Name: Chamomilla Recutita Flower Water NOAEL Studies
Creator: Roots by Benda

CIR_vision_codex 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
CIR_vision_codex	NOAEL	=200	mg/kg/d	rat	oral	7 d	oral toxicity	{"citation":"(87; 5; 10","dose":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight.","effect":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight. Doses applied 7 d/wk (6 h/d) for 4 weeks No treatment-related effects in low- and mid-dose groups. Slight decrease in body weight gain and feed efficiency in all rats of high- dose group only on day 7; also, decreased mean terminal body weight (high-dose males and females). High-dose female rats also had transient, moderate erythema. NOAEL ¼ 200 mg/kg/d108 Ocular irritation (\u0002)-a-Bisabolol (undiluted) 3 rabbits Instilled into 1 conjunctival sac of each animal; eyes not rinsed Well-defined conjunctival redness in all rabbits at 1, 24, and 48 hours, but not at 72 hours109 Skin irritation and sensitization (\u0002)-a-Bisabolol (undiluted) 3 white Vienna rabbits Semiocclusive patches with test substance applied for 4 hours to clipped back or flank At 4 hours reading, very slight erythema in all rabbits. Well-defined erythema in 2 rabbits at 24 hours and very slight erythema in 1 rabbit at 72 hours110 Bisabolo...","page":3,"pdf":"PRS707.pdf","row_type":"noael_study","study_id":"PRS707_noael_001"}
CIR_vision_codex	NOAEL	=200	mg/kg/d	rat	oral	7 d	oral toxicity	{"citation":"(87; 5; 10","dose":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight.","effect":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight. Doses applied 7 d/wk (6 h/d) for 4 weeks No treatment-related effects in low- and mid-dose groups. Slight decrease in body weight gain and feed efficiency in all rats of high- dose group only on day 7; also, decreased mean terminal body weight (high-dose males and females). High-dose female rats also had transient, moderate erythema. NOAEL ¼ 200 mg/kg/d108 Ocular irritation (\u0002)-a-Bisabolol (undiluted) 3 rabbits Instilled into 1 conjunctival sac of each animal; eyes not rinsed Well-defined conjunctival redness in all rabbits at 1, 24, and 48 hours, but not at 72 hours109 Skin irritation and sensitization (\u0002)-a-Bisabolol (undiluted) 3 white Vienna rabbits Semiocclusive patches with test substance applied for 4 hours to clipped back or flank At 4 hours reading, very slight erythema in all rabbits. Well-defined erythema in 2 rabbits at 24 hours and very slight erythema in 1 rabbit at 72 hours110 Bisabolo...","page":3,"pdf":"PRS707.pdf","row_type":"noael_study","study_id":"PRS707_noael_001"}
CIR_vision_codex	NOAEL	=200	mg/kg/d	rat	oral	7 d	oral toxicity	{"citation":"(87; 5; 10","dose":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight.","effect":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight. Doses applied 7 d/wk (6 h/d) for 4 weeks No treatment-related effects in low- and mid-dose groups. Slight decrease in body weight gain and feed efficiency in all rats of high- dose group only on day 7; also, decreased mean terminal body weight (high-dose males and females). High-dose female rats also had transient, moderate erythema. NOAEL ¼ 200 mg/kg/d108 Ocular irritation (\u0002)-a-Bisabolol (undiluted) 3 rabbits Instilled into 1 conjunctival sac of each animal; eyes not rinsed Well-defined conjunctival redness in all rabbits at 1, 24, and 48 hours, but not at 72 hours109 Skin irritation and sensitization (\u0002)-a-Bisabolol (undiluted) 3 white Vienna rabbits Semiocclusive patches with test substance applied for 4 hours to clipped back or flank At 4 hours reading, very slight erythema in all rabbits. Well-defined erythema in 2 rabbits at 24 hours and very slight erythema in 1 rabbit at 72 hours110 Bisabolo...","page":3,"pdf":"PRS707.pdf","row_type":"noael_study","study_id":"PRS707_noael_001"}
CIR_vision_codex	NOAEL	=200	mg/kg/d	rat	oral	7 d	oral toxicity	{"citation":"(87; 5; 10","dose":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight.","effect":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight. Doses applied 7 d/wk (6 h/d) for 4 weeks No treatment-related effects in low- and mid-dose groups. Slight decrease in body weight gain and feed efficiency in all rats of high- dose group only on day 7; also, decreased mean terminal body weight (high-dose males and females). High-dose female rats also had transient, moderate erythema. NOAEL ¼ 200 mg/kg/d108 Ocular irritation (\u0002)-a-Bisabolol (undiluted) 3 rabbits Instilled into 1 conjunctival sac of each animal; eyes not rinsed Well-defined conjunctival redness in all rabbits at 1, 24, and 48 hours, but not at 72 hours109 Skin irritation and sensitization (\u0002)-a-Bisabolol (undiluted) 3 white Vienna rabbits Semiocclusive patches with test substance applied for 4 hours to clipped back or flank At 4 hours reading, very slight erythema in all rabbits. Well-defined erythema in 2 rabbits at 24 hours and very slight erythema in 1 rabbit at 72 hours110 Bisabolo...","page":3,"pdf":"PRS707.pdf","row_type":"noael_study","study_id":"PRS707_noael_001"}

UnifiedCodex:CIR:beta.noael_studies 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:CIR:beta.noael_studies	oral toxicity	200	mg/kg/d	rat	oral	7 d	oral toxicity	SOURCE_SUBDIR=PRS707; REPORT_TITLE=Amended Safety Assessment of Chamomilla recutita-Derived Ingredients as Used in Cosmetics Wilbur Johnson Jr1, Ivan Boyer2, Wilma F. Bergfeld3, Donald V. Belsito3, Ronald A. Hill3, Curtis D. Klaassen3, Daniel C. Liebler3,; OPINION_NUMBER=PRS707; COMMITTEE=Cosmetic Ingredient Review Expert Panel; REPORT_DATE=In 2015; VALUE_TEXT=200; DOSE=dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight.; EFFECT=dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight. Doses applied 7 d/wk (6 h/d) for 4 weeks No treatment-related effects in low- and mid-dose groups. Slight decrease in body weight gain and feed efficiency in all rats of high- dose group only on day 7; also, decreased mean terminal body weight (high-dose males and females). High-dose female rats also had transient, moderate erythema. NOAEL ¼ 200 mg/kg/d108 Ocular irritation ()-a-Bisabolol (undiluted) 3 rabbits Instilled into 1 conjunctival sac of each animal; eyes not rinsed Well-defined conjunctival redness in all rabbits at 1, 24, and 48 hours, but not at 72 hours109 Skin irritation and sensitization ()-a-Bisabolol (undiluted) 3 white Vienna rabbits Semiocclusive patches with test substance applied for 4 hours to clipped back or flank At 4 hours reading, very slight erythema in all rabbits. Well-defined erythema in 2 rabbits at 24 hours and very slight erythema in 1 rabbit at 72 hours110 Bisabolo...; CITATION=(87; 5; 10; CITATION_NUMBERS=[87,5,10]; REFERENCE=(87; 5; 10; DETAILS_JSON={"cas_number":"84082-60-0","citation":"(87; 5; 10","dose":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight.","duration":"7 d","effect":"dure Results a-Bisabolol (87.5% pure, in olive oil) 10 Wistar rats (5 per sex) Applied to clipped skin (under semiocclusive dressing) at doses of 50, 200, and 1,000 mg/kg body weight. Doses applied 7 d/wk (6 h/d) for 4 weeks No treatment-related effects in low- and mid-dose groups. Slight decrease in body weight gain and feed efficiency in all rats of high- dose group only on day 7; also, decreased mean terminal body weight (high-dose males and females). High-dose female rats also had transient, moderate erythema. NOAEL ¼ 200 mg/kg/d108 Ocular irritation (\u0002)-a-Bisabolol (undiluted) 3 rabbits Instilled into 1 conjunctival sac of each animal; eyes not rinsed Well-defined conjunctival redness in all rabbits at 1, 24, and 48 hours, but not at 72 hours109 Skin irritation and sensitization (\u0002)-a-Bisabolol (undiluted) 3 white Vienna rabbits Semiocclusive patches with test substance applied for 4 hours to clipped back or flank At 4 hours reading, very slight erythema in all rabbits. Well-defined erythema in 2 rabbits at 24 hours and very slight erythema in 1 rabbit at 72 hours110 Bisabolo...","endpoint":"oral toxicity","ingredient":"Chamomilla recutita-Derived Ingredients","loael_value":"","noael_unit":"mg/kg/d","noael_value":"200","page":3,"route":"oral","species":"rat","study_id":"PRS707_noael_001"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	FGL3685T2X	UNII	-	-	-	structurallyDiverse	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"FGL3685T2X"}
openFDA substances	FDA UNII substance identifier	FGL3685T2X	UNII	-	-	-	structurallyDiverse	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"FGL3685T2X"}
openFDA substances	FDA UNII substance identifier	FGL3685T2X	UNII	-	-	-	structurallyDiverse	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"FGL3685T2X"}
openFDA substances	FDA UNII substance identifier	FGL3685T2X	UNII	-	-	-	structurallyDiverse	{"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"structurallyDiverse","unii_code":"FGL3685T2X"}