparable in the satellite groups. Food consumption was describedas normal. Due to the absence of a dose-response relationship, and a higher mortality rate in control rats of both sexes, it was
concluded that the test substance did not affect survival. No remarkable test substance-related clinical signs were observed in
the study. Body weight and body weight change were statistically significantly reduced in high-dose males at most time
points throughout most of the study. Marginal differences in hematological parameters (within historical control ranges)
were observed, but there was no dose-response relationship and the differences were not considered treatment-related. The
vast majority of the gross lesions in the main groups in the study were comparable to the incidence in controls, and there wasno clear dose-response relationship. The NOAEL was determined to be the target dose of 2800 mg/kg/day (target dose forhigh dose group). Results relating to tumor formation are included in the Carcinogenicity section of this report.
A 2-year feeding study on VP/VA Copolymer (60% VP and 40% VA) was performed using 2 groups of SpragueDawley rats (51 males and 51 females/group, test and control groups).15 Test animals were given feed containing 5% VP/VA
Copolymer, and control animals were given feed containing 5% cellulose. Based on the consumption of the entire diet, test
animals were fed ~0.67 g VP/VA Copolymer (equivalent to ~450 mg/kg/day) for the duration of the study. Hemoglobin
content and leukocyte count were determined in 5 rats per sex (test and control groups) for up to 364 days of the study.
Hematology, blood chemistry, and urinalysis parameters were evaluated after ~500 days of the study. These 3 parameters
were evaluated using 10 test and control rats of each sex, as well as in all test (20 rats) and control (11 rats) animals thatremained alive after 675 days. Survival in both the control and test groups was described as poor (8% to 14%), due to
inflammatory diseases of the respiratory tract. There were no signs of toxicity in test or control rats, and no treatment-related
clinical chemistry changes. At histopathological examination of organs (liver, kidneys, and other organs [not stated]), an
increased incidence of liver congestion and fatty degeneration in the test group, compared to the control group, was reported.
No gross pathologically detectable lesions were observed. Results relating to carcinogenic potential are included in the
Carcinogenicity section of this report.
PVP and Modified PVP Polymers
PVP
Neither toxic effects nor gross lesions attributable to PVP were found in rats maintained for 2 years on a dietcontaining up to 10% of a PVP trade name material. 8 A similar 2-year feeding study in dogs found swollen phagocytic cells
in the lymph nodes.
Inhalation
VP Copolymers
VP/VA Copolymer
Thirty-six male and 36 female Syrian hamsters were exposed to the low concentration of 0.08 ± 0.08 mg/l VP/VA
Copolymer in air, 4-32 minutes a day, once a week for up to 2 years.2 The high-level group consisted of 36 male and 36
female hamsters exposed to 0.35 ± 0.09 mg/l, 9-35 minutes a day, once a week for up to two years. Necropsies wereperformed on all that were sacrificed or that died spontaneously. Survival time, body weight, and weight and appearance oflungs were similar in control and aerosol-exposed animals.

DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIESIn Vitro
PVP and Modified PVP Polymers
PVP
No teratogenic effects were observed when up to 500 µg of PVP (MW 11,500) was injected into the yolk sac of
rabbit embryos.8
Additional DART data were not discovered in the published literature, and unpublished data were not submitted.
GENOTOXICITY STUDIESIn Vitro
VP Acrylate Copolymers
Ammonium Acryloyldimethyltaurate/VP Copolymer
Ammonium Acryloyldimethyltaurate/VP Copolymer was not mutagenic (up to 5000 µg/plate) in bacterial reverse
mutation assays.6
PVP and Modified PVP Polymers
PVP
The genotoxicity of PVP was evaluated in in vitro and in vivo mutagenicity assays.8 Bacterial assay results were as
follows: PVP-iodine, up to 20 µl (non-mutagenic in Ames test), PVP-iodine, in various amounts (mutagenic at > 2 µl in Ames
test), PVP-iodine, amount not stated (mutagenic to Salmonella typhimurium strain TA1530 in Ames test). In the in vitro
mouse lymphoma assay, PVP (up to 100 mg/ml) was not mutagenic with or without metabolic activation. In the same assay,
PVP-iodine (up to 10 mg/ml) caused aberrant non-dose-related mutations with, but not without, activation. In the in vitro
BAlb/c 3T3 transformation assay, PVP (up to 100 mg/ml) was not mutagenic (non-dose-related transformations observed.
Three formulations containing PVP-iodine were not genotoxic in a comet assay or a chromosome aberration test,with or without metabolic activation.37 The solutions contained 3% or 10% PVP-iodine. In both tests, Chinese hamster ovary(CHO)-K1 cells were exposed for 4 h to the test solutions. Expected results were observed with positive and negative
controls.
The genotoxicity of PVP was evaluated in the Ames test using the following Salmonella typhimurium strains:
TA98, TA100, TA1535, and TA1537.38 Each strain was tested with aqueous PVP (doses up to 10,000 µg/plate) with andwithout metabolic activation. The results were classified as negative in all bacterial strains, with and without metabolic
activation.
Triacontanyl PVP
The genotoxicity of a Triacontanyl PVP trade name material was evaluated in the Ames test using the following S.
typhimurium strains: TA98, TA100, TA1535, TA1537, and TA1538. 10 The test substance was evaluated (with and without
metabolic activation) at doses up to 2500 µg/plate. 2-Aminoanthracene, 2-nitrofluorene, sodium azide, and ICR-191 served
as positive controls. The test substance was not genotoxic in any of the S. typhimurium strains tested. Marked increases in
the number of revertant colonies were observed in positive control cultures.

VP Crosspolymers
Sodium Acryloyldimethyltaurate/VP Crosspolymer
The genotoxicity of Sodium Acryloyldimethyltaurate/VP Crosspolymer was evaluated in the Ames test (bacterial
strains and doses not stated) (Organization for Economic Co-operation and Development (OECD) Test Guideline (TG)471).12 The test substance was classified as non-genotoxic.

In Vivo
PVP and Modified PVP Polymers
PVP
PVP-iodine complex (11.2% available iodine) was evaluated in the following 3 in vivo genotoxicity assays:
dominant lethal assay (male NMRI mice dosed intraperitoneally (i.p.) with 72 mg of PVP-iodine/kg), micronucleus test (maleand female NMRI mice dosed i.p. with 36 mg of PVP-iodine/kg), and a bone marrow assay (male and female Chinese
hamsters dosed i.p. with up to 82.5 mg PVP-iodine/kg).8 In the dominant lethal assay, the conception rate decreased
significantly during the first week, but the average number of implantations (and resultantly, the mutagenicity index) was notaffected. In the remaining weeks, all parameters remained similar between control and treated groups. Micronucleus test
results indicated a significant increase in the number of micronuclei when compared to controls, but the value wasconsidered within normal range. In the bone marrow assay, there were no increases in the rates of aberrant metaphases.

CARCINOGENICITY STUDIES
AnimalOral
VP Polymers
VP/VA Copolymer
The carcinogenicity of VP/VA Copolymer was evaluated using 3 groups of male and female Wistar rats of the
Chbb:THOM (SPF) strain (50 males, 50 females/group). 36 The 3 groups were fed the test substance (in the diet) at thefollowing doses for 24 months: group 1 (high dose: 2625 mg/kg/day [males] and 2759 mg/kg/day [females]), group 2 (middose: 1374 mg/kg/day [males] and 1378 mg/kg/day [females), and group 3 (low dose: 686 mg/kg/day [males] and 691
mg/kg/day [females]). A fourth group (control) was fed a diet without the test substance for the same duration. At
histopathological examination, there was no treatment-related increase in the number of animals with the following:neoplasms (primary neoplasm or benign, malignant, systemic and metastasized neoplasms). There also was no treatmentrelated increase in the total number of primary neoplasms, or benign, malignant, systemic, or metastasized neoplasms.
Additionally, there was no indication that the test substance caused any non-neoplastic alteration of organs or organ systems,
when comparing the incidence and graded severity of microscopic findings of treated animals with the corresponding
observations in control animals. All neoplastic and non-neoplastic microscopic findings were considered to have developed
spontaneously and were not related to treatment. (Results relating to chronic toxicity were described earlier in this report.)
A 24-month feeding study on VP/VA Copolymer (60% VP and 40% VA) was performed using 2 groups ofSprague-Dawley rats (51 males and 51 females/group, test and control groups). 15 Test animals were given feed containing
5% VP/VA Copolymer, and control animals were given feed containing 5% cellulose. Based on the consumption of theentire diet, test animals were fed ~0.67 g VP/VA Copolymer (equivalent to ~450 mg/kg/day) for the duration of the study.
No treatment-related tumors or other gross pathologically detectable lesions were induced. (Results relating to chronic
toxicity were described earlier.)Implantation
PVP and Modified PVP Polymers
PVP
The implantation of PVP sponges into mice and rats resulted in development of local sarcomas, but without
metastases.8
Human
PVP and Modified PVP Polymers
PVP
According to the International Agency for Research on Cancer, PVP is not classifiable as to its carcinogenicity tohumans.39

ANTICARCINOGENICITY STUDY
PVP and Modified PVP Polymers
PVP
Orally administered PVP significantly decreased the rate of bladder tumors in mice exposed to bracken fern.8

OTHER RELEVANT STUDIES
Cytotoxicity
PVP and Modified PVP Polymers
PVP
The effect of PVP on the ultrastructure of spermatozoa from 12 fertile patients was evaluated. 40 A sperm suspension(0.1 ml) from each patient was added to a 10% PVP solution (0.5 ml) and incubated for 30 minutes. An aliquot of the sperm
suspension without PVP served as the control. The samples were analyzed by transmission electron microscopy. Results
indicated that the untreated sperm fractions and the PVP-treated fractions were significantly different. The means of thepercentages of spermatozoa devoid of defects in untreated sperm fractions versus PVP-treated fractions were 4.2808% and0.5490%, respectively (P = 0.001). The sperm organelles that were deteriorated by PVP treatment were as follows: swollen,
reacted or absent acrosomes, the granular and decondensed chromatin, and swollen and badly shaped mitochondria. The mostaffected organelle was the plasma membrane, which appeared broken in a high percentage of the cells. In cross sections ofsperm tails after PVP treatment, the plasma membrane was broken, the mitochondria were swollen, and the axoneme wasdisassembled. Thus, the 10% PVP solution strongly affected the fine structure of spermatozoa. The authors concluded thatthe 10% PVP solution exerted a disintegrating effect on the various kinds of sperm membranes, and, as a secondary
consequence of the eventual necrotic process, alteration of chromatin and cytoskeletal components.
The effect of a PVP trade name material on cultured HeLa cells (human cervical carcinoma cells) was evaluated. 41
HeLa cells were incubated with the trade name material (at concentrations of 5%, 10%, and 20%) for 24 h. Treatment withthe test substance produced a dose- and time-dependent toxicity (i.e., inhibitory effect on cell proliferation) to HeLa cells.
The hallmarks of apoptosis, such as chromatin condensation, DNA fragmentation, and formation of apoptotic bodies, wereobserved. Other results indicated that the apoptosis induced by the test substance may have been via cell cycle arrest at theG2/M phase.

DERMAL IRRITATION AND SENSITZATION STUDIES
Irritation

In Vitro
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP Crosspolymer
The skin irritation potential of Hydrolyzed Wheat Protein/PVP Crosspolymer (21% solids, i.e., concentration of
Hydrolyzed Wheat Protein/PVP Crosspolymer) was evaluated using the Episkin TM reconstituted human epidermis model.42
The principle of this assay is based on the measurement of cytotoxicity in epidermal cultures, following topical exposure to
the test substance, using the colorimetric MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tertrazolium bromide) reduction
assay. Cell viability is measured by enzymatic reduction of the yellow MTT tetrazolium salt to a blue formazan salt (within
the mitochondria of viable cells) in test substance-treated cells relative to the negative controls. Dulbecco’s phosphatebuffered saline (PBS) with calcium and magnesium served as the negative control, and 5% w/v aqueous sodium dodecyl
sulfate served as the positive control. Triplicate tissues were treated with the test substance (as supplied, 10 µl) for 15 min,followed by a post-exposure incubation period of 42 h. After 42 h, each tissue was obtained for MTT-loading. Afterloading, a total biopsy of each epidermis was made and formazan crystals were extracted out of the MTT-loaded tissues. At
the end of extraction, optical density was measured at 540 nm. Data were presented in the form of % viability (i.e., MTT
reduction in test substance-treated tissues relative to negative control tissues). The relative mean viability of tissues treatedwith Hydrolyzed Wheat Protein/PVP Crosspolymer for 15 min was 86.6%, and the test substance was classified as a nonirritant.
AnimalVP Copolymers
VP/VA Copolymer
VP/VA Copolymer (50% in alcohol solution, 5 g dose) was mildly irritating to the skin in 24-h patch tests involving
groups of 6 rabbits, whereas the undiluted ingredient was non-irritating to the skin of 6 rabbits.2 In 24-h skin irritation
tests, using groups of 3 to 9 rabbits, on product formulations containing various concentrations of VP/VA Copolymer,
concentrations of 0.5%, 1.50% and 4% were non-irritating and a test concentration of 1.75% had the potential for minimal
irritation.
Acute skin irritation studies of VP/VA Copolymer were conducted on the abraded and intact skin of rabbits.
Formulations containing 0.25%-4.0% VP/VA Copolymer produced mild irritation. Solutions of 50% VP/VA in alcohol
produced mild irritation, and one sample of the 100% powder moistened in water produced no irritation.2
VP Acrylate Copolymers
Ammonium Acryloyldimethyltaurate/VP Copolymer
In a study involving rabbits (number and strain not stated), Ammonium Acryloyldimethyltaurate/VP Copolymer(assumed applied neat, not specified) was applied for 4 h to a 6 cm2 area of skin. The test substance was non-irritating to
the skin of rabbits.6
PVP and Modified PVP Polymers
PVP
A 10% PVP-iodine solution was applied, under an occlusive patch, for 96 h to hairless dorsal skin of 25 rabbits.8
After a 2-week non-treatment period, another occlusive patch was similarly applied for 48 h. No dermal reactions wereobserved after either duration of patch application.

Triacontanyl PVP
The skin irritation potential of a Triacontanyl PVP trade name material (moistened with saline) was evaluated using
6 new Zealand white rabbits.10 The test substance (0.5 g) was applied, under an occlusive wrap, for 24 h to both an abradedand intact site on each animal. The area (cm2) of the application site was not stated. Very slight erythema was observed at 2
intact sites and 4 abraded sites (at 24 h) and at 1 intact site and 2 abraded sites (at 72 h). Slight edema was observed at 1
intact site and 2 abraded sites, only at 24 h. The test substance was classified as a slight skin irritant.
Human
VP Copolymers
VP/Hexadecene Copolymer
The skin irritation potential of a cosmetic base containing 14.95% VP/Hexadecene Copolymer (undiluted) was
evaluated in an occlusive patch test involving 50 subjects, identified as follows: 27 subjects (normal, healthy), 6 (witheczema), 3 (with allergy), and 14 (with sensitive skin). 43 The product was applied to the back (dose per cm2 not stated) for 48
h using clear, square patch test chambers. Reactions were scored at 48 h (30 minutes after patch removal) and 72 h postapplication. Sodium dodecyl sulfate (1% in water) and water served as positive and negative controls, respectively. There
were no reactions to the product in any of the subjects tested. The positive control caused reactions in 21 subjects. Reactions
to the negative control were not observed.
PVP and Modified PVP Polymers
PVP
In 48-h and 96-h Shelanski patch tests, both involving 200 subjects, undiluted PVP-iodine (10% PVP and 2%
iodine) was not a skin irritant.8 In 3 studies, groups of 20 subjects were patch tested with a foundation containing 2% PVP.
One to 2 subjects in each group had minimal faint, uniform or spotty erythema.
The irritation and sensitization potential of different preparations that contain iodine, including PVP-iodine, wasinvestigated in 24 fair-skinned, healthy subjects without a history of iodine allergy.7 PVP-iodine was tested at concentrationsof 1%, 5%, 7.5%, and 10% on the intrascapular area on the back or on the volar forearm (2-day application) with Finn
Chambers on Scanpor tape. Only 1 subject reacted to PVP-iodine, at concentrations of 7.5% (vesiculation on day 4) and
10% (definite erythema on day 4).
Sensitization
AnimalVP Copolymers
VP/VA Copolymer
VP/VA Copolymer was not a sensitizer to guinea pigs after repeated intracutaneous injections.2 The skin wasinspected 24 h after each injection.
VP Acrylate Copolymers
Ammonium Acryloyldimethyltaurate/VP Copolymer
Ammonium Acryloyldimethyltaurate/VP Copolymer (neat) was not sensitizing to guinea pigs.6
PVP and Modified PVP Polymers
PVP
A 10% PVP-iodine solution did not cause dermal sensitization in rabbits.8

VP Crosspolymers
Sodium Acryloyldimethyltaurate/VP Crosspolymer
The skin sensitization potential of Sodium Acryloyldimethyltaurate/VP Crosspolymer (concentration not stated) was
evaluated in the local lymph node assay (LLNA) (OECD TG 429).12 There was no evidence of sensitization.
Human
VP Copolymers
VP/VA Copolymer
Repeated insult patch tests of a 5.0% formulation of VP/VA Copolymer caused no irritation or sensitization in 50
subjects..2 Likewise, three solutions of 50% VP/VA Copolymer in alcohol caused no irritation in 150 subjects
VP Acrylates Copolymer
VP/Acrylates/Lauryl Methacrylate Copolymer
In a human repeated insult patch test (HRIPT) involving 105 subjects, VP/Acrylates/Lauryl Methacrylate
Copolymer (96%) induced minimal erythema in 6 and 2 subjects during the induction and challenge phases, respectively. 11
These results were not considered positive by the authors of this study. Details relating to the test protocol were not included.
PVP and Modified PVP Polymers
PVP
Undiluted PVP-iodine (10% PVP, 2% iodine) did not induce sensitization in an HRIPT involving 100 subjects.8 In
an exaggerated use study (Draize-Shelanski patch test technique) on a PVP trade name material (PVP concentration notstated) involving 150 subjects, results were negative for skin sensitization. Results were also negative in an HRIPT (27subjects) on a PVP trade name material (10% aqueous solution). In a maximization test involving 25 subjects, 2% PVP did
not induce contact allergy.
Triacontanyl PVP
The skin sensitization potential of a Triacontanyl PVP trade name material was evaluated in an HRIPT involving
102 subjects (21 males, 81 females).10 Nine 24-h induction patches (type not stated), each containing ~200 mg of the test
substance, were applied to the left upper back of each subject over a 3-week period. The area of application (cm2) was notstated. A 24-h challenge patch was applied 2 weeks after removal of the last induction patch. Reactions were scored at 48 h
and 72 h post-application. A minimal reaction (not defined) was observed in 6 subjects during the induction phase.
Reactions were not observed during the challenge phase. The test substance was a non-sensitizer.
Photosensitization/Phototoxicity
AnimalVP Copolymers
VP/VA Copolymer
No photosensitization data on VP/VA Copolymer were available for review, but the UV absorption characteristics
suggest that photosensitization is unlikely.2
Human
PVP and Modified PVP Polymers
PVP
A PVP trade name material (10% aqueous solution) did not induce a phototoxic response in a study involving 10
human subjects.8

Triacontanyl PVP
The phototoxicity of a Triacontanyl PVP trade name material was evaluated using 10 subjects (1 male, 9 females).
The test substance (~200 mg) was applied, under an occlusive wrap, for 24 h to both forearms of each subject. 10 The area of
application was not stated. After removal of the occlusive wrap, 1 forearm of each subject was irradiated with UVA light.
Both arms of each subject were evaluated for reactions on days 2, 3, and 4, and reactions were not observed. The test
substance did not induce a contact dermal phototoxic response.
During the induction phase of a photoallergenicity study, a Triacontanyl PVP trade name material (200 mg) wasapplied, under an occlusive wrap, for 24 h to both forearms of 28 subjects. 10 The area of application was not stated. The
study involved a 3-week induction phase, 2-week non-treatment period, and then a challenge phase. After 24 h, theocclusive wraps were removed and 1 forearm of each subject was irradiated for 15 minutes with UVA light (3.3 J) and UVBlight (108 to 144 mJ). Induction was repeated 6 times during a 3-week period. The challenge phase began 2 weeks after thelast induction (followed by irradiation). The test substance was applied (under an occlusive wrap) for 24 h to a new site on
the forearm. After removal of the occlusive wrap, 1 forearm was irradiated with UVA light. Test sites were evaluated
immediately after irradiation and at 48 h and 72 h post-application. A challenge reaction (minimal reaction) was observed in
1 subject, only at the site that was irradiated after test substance application. The test substance did not induce contact
photoallergy.

OCULAR IRRITATION STUDIESIn Vitro
PVP and Modified PVP Polymers
PVP
PVP-iodine was severely toxic to corneal endothelium at concentrations of 5% and 10% in a rabbit eye model.7 An
in vitro study of cultured bovine corneal endothelial cells with PVP-iodine concentrations up to 0.1% found thatconcentrations of 0.05% or less did not induce endothelial cell damage.7
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP Crosspolymer
The ocular irritation potential of Hydrolyzed Wheat Protein/PVP Crosspolymer (21% solids, i.e., concentration of
Hydrolyzed Wheat Protein/PVP Crosspolymer) was evaluated using the SkinEthic TM reconstituted human corneal epithelium
model.44 This test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are
sufficiently cytotoxic to cause cell death. The tissues were treated with 30 µl of the test substance for 10 min, and the study
design consisted of a test for direct reduction of MTT. Triplicate tissues were also treated with 30 µl of a negative control
solution (negative control) and 30 µl of 1% w/v sodium dodecyl sulfate (positive control). Following MTT loading, thereduced MTT was extracted from the tissues. After extraction, the absorbency of triplicate aliquots of the extracted MTT
solution for each SkinEthicTM tissue was measured. The optical density was measured at 540 nm, and data were presented in
the form of % viability (i.e., MTT conversion relative to negative controls). The % relative mean tissue viability ofHydrolyzed Wheat Protein/PVP Crosspolymer was ≥ 60%, classifying the test substance as a non-irritant.
AnimalVP Copolymers
VP/VA Copolymer
The acute ocular irritation potential of VP/VA Copolymer, as supplied and in formulation, was evaluated using
albino rabbits.2 For the solutions that were tested, moderate to severe ocular irritation was observed at a concentration of
50% and mild irritation was observed at concentrations of 25% and 37.5% VP/VA Copolymer. For the product formulations
that were tested, ocular irritation (degree not stated) was observed at concentrations of 2.4% and 24% VP/VA Copolymer,
minimal to moderate ocular irritation was observed at a concentration of 4%, and concentrations of 0.25%, 0.5%, and1.75% were non-irritating.

VP Acrylate Copolymers
Ammonium Acryloyldimethyltaurate/VP Copolymer
In an ocular irritation assay, Ammonium Acryloyldimethyltaurate/VP Copolymer (undiluted, 0.1 ml) was nonirritating to the eyes of rabbits.45
VP/Acrylates/Lauryl Methacrylate Copolymer
Undiluted VP/Acrylates/Lauryl Methacrylate Copolymer was slightly irritating to the eyes of rabbits.11 The numberof animals tested and details relating to the test protocol and study results are not included.
PVP and Modified PVP Polymers
PVP
In ocular irritation studies using rabbits, a 10% PVP-iodine solution (without detergent) was minimally irritating,whereas repeated instillations of 0.5% PVP-iodine did not cause ocular irritation.8
An in vivo study on rabbits with PVP-iodine up to 1% found concentrations of 0.1% or less did not damage thecorneal endothelium.46
Triacontanyl PVP
In a study involving 6 New Zealand white rabbits, a Triacontanyl PVP trade name material (unknown concentration;
50 mg was instilled into the conjunctival sac of 1 eye of each animal.10 Untreated eyes served as controls. The eyes of 3
rabbits were rinsed after instillation. Reactions were scored for up to 7 days post-instillation according to the Draize scale.
In all treated eyes, slight erythema, edema, and discharge were observed at 1 h post-instillation. Conjunctival irritation
persisted for 4 days in 1 eye (unrinsed) and, for 1 day, in 1 rinsed eye. The test substance was classified as a slight ocular
irritant.
VP Crosspolymers
Sodium Acryloyldimethyltaurate/VP Crosspolymer
The ocular irritation potential of Sodium Acryloyldimethyltaurate/VP Crosspolymer (test concentration unknown)
was evaluated using rabbits in accordance with OECD TG 405. 12 Slight conjunctival effects were observed and had resolved
by 24 h. The test substance was classified as slightly irritating.

Human
VP Copolymers
VP/Hexadecene Copolymer
A controlled use test of an eye shadow containing 12.22% VP/Hexadecene Copolymer was performed using 10
healthy female subjects, 5 of whom wore contact lenses. 47 The product was applied to the face (eye region) daily for 2
weeks, and the subjects were examined by an ophthalmologist. No subject had subjective or objective eye irritation in theform of tears or pain, and there was no evidence of eyelid irritation or incompatibility (redness, itching). Furthermore,examination of the eye with a slit-lamp microscope did not reveal any evidence of irritant contact conjunctivitis withchemosis. The authors concluded that the product should be classified as harmless regarding the possibility of eye or eyelid
irritation.

CLINICAL STUDIES
Case Reports
VP Copolymers
VP/Eicosene Copolymer
An atopic male with a history of xerosis and pruritus of the hands, lower arms, and legs applied a prescribedemollient cream containing VP/Eicosene Copolymer (concentration not stated) daily.48 Within a month, the patientdeveloped an itchy, vesicular dermatitis of the limbs. Patch testing of the cream was performed, and reactions were scored ondays 2 and 3. A mild erythemato-edematous (+) reaction to the cream was observed on both days. In a ROAT in which thecream was applied to the antecubital fossa, a positive reaction was observed within 3 days. At 6 months after resolution of
the dermatitis, the patient was patch tested with the cream and its ingredients. Reactions were scored on days 2, 3, and 4. A
delayed, but clearly positive, erythemato-edematous reaction (+ reaction) to 10% VP/Eicosene Copolymer in petrolatum wasobserved on day 4. A positive reaction to the cream (+/+) was observed on days 3 and 4. The patch test reaction to
VP/Eicosene Copolymer was considered allergic and clinically relevant. Positive reactions were not observed in the 15
control subjects patch tested with VP/Eicosene Copolymer.
Acute facial eczema was observed in a female patient after application of a sunscreen containing VP/Eicosene
Copolymer (concentration not stated) and 23 other ingredients.49 Product application was followed by moderate sun
exposure. The patient had a childhood history of eczema. One month later, patch testing (Finn chambers, applied to back) of
the ingredient and product was performed. Reactions were scored after days 2 and 3, and a positive reaction (+/+) to thesunscreen was observed. In a second patch test on the sunscreen, the test site was irradiated with UVA (10 J/cm 2) on day 2.
A positive reaction was observed on days 2 and 3 (+/+). Patch testing of the individual ingredients was also performed, andtest results indicated that VP/Eicosene Copolymer was the only ingredient that caused a positive reaction. A positive
reaction to this ingredient (1% in petrolatum) was observed on days 2 and 3 (+/+).
PVP and Modified PVP Polymers
PVP
A woman with pollinosis developed anaphylaxis after vaginal application of a PVP-iodine solution for disinfection
during a medical examination. 50 Wheal and flare responses (3+) to the PVP-iodine solution (10% aq.), PVP-iodine (0.1%aq.) and PVP (0.001% aq.) were observed following prick tests. In another case study, a man had an anaphylactic reaction
minutes after oral ingestion of acetaminophen-containing tablets.51 A positive test reaction to PVP (5% in water), one of thecomponents of the drug, was reported.
A case of a boy with a history of anaphylactic reactions following treatment for impetigo contagiosum wasreported.52 Skin prick tests with PVP-iodine solution (0.1 - 100 mg/dl in water) and PVP (K30; 0.1 - 10 mg/ml in water)
were negative. However, in a histamine release test (using peripheral blood basophils), histamine release was observed in adose-dependent manner after stimulation with PVP in the presence of autologous serum. A rare case of iododerma wasreported in a man with a history of diabetes, hypertension, asthma, and gout.53 Treatment with a 10% topical solution of
PVP-iodine resulted in multiple pinpoint pustules (consistent with iododerma) on both lower extremities.
Four days following surgery to treat carpal tunnel syndrome, a woman presented with an acute vesicular dermatitis
on her left hand, palm and dorsal surface, and interdigital spaces.54 These reactions were observed after application of a 10%
PVP-iodine solution to the surgical site. Patch testing with PVP-iodine solution (1% diluted in water) caused a positive (4+)
reaction. A positive reaction (++) was also observed in the repeated open application test (ROAT).
Severe irritant contact dermatitis resulting in necrosis of the skin occurred in a woman following surgicalpreparation of her chest and upper abdomen with 10% PVP-iodine solution.55 A woman with no significant medical history
developed transient hypotension, anuric renal failure, hemolysis, coagulopathy, and uterine infarction following intra-uterine
injection of 2% PVP-iodine solution as a dye in a hydrotubation procedure. 56 In another report, PVP-iodine-induced irritantcontact dermatitis was diagnosed in a woman following antiseptic preparation of a spinal anesthesia site for an emergency
Caesarean section.57
A case of a girl with an anaphylactic reaction to eye drops containing PVP (excipient) has been reported. The
patient prick-by-prick test results for a PVP-iodine 7.5% antiseptic solution were positive.58
Other Clinical Reports

PVP and Modified PVP Polymers
PVP
In the patch testing of 500 consecutive patients with 10% PVP-iodine solution (diluted 10 times in water), 14
patients (2.8%) had a positive reaction to the test material. 59 These patients then underwent ROATs with a PVP-iodine
solution and only 2 of the 14 patients tested positive.
Patch testing was performed on 10 patients with a history of contact dermatitis following application of PVP-iodine
preparations and positive patch test reactions to the preparations.60 On days 3 and 5, “+” reactions or stronger were observedin 10/10 patients with 10% PVP-iodine, in 9/9 patients with 5% PVP-iodine, and in 5/9 patients with 2% PVP-iodine. All
patients (10/10) had positive reactions to the PVP-iodine preparation tested neat. In the control group, “+” reactions wereobserved in 3/10 to 5% and 10% PVP-iodine and to the PVP-iodine preparation. No reactions were observed to lower test
concentrations or to any of the other components tested. The strong reactions were classified as allergic sensitization.
In a survey of physicians in Japan for occupational allergy, 17 out of 307 reported contact allergy to PVP-iodine.61
Nineteen patients (12 men and 7 women) developed extensive patchy or linear erythema, sometimes accompanied by bullae
and erosion, on both sides of the buttocks, the back and posterior areas of the thighs a few days after operations or
cardioangiography.62 The patients were patch tested with 10% PVP-iodine solution and had strongly positive results (irritantcontact dermatitis).

SUMMARY
The safety of 30 vinylpyrrolidone polymers as used in cosmetics is reviewed in this safety assessment; 9 of these
ingredients have been reviewed previously. All of these ingredients share in common a vinylpyrrolidone monomer. Most ofthese ingredients have the reported function of film former in cosmetics in common. Viscosity increasing agent and binderare 2 other functions that are reported for many of these ingredients.
VP/VA Copolymer is produced by free radical copolymerization of NVP and VA in an isopropanol solution, in thepresence of initiators. The process is continuous and temperature-controlled. Hydrazine is formed from amines present inthis reaction mixture; but specifications limit the concentration to a maximum of 0.1%. Some of the proposed maxima for
VP/VA Copolymer, as a food ingredient, in a petitioner’s submission to the EFSA are: vinylpyrrolidone (5 mg/kg), vinyl
acetate (5 mg/kg), and hydrazine (1 mg/kg).
Due to the method of production (radical polymerization) provided by one supplier, residual monomers may bepresent in VP/VA Copolymer at a maximum of 50 ppm vinylpyrrolidone and a maximum of 100 ppm vinyl acetate. Other
suppliers reported that that radical polymerization is used to make PVP. Due to production via this method, residual
monomers may be present at a maximum of 100 ppm vinylpyrrolidone and a maximum of 100 ppm vinyl acetate. Impurities
that may be present are acetaldehyde at a maximization concentration of 100 ppm and heavy metals in sum (as lead) at a
maximum of 10 ppm.
One supplier reported that Maltodextrin/VP Copolymer contains an unnamed low molecular weight species that is< 1000 Da (0.8% of composition) and an unnamed low molecular weight species that is < 500 Da (0.1% of composition).
The residual NVP monomer content in the PVP imported into Australia varies and ranges from 10 ppm to 2000 ppm. In
Europe (countries not specified), NVP residues in PVP are generally below 100 ppm. Overall, values for molecularweight, residual monomer content, and other impurities on 15 vinylpyrrolidone polymers were provided by the Council. The
values for residual monomer content and other impurities may be regarded as low levels.
According to 2018 VCRP data, the greatest use frequency is reported for PVP, which is being used in 900 cosmetic
products (798 leave-on products + 101 rinse-off products + 1 product diluted for bath use). The second highest use frequency
is being reported for Ammonium Acryloyldimethyltaurate/VP Copolymer (597 cosmetic products: 525 leave-on products +62 rinse-off products). In general, the differences in current use frequencies of vinylpyrrolidone polymers in cosmetics
versus those reported in previous years are unremarkable.
The results of a concentration of use survey conducted in 2017 indicate that VP/VA Copolymer is being used atconcentrations up to 44% in rinse-off products (paste masks and mud packs), which is the highest maximum ingredient use
concentration that is being reported for vinylpyrrolidone polymers. Notably, in 2003, the highest maximum use
concentration of VP/VA Copolymer in rinse-off products was 10%, which is 4-fold lower than the current highest maximum
use concentration in rinse-off products. The highest maximum ingredient use concentration of vinylpyrrolidone polymers inleave-on products is being reported for PVP, which is used at concentrations up to 35% in leg and body paints. Notably, in
2013, the highest maximum use concentration of PVP in leave-on products was lower, 12%. Thus, the highest maximum use
concentration of PVP in leave-on products is approximately 3-fold greater than the highest maximum use concentration ofthis ingredient in leave-on products that was reported in 2013. It should also be noted that 35% was the maximum cosmetic
use concentration that was reported in the original final report on PVP that was published in 1998.
A single dose of a Triacontanyl PVP (unknown concentration) trade name material was applied, under an occlusive
wrap, for 24 h to the backs of 10 New Zealand white rabbits; the acute dermal LD50 was > 2 g/kg. An oral LD50 of > 5 g/kg
(rats) has been reported for undiluted VP/Acrylates/Lauryl Methacrylate Copolymer.
A single 5 g/kg oral dose of a Triacontanyl PVP trade name material (ground into a powder and mixed with peanutbutter and honey) was fed to 10 Sprague-Dawley rats. None of the animals died and no gross organ changes were observedat necropsy. The LD50 was > 5 g/kg.
VP/VA Copolymer was administered in the diet of 3 groups of male and female Sprague-Dawley rats (5animals/sex/group) for 28 days at doses up to 1000 mg/kg/day. There were no clinical signs of toxicity or test substancerelated macroscopic or microscopic tissue changes. The short-term (28 days) oral toxicity of a PVP trade name material (5%w/v in water) was evaluated using 2 groups of 6 HanWistar rats (RccHan:WIST strain). There were no toxicologically
relevant effects on body weight gain, food consumption, or water consumption, and there were no treatment-related
microscopic changes.
In a 90-day study, VP/VA Copolymer was also administered in the diet of 3 groups of male and female SpragueDawley rats (10 animals/sex/group) at doses up to 1000 mg/kg/day. There were no clinical signs of toxicity or test
substance-related macroscopic or microscopic tissue changes.
The chronic oral toxicity of VP/VA Copolymer was evaluated using groups of 50 male and 50 female Wistar rats of
the Chbb:THOM (SPF) strain. The groups were fed the test substance (in the diet) for 2 years, and 2759 mg/kg/day was thehighest dose that was administered. There were no effects on survival and no remarkable test substance-related clinical signs
in any of the dose groups. The vast majority of the gross lesions were comparable to the incidence in controls, and there wasno clear dose-response relationship. A 2-year feeding study on VP/VA Copolymer (5% in diet) was also performed usinggroups of 102 Sprague-Dawley rats. Survival in both the control and test groups was described as poor (8% to 14%), due to
inflammatory diseases of the respiratory tract. There were no signs of toxicity in test or control rats, and no treatment-related
clinical chemistry changes. No gross pathologically detectable lesions were observed. However, at microscopic
examination, an increased incidence of liver congestion and fatty degeneration was observed.
In a chronic (52 weeks) feeding study, groups of 8 to 12 Beagle dogs were fed VP/VA Copolymer in the diet, and2522 mg/kg/day was the highest dose that was administered. None of the animals died and no treatment-related clinical signs
were observed. At gross and microscopic examinations, the type and incidence of findings were comparable between test
and control groups.
The genotoxicity of aqueous PVP (doses up to 10,000 µg/plate) was evaluated in the Ames test (with and without
metabolic activation) using the S. typhimurium TA98, TA100, TA1535, and TA1537. Results were negative. Sodium
Acryloyldimethyltaurate/VP Crosspolymer was also non-genotoxic (doses not stated) in the Ames test, and the same was true
for a Triacontanyl PVP trade name material (doses up to 2500 µg/plate, with and without metabolic activation).
The carcinogenicity of VP/VA Copolymer was evaluated using groups of 100 male and female Wistar rats of the
Chbb:THOM (SPF) strain. The groups were fed the test substance (in the diet) for 2 years, and 2759 mg/kg/day was thehighest dose that was administered. All neoplastic and non-neoplastic microscopic findings were considered to havedeveloped spontaneously and were not related to treatment. A 2-year feeding study on VP/VA Copolymer (5% in diet) was
also performed using groups of 102 Sprague-Dawley rats. No treatment-related tumors or other gross pathologicallydetectable lesions were induced.
The skin irritation potential of Hydrolyzed Wheat Protein/PVP Crosspolymer (21% solids, i.e., concentration of
Hydrolyzed Wheat Protein/PVP Crosspolymer) was evaluated using the EpiskinTM reconstituted human epidermis model.
The relative mean viability of tissues treated with Hydrolyzed Wheat Protein/PVP Crosspolymer for 15 min was 86.6%, andthe test substance was classified as a non-irritant.
A Triacontanyl PVP trade name material (0.5 g, moistened with saline) was slightly irritating to the skin of 6 New
Zealand white rabbits. The skin irritation potential of a cosmetic base containing 14.95% VP/Hexadecene Copolymer(undiluted) was evaluated in an occlusive patch test involving 50 subjects (27 with normal skin; remainder with eczema,
allergy, or sensitive skin). Skin irritation was not observed.

Results for an LLNA of Sodium Acryloyldimethyltaurate/VP Crosspolymer (test concentration not stated) were
negative. The skin sensitization potential of a Triacontanyl PVP (unknown concentration) trade name material (~200 mg)
was evaluated in an HRIPT involving 102 subjects, and results were negative. In an HRIPT involving 105 subjects,
VP/Acrylates/Lauryl Methacrylate Copolymer (96%) induced minimal erythema in 6 and 2 subjects during the induction andchallenge phases, respectively. These reactions were not considered positive.
In a study involving 10 subjects, a Triacontanyl PVP (unknown concentration) trade name material (~200 mg) did
not induce a contact dermal phototoxic response in the presence of UVA light. During the induction phase of aphotoallergenicity study, a Triacontanyl PVP (unknown concentration) trade name material (200 mg) was applied to theforearms of 28 subjects. A challenge reaction (minimal reaction) was observed in 1 subject, only at the site that wasirradiated after test substance application. It was concluded that the trade name material did not induce contact photoallergy.
The ocular irritation potential of Hydrolyzed Wheat Protein/PVP Crosspolymer (21% solids, i.e., concentration of
Hydrolyzed Wheat Protein/PVP Crosspolymer) was evaluated using the SkinEthicTM reconstituted human corneal epithelium
model. The % relative mean tissue viability of Hydrolyzed Wheat Protein/PVP Crosspolymer was ≥ 60%, classifying the test
substance as a non-irritant.
An unknown concentration of Sodium Acryloyldimethyltaurate/VP Crosspolymer was classified as slightly irritating
to the eyes of rabbits. Undiluted VP/Acrylates/Lauryl Methacrylate Copolymer was also slightly irritating to the eyes ofrabbits. In a study involving 6 New Zealand white rabbits, a Triacontanyl PVP (unknown concentration) trade name material(50 mg) was classified as slightly irritating. A controlled use test of an eye shadow containing 12.22% VP/Hexadecene
Copolymer was performed using 10 healthy female subjects. The product was applied to the face (eye region) daily for 2
weeks, and neither ocular or eyelid irritation was observed in any of the subjects.
An allergic (erythemato-edematous) reaction was observed in an atopic patient patch-tested with 10% VP/Eicosene
Copolymer in petrolatum, but not in 15 control subjects. Acute facial eczema was observed in a female patient after
application of a sunscreen containing VP/Eicosene Copolymer (concentration not stated). When the patient was patch-tested
with the ingredient (1% in petrolatum), a positive reaction was observed.

DISCUSSION
The Panel determined that the data were sufficient to conclude on the safety of 27 vinylpyrrolidone polymers, but
additional data are needed for completion of the safety assessment of the remaining 3 vinylpyrrolidone polymers. The 27
vinylpyrrolidone polymers for which safety could be assessed comprise the following 4 subgroups combined: VP
Copolymers, VP Acrylate Copolymers, Polyvinylpyrrolidone (PVP) and Modified PVP Polymers, and PVP Crosspolymers.
For these 27 ingredients deemed safe, the Panel noted that concern over the lack of dermal absorption data was mitigated bylarge ingredient molecular weights, low residual monomer content, and related compositional characteristics and physicalproperties, despite differences in monomer identities. Regarding 2 of the 27 ingredients, Methacrylic Acid/Styrene/VP
Copolymer and VP Acrylates/Lauryl Methacrylate Copolymer, the Panel noted that were these ingredients to be used in
products that are applied to the nail they would be safe as used in nail products when skin contact is avoided. Furthermore,
the Panel noted that products containing these 2 ingredients should be accompanied with directions to avoid skin contact,because of the sensitizing potential of methacrylates.
The Panel also noted that the production process for VP/VA Copolymer can yield hydrazine from amines that arepresent in the reaction mixture, and also considered that the Food Chemicals Codex acceptance criteria specifies that food useof PVP cannot contain more than 1 ppm hydrazine. The cosmetics industry should continue to use current good
manufacturing practices (cGMPs) to limit impurities of prospective toxicological concern, including hydrazine and acrylates.
The issue of incidental inhalation exposure from powders and hair sprays was discussed by the Panel. The
Council’s survey results indicate that VP/VA Copolymer is being used in both pump hair sprays (maximum use
concentrations up to 9%) and aerosol hair sprays (maximum use concentrations up to 10%). VP/Eicosene Copolymer isbeing used in face powders at concentrations up to 0.5%. The Panel noted that in aerosol products, 95% – 99% of
droplets/particles would not be respirable to any appreciable amount. Furthermore, droplets/particles deposited in thenasopharyngeal or bronchial regions of the respiratory tract present no toxicological concerns based on the chemical andbiological properties of these ingredients. Coupled with the small actual exposure in the breathing zone and theconcentrations at which the ingredients are used, the available information indicates that incidental inhalation would not be asignificant route of exposure that might lead to local respiratory or systemic effects. A detailed discussion and summary of
the Panel’s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products is available athttps://www.cir-safety.org/cir-findings.

The subgroup of 3 vinylpyrrolidone polymers for which data are insufficient to determine safety comprise, in part,the residues of urethane monomers; and the data needed for this subgroup are:

Residual monomer concentration for at least one representative ingredient from this subgroup

In addition to the above request, the Panel agreed that data on the molecular weight range for the 3 urethane monomers
should be provided.
CONCLUSION
The Panel determined that the following 27 vinylpyrrolidone polymers are safe in cosmetics in the present practices
of use and concentration described in the safety assessment:
VP Copolymers
Acrylic Acid/VP Crosspolymer
Maltodextrin/VP Copolymer
PVP/Decene Copolymer*
PVP/VA/Itaconic Acid Copolymer*
PVP/VA/Vinyl Propionate Copolymer*
Styrene/VP Copolymer
Triacontene/VP Copolymer*
VP/Eicosene Copolymer
VP/Hexadecene Copolymer
VP/VA Copolymer
VP/Vinyl Alcohol Copolymer*
VP Acrylate Copolymers
Acrylates/Stearyl Methacrylate/VP Copolymer*
Acrylates/VP Copolymer
Ammonium Acryloyldimethyltaurate/VP Copolymer
Ethylhexyl Acrylate/VP/Dimethicone Methacrylate Copolymer*
Ethylhexyl Methacrylate/Methyl Methacrylate/VP Copolymer*
Methacrylic Acid/Styrene/VP Copolymer*
Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer
VP/Acrylates/Lauryl Methacrylate Copolymer
VP/Dimethylaminoethylmethacrylate Copolymer
VP/DMAPA Acrylates Copolymer
VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer
Polyvinylpyrrolidone (PVP) and Modified PVP Polymers
Butylated PVP
PVP
Triacontanyl PVP
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP Crosspolymer
Sodium Acryloyldimethyltaurate/VP Crosspolymer*Not reported to be in current use. Were the ingredients in this group not in current use to be used in the future, theexpectation is that it would be used in product categories and at concentrations comparable to others in this group.
The Panel also concluded that the available data are insufficient to make a determination that the vinylpyrrolidone
polymers listed below are safe under the intended conditions of use in cosmetic formulations:
Urethanes
VP/Dimethiconylacrylate/Polycarbamyl/Polyglycol Ester
VP/Dimethylaminoethylmethacrylate/Polycarbamyl Polyglycol Ester
VP/Polycarbamyl Polyglycol Ester

TABLES
Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
VP Copolymers
Acrylic Acid/VP Crosspolymer is a copolymer of acrylic acid and N-vinyl
Acrylic Acid/VP Crosspolymer
pyrrolidone crosslinked with pentaerythritol triallyl ether (PETE).
527685-31-0

Function(s)Dispersing
Agents Nonsurfactant;
Slip Modifiers;
Surface Modifiers[wherein R is hydrogen or a crosslink through PETE]VP/Hexadecene Copolymer
32440-50-9
63231-81-2

VP/Hexadecene Copolymer is a polymer of hexadecene and vinylpyrrolidone
monomers

Binders;
Dispersing
Agents Nonsurfactant;
Film Formers;
Hair Fixatives;
Viscosity
Increasing Agents- NonaqueousTable 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
VP/Eicosene Copolymer
VP/Eicosene Copolymer is a polymer of vinylpyrrolidone and eicosene monomers.
28211-18-9
It conforms generally to the formula:
77035-98-4

Function(s)Binders;
Dispersing
Agents Nonsurfactant;
Film Formers;
Viscosity
Increasing Agents- Nonaqueous

Maltodextrin/VP Copolymer
1323833-56-2

Maltodextrin/VP Copolymer is a copolymer of Maltodextrin and vinylpyrrolidone.

Film Formers

PVP/Decene Copolymer

PVP/Decene Copolymer is a polymer of vinylpyrrolidone and decene monomers. It
conforms generally to the formula:Binders;
Emulsion
Stabilizers;
Viscosity
Increasing Agents- Aqueous;
Viscosity
Increasing Agents- NonaqueousTable 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
PVP/VA/Itaconic Acid Copolymer
PVP/VA/Itaconic Acid Copolymer is a polymer formed from vinylpyrrolidone,
68928-72-3vinyl acetate and itaconic acid monomers.

Function(s)Binders;
Dispersing
Agents Nonsurfactant;
Film Formers;
Hair Fixatives

PVP/VA/Vinyl Propionate Copolymer

PVP/VA/Vinyl Propionate Copolymer is a polymer of vinylpyrrolidone, vinyl
acetate and vinyl propionate monomers.

Film Formers;
Hair Fixatives

Styrene/VP Copolymer
25086-29-7

Styrene/VP Copolymer is a copolymer prepared from vinylpyrrolidone and styrene
monomers.

Film Formers

Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
Triacontene/VP Copolymer
Triacontene/VP Copolymer is a copolymer of triacontene and vinylpyrrolidone
monomers.

VP/VA Copolymer
25086-89-9

VP/VA Copolymer is a copolymer of vinyl acetate and vinylpyrrolidone monomers.

Function(s)Emulsion
Stabilizers; Film
Formers

Binders;
Dispersing
Agents Nonsurfactant;
Film Formers;
Hair Fixatives

Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
VP/Vinyl Alcohol Copolymer
VP/Vinyl Alcohol Copolymer is the product formed by the polymerization and
26008-54-8
subsequent hydrolysis of vinylpyrrolidone and vinyl acetate.

VP Acrylate Copolymers
Acrylates/Stearyl Methacrylate/VP
Copolymer

Acrylates/VP Copolymer
26589-26-4

Acrylates/Stearyl Methacrylate/VP Copolymer is a copolymer of vinylpyrrolidone,
stearyl methacrylate, and one or more monomers of acrylic acid, methacrylic acidor one of their simple esters.

[wherein R is methyl or hydrogen and R’ is hydrogen, methyl, ethyl, propyl, or
butyl]
Acrylates/VP Copolymer is a copolymer of N-vinylpyrrolidone and one or moremonomers of acrylic acid, methacrylic acid or one of their simple esters.

[wherein R is methyl or hydrogen and R’ is hydrogen, methyl, ethyl, propyl, or
butyl]

Function(s)Film Formers;
Hair Fixatives;
Humectants;
Viscosity
Increasing Agents- AqueousEmulsion
Stabilizers; Film
Formers; Hair
Fixatives;
Viscosity
Increasing Agents- AqueousBinders;
Dispersing
Agents Nonsurfactant;
Film Formers;
Hair Fixatives

Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
Ammonium Acryloyldimethyltaurate/VP
Ammonium Acryloyldimethyltaurate/VP Copolymer is a copolymer of ammonium
Copolymer
acryloyldimethyltaurate and vinylpyrrolidone monomers.

Function(s)Viscosity
Increasing Agents- AqueousEthylhexyl Acrylate/VP/Dimethicone
Methacrylate Copolymer

Ethylhexyl Acrylate/VP/Dimethicone Methacrylate Copolymer is a copolymer ofvinylpyrrolidone, 2-ethylhexyl acrylate, and dimethicone propylmethacrylate. It
conforms to the formula:

SkinConditioning
Agents Miscellaneous;
Viscosity
Increasing Agents- Nonaqueous

Ethylhexyl Methacrylate/Methyl
Methacrylate/VP Copolymer
155532-97-1

Ethylhexyl Methacrylate/Methyl Methacrylate/VP Copolymer is the copolymer ofethylhexyl methacrylate, methyl methacrylate and vinylpyrrolidone monomers.

Film Formers

Methacrylic Acid/Styrene/VP Copolymer
27554-92-3

Methacrylic Acid/Styrene/VP Copolymer is a copolymer of styrene, methacrylicacid and vinylpyrrolidone.

Opacifying
AgentsTable 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
Vinyl Caprolactam/VP/Dimethylaminoethyl
Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate Copolymer is a
Methacrylate Copolymer
copolymer of vinylcaprolactam, vinylpyrrolidone, and dimethylaminoethyl
methacrylate monomers.

VP/Acrylates/Lauryl Methacrylate
Copolymer
83120-95-0

VP/Acrylates/Lauryl Methacrylate Copolymer is a copolymer of vinylpyrrolidone,lauryl methacrylate, and one or more monomers of acrylic acid, methacrylic acid or
one of its simple esters.

[wherein R is methyl or hydrogen and R’ is hydrogen, methyl, ethyl, propyl, or
butyl]

Function(s)Film Formers;
Hair Fixatives

Hair Fixatives

Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
VP/Dimethylaminoethylmethacrylate
VP/Dimethylaminoethylmethacrylate Copolymer is a polymer prepared from
Copolymer
vinylpyrrolidone and dimethylaminoethylmethacrylate monomers.
30581-59-0

VP/DMAPA Acrylates Copolymer
175893-71-7

VP/DMAPA Acrylates Copolymer is a copolymer of vinylpyrrolidone anddimethylaminopropylacrylamide or methacrylamide.

VP/Vinyl Caprolactam/DMAPA Acrylates
Copolymer[wherein R is hydrogen or methyl]
VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer is a copolymer ofvinylpyrrolidone, vinyl caprolactam, dimethylaminopropylacrylamide, and one ormore monomers of acrylic acid or one of their simple esters.

[wherein R is hydrogen or methyl]

Function(s)Binders;
Dispersing
Agents Nonsurfactant;
Film Formers;
Hair Fixatives

Hair Fixatives

Hair Fixatives

Table 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
PVP and Modified PVP Polymers
Butylated PVP
Butylated PVP is a polymer of butylated vinylpyrrolidone that conforms generally
to the formula:

PVP
9003-39-8

Triacontanyl PVP
157148-07-7
136445-69-7

where R represents either a butyl group or hydrogen.
PVP is the linear polymer that consists of 1-vinyl-2-pyrrolidone monomers
conforming generally to the formula:

Triacontanyl PVP is a polymer of vinylpyrrolidone and 1-triacontene. It conforms
to the formula:

Function(s)Binders; Film
Formers; Hair
Fixatives

Binders;
Dispersing
Agents Nonsurfactant;Emulsion
Stabilizers; Film
Formers; Hair
Fixatives
Film Formers;
Viscosity
Increasing Agents- Nonaqueous

where R represents the triacontene moiety [a 30 carbon, straight alkyl chain] orhydrogen.
VP Crosspolymers
Hydrolyzed Wheat Protein/PVP
Crosspolymer

Hydrolyzed Wheat Protein/PVP Crosspolymer is a crosslinked copolymer ofhydrolyzed wheat protein and PVP.

[Monomer:][The monomer, hydrolyzed wheat protein, is the partial hydrolysate of wheat
protein derived by acid, enzyme or other method of hydrolysis.]Film Formers;
Hair Conditioning
Agents; Hair
Fixatives; SkinConditioning
Agents MiscellaneousTable 1. Definitions, idealized structures, and functions of the ingredients in this safety assessment.(1; CIR Staff) *Ingredient CAS No.
Definition & Structures
Sodium Acryloyldimethyltaurate/VP
Sodium Acryloyldimethyltaurate/VP Crosspolymer is a copolymer of sodium
Crosspolymer
acryloyldimethyltaurate and vinylpyrrolidone crosslinked by
1,1,1-trimethylolpropane triacrylate.

Function(s)Emulsion
Stabilizers[crosslinked with]

Urethanes
VP/Dimethylaminoethylmethacrylate/Polycarbamyl Polyglycol Ester

VP/Dimethylaminoethylmethacrylate/Polycarbamyl Polyglycol Ester is acopolymer of vinylpyrrolidone, dimethylaminoethylmethacrylate and polyurethane.

VP/Dimethiconylacrylate/
Polycarbamyl/Polyglycol Ester[More information needed to depict structure.]
VP/Dimethiconylacrylate/Polycarbamyl/Polyglycol Ester is a copolymer ofvinylpyrrolidone, acrylated dimethiconol and polyurethane.

Film Formers[More information needed to depict structure.]
VP/Polycarbamyl Polyglycol Ester is a copolymer of vinylpyrrolidone andpolyurethane.

Film Formers

VP/Polycarbamyl Polyglycol Ester

Film Formers[More information needed to depict structure.]*Please note: For the sake of simplicity, these ingredients have only been drawn as simple block co-polymers. The periodicity and pattern ofinterconnectivity between each monomer may vary significantly per ingredient, or even per supplier of the same ingredient.

Ingredients

Table 2. Reports on Polymers Previously Reviewed by CIR
CIR Review Status

Acrylates/VP Copolymer, VP/Dimethylaminoethylmethacrylate
Copolymer, and Vinyl Caprolactam/VP/Dimethylaminoethyl Methacrylate
Copolymer

Published Final Report (2002) - Conclusion: Safe for use incosmetics when formulated to avoid skin irritation.4 A
rereview of this safety assessment is in progress.

Ammonium Acryloyldimethyltaurate/VP Copolymer and Sodium
Acryloyldimethyltaurate/VP Crosspolymer

Final Report (issued in 2017) - Conclusion: Safe in cosmetics
in the present practices of use and concentration described inthis safety assessment.6

Methacrylic Acid/Styrene/VP Copolymer and Styrene/VP Copolymer

Final Report (issued in 2014) - Conclusion: Safe in thepresent practices of use and concentration in cosmetics, as
described in this safety assessment.5

PVP

Published Final Report (1998) - Conclusion: Safe as used incosmetics.8
Published Rereview (2017) - Conclusion: Panel reaffirmed
the original conclusion7

VP/VA Copolymer

Published Final Report (1983) - Conclusion: Safe as acosmetic ingredient under present conditions of concentration
and use.2
Published Rereview (2006) - Conclusion: The Panel
reaffirmed the original conclusion 3

MonomerTable 3. Monomer Components of Vinylpyrrolidone Polymers
CIR Review Status

Acrylated Dimethiconol

Not reviewed

Acrylic Acid

Not reviewed. However, data on this monomer are summarized in the published(2002) CIR final report on Acrylates Copolymer.4

Ammonium Acryloyldimethyltaurate

Not reviewed

Butylated Vinylpyrrolidone

Not reviewed

DeceneNot reviewed

Dimethicone Propylmethacrylate

Not reviewed

Dimethylaminoethyl Methacrylate

Not reviewed

Dimethylaminopropylacrylamide

Not reviewed

EicoseneNot reviewed

Ethylhexyl Methacrylate

Not reviewed

Hexadecene

Not reviewed

Hydrolyzed Wheat Protein

Final Report - Conclusion: Safe for use in cosmetics when formulated to restrict
peptides to a weight-average MW of 3500 Da or less.63

Itaconic Acid

Not Reviewed

Lauryl Methacrylate

Published Final Report - Conclusion: Safe as used in nail enhancement products
when skin contact is avoided. Products containing these ingredients should beaccompanied with directions to avoid skin contact, because of the sensitizing
potential of methacrylates.64

Maltodextrin

Final Report - Conclusion: Safe in the present practices of use and concentration incosmetics, as described in this safety assessment.65

Methacrylamide

Not Reviewed

Methacrylic Acid

Published Final Report - Conclusion: Safe as used as a nail primer by trained
professionals, but there are insufficient data for retail use by consumers. 66

Methyl Methacrylate

Scientific Literature Review (SLR) was issued in 2003, but the report was
terminatedPolyurethane

Final Report - Conclusion: Safe as used in the present practices of use andconcentration described in this safety assessment.67

Sodium Acryloyldimethyltaurate

Not Reviewed

Stearyl Methacrylate

Not Reviewed

StyreneNot Reviewed

Triacontene

Not Reviewed

Vinyl Acetate

Not Reviewed

Vinyl Caprolactam

Not Reviewed

Vinyl Propionate

Not Reviewed

Vinylpyrrolidone

Not Reviewed

Table 4. Chemical and Physical Properties of Vinylpyrrolidone Polymers
Property
Value/Results
Reference
Acrylic Acid/VP Crosspolymer
20
23,200; fraction < 1000 = 11%
Average molecular weight (Da)
Butylated PVP
2037,300; fraction < 1000 = 1%
Average molecular weight (Da)
Hydrolyzed Wheat Protein/PVP
Crosspolymer
68
41,020Weight average molecular weight (Da)Maltodextrin/VP Copolymer
9132,999
Weight average molecular weight (Da)921,499Number average molecular weight (Da)PVP
20
4 tradename materials: 6,000 – 15,000 (fraction < 1000 = 13%); 40,000 – 80,000 (fraction < 1000
Average molecular weight (Da)= 1%); 240,000 – 450,000 (fraction < 1000 = 0%); 1,000,000 – 1,700,000 (fraction < 1000 =0%)
Sodium Acryloyldimethyltaurate/VP Crosspolymer
12
White powder
Form (at 20 ºC and 101.3 kPa)
12
Particle size (µm)
< 10 (65.4%); < 100 (86.8%)
12
Formula Weight (Da)
> 10,000
12
Melting Point (ºC)
Not determined. Decomposes prior to melting
12
Water solubility (mg/l)
Miscible, gel forming. When gel was diluted by further addition of water, low viscosity solution
was formed
Styrene/VP Copolymer
20
Average molecular weight (Da)
2,400,000 (fraction < 1000 = 0%)
Triacontanyl PVP (trade name mixture)
10
Form
White to off-white solid flakes
10
Particle size distribution (cm2)0.25 to 1
10,20
Molecular weight (Da)129,000 (fraction < 1000 = 9%); Approximately 70 to 80% of the polymer has a molecularweight of > 1000
10
Maximum percentage of low molecular
20 to 30weight species (molecular weight <1000
Da) (%)
10
Density (g/ml)
0.947
10
Solubility
Insoluble in water, acid or base solutions
10
Partition coefficient
Not applicable, as the polymer is insoluble in water
Vinyl Caprolactam/VP/Dimethylaminoethyl
Methacrylate Copolymer
20
Average molecular weight
53,000 (fraction < 1000 = 5%)
VP/Acrylates/Lauryl Methacrylate Copolymer
11
Form
White powder
11
Particle size (µm)
< 10
11,20
Number average molecular weight (Da)~ 185,000 (fraction < 1000 = 0%; fraction < 1000 = 1%); > 10,000
11Density (g/ml)
1
11
Solubility
Expected to have low water solubility based on highmolecular weight and predominantly hydrophobic structure
VP/Dimethylaminoethylmethacrylate Copolymer
20
Average molecular weight (Da)
3 tradename materials: 1,100,00 (fraction < 100 = 0%); 1,190,000 (fraction < 1000 = 0%);102,000 (fraction < 1000 = 0%)
13
Density (g/ml)
1.047
VP/DMAPA Acrylates Copolymer
20
Average molecular weight (Da)2,390,000 (fraction < 1000 = 0%)
VP/Eicosene Copolymer
20
Average molecular weight (Da)116,000 (fraction < 1000 = 12%)VP/Hexadecene Copolymer
20
Average molecular weight (Da)60,000 to 125,000 (fraction < 1000 = 14%; fraction < 1000 = 17%)
VP/VA Copolymer
20
Average molecular weight (Da)
9 tradename materials: 26,700 (fraction < 1000 = 3%); 31,000 (fraction < 1000 = 2%); 40,000(fraction < 1000 = 2%); 45,800 (fraction < 1000 = 2%); 12,900 (fraction < 1000 = 6%); 15,800(fraction < 1000 = 5%); 22,700 (fraction < 1000 = 4%); 22,600 (fraction < 1000 = 3%); 26,000(fraction < 1000 = 3%)
VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer
20
Average molecular weight (Da)29,800 (fraction < 1000 =1%)

Table 5. Specifications for VP/VA Copolymer.
Characteristics
K-value (1% solids in aqueous solution)
pH-value (10% w/w in distilled water)
Vinyl acetate component in copolymer (%)
Nitrogen content (%)
Loss on drying (%)
Residuals
Aldehydes (as acetaldehyde) (%)
Vinyl acetate (mg/kg)
Vinylpyrrolidone (mg/kg)
Hydrazine (mg/kg)
Peroxide content (mg/kg)
Isopropanol (mg/kg)
Arsenic
Lead
Mercury
CadmiumAsh (residue on ignition/sulfated) (%)

15

Proposed Specifications
25.2 to 30.8
3 to 7
Maximum: 35.3 to 42.0
7 to 8Maximum: 5
0.2
Maximum: 5
Maximum: 5
Maximum: 1
Maximum: 400
Maximum: 150
Maximum: 3
Maximum: 2
Maximum: 1
Maximum: 1
0.1

Table 6. Frequency and Concentration of Vinylpyrrolidone Polymers According to Duration and Exposure.
# of Uses
Max Conc of Use (%)# of Uses
Max Conc of Use (%)
VP/Hexadecene Copolymer
VP/Eicosene Copolymer
201824201725201824201725
Totals*443
378
0.036-24.1
0.11-8Duration of Use
Leave-On442
0.036-24.1
377
0.11-8Rinse-Off
1
2
1
NR
Diluted for (Bath) Use
NR
NR
NR
NR
Exposure TypeEye Area87
0.25-17.2
239
0.44-8
Incidental Ingestion268
0.7-24.1
101
0.96-5.6
Incidental Inhalation-Spray
6;5a
NR
NR;6a
4.3
Incidental Inhalation-Powder
3NRNR
0.3-0.5
Dermal Contact
144
0.036-17.2
92
0.11-8Deodorant (underarm)
NR
NR
NR
NR
Hair - Non-Coloring
NR
NR
1
NR
Hair-Coloring
NR
NR
NR
NR
Nail
NR
10.3
NR
NR
Mucous Membrane
268
0.7-24.1
101
0.96-5.6
Baby Products
NR
NR
NR
2
Acrylic Acid/VP Crosspolymer
Ammonium Acryloyldimethyltaurate/VP Copolymer
20182420172520182420176
201725
20166
Totals*
20
0.3-1
597
584
0.096-2
0.016-3
Duration of Use
Leave-On
20
0.3-1
535
524
0.096-2
0.016-3
Rinse-Off
NR
0.5
62
60
0.2-2
0.3-1.8
Diluted for (Bath) Use
NR
NR
NR
NR
NR
NR
Exposure TypeEye Area
3
1
60
66
0.5-3
1.4-3
Incidental Ingestion
NR
NR
2
2
1.5
1.5
a
a
a
a
a
Incidental Inhalation-Spray
NR;14
0.3-1
1;197
1;199 ;
0.096-1;1.5
0.096-1;0.4a205bIncidental Inhalation-Powder
NR
NR
3
1;1c;
NR
0.18-2c205b
Dermal Contact
10
0.5-1
591
579
0.096-3
0.016-3
Deodorant (underarm)
NR
NR
NR
NR
NR
NR
Hair - Non-Coloring
8
0.3-1
NR
NR
0.8
0.4
Hair-Coloring
NR
NR
NR
NR
NR
NR
Nail
1
NR
NR
NR
NR
NR
Mucous Membrane
NR
0.5
7
5
0.25-1.5
1.5
Baby Products
NR
NR
2
1
0.5
NR
Butylated PVPHydrolyzed Wheat Protein/PVP Crosspolymer
201824201725201824201725
Totals*4NR
48
0.017-0.45
Duration of Use
Leave-OnNR
NR
3
34
0.017-0.45
Rinse-Off
NR
NR
1
14
NR
Diluted for (Bath) Use
NR
NR
NR
NR
NR
Exposure TypeEye Area
NR
NR
NR
23
0.18-0.4
Incidental Ingestion
NR
NR
NR
NR
NR
Incidental Inhalation-Spray
NR;2a
NR
NR
NR;8a
0.017-0.055;
0.088-0.24a
Incidental Inhalation-Powder
NR
NR
NR
NR
NR
Dermal Contact
NR
NR
NR
7
0.038-0.45
Deodorant (underarm)
NR
NR
NR
NR
NR
Hair - Non-Coloring
4
NR
NR
18
0.017-0.24
Hair-Coloring
NR
NR
NR
1
NR
Nail
NR
NR
NR
NR
NR
Mucous Membrane
NR
NR
NR
NR
NR
Baby Products
NR
NR
NR
NR
NR

Table 6. Frequency and Concentration of Vinylpyrrolidone Polymers According to Duration and Exposure.
# of Uses
Max Conc of Use (%)# of Uses
Maltodextrin/VP Copolymer
201824201725201824
20137
Totals*30.35-3900
799
Duration of Use
Leave-On
3
0.35-3
798
675
Rinse-Off
NR
NR
101
123
Diluted for (Bath) Use
NR
NR
1
1
Exposure TypeEye Area
NR
NR
292
222
Incidental Ingestion
NR
NR
43
35
Incidental Inhalation-Spray
NR;3a
0.35
31;283a22
Incidental Inhalation-Powder
NR
NR
NR
NR
Dermal Contact
NR
0.35
299
186
Deodorant (underarm)
NR
NR
NR
NR
Hair - Non-Coloring
3
3
378
423
Hair-Coloring
NR
NR
11
7
Nail
NR
NR
NR
1
Mucous Membrane
NR
NR
44
37
Baby Products
NR
NR
2
1

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray
Incidental Inhalation-Powder
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray
Incidental Inhalation-Powder
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

Sodium Acryloyldimethyltaurate/VP Crosspolymer
20182420176
201725
20166
9
8
0.5-1
NR

20182470

Max Conc of Use (%)
PVP2017250.000003-35

20137
0.0005-120.005-35
0.000003-13.3
0.016-3

0.002-120.0005-10.5
NR

0.005-12
0.065-13.3
0.6-5;0.5-9a
0.1
0.000003-35
0.66
0.0005-9
1.4-100.5-50.065-13.3
4.4

0.05-120.1-10.5
0.002-5NR
0.0005-120.50.0005-10.5
1.6-3.3
0.3-5
0.1-10.5
NR

Styrene/VP Copolymer
20135
20172582
0.007-0.8

2013-20145
0.000038-1

9
NR
NR

8
NR
NR

0.5-1
NR
NR

NR
NR
NR

17
53
NR

30
52
NR

0.012-0.62
0.007-0.8
NR

1
NR
NR;5a
NR
9
NR
NR
NR
NR
NR
NR

1
NR
a b
4 ;3
3b
8
NR
NR
NR
NR
NR
NR

NR
NR
NR;0.89-1a
NR
0.5-1
NR
NR
NR
NR
NR
NR

NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

1
NR
0.038-0.4
0.2-0.4
NR
1
NR
NR
a
a
3;8
22
NR;0.016-0.2
0.12
NR
6
NR
0.12-0.2c
1518
0.012-0.62
0.000038-0.4
NR
NR
NR
NR
19
36
0.08-0.2
0.032-1
33
25
0.007-0.8
0.04-0.7
2
2
0.29
NR
3
6
NR
0.057
NR
NR
NR
NR
Vinyl Caprolactam/ VP/Dimethylaminoethyl
Methacrylate Copolymer
20182420172570
0.3-520182472

Triacontanyl PVP
2017250.66-7.3

72
NR
NR

0.66-7.3
NR
NR

NR
NR
NR

65
5
NR

0.3-5
1.2
NR

23
31
NR;1a
3
24
NR
1
NR
NR
31
NR

0.66-3.2
3-7.3
6.3;1.5-4.5aNR
0.66-2NR
1.5-6.3
NR
NR
3-7.3
NR

NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

1
NR
21;35a
NR
3
NR
49
17
NR
NR
NR

NR
NR
1;1.2-5a
NR
0.3
NR
1.2-5
1-1.2
NR
NR
NR

0.000038-0.4
0.02-1NR

Table 6. Frequency and Concentration of Vinylpyrrolidone Polymers According to Duration and Exposure.
# of Uses
Max Conc of Use (%)# of Uses

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray
Incidental Inhalation-Powder
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray
Incidental Inhalation-Powder
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray
Incidental Inhalation-Powder
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

VP/Acrylates/Lauryl Methacrylate Copolymer
201824201725150.0097-3.5

Max Conc of Use (%)

VP/Dimethiconylacrylate/ Polycarbamyl/ Polyglycol Ester
201824201725
3
0.04-2.5

15
NRNR

0.0097-3.5
NR
NR

3
NR
NR

0.1-2.5
0.04
NR

NR
NR
1;4a
NR
NR
NR
15
NR
NR
NR
NR

0.0097NR
NR;3.5aNR
0.0097-3.5
NR
NR
NR
NR
NR
NR

NR
NR
NR;1a
NR
2
NR
NR
NR
NR
NR
NR

0.3-2.5
NR
NR; 0.2-0.6a
NR
0.04-2.5
NR
NR
NR
NR
NR
NR

VP/Dimethylaminoethylmethacrylate Copolymer
201824
19984
20172519844
72
43
0.04-6
5-10
65
7
NR

37
6
NR

0.2-6
0.04
NR

201824
31

NR
NR
NR

23
8
NR

3
0.2-1
NR
NR
a
NR;21
NR
NR
NR
NR
0.04-1.2
NR
NR
40
0.5-6
NR
NR
NR
NR
NR
NR
NR
NR
VP/Polycarbamyl Polyglycol Ester
201824201725
6
0.036

NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

NR
NR
1;21a
NR
NR
NR
27
4
NR
NR
NR

6
NR
NR

0.036
NR
NR

3
NR
NR
NR
5
NR
NR
NR
NR
NR
NR

0.036
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

4
NR
1;45a
NR
6
NR
63
1
NR
NR
NR

VP/DMAPA Acrylates Copolymer
2017250.08-7.5
1-7.5
0.08
NR

201824480

NR
NR
NR;1-7.5aNRNR
NR
0.08-7.5
NR
NR
NR
NR
VP/VA Copolymer
20023
2017252100.001-44

20033
0.3-12

NR
NR
NR

442
37
1

181
29
NR

0.001-10
0.07-44NR

0.3-12
3-10
NR

NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

46
NR
35;236a
5
93
NR
330
33
1
1
NR

10
NR
27;87a
NR
15
NR
190
3
NR
NR
NR

0.5-100.07-4
1-10;0.07-9.9a
NR
0.0075-44
NR
1-10
0.29-1.5
0.001
0.07-4NR

0.3-9
NR
0.5-4;4-12aNR
0.3-10
NR
2-12
0.5
NR
NR
NR

Table 6. Frequency and Concentration of Vinylpyrrolidone Polymers According to Duration and Exposure.
# of Uses
Max Conc of Use (%)# of Uses

Totals*Duration of Use
Leave-On
Rinse-Off
Diluted for (Bath) Use
Exposure TypeEye Area
Incidental Ingestion
Incidental Inhalation-Spray
Incidental Inhalation-Powder
Dermal Contact
Deodorant (underarm)
Hair - Non-Coloring
Hair-Coloring
Nail
Mucous Membrane
Baby Products

VP/Vinyl Caprolactam/DMAPA Acrylates Copolymer
20182420172519
0.5-1.4
19
NR
NR
NR
NR
19
NR
NR
NR
6
13
NR
NR
NR

0.5-1.4
1.4
NR

NR
NR
0.5-1.4
NR
NR
NR
1.4
0.5
NR
NR
NR
VP/Dimethylaminoethylmethacrylate/
Polycarbamyl/Polyglycol Ester
201824201725NR
5.6

201824
9Max Conc of Use (%)

Acrylates/VP Copolymer
19984
201725
4
0.67-1.5

19974
NR

4
5
NR

2
2
NR

0.67-1.5
0.81
NR

NR
NR
NR

3
NR
NR
NR
2
NR
3
1
NR
NR
NR

NR
NR
NR;2a
NR
NR
NR
4
NR
NR
NR
NR

NR
NR
0.67-0.95a
NR
0.67 -1.5
NR
0.95
NR
NR
NR
NR

NR
NR
NR
NR
NR
NR
NR
NR
NR
NR
NR

Totals*Duration of Use
Leave-On
5.6
NR
Rinse-OffNR
NR
Diluted for (Bath) Use
NR
NRExposure TypeEye Area
NR
NR
Incidental Ingestion
NR
NR
Incidental Inhalation-SprayNR
5.6
Incidental Inhalation-Powder
NR
NR
Dermal Contact
NR
NR
Deodorant (underarm)
NR
NR
Hair - Non-ColoringNR
5.6
Hair-Coloring
NR
NR
Nail
NR
NR
Mucous Membrane
NR
NR
Baby Products
NR
NR*Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses.
a
It is possible that these products may be sprays, but it is not specified whether the reported uses are sprays.
b
Not specified whether a powder or a spray, so this information is captured for both categories of incidental inhalation.
c
It is possible that these products may be powders, but it is not specified whether the reported uses are powders
NR - no reported use

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2.

Elder RL. Final report on the safety assessment of polyvinylpyrrolidone/vinyl acetate copolymer. Journal of the American
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3.

Andersen FA. Annual review of cosmetic ingredient safety assessments - 2004/2005. Polyvinylpyrrolidone/vinyl acetate
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4.

Andersen FA. Final report on the safety assessment of acrylates copolymer and 33 related cosmetic ingredients. International
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5.

Johnson, W. Jr., Bergfeld, WF, Belsito, DV, Hill, RA, Klaassen, CD, Liebler, DC, Marks, JG, Shank, RC, Slaga, TJ, Snyder, PW,
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6.

Becker, LC, Bergfeld, WF, Belsito, DV, Hill, RA, Klaassen, CD, Liebler, DC, Marks, JG, Shank, RC, Slaga, TJ, Snyder, PW,
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https://www.cir-safety.org/ingredients. Washington, D.C. Last Updated 2017.

7.

Heldreth B.and Fiume MZ. 40th annniversary overview and rereview summaries from 2011 to 2015. PVP(polyvinylpyrrolidone). International Journal of Toxicology. 2017;36(2):50S-51S.

8.

Andersen FA. Final report on the safety assessment of polyvinylpyrrolidone (PVP). Inrternational Journal of Toxicology.
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9.

National Industrial Chemicals Notification and Assessment Scheme (NICNAS). Polymer of low concern public report.
Maltodextrin, polymer with 1-ethenyl-2-pyrrolidone (INCI name: maltodextrin/VP copolymer).
https://www.nicnas.gov.au/search?query=Maltodextrin%2C+polymer+with+1-ethenyl-2pyrrolidinone&collection=nicnas-meta. Last Updated 2016. Date Accessed 3-26-2018.

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