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Antibacterial effects and safety data

Table of contents

Evaluation data

Safety data

Evaluation data

Antiviral test

Antiviral test results
Evaluative organs
Biomedical Science Association (BMSA), an NPO
Test modalities
Measuring rate of infection using MDCK (canine liver cell) plaque assays against A/California 07/09 (H1N1Pdm)

Antibacterial tests

Antibacterial test results
Evaluative organs
Boken Quality Evaluation Institute
Test modalities
JIS L 1902
Test bacteria
Staphylococcus aureus, Klebsiella pneumoniae, MRSA

Deodorizing/odor resistance tests

Deodorizing/odor resistance test results

Deodorizing effect is from 2 hours after start of test

Deodorizing performance test modality
Japan Textile Evaluation Technology Council deodorant treated textile fiber approval standards analysis manual

Determination of antibacterial activity of textile products (ISO20743)

Antibacterial performance was confirmed after 100 washes.

Material was washed using test methodology (high temperature accelerated washing) per the “specific use” defined for antibacterial treated textiles.

(Test performed using JAFET-compliant blended detergent)

Staphylococcus aureus (ATCC6538)

Substrate After inoculation 18 hours later Decrease rate
earthplusTM treated fabric 239,000 ＜20 99.9%+
Untreated 239,000 1,510,000 –

Pneumobacillus (ATCC4352)

Substrate After inoculation 18 hours later Decrease rate
earthplusTM treated fabric 10,500 ＜20 99.9%+
Untreated 10,500 1,750,000 –

MRSA (ATCC33592)

Substrate After inoculation 18 hours later Decrease rate
earthplusTM treated fabric 368,000 ＜20 99.9%+
Untreated 368,000 3,760,000 –
Certification tag issued by the Hohenstein Institute

Certification tag issued by the Hohenstein Institute

*Performed against SEK mark red label, a certification standard of bacterial treatment for specific use at medical institutions.

Results
Antibacterial performance was observed in the fabric after 100 washes.
Evaluative organs
Hohenstein Institute, Germany
Test modalities
DIN EN ISO 20743A,Z:2007-10
Test bacteria

Staphylococcus aureus ATCC6538

Klebsiella pneumoniae ATCC4352

MRSA Staphylococcus aureus(MRSA) ATCC33592

Measurement of antibacterial activity on plastics and other non-porous surfaces (ISO22196)

MRSA (ATCC33592)

Substrate After inoculation 18 hours later Decrease rate
earthplusTM melting type 202,000 ＜20 99.9%+
earthplusTM paint model 95,300 ＜20 99.9%+

E. coli (ATCC8739)

Substrate After inoculation 18 hours later Decrease rate
earthplusTM melting type 85,600 ＜20 99.9%+
earthplusTM paint model 264,000 1,622 99.3%+
Certification tag issued by the Hohenstein Institute

Certification tag issued by the Hohenstein Institute

Evaluative organs
Hohenstein Institute, Germany
Test modalities
ISO 22196:2007-10
Test bacteria

MRSA Staphylococcus aureus(MRSA) ATCC33592

E.coli ATCC8739

Illuminance and antibacterial performance

Differences in antibacterial properties were confirmed in terms of illuminance.

A change was confirmed (logarithmic value) in the number of live bacteria on the earthplusTM treated fabric and untreated fabric.

Illuminance and antibacterial performance
Results
No noticeable difference in antibacterial properties was observed in terms of light intensity. Antibacterial performance was observed at all light intensity levels.
Test specimen
earthplusTM treated fabric (paint model)
Test modalities
JIS L 1902
Test bacteria
Staphylococcus aureus (ATCC6538)
Illuminance
DIGITAL LUX METER MODEL：LX-1010B

Tick allergen tests

Evaluative organs
ITEA Co., Ltd. Tokyo Environmental Allergy Research Institute
Test name
Tick allergen (Der f 1) reaction test
Test objective
Measuring concentration of tick allergens over time on an earthplusTM treated nonwoven fabric
Specimen
earthplusTM treated nonwoven fabric
Control
Untreated
Sample size
4×5[cm]
Concentration
100[ng/ml]
Reaction conditions

Temperature: 4 [Celsius]

Reaction time: 0/6/24 [hours]

Amount added
1000 [μl] per sample
Allergen solution

Tick allergen (Der f 1)

Allergen solution/crude tick extract

(Produced by ITEA; solution concentration: Der f 1:100ng/ml)

Number of experimental samples
n = 1 x 3 for each (carried out independently on each date)
Measurement samples
Allergen solution reacting to the sample
Methodology
A tick allergen solution (includes tick allergens) was applied to the sample and left under reaction conditions. The control was made only with allergens added to an untreated sample. After the given time elapsed, the sample was recovered, and the concentration in the allergen solution was measured.
Allergen measurement

Enzyme immunoassay (Sandwich ELISA)

Primary solid phase antibodies were applied to each well of a 96-well microplate and supplemented with allergens. Next, a pre-labeled secondary antibody was reacted, followed by enzyme and substrate reactions. The absorbance of each colored well was measured and antigen amount of the specimen was measured against a standard curve.

Tick allergen (Der f 1) measurement results

(ng/ml)

0h 6h 24h
earthplusTM treated nonwoven fabric ① 58.31 11.29 6.123
② 101.53 20.15 5.3
③ 90.86 0.41 0.10
Average 83.57 10.62 3.84
Standard deviation 22.51 9.89 3.27
Untreated ① 58.31 72.74 59.1
② 101.53 118.08 115.74
③ 90.86 85.94 90.81
Average 83.57 92.25 88.55
Standard deviation 22.51 23.32 28.39

Change in tick allergen concentration over time (average)

Tick allergen test results

Notes

One reason for the decrease in allergens seen in the untreated sample was the effects of nonspecific adsorption and allergen decrease in components of the material.

Cedar pollen allergen test results

Evaluative organs
ITEA Co., Ltd. Tokyo Environmental Allergy Research Institute
Test name
Evaluating cedar pollen allergen reaction in earthplusTM treated nonwoven fabric
Test objective
Evaluating decrease in cedar pollen allergen concentration in earthplusTM treated nonwoven fabric
Specimen
earthplusTM treated nonwoven fabric
Control
Untreated
Sample size
2×5[cm]
Reaction conditions

Temperature: 4 [Celsius]

Other parameters: left overnight under fluorescent light in refrigerator

Amount added
500[μl] per cloth sample
Allergens measured
Cedar pollen allergen (Cry j 1)
Allergen solution

Crude allergen solution (produced by ITEA) dissolved in acetate buffer (Tween 20)

(Allergen concentration set at 100ng/ml)

Number of experimental samples
n = 3 for each
Measurement samples
Sample of recovered allergen solution reacted to the specimen
Methodology
A buffer containing allergen solution was added to the sample and concentration of allergen in the sample and solution post-contact was measured
Allergen measurement

Enzyme immunoassay (Sandwich ELISA)

Primary solid phase antibodies were applied to each well of a 96-well microplate and supplemented with allergens. Next, a pre-labeled secondary antibody was reacted, followed by enzyme and substrate reactions. The absorbance of each colored well was measured and antigen amount of the specimen was measured against a standard curve.

Cedar pollen allergen concentration

(ng/ml)

0h 24h
Measured value Average value Standard deviation
earthplusTM treated nonwoven fabric 116.14 ＜0.50 ＜0.50 0
＜0.50
＜0.50
Untreated 86.09 77.44 12.93
67.80
78.42

Decrease in concentration of cedar pollen allergen

Cedar pollen allergen test results

Safety data

Skin sensitivity

Skin sensitization test (adjuvant and patch test) using earthplusTM on guinea pigs

Test number
B020880
Test outsourcee
Shinshu Ceramics Co., Ltd.
Test date
01/20/03
Test performer
Seiji Otake, Mitsubishi Safety Research Laboratories Toxicity Research Lab

Observations and conclusions

An adjuvant and patch test using earthplusTM was performed for this evaluation.

After stimulating the skin, both the animals in the group were administered the sample and the control group showed no reaction on the site of dosage. We believe this indicates that the test material does not cause skin reactivity under these test conditions.

Given that, compared to a positive control group, obvious skin reactions were found on DNCB-administered areas in all cases, the experimental procedures are found to be valid.

Per these findings, earthplusTM was found to not show skin reactivity in guinea pigs when administered under these test conditions.

Cytotoxicity tests

Cytotoxicity test using earthplusTM extract (colony-forming assay)>

Test number
B10757
Test outsourcee
Shinshu Ceramics Co., Ltd.
Test date
01/20/03
Test performer
Seiji Otake, Mitsubishi Safety Research Laboratories Toxicity Research Lab

Observations and conclusions

An evaluation of earthplusTM cytotoxicity was performed using V79 cells in a colony-forming assay.

The colony-forming assay test found that rate of colony formation in the plate treated with the specimen extract decreased commensurate to the concentration of extract, suggesting cytotoxicity. IC50 of the specimen extract was 53.%% (95% confidence limit: 47.3-63.0%), a lower value compared to IC50 of standard material B (69.7%), but higher than IC50 of standard material A (2.3%). Therefore, we believe the cytotoxicity of the specimen is stronger than the standard material B, but lower than the standard material A.

The IC50 value of the extract from standard materials A and B was respectively <7% and <70%, showing no significant difference in number of colonies formed between the plate treated with negative material extract and the negative control plate. The results from standard materials A, B, and the negative material meet the threshold of 5.5 in the applicable guidelines, indicating that the experiment parameters were valid.

Per the above, earthplusTM was found to exhibit cytotoxicity in V79 cells, with IC50 of 53.5% (95% confidence limit: 47.3-63.0%). Furthermore, cytoxicity of earthplusTM in V79 cells was higher than in standard material B, but lower than standard material A.

Acute toxicity tests

Acute toxicity test on rats using calibered dosage of earthplusTM

Test number
9L384
Test outsourcee
Shinshu Ceramics Co., Ltd.
Test date
08/06/99
Test performer
Mitsubishi Safety Science Laboratory, Hiroyuki Ishii

Test objective

Evaluation of acute toxicity in calibered dosage of earthplusTM in rats

Results and observations

1. Death
During the observation period, no cases of death were observed.
2. General state
During the observation period, no abnormalities were observed.
3. Weight (Tables 1 and 2)
During the observation period, weight steadily increased.
4. Necropsy results
No abnormalities were found.
5. Observations

After dosing 2000mg/Kg of earthplusTM to male and female rats in order to measure its acute toxicity, no cases of death were observed, nor were any abnormalities found in general conditions, weight change, or under necropsy.

The minimum lethal dose (LDLo value) for earthplusTM in this test was thus 2000mg/Kg or greater.

Acute toxicity tests

Test of revertant colonies in earthplusTM bacteria

Test number
B10756
Test outsourcee
Shinshu Ceramics Co., Ltd.
Test performer
Nippon Yuryo Kentei Kyokai

Results and observations

In this test, the number of revertant colonies induced through the specimen did not exceed two or more times greater than the spray control amount in both tests containing and not containing S9 mix.

The same results were obtained in dose-setting tests, confirming reproducibility of the results.

  • No contamination was observed in the aseptic test.
  • No growth impairment was observed in the test strains.
  • Precipitation was observed on the plate, and this dose was indicated with a +.

The number of bacteria used was as follows.

Strain name Base-pair substitution Frameshifting
TA100 TA1535 WP2uvrA- TA98 TA1537
Bacterial count Dose-setting test 3.7 3.7 5.5 3.9 2.0
(x 109/ml) This test 3.8 4.3 4.7 3.9 2.6

In addition, the number of revertant colonies induced by the positive control in each strain with coexistence/non-coexistence of S9 mix clearly showed, compared to the number of revertant colonies in the spray control groups for each strain, a twofold increase, suggesting positive results. The mean of the spray control and positive control groups was within the range of past data found at this center, indicating that the test was conducted properly.

Based on these results, mutagenicity of earthplusTM was found to be negative.

Acute toxicity tests

Evaluation of skin irritation of earthplusTM in healthy subjects

Test outsourcee
Shinshu Ceramics Co., Ltd.
Test date
12/04/02
Test performer
Yasushi Watanabe, Japan Hair Science Association
1. Test objective
Evaluation of skin irritation in healthy subjects
2. Specimen
earthplusTM treated fabric
3. Test modality

Subjects: 12 males and 13 females (total: 25) between the ages of 27 and 61

  1. Area of application: 10x10mm
  2. Patch test method: using Finchamber (manufactured by EPITEST Ltd.Oy) tape, a 10x10mm was square was used to occlude the upper arm flexor for 48 hours. The sample was removed after 48 hours had elapsed, and the skin condition observed and evaluated one hour after removal and 24 hours after removal.
4. Test results
The results of patch tests on all 25 subjects were negative. The reaction 24 hours after removal of the sample (the table lists this as 72 hours of time) was negative in all cases, with no abnormalities.

Overall evaluation by test representative

The results of the past test we were contracted to perform for your company are as above, indicating that earthplusTM treated fabric has a low likelihood of causing an irritation.

I certify that I created this document per these test results.

Keiji Nagashima, MD

Primary skin irritation tests

Primary skin irritation using earthplusTM on rabbits

Test number
No.: 397050222-002
Test outsourcee
Shinshu Ceramics Co., Ltd.
Test date
06/13/99
Test performer
Japan Food Research Laboratories, Tokyo headquarters

Summary

A primary skin irritation test was performed on earthplusTM printed antibacterial towels in compliance with the OECD test guidelines for chemicals (1981).

Three rabbits were administered occlusion tests for four hours on injured and intact parts of the sheared skin. No irritation of the rabbits’ skin was found after four hours had elapsed.

1. Test methodology

The hair coat of the trunk of each test animal was shaved 24 hours prior to the test.

After weighing the animals, each was designated with four sections six centimeters square, two of which were scratched on the keratinous layer so as to not reach the dermis (injured skin), and the other two sections left untreated (intact skin).

The sample was cut into approximately 2cm x 3cm, and the sheared surface moistened with approximately 0.5ml of purified water, with one injured and one intact skin section being sealed with bandages (Japanese Pharmacopoeia). 3M-Blenderm surgical tape was also used in order to hold the sample from coming in contact with the skin. The remaining injured and intact segments of skin were used for the test. Exposure time was set as four hours, after which time the samples were removed and the exposed skin was cleaned with purified water. Visual observation was performed 1, 24, and 48 hours after removal, with the degree of irritation being ranked per Table 1.

2. Test results
No irritation was observed in any of the three test animals at each time interval after removing the sample.

Publications

International Journal of Nanomedicine, 2011
Paper presented in collaboration with Shinshu University School of Medicine concerning bacterial activity on cotton fabric treated with earthplusTM (titanium oxide, hydroxyapatite, and silver metal) and polypropylene nonwoven fabric
The Japanese Association for Infectious Diseases, 2011

Evaluation of antibacterial performance of earthplusTM (e+) ceramic composite textile material

Poster presentation with Shinshu University Medical Department

Household and Personal Care Products, 2012
Antibacterial efficacy of TiO2/Ag treated fabrics (earthplusTM), paper presented with University of Arizona
Japanese Society for Infection Prevention and Control, 2013
Poster presentation: “Ongoing advances in the antiviral material earthplusTM -- basic findings in antiviral performance” (antiviral effects in cotton suits)
Healthcare Infection Society Society, 2014 *1
Details on antibacterial performance of earthplusTM against multidrug-resistant bacteria Poster presentations by Tohoku University Graduate School and Fukushima Medical University

*1 The Healthcare Infection Society is a British society for infectious control science. This body is considered one of the most prestigious groups involved with infection studies.

*2 Multidrug-resistant bacteria is a type of bacteria resistant to several antibacterial agents.

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