Products / Macrophi Inc. | LPS material | innate immunity

Safety Data

LPS for foods

■Somacy-FL100 (liquid product), Somacy-FP100 (powder product)

Test	Terms	Dosage (as raw material)	Dose (as LPS)	Result
1) Reverse mutation [a].	Five types of bacteria	150mg/plate	1.5mg/plate	No mutagenicity
2) Chromosome aberrations [a].	CHL/IU	150mg/ml	1.5mg/ml	No abnormal findings
3) Single-dose toxicity [a].	Rats, 1 day	60g/kg/day	600mg/kg/day	No toxicity
4) Repeated dose toxicity [b].	Rats, 28 consecutive days	30g/kg/day	300mg/kg/day	No toxicity
5) Repeated dose toxicity [c].	Rats, 90 consecutive days	4.5g/kg/day	45mg/kg/day	No toxicity

The above 1) to 4) were performed using lyophilized Somacy-FL100. 5) was performed using Somacy-FP100. The data were conducted by Ina Research Inc.[a], Nihon Bioresearch Inc. [b], and Covance Laboratories Ltd [c].

■SomacyRB-FP100 (powder product)

Test	Terms	Dose (as raw material)	Dose (as LPS)	Result
Reverse mutation	Five types of bacteria	5mg/plate	0.05mg/plate	No mutagenicity
Chromosome aberrations	CHL/IU	5mg/ml	0.05mg/ml	No abnormal findings
Single dose toxicity	Rats, 1 day	5000mg/kg/day	50mg/kg/day	No toxicity
Repeated dose toxicity	Rats, 13 consecutive weeks	5000mg/kg/day	50mg/kg/day	No toxicity

*Conducted at Iwase Cosfa Co., Ltd.

LPS for cosmetics

■Somacy-CL001 (liquid product)

Test	Terms	Dosage (as raw material)	Dose (as LPS)	Result
Reverse mutation [a].	Five types of bacteria	15g/plate	1.5mg/plate	No mutagenicity
Chromosome aberrations [a].	CHL/IU	15g/ml	1.5mg/ml	No abnormal findings
Single-dose toxicity [b].	Rat, 1 day	6kg/kg/day	600mg/kg/day	No toxicity
Repeated dose toxicity [b].	Rat, 28 consecutive days	3kg/kg/day	300mg/kg/day	No toxicity
Primary skin irritation [b].	Rabbit, 24-hour occlusion	750mg/ml	75μg/ml	Non-irritant
Eye mucous	rabbit	750μg/eye	75ng/eye	Non-irritant
Skin sensitization [a].	Guinea pig (Adjuvant and Patch Test method)	10g/ml	1mg/ml	negative
Skin phototoxicity [a].	Guinea pig (Morikawa method)	10g/ml	1mg/ml	negative
Skin photosensitization [a]	Guinea pig (Adjuvant and Strip method)	10g/ml	1mg/ml	negative
Human patch test [c].	-20 men and 20 women, - 24-hour blockage	100mg/ml （10%）	10μg/ml	24 hours later: erythema, faint erythema 1 each 48 hours later: negative

*Except for the human patch test, the tests were conducted using lyophilized products.
*Except for the human patch test, the tests were conducted in 2007.
*Conducted by BoZo Research Center Inc. [a] / Nihon Bioresearch Inc. [b] / Clinical Pharmacology Institute of Dermatology [c].

■SomacyN-CL001 (liquid product)

Test	Terms	Dosage (as raw material)	Dose (as LPS)	Result
RIPT [*].	-52 humans, -24-hour occlusion patch 9 times/3 weeks	50 mg/ml (5%)	5μg/ml	No cumulative skin irritation ・ No sensitization

*Conducted by BioScreen Testing Services, Inc.

■SomacyN-COS001 (oil suspension product)

Test	Terms	Dose (as raw material)	Dose (as LPS)	Result
RIPT [*].	-53 humans, -24 hour occlusion patch 9 times/3 weeks -Reapply to different sites 10-14 days later to confirm skin sensitization at 48 and 96 hours	100 mg/ml (10%)	10μg/ml	No cumulative skin irritation ・ No sensitization

*Conducted by BioScreen Testing Services, Inc.

■RiB-CL001 (liquid product)

test	terms	Dose (as raw material)	Dose (as LPS)	result
Reverse mutation [a].	Five types of bacteria	500mg/plate	50μg/plate	No mutagenicity
Chromosome aberrations [a].	CHL/IU	500mg/ml	50μg/ml	No abnormal findings
RIPT [b].	-50 humans, -24-hour occlusion patch 9 times/3 weeks	20mg/ml (2%)	2μg/ml	No primary skin irritation No primary skin sensitization

*Except for RIPT, the tests were conducted using a high-concentration product before concentration adjustment.
*Conducted at Iwase Cosfa Co.,Ltd [a] / AMA Laboratories, Inc. [b].

■RiB-COS001 (oil suspension product)

Test	Terms	Dose (as raw material)	Dose (as LPS)	Result
RIPT [*].	-51 human subjects, -24 hour occlusion patch 9 times/3 weeks -Reapply to different sites 10-14 days later to confirm skin sensitization at 48 and 96 hours	50 mg/ml (5%)	5μg/ml	-No cumulative skin irritation ・ -No sensitization

*Conducted by BioScreen Testing Services, Inc.

■APV-CL001 (liquid product)

Test	Terms	Dosage (as raw material)	Dose (as LPS)	Result
Reverse mutation [a].	Five types of bacteria	158mg/plate	15.8μg/plate	No mutagenicity
Chromosome aberrations [a].	CHL/IU	158mg/ml	15.8μg/ml	No abnormal findings
RIPT [b].	-50 humans, -24-hour occlusion patch -9 times/3 weeks	20mg/ml (2%)	2μg/ml	No primary skin irritation -No primary skin sensitization

*Except for RIPT, the tests were conducted using a high-concentration product before concentration adjustment.
*Conducted at Iwase Cosfa Co.,Ltd [a] / AMA Laboratories, Inc. [b].

■APV-COS001 (oil suspension product)

Test	Terms	Dose (as raw material)	Dose (as LPS)	Result
RIPT [*].	-53 humans, -24 hour occlusion patch 9 times/3 weeks -Reapply to different sites 10-14 days later to confirm skin sensitization at 48 and 96 hours	100 mg/ml (10%)	10μg/ml	-No cumulative skin irritation ・ -No sensitization

*Conducted by BioScreen Testing Services, Inc.

LPS for Feed/Pet food

■Somacy-SP050/Somacy-PP050 (powder product)

Test	Terms	Maximum feed concentration (as raw material)	Maximum feed concentration (as LPS)	Result
Chicken chick growth test [a].	Conducted in accordance with the "Safety Evaluation Standard of Feed: Growth Test of Chicken Chicks" (Notification No. 63 Livestock B No. 617, dated April 12, 1988, by the Director-General of the Livestock Products Bureau, Ministry of Agriculture, Forestry and Fisheries)	5 times the normal dose 10 mg/kg feed (10 ppm)	50 μg/kg Feed	No toxicity
Fish (rainbow trout) growth test [b].	Conducted in accordance with "Growth Tests of Safety Evaluation Standards for Aquaculture Animal Feed" (February 13, 1991, Ministry of Agriculture, Forestry and Fisheries, Livestock and Aquaculture Bureau Director-General Notification No. 2 Livestock B 2103).	5 times the normal dose 10 mg/kg feed (10 ppm)	50 μg/kg Feed	No toxicity
Mold poisoning and others [c].	Conducted for pet food			negative

*Conducted by NAS Laboratory, Ltd. [a] / Kochi University [b] / Japan Food Research Laboratories [c].

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