TOY WITH ANTIMICROBIAL PROPERTIES AND METHOD FOR PRODUCING SAME

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application 63/054,615, filed on July 21, 2020, and U. S. Patent Application 17/128,637, filed December 21, 2020. They are incorporated herein by reference.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH AND DEVELOPMENT

[0002] Not applicable.

FIELD OF THE INVENTION

[0003] The invention relates to a toy product, preferably a plush toy product, with antimicrobial properties that permit it to resist odors and stains even after repeated washings and a method for manufacturing the same.

BACKGROUND

[0004] Plush toy products are a staple of the toy industry and have been marketed and used by children for generations. One of the inherent problems with any toy product, particularly one that has a plush outer surface, is that it can become a collector of various bacteria and viruses which can then be spread to the users.

[0005] The parents of children, particularly during a pandemic, are particularly sensitive to this problem. Therefore, there is a need for such a plush toy product that has antimicrobial properties that permit it to resist odors and stains. Since these products are frequently washed or cleaned by the parents of the users, the plush product must be able to maintain its antimicrobial properties after repeated washings.

[0006] Manufacturers of toy products, particularly plush toy products, have attempted to address this problem in the past although most, if not all, have been unsuccessful. Some manufacturers have attempted to simply apply an antimicrobial agent to the finished products which quickly wore off during use and after an initial washing because it was not embedded in the matrix of the products. Other attempts failed because they were either ineffective to prevent microbial growth or, worse yet, because they were considered unsafe to the children who would be playing with the toy product. To be considered effective and safe, these products needed to pass both efficacy and safety tests.

[0007] Examples of such prior art attempts include, for example, W00002636 (Al) for Sanitary Finished Stuffed/Piush Toy and its Manufacturing Method in which a finished stuffed/plush toy is treated with an antibacterial chemical after fabrication rather than during the manufacturing process.

[0008] See also JP2008065705A for Deodorant Stuffed Toy where, again, the antimicrobial agent is sprayed onto the finished toy product after manufacture and CN102500110A for Antibacterial Fabric for Plush Toy where, again, the antimicrobial agent is not introduced during the manufacturing process.

[0009] In US Patent No. 6,240,879 for an Amusement Articles Possessing Microbe-Inhibiting Properties, a pet toy product including microbe-inhibiting properties is taught and identifies a host of different microbe-inhibiting agents, many of which are banned by the FDA due, no doubt, to the fact that the intended use of the product is for domestic animals, not children.

SUMMARY OF THE INVENTION

[0010] The toy product of the present invention incorporates an antimicrobial agent that is introduced during the manufacturing process, to render the resultant product fresh, hypoallergenic, and resistant to stains and odors during use, even after repeated washings.

[0011] In a preferred embodiment, the toy product is a stuffed plush animal in which some or all of the yarn/fabric used in fabricating the toy product is treated with an antimicrobial agent during the knitting of the yarn to create the plush. While several different antimicrobial agents may be used, a preferred antimicrobial agent is a solution selected from the group consisting of silver nitrate, pyrithione zinc, 3-(trimethoxysilyl) propyl dimethyl octadecyl ammonium chloride, cupric ion, zinc oxide, dimethyl distearylammonium chloride, and polyhexamethylene guanidine hydrochloride and phosphate.

[0012] According to the method of the present invention, the antimicrobial agent is preferably introduced into a water tank after the weaving and dying step and prior to the creation of the plush fabric used for the top product.

BRIEF DESCRIPTION OF THE DRAWINGS

[0013] Fig. 1 is a flow chart that describes the steps in the process of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0014] The toy product of the present invention, preferably in the form of a stuffed plush animal, is made from a super soft, plush material that is treated with an antimicrobial agent during the manufacturing process to render it safe, stain-resistant, and washable up to as many as 10 to 20 industrial washings without losing its antimicrobial properties. Such a product is safe for both humans and pets. The product can similarly be used for other toys, gifts, and novelty products including, blankets, pillows, decorative pillows, travel products, seasonal products, pet toys, and baby products.

[0015] To achieve its antimicrobial properties, the yarns or fabric used in fabricating the plush animal are woven, dyed, and then treated with the antimicrobial agent followed by exposure to elevated temperatures to cure or otherwise set the antimicrobial agent. Polyester is the best material for accepting the antimicrobial treatment although cotton, acrylic, and nylon also have a good acceptance level. The resultant fabric can then be knitted or woven to form the plush toy. While the antimicrobial agent may be introduced during the dying process, it has been found that it is more commercially effective to add such antimicrobial agent after the dying process. Alternatively, the antimicrobial agent can be sprayed or coated on the fabric or yarn. The spraying process can be treated by brush, ordinary hand pressure sprinkler, air pressure spray gun, special spray machine, etc., and it does not need high-temperature baking and natural air drying at normal temperature.

[0016] The antimicrobial agents used herein are added in varying concentrations depending upon the specific antimicrobial agent selected. In almost all instances, they are diluted with water to achieve their desired effect. The specific antimicrobial agents used are generally effective in concentrations between 0.2% and 10%.

[0017] While several different antimicrobial agents may be used, it has been found that antimicrobial agents, including silver nitrate, silver chloride, and/or alkyl dimethyl benzyl ammonium chloride are particularly effective antimicrobial agents, preferably in combination with alkyl (50% C12, 30%C14, 17% C16, 3% C18) dimethyl benzyl ammonium chloride.

[0018] An antimicrobial solution of between about 0.2% and 0.6% silver nitrate mixed with between about 0.75% and 1.25% of alkyl (50% C12, 30% C14, 17% C16, 3% C18) Dimethyl Benzyl Ammonium Chloride is a very effective antimicrobial agent and may be used in concentrations of between about 1% and 10% when mixed with water. A particularly preferred concentration range is between about 3% and 5% when mixed with water.

[0019] Such silver nitrate antimicrobial agents are available commercially, including the commercial product known as SilverClear solution for the treatment of textiles which is marketed by TransTex Technologies of Montreal, Canada. It is supplied at a concentration of about 1% silver nitrate and Dimethyl Benzyl Ammonium Chloride. SilverClear does not contain any Substances of Very High Concerns (SVHC) as defined in Article 57 of the Ell's REACH Regulation and as published by ECHA through June 1, 2020.

[0020] Toy products treated with silver nitrate antimicrobial agents have demonstrated a significant anti-bacterial reduction with staphylococcus aureus and klebsiella pneumonia, typically above a 99% reduction in bacterial growth. More significantly, after 10 washes in a normal cycle and normal tumble dry cycle, the products retained a 95% reduction in bacterial growth with Staphylococcus aureus and 87.5% with Klebsiella pneumonia and passed all appropriate toy safety tests. See, for example, the test results in Example 1.

[0021] Another acceptable antimicrobial agent that may be used includes pyrithione zinc in concentrations between about 0.2% and about 10% and, preferably between about 1% and 3% when mixed with water. One particularly preferred pyrithione zinc antimicrobial agent is the commercial product known as Sanitized marketed by Sanitized AG of Burgdorf, Switzerland which is supplied at a concentration of about 30% pyrithione zinc.

[0022] Toy products treated with pyrithione zinc antimicrobial agents have demonstrated a 99% reduction in the growth of Staphylococcus aureus and Klebsiella pneumonia. More significantly, after 20 washes in a normal cycle and normal tumble dry cycle, the products retained a 99.9% reduction in bacterial with both Staphylococcus aureus and Klebsiella pneumonia and passed all appropriate toy safety tests. See, for example, the test results in Example 2.

[0023] Yet another acceptable antimicrobial agent that may be used is 3-(trimethoxysilyl) propyldimethyloctadecy ammonium chloride in concentrations between about 0.2% and about 10% and, preferably, in concentrations between about 2% and 3%. One particularly preferred 3- (trimethoxysilyl) propyldimethyloctadecy ammonium chloride antimicrobial agent is the commercial product known as Microban by Microban International Ltd. of Huntersville, NC. Microban is supplied at a concentration of about 42% 3-(trimethoxysilyl) propyldimethyloctadecy ammonium chloride.

[0024] Toy products treated with 3-(trimethoxysilyl) propyldimethyloctadecy ammonium chloride antimicrobial agents have demonstrated a 99% reduction anti-bacterial with Staphylococcus aureus and a 97.7% reduction with Klebsiella pneumonia and it passed all appropriate toy safety tests. See, for example, the test results in Example 3.

[0025] Other possible antimicrobial agents that can be used include, for example, cupric ion, zinc oxide, dimethyl distearylammonium chloride, and polyhexamethylene guanidine hydrochloride and phosphate, preferably in concentrations between about 0.2% and about 10%. Products so tested under normal conditions reported a 99% reduction anti-bacterial with staphylococcus aureus and klebsiella pneumonia and passed all children's safety tests. See, for example, the actual test results in Examples 4 through 7.

[0026] The process of the present invention is best described in the flow chart of Fig. 1. After the weaving and drying of the yarn in Steps 1 and 2, the antimicrobial agent of the present invention is added to the tank and diluted with water in Step 3 as described above so that the fabric absorbs the antimicrobial agent. It then passes through an industrial oven as described in Step 4 for between 45 and 60 seconds at a temperature of between 170° and 180° C. The resultant and treated yarn in Step 5 can then be processed into the plush animal toy of the present invention.

In an alternative embodiment, the antimicrobial agent can be added to the yarn fibers before they are spun into yam or to the yarn before it is knitted or woven.

Example 1

[0027] A plush toy product was treated with the silver nitrate antimicrobial agent described herein was tested for both efficacy and safety. The efficacy test results were as follows:

Sample Description:

Two (2) Group of Submitted Samples Said to be:

(A) Anti-Microbial Fabric in Black (After Washed)

(B) Anti-Microbial Fabric in Black Standard : -

Buyer's Name : -

Color : --

Vendor : --

Manufacturer : --

Supplier : --

Style No./Name : -

P.O. No. : -

Ref. : Anti-microbial Fabric Country of Origin : China

Goods Exported To : -

Date Rec'd/Test Started : Jul 29, 2020 Date Final Information : Confirmed Anti-Bacterial Activity Test (Quantitative)

Pre-treatment conditions: AATCC 135-2012, Test No. (1) (III) (Ai), Machine Wash At 105°F With 1.8 kg Total Loading (Type I Bleach Cotton Ballast + Specimen) And 66±lg of 1993 AATCC Standard Reference Detergent (Without Optical Brightener). Normal Cycle, Tumble Dry Normal, 10 washes.

With Reference To 2020 American Association of Textile Chemists and Colorists, Technical Manual, AATCC TM 100- 2019.

Sterilization Method: Autoclave Before Test Neutralizing Solution: SCDLP Contact Time: 24 Hours Contact Temperature: 37°C.

Incubation conditions: 37°C, 48 hours. Agar Medium: Nutrient Agar

Test Culture: Staphylococcus Aureus (ATCC 6538). Klebsiella Pneumoniae (ATCC 4352).

Test Specimen: l g Square/3.8 X 3.8 cm Sample with 1 ml Inoculum Per Trial.

Results:

Sample Received condition: Sample in Closed Plastic Bag Reference Rating:

Comments:

Anti-Microbial Activity of Immobilized Antimicrobial Agents Under Dynamic Contact Conditions with Reference to Standard Test Method ASTM E2149-13a

Contact Time: 1 Hours Incubation Condition 35°C, 24 Hours Agar Medium: Plate Count Agar

Test Culture: Escherichia Coli (ATCC 25922)

Test Specimen: lg Of Submitted Sample Shaked in 50 ml

Microorganism Inoculum Solution

Results:

Sample Received Condition: Sample in Closed Plastic Bag Reference Rating:

Comments:

[0028] The safety test results were as follows:

Sample Description:

Ten (10) pieces of the submitted sample said to be Item Name: Toy

Labeled Age Group: 3+

Applicant Spec. Age: All Ages

Grading for Testing:

Packaging provided by Applicant: Yes (Artwork)

Additional Material & Wet: No Paint provided:

Country of Origin: China

Date Sample Provided: July 30, 2020

Testing Period: July 30, 2020 - Aug 4, 2020

Tests conducted:

As requested by the applicant, refer to the attached page(s) for details.

Conclusion:

Conclusion

Tested Samples Standard Testing Item Result

Tested component(s) of U.S. ASTM F963-17 on DEHP test See comment Submitted sample(s) U.S. ASTM F963-17 on soluble heavy Pass Elements test

Submitted sample(s) U.S. ASTM F063-17 on total Lead content Not applicable In surface coating

Tested component(s) of U.S. ASTM F963-17 on total Lead content Pass Submitted sample(s) in non-surface coating

Consent Judgment No. RG-356892 for Toys Pass On total Lead content based on California'

Proposition 65

Submitted sample(s) U.S. CFR Title Part 1303 total Lead content Not applicable U.S. Consumer Product Safety Improve- Not applicable ment Act 2008 Title I, Section 101 for Total Lead content

Tested component(s) of U.S. Consumer Product Safety Pass

Improvement Act 2008 Title I, Section 101 for Total Lead content in Non-surface coating materials (substrate)

Illinois Lead Poisoning Prevention Act 410 Pass on total Lead content requirement /

Illinois Lead Poisoning Prevention Act 410 ILCS 45 (Public Act 97/612) on warning statement requirement for specified products

Comment: The testing scope of the standard was not applicable to the submitted samples. However, the test results of the samples met the related requirements as stated in this report.

Example 2

[0029] A plush toy product was treated with pyrithione zinc in amounts between about 0.2% and about 10% with the following results. The efficacy test results were as follows: Sample Description:

One (1) Group of Submitted Samples Said to Be: Textile Material in Pink

Standard : -

Buyer's Name : -

Colour : Pink

Vendor : -

Manufacturer : -

Supplier : -

Style No./Name : -

P.O. No.

Ref. : Anti-Microbial Plush

Sanitized ^® TH 27-24 Padding 2% OWF Country of Origin : China

Goods exported to : -

Date Received/Date Test Started : Aug 12, 2020

Date Final Information Confirmed : Aug 14, 2020

TEST REPORT Number: GXZHT90985232

Tests Conducted (as requested by Applicant)

Anti-Bacterial Activity test (Quantitative)

Pre-treatment conditions: AATCC 135-2012, Test No. (1) (III) (A), Machine Wash at 105°F with 1.8 kg Total Loading (Type I Bleach Cotton Ballast + Specimen) And 66±lg of 1993 AATCC Standard Reference Detergent (without Optical Brightener), Normal Cycle, Tumble Dry Normal, 20 washes.

With Reference to 2020 American Association of Textile Chemists and Colorists, Technical Manual, AATCC TM100-2019. Sterilization Method: Autoclave Before Test Neutralizing Solution: 100 mL D/E Contact Time: 24 hours Contact Temperature: 37°C.

Incubation condition: 37°C, 48 hours.

Agar Medium: Nutrient Aga Test Culture: Staphylococcus Aureus (ATCC 6538) Klebsiella Pneumonia (ATCC 4352)

Test Specimen: 1 g. Square / 3.8 x 3.8 cm Sample with 1 mi. Inoculum Per Trial. Result:

Sample Received Condition: Sample in Closed Plastic Bag Reference Rating*:

Comment*:

[0030] The safety test results were as follows: Sample Description:

Two (2) submitted sample said to be:

Item Name Anti-Microbial Black Fabric/Anti-Microbial Pink Plush

Applicant Specified Age: All ages Grading for Testing Country of Origin China Conclusion:

Tested sample Standard Result Tested component(s) of U.S. ASTM F963-17 on heavy elements Pass Submitted samples test

U.S. CFR Title 18 Part 1303 total Lead Not Applicable

Content

U.S. Consumer Product Safety Not Applicable Improvement Act 2008 Title I, Section 101 For Total Lead content in Surface Coating U.S. Consumer Product Safety Not Applicable Improvement Act 2008 Title I, Section 101 For Total Lead content in Non-Surface Coating materials (substrate)

EN 71-3 2019 on migration of certain Pass Elements and (EIJ) 2019/ 1922 amending 2009/48/EC (applies from 20 May 2021) For Aluminum migration Test Item

Applicant's requirement on heavy metal Pass

Content

Standard

Azocolourants Content Requirements on Pass Annex XVII Entry 43 of the REACH Regulation (EC) No 1897/2006 and Amendment (EC) No 552/2019 and (EU) No 126/2013 (formerly known as Directive 2002/61(EC)

Test Item

Free formaldehyde content See Test

Example 3

[0031] A plush toy product was treated with the 3-(trimethoxysilyl) propyldimethyloctadecy ammonium chloride antimicrobial agents described herein was tested for both efficacy and safety. The efficacy test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Fabric.

Reference No. 3-(Trimethoxysilyl) Propyldimethyloctadecy Ammonium

Chloride. Vendor Microban_AEGIS.

Date Sample Received Oct 27, 2020.

Testing Period : Oct 27, 2020 - Nov 12, 2020

Anti-Bacterial Activity Test (Quantitative)

With reference to 2013 American Association of Textile Chemists and Colorists, Technical Manual, AATCC Test Method 100-2012.

Sterilization method: Autoclave before the test.

Contact time: 24 hours

Contact temperature: 37°C Neutralizing solution: Lethean broth.

Incubation condition: 37°C, 48 hours.

Agar medium: Nutrient agar. Test culture: Staphylococcus aureus (ATCC 6538). Klebsiella pneumonia (ATCC 4352).

No. of test specimen: 2 Pieces / circular/ @ 4.8 cm in diameter with 1 ml inoculum per trial.

Results:

Sample received condition: sample in a closed plastic bag. Reference Rating:

% Reduction _ Anti-bacterial Activity 0% Not Acceptable

<50% Insignificant

>50% Acceptable

>95% Acceptable & Significant

Comments:

[0032] The safety test results were as follows:

Sample Description: One (1) set of submitted Sample said to be:

Item Name: Anti-Microbial Purple Fabric

Applicant Specified Age: All ages Grading for Testing:

Country of Origin: China

Date Sample Received: Sept. 18, 2020

Testing Period: Sept. 18, 2020-Sept. 27, 2020

Conclusion:

Tested Sample_ Standard Result

Tested components of U.S. ASTM F963-17 on soluble heavy elements test Pass Submitted sample set

U.S. ASTM F963-17 on total Lead content in non-surface N/A Coating

U.S. ASTM 963-17 on total lead content in surface coating N/A U.S. Consumer Product Safety Improvement Act 2008, N/A Title 1, Section 101 for total Lead content in surface Coating

U.S. Consumer Product Safety Improvement Act 2008, N/A Title 1, Section 101 for total Lead content in Non-surface Coating materials (substrate)

Canada Consumer Product Safety Act Toys Regulations N/A SOR/2011-17, Section 23 on toxic elements test EN 71-3-2019 on migration of certain elements and (EU) Pass 2019/1922 amending 2009/48/EC (applies from 20 May 2021) for Aluminum migration

Australian/New Zealand Standard AS/NZS 8124 3:2012/ Pass Arndt 1:2016 for toxic elements test

Azocolorants Content Requirement in Annex XVII Entry Pass 43 of the REACH Regulation (EC) No. 1907/2006 and Amendment (EC) No. 552/2009 and (EU) 1262013 (Formerly Known as Directive 2002/61(EC)

Example 4

[0033] A plush toy product was treated with a cupric ion antimicrobial agents described herein was tested for both efficacy and safety. The efficacy test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Fabric.

Reference No. :

Cupr ic Ion. Date Sample Received

Oct

27, 2020.

Testing Period : Oct 27, 2020 ~ Nov 12, 2020.

1 Anti-Bacterial Activity Test (Quantitative)

With reference to 2013 American Association of Textile Chemists and Colorists, Technical Manual, AATCC Test Method 100-2012.

Sterilization method: Autoclave before test

Contact time: 24 hours

Contact temperature: 37°C

Neutralizing solution: Letheen broth

Incubation condition: 37°C, 48 hours

Agar medium: Nutrient agar

Text culture: Staphylococcus aureus (ATCC 6538)

Klebsiella pneumoniae (ATCC 43620)

No. of test specimen: 4 piece/s / circular @ 4.8 cm in diameter with 1 mi. inoculum per trial.

Result:

Sample received condition: sample in closed plastic bag Reference rating*

% Reduction _ Anti-bacterial Activity

0% Not acceptable

<50% Insignificant

>50% Acceptable

>95% Acceptable & Significant

Comment :

[0034] The safety test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Pink Fabric

Reference No. Cupric Ion Applicant Specified Age All ages Grading for Testing Country of Origin China Date Sample Received Oct 27, 2020 Testing Period Oct 27, 2020 - Nov 03, 2020 Conclusion: Tested Sample Standard Result

Tested component(s) of U.S. ASTM F963-17 on soluble Pass Submitted sample heavy elements test U.S. ASTM F963-17 on total Not Applicable Lead content in surface coating Pass U.S. ASTM F963-17 on total

Lead content in non-surface coating

Conclusion:

Tested sample Standard Result Tested component(s) of U.S. CFR Title 16 Part 1303 Not Applicable Submitted sample total Lead content

U.S. Consumer Product Safety Not Applicable Improvement Act 2008 Title I, Section 101 for total Lead content in surface coating U.S. Consumer Product Safety Pass

Improvement Act 2008 Title I,

Section 101 for Total Lead content in Non-surface coating materials (substrate)

Tested sample Standard Result Tested components of Canada Consumer Product Safety Not Applicable Submitted sample Act Toys Regulations SOR/2011-17 Section 23 on toxic elements test Canada Consumer Products Pass Containing Lead Regulations SCR/22018-83

Tested sample Standard Result

Tested components of EN 711-3:2019 on migration of Pass Submitted sample certain elements and (EU) 2019/ 1922 amending 2009/48/EC (applies From 20 May 2021) for Aluminum Migration

Phthalates Content Requirement Pass In Annex XVII Entry 51 & 52 of the REACH Regulation (EC) No. 1907/

2008 and Amendment (EC) No 552/2009 and (EU) 2018//2005 Azocolocurants Content Requirement Pass

Of the REACH Requirement in Annex XVII Entry 43 of the REACH Regulation (EC) No 1907/2008 and Amendment (EC) No 552/2008 and (EU) No 126/2013 (Formerly known as Directive 2002/61(EC)

Test Item

Free formaldehyde content See Test

Conducted 11

Tested sample Standard Result

Tested components of Australian/New Zealand Standard Pass Submitted sample AS/NZ 8124.3 2012/Amdt 1:2016 For toxic elements test

Example 5

[0035] A plush toy product was treated with a zinc oxide antimicrobial agents described herein was tested for both efficacy and safety. The efficacy results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Fabric.

Reference No. : Zinc Oxide.

Date Sample Received Oct 27, 2020

Testing Period Oct 27, 2020-Nov 12, 2020

1 Anti-Bacterial Activity Test (Quantitative) With reference to 2013 American Association of Textile Chemists and Colorists, Technical Manual, ATCC Test Method 100-2012.

Sterilization method: Autoclave before test

Contact time: 24 hours

Contact temperature: 37°C

Neutralizing solution: Letheen broth

Incubation condition: 37°C, 48 hours

Agar medium: Nutrient agar

Test culture: Staphylococcus aureus (ATCC 6538)

Klebsiella pneumoniae (ATCC 4352)

No. of test specimen: 4 piece/s / circular / (® 4.8 cm in diameter with 1 ml inoculum per trial.

Result:

Sample received condition: sample in closed plastic bag. Reference rating*:

% Reduction: Anti-Bacterial Activity 0% Not acceptable

<50% Insignificant

>50% Acceptable

>95% Acceptable & Significant

Commment*

[0036] The safety test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Pink Fabric

Reference No. Zinc Oxide

Applicant Specified Age All ages Grading for Testing Country of Origin China Date Sample Received Oct 27, 2020 Testing Period Oct 27, 2020 - Nov 03, 2020 Conclusion:

Tested sample Standard Result Tested component(s) of U.S. ASTM F983-17 on soluble Pass Submitted sample heavy elements test U.S. ASTM F983-17 on total Lead Not Applicable Content in surface coating U.S. ASTM F963-17 on total Lead Pass

In non-surface coating

Conclusion:

Tested sample Standard Result Tested component(s) of U.S. CFR Title 16 Part 1303 Not Applicable Submitted sample total Lead content U.S. Consumer Product Safety Not Applicable Improvement Act 2008 Title I,

Section 101 for total Lead content In surface coating U.S. Consumer Product Safety Pass Improvement Act 2008 Title I, Section 101 for Total Lead content in Non-surface coating materials (substrate)

Canada Consumer Product Safety Not Applicable

Act Toys Regulations SOR/2011-17

Section 23 on toxic elements test

Canada Consumer Products Pass

Containing Lead Regulations

SOR/2018-83

EN 71-3:2019 on migration Pass

Of certain elements and (EU)

2019/1922 amending 2009/48/EC (applies from 20 May 2021) for Aluminum migration

Phthalates Content Requirement Pass

In Annex XVII Entry 51 & 52 of the REACH Regulation (EC) No 1907/

2006 and Amendment (EC) No 552/2009 and (EU) 2018/2005 Azocolourants Content Requirement Pass In Annex XVII Entry 43 of the REACH Regulation (EC) No 1907/2006 and Amendment (EC) No 552/2009 and (EU)

No 125/2013 (Formerly Known as Directive

2002/51/EC

Test Item

Free formaldehyde content See Test

Conducted 11

Standard

Australian/New Zealand Pass

AS/NZS 8124 3:2012/Amdt 1:2016 For toxic elements test

Example 6

[0037] A plush toy product was treated with Dimethyl Distearylammonium Chloride antimicrobial agents described herein was tested for both efficacy and safety. The efficacy tests and test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Fabric Reference No. Dimethyl Distearylammonium Chloride

Date Sample Received Oct 27, 2020

Testing Period Oct 27, 2020 - Nov 12, 2020

1 Anti-Bacterial Activity Test (Quantitative)

With reference to 2013 American Association of Textile Chemists and Colorists, Technical Manual, AATCC Test Method 100-2012.

Sterilization method: Autoclave before test.

Contact time: 24 hours

Contact temperature: 37°C

Neutralizing solution: Latheen broth

Incubation condition: 37°C, 48 hours

Agar medium: Nutrient agar

Test culture: Staphylococcus aureus (ATCC 6538)

Klebsella pneumoniae (ATCC 4352)

No. of test specimen: 4 pieces / circular / @ 4.8 cm in diameter with 1 mi noculum per trial.

Result:

Sample received condition: sample in closed plastic bag. Reference rating*:

% Reduction: Anti-Bacterial Activity 0% Not acceptable

<50% Insignificant

>50% Acceptable

>95% Acceptable & Significant

Comment*

[0038] The safety test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Pink Fabric

Reference No. Dimethyl Distearylammonium Chloride

Applicant Specified Age All ages Grading for testing Country of Origin China Date Sample Received: Oct 27, 2020 Testing period Oct 27, 2020 - Nov 03, 2020 Conclusion:

Tested sample Standard Result Tested component(s) of U.S. ASTM F963-17 on soluble heavy Pass Submitted sample elements test Submitted sample U.S. ASTM F963-17 on total Lead Not Applicable content in surface coating

Tested component(s) of U.S. ASTM F983-17 on total Lead Pass Submitted sample in non-surface coating Submitted sample U.S. CFR Title 16 Part 1303 total Lead Not Applicable content

U.S. Consumer Product Safety Not Applicable Improvement Act 2008 Title I,

Section 101 for total Lead content in surface coating

Tested component(s) of U.S. Consumer Product Safety Pass Submitted sample Improvement Act 2008 Title I,

Section 101 for Total Lead content in Non-surface coating materials (substrate)

Submitted sample Canada Consumer Product Safety Act Not Applicable Toys Regulations SCR/2011-17 Section 23 on toxic elements test

Tested component(s) Canada Consumer Products Containing Pass Of submitted sample Lead regulations SCAR/2018-83

EN71-32019 on migration of certain Pass elements and (EU) 2019/1922 amending 2009/48/EC (applies from 20 May 2021) For Aluminum migration Phthalates Content Requirement in Annex Pass XVII Entry 51 & 52 of the REACH Regulation (EC) No 1907/2008 and Amendment (EC) No 552/2009 and (EU) 2018/2005 Azocolourants Content Requirements in Pass

XVII Entry 32 of the REACH Regulation (EC)

No 1907/2008 and Amendment (EC) No 552/2009 and (EU) No 126//2013 (formerly Known as Directive 2002/61/EC)

Test Item

Free formaldehyde content See Test

Conducted 11

Conclusion:

Tested sample Standard Result Tested component(s) Australian/New Zealand Standard ASNZS Pass Of submitted sample 81243 2012/Amdt 1 20116 for toxic Elements test

Example 7

[0039] A plush toy product was treated with Polyhexamethylene Guanidine Hydrochloride and Phosphate antimicrobial agents described herein was tested for both efficacy and safety. The efficacy test and test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Fabric.

Reference No. : Polyhexamethylene Guaidine Hydrochloride and

Phosphate.

Date Sample Received: Oct 27, 2020

Testing Period Oct 27, 2020 - Nov 12, 2020

1 Anti-Bacterial Activity Test (Quantitative)

With reference to 2013 American Association of Textile Chemists and Colorists, Technical Manual. AATCC test Method 100-2012.

Sterilization method: Autoclave before test.

Contact time: 24 hours Contact temperature: 37 °C Neutralizing solution: Letheen broth Incubation condition: 37°C, 48 hours Agar medium: Nutrient agar.

Test culture: Staphylococcus auneus (ATCC 6538)

Klebsiela penumoniae (ATCC 4352)

No. on test specimens pieces / circcular / @ 4.8 cm in diameter with 1 mi. inoculum per trial.

Result:

Sample received condition: sample in closed plastic bag. Reference rating*:

% Reduction: Anti-Bacterial Activity 0% Not acceptable

<50% Insignificant

>50% Acceptable

>95% Acceptable & Significant

Comment*: [0040] The safety test and test results were as follows:

Sample Description:

One (1) submitted sample said to be Anti-Microbial Fabric.

Reference No. Polyhexamethylene Guaidine Hydrochloride and

Phospate

Applicant Specified Age All ages Grading for testing Country of Origin China Date Sample Received Oct 27, 2020 Testing Period Oct 27, 2020 - Nov 03, 2020 Conclusion:

Tested sample Standard Result Tested component(s) of U.S. ASTM F963-17 on soluble heavy Pass Submitted sample(s) elements test Submitted sample(s) U.S. ASTAM F963-17 on total Lead Not Applicable Content in surface coating

Tested component(s) of U.S. ARTM F963 on total Lead in Pass Non-surface coating

Conclusion:

Tested sample Standard Result Submitted sample(s) U.S. CFR Title 16 Part 11303 total Not Applicable lead content

U.S. Consumer Product Safety Not Applicable Improvement Act 2008 Title I, Section 101 for Total Lead content in surface Coating.

Tested component(s) of U.S. Consumer Product Safety Pass Improvement Act 2008 Title I, Section 101 for Total Lead content in Non-Surface

Coating materials (substrate)

Submitted sample(s) Canada Consumer Product Safety Act Not Applicable Toys Regulations SCR2011-17 Section 23 on toxic elements test

Tested component(s) of Canada Consumer Products Containing Pass Submitted sample(s) Lead Regulations SCR/2018-82 EN 71-3 2019 on migration of certain Pass Elements and (EU) 2010/1922 amending 2009/48/EC (applies from 20 May 2021) For Aluminum migration Phthalates Content Requirement in Pass

Annex XVII Entry 51 & 52 of the REACH Regulation (EC) No 1907/2008 and Amendment (EC) No 582/2009 and (EU) 2018/2005

Azosocolourants Content Requirement Pass In Annex XVII Entry 43 of the REACH Regulation (EC) No 1807/2008 and Amendment (EC) No 552/2009 and (EU) 125/2013 (Formerly known as Directive 20023/61(EC)

Test Item

Free formaldehyde content See Test

Concluded 11

Standard

Australian/New Zealand Standard FAS/NZS Pass 8124.3.2012 /Arndt 1:2016 to toxic elements test [00041] While a particular form of the invention has been illustrated and described, it will be apparent that various modifications can be made without departing from the spirit and scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

[00042] Particular terminology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the invention with which that terminology is associated. In general, the terms used in the following claims should not be construed to limit the invention to the specific embodiments disclosed in the specification, unless the above Detailed Description section explicitly defines such terms. Accordingly, the actual scope of the invention encompasses not only the disclosed embodiments but also all equivalent ways of practicing or implementing the invention.

[0043] The above-detailed description of the embodiments of the invention is not intended to be exhaustive or to limit the invention to the precise form disclosed above or to the particular field of usage mentioned in this disclosure. While specific embodiments of, and examples for, the invention are described above for illustrative purposes, various equivalent modifications are possible within the scope of the invention, as those skilled in the relevant art will recognize. Also, the teachings of the invention provided herein can be applied to other systems, not necessarily the system described above. The elements and acts of the various embodiments described above can be combined to provide further embodiments.

[0044] All of the above patents and applications and other references, including any that may be listed in accompanying filing papers, are incorporated herein by reference. Aspects of the invention can be modified, if necessary, to employ the systems, functions, and concepts of the various references described above to provide yet further embodiments of the invention.

[0045] Changes can be made to the invention in light of the above "Detailed Description." While the above description details certain embodiments of the invention and describes the best mode contemplated, no matter how detailed the above appears in text, the invention can be practiced in many ways. Therefore, implementation details may vary considerably while still being encompassed by the invention disclosed herein. As noted above, particular terminology used when describing certain features or aspects of the invention should not be taken to imply that the terminology is being redefined herein to be restricted to any specific characteristics, features, or aspects of the invention with which that terminology is associated.

[0046] While certain aspects of the invention are presented below in certain claim forms, the inventor contemplates the various aspects of the invention in any number of claim forms. Accordingly, the inventors reserve the right to add additional claims after applying to pursue such additional claim forms for other aspects of the invention.