Hydrogen Peroxide NOAEL Studies

COSMOS_DB 9 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
COSMOS_DB	LOAEL	300	ppm	mouse	oral	90 day	Subchronic	PAFA; study report
COSMOS_DB	NOAEL	60	mg/kg bw/day	rat	oral	100 day	Subchronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	100	ppm	mouse	oral	90 day	Subchronic	PAFA; study report
COSMOS_DB	NOAEL	150	mg/kg bw/day	rat	oral	245 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	250	mg/kg bw/day	mouse	oral	756 day	Carcinogenicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	450	mg/kg bw/day	rat	oral	21 day	Short Term Toxicity	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	500	mg/kg bw/day	rat	oral	153 day	Reproductive	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	1000	mg/kg bw/day	mouse	oral	180 day	Chronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study
COSMOS_DB	NOAEL	2500	mg/kg bw/day	rat	oral	146 day	Subchronic	US FDA CFSAN PAFA; US FDA CFSAN PAFA Study

EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=100	mg/kg	Mouse	oral: drinking water	90 days	subchronic	EFSA CEF - 2013 - OutputID 2206 - food consumption - systemic - Scientific Opinion on the safety evaluation of the active substances, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active food contact materials. - doi:10.2903/j.efsa.2013.3153
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx	NOAEL	=100	mg/kg	Mouse	oral: drinking water	90 days	subchronic	EFSA CEF - 2013 - OutputID 2206 - food consumption - systemic - Scientific Opinion on the safety evaluation of the active substances, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active food contact materials. - doi:10.2903/j.efsa.2013.3153

IARC Monographs 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
IARC Monographs	IARC carcinogenicity classification	3	IARC group	-	-	1998	IARC Monographs	{"additional_info":"volume_publication_year=1999","evaluation_year":1998,"source_table":"iarc_classifications","volume":"36, Sup 7, 71"}

NTP_ICE_acute_dermal 3 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_dermal	EPA classification	4	unitless	Rat	Dermal	-	In Vivo; Rat Acute Dermal Toxicity	sheet=Data; excel_row=659; Record_ID=acute_dermal_559; Data_Type=In Vivo; Formulation_ID=MIX552; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=4.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715
NTP_ICE_acute_dermal	GHS classification	5	unitless	Rat	Dermal	-	In Vivo; Rat Acute Dermal Toxicity	sheet=Data; excel_row=660; Record_ID=acute_dermal_559; Data_Type=In Vivo; Formulation_ID=MIX552; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Rat Acute Dermal Toxicity; Endpoint=GHS classification; Response=5.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715
NTP_ICE_acute_dermal	LD50	>5000	mg/kg	Rat	Dermal	-	In Vivo; Rat Acute Dermal Toxicity	sheet=Data; excel_row=658; Record_ID=acute_dermal_559; Data_Type=In Vivo; Formulation_ID=MIX552; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=5000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715

NTP_ICE_acute_inhalation 3 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_inhalation	GHS Classification	4	unitless	-	Inhalation	-	In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity	sheet=Data; excel_row=1334; Record_ID=acute_inhalation_458; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX552; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Rat Acute Inhalation Toxicity; Endpoint=GHS Classification; Response=4; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715
NTP_ICE_acute_inhalation	LC50	2.15	mg/L	-	Inhalation	-	In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity	sheet=Data; excel_row=1337; Record_ID=acute_inhalation_458; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX552; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2.15; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715
NTP_ICE_acute_inhalation	LC50	2	mg/L	-	Inhalation	Duration=4 hr	In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity	sheet=Data; excel_row=1335; Record_ID=acute_inhalation_2774; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID2020715; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=2; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715

NTP_ICE_acute_oral 5 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_acute_oral	EPA classification	=3	Unitless	Rat	oral	acute	Rat Acute Oral Toxicity	Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13220; row=3815; data_type=In Vivo; mixture=Mixture; formulation_id=MIX697; formulation_name=Greenclean 6% Liquid; chemical_name=Hydrogen peroxide; preferred_name=Hydrogen peroxide; percent_active_ingredient=5.34; dtxsid=DTXSID2020715; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	EPA classification	=3	Unitless	Rat (Female)	oral	acute	Rat Acute Oral Toxicity	Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13142; row=3819; data_type=In Vivo; mixture=Mixture; formulation_id=MIX552; formulation_name=Ygiene 206; chemical_name=Hydrogen Peroxide; preferred_name=Hydrogen peroxide; percent_active_ingredient=5.6; dtxsid=DTXSID2020715; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	GHS classification	=4	Unitless	Rat	oral	acute	Rat Acute Oral Toxicity	Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13220; row=3816; data_type=In Vivo; mixture=Mixture; formulation_id=MIX697; formulation_name=Greenclean 6% Liquid; chemical_name=Hydrogen peroxide; preferred_name=Hydrogen peroxide; percent_active_ingredient=5.34; dtxsid=DTXSID2020715; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	GHS classification	=5	Unitless	Rat (Female)	oral	acute	Rat Acute Oral Toxicity	Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13142; row=3817; data_type=In Vivo; mixture=Mixture; formulation_id=MIX552; formulation_name=Ygiene 206; chemical_name=Hydrogen Peroxide; preferred_name=Hydrogen peroxide; percent_active_ingredient=5.6; dtxsid=DTXSID2020715; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715; source_file=acute_oral.xlsx
NTP_ICE_acute_oral	LD50	=3129	mg/kg bw	Rat (Female)	oral	acute	Rat Acute Oral Toxicity	Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13142; row=3818; data_type=In Vivo; mixture=Mixture; formulation_id=MIX552; formulation_name=Ygiene 206; chemical_name=Hydrogen Peroxide; preferred_name=Hydrogen peroxide; percent_active_ingredient=5.6; dtxsid=DTXSID2020715; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715; source_file=acute_oral.xlsx

NTP_ICE_cancer 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_cancer	IARC group	3	unitless	-	-	-	WOE; IARC Carcinogenicity	sheet=Data; excel_row=2448; Record_ID=cancer_3924; Data_Type=WOE; Formulation_Name=Hydrogen peroxide; Mixture=Chemical; DTXSID=DTXSID2020715; Assay=IARC Carcinogenicity; Endpoint=IARC group; Response=3; Response_Unit=Unitless; URL=http://publications.iarc.fr/54; http://publications.iarc.fr/139; http://publications.iarc.fr/89; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715

NTP_ICE_eye_irritation 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_eye_irritation	EPA Classification	1	unitless	Rabbit	Ocular	-	In Vivo; Draize Eye Irritation/Corrosion Test	sheet=Data; excel_row=738; Record_ID=eye_irritation_1205; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID1059; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715

NTP_ICE_skin_irritation 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
NTP_ICE_skin_irritation	EPA classification	3	unitless	Rabbit	Dermal	-	In Vivo; Draize Skin Irritation/Corrosion Test	sheet=Data_invivo; excel_row=518; Record_ID=skin_irritation_invivo_666; Data_Type=In Vivo; Formulation_ID=MIX552; Formulation_Name=Ygiene 206; Percent_Active_Ingredient=5.6; Mixture=Mixture; DTXSID=DTXSID2020715; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2020715

SCCNFP_vision_codex 16 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCNFP_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"de for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S Cosmetic, Toiletry and Fragrance Association (CTFA, 1994) indicated one adverse reaction for every 100,000 units so","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg bw/day	rat	oral	-	repeated dose toxicity	{"dose":"The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day).","effect":"g body weight. The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day). In the safety evaluation below, calculations based on estimated daily exposure is given in bold and calculation based estimated maximum exposure in italic. As indicated in 2.3.11.1. Assessment of human exposure the exposure data are probably to low as they are based on a saliva flow of 0.3 ml/min. The real exposure may thus be closer to the estimated maximum exposure. Acute and repeated dose toxicity NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity (see 3.6) was 30 mg/kg bw/day (Kawasaki et al., 1969) and from a mice study was 26 mg/kg/day (Weiner et al., 1998). In one mice experiment an oral LD50 of 87.2 mg/kg bw with tooth whitener containing 10-22% carbamide peroxide is reported (Woolverton et al., 1993). This corresponds to about 9","page":30,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"de for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S Cosmetic, Toiletry and Fragrance Association (CTFA, 1994) indicated one adverse reaction for every 100,000 units so","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg bw/day	rat	oral	-	repeated dose toxicity	{"dose":"The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day).","effect":"g body weight. The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day). In the safety evaluation below, calculations based on estimated daily exposure is given in bold and calculation based estimated maximum exposure in italic. As indicated in 2.3.11.1. Assessment of human exposure the exposure data are probably to low as they are based on a saliva flow of 0.3 ml/min. The real exposure may thus be closer to the estimated maximum exposure. Acute and repeated dose toxicity NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity (see 3.6) was 30 mg/kg bw/day (Kawasaki et al., 1969) and from a mice study was 26 mg/kg/day (Weiner et al., 1998). In one mice experiment an oral LD50 of 87.2 mg/kg bw with tooth whitener containing 10-22% carbamide peroxide is reported (Woolverton et al., 1993). This corresponds to about 9","page":30,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"de for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S Cosmetic, Toiletry and Fragrance Association (CTFA, 1994) indicated one adverse reaction for every 100,000 units so","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg bw/day	rat	oral	-	repeated dose toxicity	{"dose":"The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day).","effect":"g body weight. The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day). In the safety evaluation below, calculations based on estimated daily exposure is given in bold and calculation based estimated maximum exposure in italic. As indicated in 2.3.11.1. Assessment of human exposure the exposure data are probably to low as they are based on a saliva flow of 0.3 ml/min. The real exposure may thus be closer to the estimated maximum exposure. Acute and repeated dose toxicity NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity (see 3.6) was 30 mg/kg bw/day (Kawasaki et al., 1969) and from a mice study was 26 mg/kg/day (Weiner et al., 1998). In one mice experiment an oral LD50 of 87.2 mg/kg bw with tooth whitener containing 10-22% carbamide peroxide is reported (Woolverton et al., 1993). This corresponds to about 9","page":30,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"de for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S Cosmetic, Toiletry and Fragrance Association (CTFA, 1994) indicated one adverse reaction for every 100,000 units so","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_003"}
SCCNFP_vision_codex	NOAEL	=30	mg/kg bw/day	rat	oral	-	repeated dose toxicity	{"dose":"The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day).","effect":"g body weight. The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day). In the safety evaluation below, calculations based on estimated daily exposure is given in bold and calculation based estimated maximum exposure in italic. As indicated in 2.3.11.1. Assessment of human exposure the exposure data are probably to low as they are based on a saliva flow of 0.3 ml/min. The real exposure may thus be closer to the estimated maximum exposure. Acute and repeated dose toxicity NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity (see 3.6) was 30 mg/kg bw/day (Kawasaki et al., 1969) and from a mice study was 26 mg/kg/day (Weiner et al., 1998). In one mice experiment an oral LD50 of 87.2 mg/kg bw with tooth whitener containing 10-22% carbamide peroxide is reported (Woolverton et al., 1993). This corresponds to about 9","page":30,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_004"}
SCCNFP_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"a, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"a, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"a, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"a, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_002"}
SCCNFP_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976)","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976)","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976)","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_001"}
SCCNFP_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976)","page":11,"pdf":"out180_en.pdf","row_type":"noael_study","study_id":"out180_en_noael_001"}

SCCS_vision_codex 52 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
SCCS_vision_codex	NOAEL	=0.15	%	mouse	oral	Sub-chronic	repeated dose toxicity	{"dose":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels.","effect":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels. Control animals did not exhibit changes. The nasal localisation of the primary injury by peroxide is what can be expected from a water soluble oxidant vapour. As regards pathology in the lungs, the authors of the study considered it unlikely that the effects were treatment related due to the absence of a relationship with exposure concentration and the low incidence, and hence the NOAEL of the study would be 2.9 mg/m3 (CEFIC, 2002) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Oral Hydrogen peroxide Mice Study 1 Mice drinking 0.15% hydrogen peroxide (about 150 mg/kg/day) ad libitum grew normally and developed no visible abnormalities during a 35-week test period (FDA, 1983). Necropsy results show changes in the liver, kidney and stomach and small intestine. Hydrogen peroxide solutions at >1% (> 1 g/kg/day) caused pronounced weight loss and death of mice within 2 weeks (FD","page":19,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_001"}
SCCS_vision_codex	NOAEL	=0.15	%	mouse	oral	Sub-chronic	repeated dose toxicity	{"dose":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels.","effect":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels. Control animals did not exhibit changes. The nasal localisation of the primary injury by peroxide is what can be expected from a water soluble oxidant vapour. As regards pathology in the lungs, the authors of the study considered it unlikely that the effects were treatment related due to the absence of a relationship with exposure concentration and the low incidence, and hence the NOAEL of the study would be 2.9 mg/m3 (CEFIC, 2002) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Oral Hydrogen peroxide Mice Study 1 Mice drinking 0.15% hydrogen peroxide (about 150 mg/kg/day) ad libitum grew normally and developed no visible abnormalities during a 35-week test period (FDA, 1983). Necropsy results show changes in the liver, kidney and stomach and small intestine. Hydrogen peroxide solutions at >1% (> 1 g/kg/day) caused pronounced weight loss and death of mice within 2 weeks (FD","page":19,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_001"}
SCCS_vision_codex	NOAEL	=0.15	%	mouse	oral	Sub-chronic	repeated dose toxicity	{"dose":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels.","effect":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels. Control animals did not exhibit changes. The nasal localisation of the primary injury by peroxide is what can be expected from a water soluble oxidant vapour. As regards pathology in the lungs, the authors of the study considered it unlikely that the effects were treatment related due to the absence of a relationship with exposure concentration and the low incidence, and hence the NOAEL of the study would be 2.9 mg/m3 (CEFIC, 2002) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Oral Hydrogen peroxide Mice Study 1 Mice drinking 0.15% hydrogen peroxide (about 150 mg/kg/day) ad libitum grew normally and developed no visible abnormalities during a 35-week test period (FDA, 1983). Necropsy results show changes in the liver, kidney and stomach and small intestine. Hydrogen peroxide solutions at >1% (> 1 g/kg/day) caused pronounced weight loss and death of mice within 2 weeks (FD","page":19,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_001"}
SCCS_vision_codex	NOAEL	=0.15	%	mouse	oral	Sub-chronic	repeated dose toxicity	{"dose":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels.","effect":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels. Control animals did not exhibit changes. The nasal localisation of the primary injury by peroxide is what can be expected from a water soluble oxidant vapour. As regards pathology in the lungs, the authors of the study considered it unlikely that the effects were treatment related due to the absence of a relationship with exposure concentration and the low incidence, and hence the NOAEL of the study would be 2.9 mg/m3 (CEFIC, 2002) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Oral Hydrogen peroxide Mice Study 1 Mice drinking 0.15% hydrogen peroxide (about 150 mg/kg/day) ad libitum grew normally and developed no visible abnormalities during a 35-week test period (FDA, 1983). Necropsy results show changes in the liver, kidney and stomach and small intestine. Hydrogen peroxide solutions at >1% (> 1 g/kg/day) caused pronounced weight loss and death of mice within 2 weeks (FD","page":19,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_001"}
SCCS_vision_codex	NOAEL	=5	%	mouse	oral	25 weeks	carcinogenicity	{"effect":"ur frequency was 5% in Sencar mice after initiation with the initiator DMBA followed skin painting with hydrogen peroxide for 25 weeks corresponding to about 0.47 mg/cm2/day. The peak exposure in the saliva after teeth bleaching with 5% Whitestrip was 0.1% hydrogen peroxide (Hannig et al., 2003) corresponding to about 5 µg/cm2 which is only about 100 times lower that the concentration inducing a tumour frequency of 5% in the mice skin painting study. Mahony et al (2006) claim that 0.71 and 0.41 mg/cm2 represent a NOEL for tumour promotion in mouse skin and hamster cheek, respectively. Based on an assumed maximal human exposure of 1.5 µg/cm2, they calculated a MOS of 473 and 287 based on the mouse and hamster study, respectively. Based on the results of Klein-Szanto and Slaga (1982) as discussed above, these calculations can be questioned. Munro et al. (2006a,b) are of the opinion that the available genetic toxicity and animal toxicology data do not indicate that hydrogen peroxide poses a carcinogenic risk to the human oral muc","page":34,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_009"}
SCCS_vision_codex	NOAEL	=5	%	mouse	oral	25 weeks	carcinogenicity	{"effect":"ur frequency was 5% in Sencar mice after initiation with the initiator DMBA followed skin painting with hydrogen peroxide for 25 weeks corresponding to about 0.47 mg/cm2/day. The peak exposure in the saliva after teeth bleaching with 5% Whitestrip was 0.1% hydrogen peroxide (Hannig et al., 2003) corresponding to about 5 µg/cm2 which is only about 100 times lower that the concentration inducing a tumour frequency of 5% in the mice skin painting study. Mahony et al (2006) claim that 0.71 and 0.41 mg/cm2 represent a NOEL for tumour promotion in mouse skin and hamster cheek, respectively. Based on an assumed maximal human exposure of 1.5 µg/cm2, they calculated a MOS of 473 and 287 based on the mouse and hamster study, respectively. Based on the results of Klein-Szanto and Slaga (1982) as discussed above, these calculations can be questioned. Munro et al. (2006a,b) are of the opinion that the available genetic toxicity and animal toxicology data do not indicate that hydrogen peroxide poses a carcinogenic risk to the human oral muc","page":34,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_009"}
SCCS_vision_codex	NOAEL	=5	%	mouse	oral	25 weeks	carcinogenicity	{"effect":"ur frequency was 5% in Sencar mice after initiation with the initiator DMBA followed skin painting with hydrogen peroxide for 25 weeks corresponding to about 0.47 mg/cm2/day. The peak exposure in the saliva after teeth bleaching with 5% Whitestrip was 0.1% hydrogen peroxide (Hannig et al., 2003) corresponding to about 5 µg/cm2 which is only about 100 times lower that the concentration inducing a tumour frequency of 5% in the mice skin painting study. Mahony et al (2006) claim that 0.71 and 0.41 mg/cm2 represent a NOEL for tumour promotion in mouse skin and hamster cheek, respectively. Based on an assumed maximal human exposure of 1.5 µg/cm2, they calculated a MOS of 473 and 287 based on the mouse and hamster study, respectively. Based on the results of Klein-Szanto and Slaga (1982) as discussed above, these calculations can be questioned. Munro et al. (2006a,b) are of the opinion that the available genetic toxicity and animal toxicology data do not indicate that hydrogen peroxide poses a carcinogenic risk to the human oral muc","page":34,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_009"}
SCCS_vision_codex	NOAEL	=5	%	mouse	oral	25 weeks	carcinogenicity	{"effect":"ur frequency was 5% in Sencar mice after initiation with the initiator DMBA followed skin painting with hydrogen peroxide for 25 weeks corresponding to about 0.47 mg/cm2/day. The peak exposure in the saliva after teeth bleaching with 5% Whitestrip was 0.1% hydrogen peroxide (Hannig et al., 2003) corresponding to about 5 µg/cm2 which is only about 100 times lower that the concentration inducing a tumour frequency of 5% in the mice skin painting study. Mahony et al (2006) claim that 0.71 and 0.41 mg/cm2 represent a NOEL for tumour promotion in mouse skin and hamster cheek, respectively. Based on an assumed maximal human exposure of 1.5 µg/cm2, they calculated a MOS of 473 and 287 based on the mouse and hamster study, respectively. Based on the results of Klein-Szanto and Slaga (1982) as discussed above, these calculations can be questioned. Munro et al. (2006a,b) are of the opinion that the available genetic toxicity and animal toxicology data do not indicate that hydrogen peroxide poses a carcinogenic risk to the human oral muc","page":34,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_009"}
SCCS_vision_codex	NOAEL	=20	mg/kg bw/day	rat	oral	100 days	NOAEL study	{"dose":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day.","effect":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase was significantly decreased at the termination on day 100 in the 30 and 60 mg/kg bw/day dose groups. Thus, NOAEL was 20 mg/kg bw/day. Study 3 Groups of 10 male and female F344 rats were given 0, 0.15, 0.3, 0.6, 1.2, or 2.4% hydrogen peroxide in drinking water for 10 weeks (Takayama, 1980). Prominent weight losses and nasal bleeding were noted in the rats on the 2.4% solution starting immediately after initiation of the treatment. Also in the 1.2 and 0.6% dose groups, weight losses were noted from an early stage of hydrogen peroxide treatment. Regarding body weight gain, a gain rate of 66.1% was achieved in the male controls","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_004"}
SCCS_vision_codex	NOAEL	=20	mg/kg bw/day	rat	oral	100 days	NOAEL study	{"dose":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day.","effect":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase was significantly decreased at the termination on day 100 in the 30 and 60 mg/kg bw/day dose groups. Thus, NOAEL was 20 mg/kg bw/day. Study 3 Groups of 10 male and female F344 rats were given 0, 0.15, 0.3, 0.6, 1.2, or 2.4% hydrogen peroxide in drinking water for 10 weeks (Takayama, 1980). Prominent weight losses and nasal bleeding were noted in the rats on the 2.4% solution starting immediately after initiation of the treatment. Also in the 1.2 and 0.6% dose groups, weight losses were noted from an early stage of hydrogen peroxide treatment. Regarding body weight gain, a gain rate of 66.1% was achieved in the male controls","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_004"}
SCCS_vision_codex	NOAEL	=20	mg/kg bw/day	rat	oral	100 days	NOAEL study	{"dose":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day.","effect":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase was significantly decreased at the termination on day 100 in the 30 and 60 mg/kg bw/day dose groups. Thus, NOAEL was 20 mg/kg bw/day. Study 3 Groups of 10 male and female F344 rats were given 0, 0.15, 0.3, 0.6, 1.2, or 2.4% hydrogen peroxide in drinking water for 10 weeks (Takayama, 1980). Prominent weight losses and nasal bleeding were noted in the rats on the 2.4% solution starting immediately after initiation of the treatment. Also in the 1.2 and 0.6% dose groups, weight losses were noted from an early stage of hydrogen peroxide treatment. Regarding body weight gain, a gain rate of 66.1% was achieved in the male controls","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_004"}
SCCS_vision_codex	NOAEL	=20	mg/kg bw/day	rat	oral	100 days	NOAEL study	{"dose":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day.","effect":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase was significantly decreased at the termination on day 100 in the 30 and 60 mg/kg bw/day dose groups. Thus, NOAEL was 20 mg/kg bw/day. Study 3 Groups of 10 male and female F344 rats were given 0, 0.15, 0.3, 0.6, 1.2, or 2.4% hydrogen peroxide in drinking water for 10 weeks (Takayama, 1980). Prominent weight losses and nasal bleeding were noted in the rats on the 2.4% solution starting immediately after initiation of the treatment. Also in the 1.2 and 0.6% dose groups, weight losses were noted from an early stage of hydrogen peroxide treatment. Regarding body weight gain, a gain rate of 66.1% was achieved in the male controls","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_004"}
SCCS_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"ales and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes et al. (1993) reported discoloration of the mucosal surfaces and the tongue following 5 weeks of rinsing 4 times dai","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_003"}
SCCS_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"ales and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes et al. (1993) reported discoloration of the mucosal surfaces and the tongue following 5 weeks of rinsing 4 times dai","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_003"}
SCCS_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"ales and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes et al. (1993) reported discoloration of the mucosal surfaces and the tongue following 5 weeks of rinsing 4 times dai","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_003"}
SCCS_vision_codex	NOAEL	=30	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"ales and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes et al. (1993) reported discoloration of the mucosal surfaces and the tongue following 5 weeks of rinsing 4 times dai","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_003"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_002"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"n food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). Study 2 In another Wistar rat study (Kawasaki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase w","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_003"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_002"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_002"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"n food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). Study 2 In another Wistar rat study (Kawasaki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase w","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_003"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"n food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). Study 2 In another Wistar rat study (Kawasaki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase w","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_003"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 weeks	NOAEL study	{"dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","effect":"reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_002"}
SCCS_vision_codex	NOAEL	=56.2	mg/kg/day	rat	oral	6 days	NOAEL study	{"dose":"Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","effect":"n food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). Study 2 In another Wistar rat study (Kawasaki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase w","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_003"}
SCCS_vision_codex	NOAEL	=86	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7).","effect":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7). The losses in weight of tissues other than the brain in the top dose males roughly corresponded to the body weight loss, the same applied for females. In view of the apparent effect on the weight gain even at the lowest dose level, no NOAEL can be determined. Conclusion A LOAEL can be calculated to 75 and 86 mg/kg bw/day for male and female rats, respectively.","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_005"}
SCCS_vision_codex	NOAEL	=86	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7).","effect":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7). The losses in weight of tissues other than the brain in the top dose males roughly corresponded to the body weight loss, the same applied for females. In view of the apparent effect on the weight gain even at the lowest dose level, no NOAEL can be determined. Conclusion A LOAEL can be calculated to 75 and 86 mg/kg bw/day for male and female rats, respectively.","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_005"}
SCCS_vision_codex	NOAEL	=86	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7).","effect":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7). The losses in weight of tissues other than the brain in the top dose males roughly corresponded to the body weight loss, the same applied for females. In view of the apparent effect on the weight gain even at the lowest dose level, no NOAEL can be determined. Conclusion A LOAEL can be calculated to 75 and 86 mg/kg bw/day for male and female rats, respectively.","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_005"}
SCCS_vision_codex	NOAEL	=86	mg/kg bw/day	rat	-	-	NOAEL study	{"dose":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7).","effect":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7). The losses in weight of tissues other than the brain in the top dose males roughly corresponded to the body weight loss, the same applied for females. In view of the apparent effect on the weight gain even at the lowest dose level, no NOAEL can be determined. Conclusion A LOAEL can be calculated to 75 and 86 mg/kg bw/day for male and female rats, respectively.","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_005"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al.","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_001"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	6 days	NOAEL study	{"dose":"One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings).","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 20 Mortality: There were no treatment-related deaths. One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings). After the recovery period no hyperplasia was observed in any dose group. Conclusion NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively, based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weig","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_002"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/d	-	-	-	NOAEL study	{"dose":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d).","effect":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d). The reduced body weight gain of the dams is partly (in later stages of pregnancy) due to reduced weights of the litters, due to reduced foetal weights and increased number of resorptions. No significant differences for the different doses and no clear dose response are found for the weight gain of the dams from day 20 except for gravid uterine weight. As maternal toxicity was apparent also in earlier times of the pregnancy the NOAEL for maternal toxicity is 100 mg/kg bw/d. At 100 mg/kg bw/d six externally malformed foetuses with ablepharia, acrania, exencephaly, macroglossia, cleft palate, cleft lip and facial cleft were found. The increase compared to controls was statistically significant. The authors of the study considered this finding incidental, since these kinds of malformations were only present in 2 litters and not at the higher dosages. Historical control data for the years 1993-1999 (Instituto di Ricerche Biomediche, 2000) showed,","page":92,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_020"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al.","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_001"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al.","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_001"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	6 days	NOAEL study	{"dose":"One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings).","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 20 Mortality: There were no treatment-related deaths. One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings). After the recovery period no hyperplasia was observed in any dose group. Conclusion NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively, based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weig","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_002"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/d	-	-	-	NOAEL study	{"dose":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d).","effect":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d). The reduced body weight gain of the dams is partly (in later stages of pregnancy) due to reduced weights of the litters, due to reduced foetal weights and increased number of resorptions. No significant differences for the different doses and no clear dose response are found for the weight gain of the dams from day 20 except for gravid uterine weight. As maternal toxicity was apparent also in earlier times of the pregnancy the NOAEL for maternal toxicity is 100 mg/kg bw/d. At 100 mg/kg bw/d six externally malformed foetuses with ablepharia, acrania, exencephaly, macroglossia, cleft palate, cleft lip and facial cleft were found. The increase compared to controls was statistically significant. The authors of the study considered this finding incidental, since these kinds of malformations were only present in 2 litters and not at the higher dosages. Historical control data for the years 1993-1999 (Instituto di Ricerche Biomediche, 2000) showed,","page":92,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_020"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	6 days	NOAEL study	{"dose":"One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings).","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 20 Mortality: There were no treatment-related deaths. One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings). After the recovery period no hyperplasia was observed in any dose group. Conclusion NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively, based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weig","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_002"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/d	-	-	-	NOAEL study	{"dose":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d).","effect":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d). The reduced body weight gain of the dams is partly (in later stages of pregnancy) due to reduced weights of the litters, due to reduced foetal weights and increased number of resorptions. No significant differences for the different doses and no clear dose response are found for the weight gain of the dams from day 20 except for gravid uterine weight. As maternal toxicity was apparent also in earlier times of the pregnancy the NOAEL for maternal toxicity is 100 mg/kg bw/d. At 100 mg/kg bw/d six externally malformed foetuses with ablepharia, acrania, exencephaly, macroglossia, cleft palate, cleft lip and facial cleft were found. The increase compared to controls was statistically significant. The authors of the study considered this finding incidental, since these kinds of malformations were only present in 2 litters and not at the higher dosages. Historical control data for the years 1993-1999 (Instituto di Ricerche Biomediche, 2000) showed,","page":92,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_020"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	2 weeks	NOAEL study	{"dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al.","page":11,"pdf":"sccp_o_022.pdf","row_type":"noael_study","study_id":"sccp_o_022_noael_001"}
SCCS_vision_codex	NOAEL	=100	ppm	rat	oral	6 days	NOAEL study	{"dose":"One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings).","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 20 Mortality: There were no treatment-related deaths. One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings). After the recovery period no hyperplasia was observed in any dose group. Conclusion NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively, based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weig","page":20,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_002"}
SCCS_vision_codex	NOAEL	=100	mg/kg bw/d	-	-	-	NOAEL study	{"dose":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d).","effect":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d). The reduced body weight gain of the dams is partly (in later stages of pregnancy) due to reduced weights of the litters, due to reduced foetal weights and increased number of resorptions. No significant differences for the different doses and no clear dose response are found for the weight gain of the dams from day 20 except for gravid uterine weight. As maternal toxicity was apparent also in earlier times of the pregnancy the NOAEL for maternal toxicity is 100 mg/kg bw/d. At 100 mg/kg bw/d six externally malformed foetuses with ablepharia, acrania, exencephaly, macroglossia, cleft palate, cleft lip and facial cleft were found. The increase compared to controls was statistically significant. The authors of the study considered this finding incidental, since these kinds of malformations were only present in 2 litters and not at the higher dosages. Historical control data for the years 1993-1999 (Instituto di Ricerche Biomediche, 2000) showed,","page":92,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_020"}
SCCS_vision_codex	NOAEL	=200	mg/kg bw/d	rabbit	dermal	6 days	NOAEL study	{"citation":"Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available","dose":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.","effect":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965; 1966a) or 50 mg/kg bw/d as 2.5% solution on the intact skin for 13 weeks (Procter & Gamble, 1966b). In both studies there were no statistically significant differences compared to controls in growth, organ/body","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_018"}
SCCS_vision_codex	NOAEL	=200	mg/kg bw/d	rabbit	dermal	6 days	NOAEL study	{"citation":"Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available","dose":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.","effect":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965; 1966a) or 50 mg/kg bw/d as 2.5% solution on the intact skin for 13 weeks (Procter & Gamble, 1966b). In both studies there were no statistically significant differences compared to controls in growth, organ/body","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_018"}
SCCS_vision_codex	NOAEL	=200	mg/kg bw/d	rabbit	dermal	6 days	NOAEL study	{"citation":"Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available","dose":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.","effect":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965; 1966a) or 50 mg/kg bw/d as 2.5% solution on the intact skin for 13 weeks (Procter & Gamble, 1966b). In both studies there were no statistically significant differences compared to controls in growth, organ/body","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_018"}
SCCS_vision_codex	NOAEL	=200	mg/kg bw/d	rabbit	dermal	6 days	NOAEL study	{"citation":"Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available","dose":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.","effect":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965; 1966a) or 50 mg/kg bw/d as 2.5% solution on the intact skin for 13 weeks (Procter & Gamble, 1966b). In both studies there were no statistically significant differences compared to controls in growth, organ/body","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_018"}
SCCS_vision_codex	NOAEL	=1000	mg/kg bw/d	-	oral	8 days	NOAEL study	{"dose":"In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.","effect":"number of platelets was statistically significantly increased. The spleen size and spleenic parenchyma were reduced. In contrast in the Dufour-study, (with 8 days duration instead of 28 days in the Degussa study) no changes in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of paramete","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_015"}
SCCS_vision_codex	NOAEL	=1000	mg/kg bw/d	-	oral	8 days	NOAEL study	{"dose":"In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.","effect":"number of platelets was statistically significantly increased. The spleen size and spleenic parenchyma were reduced. In contrast in the Dufour-study, (with 8 days duration instead of 28 days in the Degussa study) no changes in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of paramete","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_015"}
SCCS_vision_codex	NOAEL	=1000	mg/kg bw/d	-	oral	8 days	NOAEL study	{"dose":"In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.","effect":"number of platelets was statistically significantly increased. The spleen size and spleenic parenchyma were reduced. In contrast in the Dufour-study, (with 8 days duration instead of 28 days in the Degussa study) no changes in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of paramete","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_015"}
SCCS_vision_codex	NOAEL	=1000	mg/kg bw/d	-	oral	8 days	NOAEL study	{"dose":"In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.","effect":"number of platelets was statistically significantly increased. The spleen size and spleenic parenchyma were reduced. In contrast in the Dufour-study, (with 8 days duration instead of 28 days in the Degussa study) no changes in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of paramete","page":90,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_015"}
SCCS_vision_codex	NOAEL	=1129	-	human	oral	developmental	reproductive toxicity	{"citation":"Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2","dose":"This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found.","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe","page":93,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_023"}
SCCS_vision_codex	NOAEL	=1129	-	human	oral	developmental	reproductive toxicity	{"citation":"Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2","dose":"This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found.","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe","page":93,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_023"}
SCCS_vision_codex	NOAEL	=1129	-	human	oral	developmental	reproductive toxicity	{"citation":"Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2","dose":"This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found.","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe","page":93,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_023"}
SCCS_vision_codex	NOAEL	=1129	-	human	oral	developmental	reproductive toxicity	{"citation":"Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2","dose":"This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found.","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe","page":93,"pdf":"sccp_o_122.pdf","row_type":"noael_study","study_id":"sccp_o_122_noael_023"}

ToxValDB_ECHA_IUCLID 12 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECHA_IUCLID	LEL	=50	mg/kg bw/day	Rat	injection	-	acute	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61c78e4b096bca8772185; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/3/5?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15815453:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_719d7178e31c6e840123e84eea436f19
ToxValDB_ECHA_IUCLID	LEL	=170	mg/m3	Rat	inhalation	-	acute	GUIDELINE=OECD Guideline 403 (Acute Inhalation Toxicity); QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/3/3?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15798639:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5c7c773a5ca1a6f49c1b1b0edc82538f
ToxValDB_ECHA_IUCLID	LEL	=2000	mg/m3	Rat	inhalation	-	acute	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059759e4b063812d6fa6de; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/3/3?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15798260:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_201ccccf64bcbffec9710cd8cab9ae98
ToxValDB_ECHA_IUCLID	LOAEL	=0.005	mg/kg bw/day	Rat	oral	chronic; 6 months	chronic	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c62039e4b096bca878081b; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/5?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15852188:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ee5841a3d358e6e080294b637a3bd939
ToxValDB_ECHA_IUCLID	LOAEL	=9.73821	mg/m3	Dog	inhalation	chronic; 6 months	chronic	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61fd3e4b096bca877efdf; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/3?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15827092:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c360a44eeb20cd3d0f5d99cf6751e01b
ToxValDB_ECHA_IUCLID	LOAEL	=14.6	mg/m3	Rat	inhalation	short-term; 28 days	short-term	QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/3?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15828181_15828182:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_af0549535ba922dbc0ef2301108f3bb4
ToxValDB_ECHA_IUCLID	LOAEL	=30	mg/kg bw/day	Rat	oral	chronic; 100 days	chronic	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620ace4b096bca878252d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/5?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15853857:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c405da4a940dcbae205f5d66bf139af1
ToxValDB_ECHA_IUCLID	LOAEL	=3000	ppm	Mouse	oral	short-term; 14 days	short-term	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbd8e4b0a7c65d227c52; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/2?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15837997_15837998:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5b05126fade684d61b15cf125ba13494
ToxValDB_ECHA_IUCLID	NOAEL	=2.9	mg/m3	Rat	inhalation	short-term; 28 days	short-term	QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/3?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Inhalation_15828181_15828182:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_409ccd1066404231094c12e40371d4e5
ToxValDB_ECHA_IUCLID	NOAEL	=9.8495	mg/m3	Rat	inhalation	subchronic; 90 days	subchronic	QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66059786e4b063812d6fa765; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/3?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15828672:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2d28b5005651b1455e6c7a309c89f882
ToxValDB_ECHA_IUCLID	NOAEL	=1000	ppm	Mouse	oral	short-term; 14 days	short-term	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cbd8e4b0a7c65d227c52; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/2?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15837997_15837998:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_77442d78fec605843fcfd50fde07b0b5
ToxValDB_ECHA_IUCLID	NOEL	=26.5	mg/kg bw/day	Mouse	oral	subchronic; 90 days	subchronic	QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaef0e4b0a7c65d1cbc84; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23353/7/6/2?documentUUID=040873e4-bba7-4c88-a533-e017ef8f65ba; STUDY_GROUP=ECHA IUCLID:15834924:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_36d27e9b3fe8930ea6fa04aac3fc943d

ToxValDB_ECOTOX 9 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_ECOTOX	LOEL	=0.0294	mmol	European Rabbit	environmental	subchronic; 35 days	subchronic	LONG_REF=Toxicol. Pathol.29(3): 308-319 Maurer,J.K., A. Molai, R.D. Parker, L. Li, G.J. Carr, W.M. Petroll, H.D. Cavanagh, and J.V. Jester Pathology of Ocular Irritation with Bleaching Agents in the Rabbit Low-Volume Eye Test 2001; TITLE=Pathology of Ocular Irritation with Bleaching Agents in the Rabbit Low-Volume Eye Test; AUTHOR=Maurer,J.K., A. Molai, R.D. Parker, L. Li, G.J. Carr, W.M. Petroll, H.D. Cavanagh, and J.V. Jester; DOI=10.1080/019262301316905264; QUALITY=Control type: Multiple control types; EXTERNAL_SOURCE_ID=97956; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2001; ORIGINAL_YEAR=2001; TOXICOLOGICAL_EFFECT=Cell(s): Area; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECOTOX:15595728:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=08d8c1cbfecabe4b8c14149916a40469
ToxValDB_ECOTOX	LOEL	=0.0441	mmol	European Rabbit	environmental	acute; 1 days	acute	LONG_REF=Toxicol. Pathol.29(3): 308-319 Maurer,J.K., A. Molai, R.D. Parker, L. Li, G.J. Carr, W.M. Petroll, H.D. Cavanagh, and J.V. Jester Pathology of Ocular Irritation with Bleaching Agents in the Rabbit Low-Volume Eye Test 2001; TITLE=Pathology of Ocular Irritation with Bleaching Agents in the Rabbit Low-Volume Eye Test; AUTHOR=Maurer,J.K., A. Molai, R.D. Parker, L. Li, G.J. Carr, W.M. Petroll, H.D. Cavanagh, and J.V. Jester; DOI=10.1080/019262301316905264; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=97956; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2001; ORIGINAL_YEAR=2001; TOXICOLOGICAL_EFFECT=Cell(s): Area; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECOTOX_dup_EPA ORD_15601834_15601835:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d324d333f8d2a29142dc3884b6ff07ff
ToxValDB_ECOTOX	LOEL	=0.6	mM	Dog	injection	acute; 0.0417 days	acute	LONG_REF=Am. J. Physiol. Heart Circ. Physiol.275(4, Pt. 2): H1434 - H1440 Thompson,G.W., M. Horackova, and J.A. Armour Sensitivity of Canine Intrinsic Cardiac Neurons to H2O2 and Hydroxyl Radical 1998; TITLE=Sensitivity of Canine Intrinsic Cardiac Neurons to H2O2 and Hydroxyl Radical; AUTHOR=Thompson,G.W., M. Horackova, and J.A. Armour; DOI=10.1152/ajpheart.1998.275.4.H1434; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=108016; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=Physiology: Neuroresponse; STUDY_GROUP=ECOTOX:15600435:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=e623a2407a824a3e407bb7c8ad7bc35b
ToxValDB_ECOTOX	LOEL	=100	mM	Rat	oral	short-term; 14 days	short-term	LONG_REF=Toxicology227(3): 248-261 Sato,T., H. Yamamoto, N. Sawada, K. Nashiki, M. Tsuji, K. Muto, H. Kume, H. Sasaki, H. Arai, T. Nikawa, Y. Taketani, an Restraint Stress Alters the Duodenal Expression of Genes Important for Lipid Metabolism in Rat 2006; TITLE=Restraint Stress Alters the Duodenal Expression of Genes Important for Lipid Metabolism in Rat; AUTHOR=Sato,T., H. Yamamoto, N. Sawada, K. Nashiki, M. Tsuji, K. Muto, H. Kume, H. Sasaki, H. Arai, T. Nikawa, Y. Taketani, an; DOI=10.1016/j.tox.2006.08.009; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=96157; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2006; ORIGINAL_YEAR=2006; TOXICOLOGICAL_EFFECT=Genetics: Cyp1A1 mRNA; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15607422:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=868c859d6962da1abb38071b57b251cf
ToxValDB_ECOTOX	LOEL	=300	mg/L	Mouse	oral	chronic; 91 days	chronic	LONG_REF=Food Chem. Toxicol.38(7): 607-615 Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier 13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice 2000; TITLE=13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice; AUTHOR=Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier; DOI=10.1016/s0278-6915(00)00048-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=57046; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=Histology: Hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECOTOX_dup_EPA ORD_15610631_15610656:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=f77a160577e7cb0f13d825458e5cc014
ToxValDB_ECOTOX	NOEL	=0.03	mmol	Rat	injection	acute; 0.0208 days	acute	LONG_REF=J. Clin. Invest.88(6): 1886-1893 Salahudeen,A.K., E.C. Clark, and K.A. Nath Hydrogen Peroxide-Induced Renal Injury. A Protective Role for Pyruvate In Vitro and In Vivo 1991; TITLE=Hydrogen Peroxide-Induced Renal Injury. A Protective Role for Pyruvate In Vitro and In Vivo; AUTHOR=Salahudeen,A.K., E.C. Clark, and K.A. Nath; DOI=10.1172/JCI115511; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=107749; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT=Immunological: Proteuria; STUDY_GROUP=ECOTOX_dup_EPA ORD_15606506_15610614:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d36b25e76b8c7ac5f3a0f7e015436afa
ToxValDB_ECOTOX	NOEL	=100	mg/L	Mouse	oral	chronic; 91 days	chronic	LONG_REF=Food Chem. Toxicol.38(7): 607-615 Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier 13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice 2000; TITLE=13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice; AUTHOR=Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier; DOI=10.1016/s0278-6915(00)00048-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=57046; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=Histology: Hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECOTOX_dup_EPA ORD_15610631_15610656:M/F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=9d61f0df4a251bb816c40ba046cde30c
ToxValDB_ECOTOX	NOEL	=1000	mg/L	Mouse	oral	chronic; 91 days	chronic	LONG_REF=Food Chem. Toxicol.38(7): 607-615 Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier 13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice 2000; TITLE=13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice; AUTHOR=Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier; DOI=10.1016/s0278-6915(00)00048-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=57046; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=Biochemistry: Protein, total|Growth: Weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|urinalysis; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595918_15597786_15597787:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=11f2c9826f6a0ded6ff8d75f03dc0297
ToxValDB_ECOTOX	NOEL	=3000	mg/L	Mouse	oral	chronic; 91 days	chronic	LONG_REF=Food Chem. Toxicol.38(7): 607-615 Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier 13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice 2000; TITLE=13-Week Drinking Water Toxicity Study of Hydrogen Peroxide with 6-Week Recovery Period in Catalase-Deficient Mice; AUTHOR=Weiner,M.L., C. Freeman, H. Trochimowicz, J. De Gerlache, S. Jacobi, G. Malinverno, W. Mayr, and J.F. Regnier; DOI=10.1016/s0278-6915(00)00048-x; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=57046; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=2000; ORIGINAL_YEAR=2000; TOXICOLOGICAL_EFFECT=Morphology: Organ weight in relationship to body weight; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECOTOX_dup_EPA ORD_15595918_15597786_15597787:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d39348e5cad48a4bbd723a3b544c483b

ToxValDB_EFSA 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_EFSA	NOAEL	=100	mg/kg bw/day	Mouse	oral	subchronic; 90 days	subchronic	LONG_REF=EFSA CEF (2013). Scientific Opinion on the safety evaluation of the active substances, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active food contact materials. doi:10.2903/j.efsa.2013.3153.; TITLE=Scientific Opinion on the safety evaluation of the active substances, sodium carbonate peroxyhydrate coated with sodium carbonate and sodium silicate, bentonite, sodium chloride, sodium carbonate for use in active food contact materials.; AUTHOR=EFSA CEF; DOI=doi:10.2903/j.efsa.2013.3153; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2013; ORIGINAL_YEAR=2013; TOXICOLOGICAL_EFFECT=food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption; STUDY_GROUP=EFSA:15614451:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c34a529f6308812813c796f45f97255f

ToxValDB_GESTIS_DNEL 1 endpoint

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
ToxValDB_GESTIS_DNEL	DNEL local	=1.4	mg/m3	Human	inhalation	-	Toxicity Value	STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15632649:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4d292fe300247cc97b8a00536cb71817

UnifiedCodex:SCCNFP:beta.noael_studies 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCNFP:beta.noael_studies	-	30	mg/kg/day	rat	oral	6 days	-	SOURCE_SUBDIR=out180_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HYDROGEN (CARBAMIDE, ZINC) PEROXIDE IN TOOTH BLEACHING / WHITENING PRODUCTS; OPINION_NUMBER=SCCNFP/0602/02; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=30; DOSE=When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.; EFFECT=de for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S Cosmetic, Toiletry and Fragrance Association (CTFA, 1994) indicated one adverse reaction for every 100,000 units so; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","duration":"6 days","effect":"de for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S Cosmetic, Toiletry and Fragrance Association (CTFA, 1994) indicated one adverse reaction for every 100,000 units so","endpoint":"","ingredient":"s and molecular weights","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":11,"route":"oral","species":"rat","study_id":"out180_en_noael_003"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	56.2	mg/kg/day	rat	oral	6 weeks	-	SOURCE_SUBDIR=out180_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HYDROGEN (CARBAMIDE, ZINC) PEROXIDE IN TOOTH BLEACHING / WHITENING PRODUCTS; OPINION_NUMBER=SCCNFP/0602/02; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=56.2; DOSE=The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).; EFFECT=a, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","duration":"6 weeks","effect":"a, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans are exposed to hydrogen peroxide (0.75%) in dentifrice products, as commercially available tooth pastes. Monitoring of adverse reactions by the U.S","endpoint":"","ingredient":"s and molecular weights","loael_value":"","noael_unit":"mg/kg/day","noael_value":"56.2","page":11,"route":"oral","species":"rat","study_id":"out180_en_noael_002"}
UnifiedCodex:SCCNFP:beta.noael_studies	-	100	ppm	rat	oral	2 weeks	-	SOURCE_SUBDIR=out180_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HYDROGEN (CARBAMIDE, ZINC) PEROXIDE IN TOOTH BLEACHING / WHITENING PRODUCTS; OPINION_NUMBER=SCCNFP/0602/02; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=100; DOSE=Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.; EFFECT=loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976); CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","duration":"2 weeks","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principle organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976)","endpoint":"","ingredient":"s and molecular weights","loael_value":"","noael_unit":"ppm","noael_value":"100","page":11,"route":"oral","species":"rat","study_id":"out180_en_noael_001"}
UnifiedCodex:SCCNFP:beta.noael_studies	repeated dose toxicity	30	mg/kg bw/day	rat	oral	-	repeated dose toxicity	SOURCE_SUBDIR=out180_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING HYDROGEN (CARBAMIDE, ZINC) PEROXIDE IN TOOTH BLEACHING / WHITENING PRODUCTS; OPINION_NUMBER=SCCNFP/0602/02; COMMITTEE=SCCNFP; REPORT_DATE=17 September 2002; VALUE_TEXT=30; DOSE=The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day).; EFFECT=g body weight. The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day). In the safety evaluation below, calculations based on estimated daily exposure is given in bold and calculation based estimated maximum exposure in italic. As indicated in 2.3.11.1. Assessment of human exposure the exposure data are probably to low as they are based on a saliva flow of 0.3 ml/min. The real exposure may thus be closer to the estimated maximum exposure. Acute and repeated dose toxicity NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity (see 3.6) was 30 mg/kg bw/day (Kawasaki et al., 1969) and from a mice study was 26 mg/kg/day (Weiner et al., 1998). In one mice experiment an oral LD50 of 87.2 mg/kg bw with tooth whitener containing 10-22% carbamide peroxide is reported (Woolverton et al., 1993). This corresponds to about 9; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day).","duration":"","effect":"g body weight. The maximum exposure (mean + 2xSD) has been estimated to be about 2.5 times higher (0.17 mg/kg/day). In the safety evaluation below, calculations based on estimated daily exposure is given in bold and calculation based estimated maximum exposure in italic. As indicated in 2.3.11.1. Assessment of human exposure the exposure data are probably to low as they are based on a saliva flow of 0.3 ml/min. The real exposure may thus be closer to the estimated maximum exposure. Acute and repeated dose toxicity NOAEL of hydrogen peroxide from a rat study (repeated dose oral toxicity (see 3.6) was 30 mg/kg bw/day (Kawasaki et al., 1969) and from a mice study was 26 mg/kg/day (Weiner et al., 1998). In one mice experiment an oral LD50 of 87.2 mg/kg bw with tooth whitener containing 10-22% carbamide peroxide is reported (Woolverton et al., 1993). This corresponds to about 9","endpoint":"repeated dose toxicity","ingredient":"s and molecular weights","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"30","page":30,"route":"oral","species":"rat","study_id":"out180_en_noael_004"}

UnifiedCodex:SCCS_SHADOW:beta.noael_studies 28 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	20	mg/kg bw/day	rat	oral	100 days	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day.; EFFECT=ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase was significantly decreased at the termination on day 100 in the 30 and 60 mg/kg bw/day dose groups. Thus, NOAEL was 20 mg/kg bw/day. Study 3 Groups of 10 male and female F344 rats were given 0, 0.15, 0.3, 0.6, 1.2, or 2.4% hydrogen peroxide in drinking water for 10 weeks (Takayama, 1980). Prominent weight losses and nasal bleeding were noted in the rats on the 2.4% solution starting immediately after initiation of the treatment. Also in the 1.2 and 0.6% dose groups, weight losses were noted from an early stage of hydrogen peroxide treatment. Regarding body weight gain, a gain rate of 66.1% was achieved in the male controls; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day.","duration":"100 days","effect":"ki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase was significantly decreased at the termination on day 100 in the 30 and 60 mg/kg bw/day dose groups. Thus, NOAEL was 20 mg/kg bw/day. Study 3 Groups of 10 male and female F344 rats were given 0, 0.15, 0.3, 0.6, 1.2, or 2.4% hydrogen peroxide in drinking water for 10 weeks (Takayama, 1980). Prominent weight losses and nasal bleeding were noted in the rats on the 2.4% solution starting immediately after initiation of the treatment. Also in the 1.2 and 0.6% dose groups, weight losses were noted from an early stage of hydrogen peroxide treatment. Regarding body weight gain, a gain rate of 66.1% was achieved in the male controls","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":20,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_004"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	30	mg/kg/day	rat	oral	6 days	-	SOURCE_SUBDIR=sccp_o_022; REPORT_TITLE=Opinion on Hydrogen Peroxide in Tooth Whitening Products; OPINION_NUMBER=SCCP/0844/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=30; DOSE=Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.; EFFECT=ales and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes et al. (1993) reported discoloration of the mucosal surfaces and the tongue following 5 weeks of rinsing 4 times dai; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","duration":"6 days","effect":"ales and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes et al. (1993) reported discoloration of the mucosal surfaces and the tongue following 5 weeks of rinsing 4 times dai","endpoint":"","ingredient":"Hydrogen peroxide, dihydrogen dioxide, hydrogen dioxide, hydrogen oxide, oxydol, peroxide.","loael_value":"","noael_unit":"mg/kg/day","noael_value":"30","page":11,"route":"oral","species":"rat","study_id":"sccp_o_022_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	56.2	mg/kg/day	rat	oral	6 weeks	-	SOURCE_SUBDIR=sccp_o_022; REPORT_TITLE=Opinion on Hydrogen Peroxide in Tooth Whitening Products; OPINION_NUMBER=SCCP/0844/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=56.2; DOSE=The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).; EFFECT=reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998).","duration":"6 weeks","effect":"reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). In another rat study (Kawasaki et al., 1969) the NOAEL of hydrogen peroxide was 30 mg/kg/day, when the animals were treated by oral gastric tubing daily for 100 days. The same study showed no adverse effect in rats receiving a diet containing 6 mg hydrogen peroxide in 20 g of food (about 12 mg/kg/day). Humans Several studies have reported the use of 0.75 or 1.5% hydrogen peroxides as a mouthwash or mouth rinse for periods of up to three months. Tombes","endpoint":"","ingredient":"Hydrogen peroxide, dihydrogen dioxide, hydrogen dioxide, hydrogen oxide, oxydol, peroxide.","loael_value":"","noael_unit":"mg/kg/day","noael_value":"56.2","page":11,"route":"oral","species":"rat","study_id":"sccp_o_022_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	56.2	mg/kg/day	rat	oral	6 days	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=56.2; DOSE=Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.; EFFECT=n food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). Study 2 In another Wistar rat study (Kawasaki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase w; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights.","duration":"6 days","effect":"n food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al., 1976). Study 2 In another Wistar rat study (Kawasaki et al., 1969) the rats were administered a 0.06 to 0.6% hydrogen peroxide by gavage for 100 days with a dose range 6 to 60 mg/kg bw/day. The top dose was associated with effects: a significant reduction of the body weight gain after day 20 of administration, a slightly higher spleen weight on day 40 (but not at termination on day 100), a decreased haematocrit and plasma proteins on day 100. Plasma catalase w","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg/day","noael_value":"56.2","page":20,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_003"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	86	mg/kg bw/day	rat	-	-	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=86; DOSE=findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7).; LOAEL_VALUE=86 mg/kg bw/day; EFFECT=findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7). The losses in weight of tissues other than the brain in the top dose males roughly corresponded to the body weight loss, the same applied for females. In view of the apparent effect on the weight gain even at the lowest dose level, no NOAEL can be determined. Conclusion A LOAEL can be calculated to 75 and 86 mg/kg bw/day for male and female rats, respectively.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7).","duration":"","effect":"findings were made only at the top dose level: all males and females exhibited multiple gastric erosions and ulcer, 2 males showed atrophy of testis (in the whole group testis weights were reduced by 60% compared to controls), one rat showed congestion of the liver (died at week 7). The losses in weight of tissues other than the brain in the top dose males roughly corresponded to the body weight loss, the same applied for females. In view of the apparent effect on the weight gain even at the lowest dose level, no NOAEL can be determined. Conclusion A LOAEL can be calculated to 75 and 86 mg/kg bw/day for male and female rats, respectively.","endpoint":"","ingredient":"s) is considered safe","loael_value":"86 mg/kg bw/day","noael_unit":"mg/kg bw/day","noael_value":"86","page":20,"route":"","species":"rat","study_id":"sccp_o_122_noael_005"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	100	ppm	rat	oral	2 weeks	-	SOURCE_SUBDIR=sccp_o_022; REPORT_TITLE=Opinion on Hydrogen Peroxide in Tooth Whitening Products; OPINION_NUMBER=SCCP/0844/04; COMMITTEE=SCCP; REPORT_DATE=15 March 2005; VALUE_TEXT=100; DOSE=Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.; EFFECT=loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks.","duration":"2 weeks","effect":"loss and death of mice within 2 weeks (FDA, 1983). Mice (C57BL/6N, catalase deficient) (groups of 15/sex) received solutions of 0, 100, 300, 1000 or 3000 ppm hydrogen peroxide in distilled water for 13 weeks. Mild-minimal duodenal mucosal hyperplasia was noted in animals receiving 1000 and 3000 ppm hydrogen peroxide and in one male receiving 300 ppm hydrogen peroxide for 13 weeks. All effects noted during treatment period, including the duodenal hyperplasia, were reversible during the 6 weeks recovery period. The NOAEL was 100 ppm or 26 and 37 mg/kg/day hydrogen peroxide for males and females respectively (Weiner et al., 1998). Rats When rats were administered hydrogen peroxide by oral gastric tube 6 days weekly for 90 days, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weights. Principal organ affected was gastric mucosa, and the effect was local. The no-observed-effect-level (NOEL) of hydrogen peroxide was 56.2 mg/kg/day (Ito et al.","endpoint":"","ingredient":"Hydrogen peroxide, dihydrogen dioxide, hydrogen dioxide, hydrogen oxide, oxydol, peroxide.","loael_value":"","noael_unit":"ppm","noael_value":"100","page":11,"route":"oral","species":"rat","study_id":"sccp_o_022_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	100	ppm	rat	oral	6 days	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings).; EFFECT=SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 20 Mortality: There were no treatment-related deaths. One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings). After the recovery period no hyperplasia was observed in any dose group. Conclusion NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively, based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weig; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings).","duration":"6 days","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 20 Mortality: There were no treatment-related deaths. One male mouse died in the control group (the cause of death was undetermined), and one male mouse in the 3,000 ppm group died on study day 43 (no histopathological findings). After the recovery period no hyperplasia was observed in any dose group. Conclusion NOAEL was 100 ppm (26 and 37 mg/kg/day) for males and females, respectively, based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia (Weiner et al., 1998). Rats Study 1 When Wistar rats were administered 5% hydrogen peroxide by oral gastric tube 6 days weekly for 90 days with a dose range 56.2 to 506 mg/kg bw/day, the dose of 506 mg/kg suppressed bodyweight gain, decreased food consumption, and caused changes in haematology, blood chemistry, and organ weig","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"ppm","noael_value":"100","page":20,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_002"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	100	mg/kg bw/d	-	-	-	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d).; EFFECT=gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d). The reduced body weight gain of the dams is partly (in later stages of pregnancy) due to reduced weights of the litters, due to reduced foetal weights and increased number of resorptions. No significant differences for the different doses and no clear dose response are found for the weight gain of the dams from day 20 except for gravid uterine weight. As maternal toxicity was apparent also in earlier times of the pregnancy the NOAEL for maternal toxicity is 100 mg/kg bw/d. At 100 mg/kg bw/d six externally malformed foetuses with ablepharia, acrania, exencephaly, macroglossia, cleft palate, cleft lip and facial cleft were found. The increase compared to controls was statistically significant. The authors of the study considered this finding incidental, since these kinds of malformations were only present in 2 litters and not at the higher dosages. Historical control data for the years 1993-1999 (Instituto di Ricerche Biomediche, 2000) showed,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d).","duration":"","effect":"gnificant reduction in food intake was observed in the top dose group (1000 mg/kg bw/d). The reduced body weight gain of the dams is partly (in later stages of pregnancy) due to reduced weights of the litters, due to reduced foetal weights and increased number of resorptions. No significant differences for the different doses and no clear dose response are found for the weight gain of the dams from day 20 except for gravid uterine weight. As maternal toxicity was apparent also in earlier times of the pregnancy the NOAEL for maternal toxicity is 100 mg/kg bw/d. At 100 mg/kg bw/d six externally malformed foetuses with ablepharia, acrania, exencephaly, macroglossia, cleft palate, cleft lip and facial cleft were found. The increase compared to controls was statistically significant. The authors of the study considered this finding incidental, since these kinds of malformations were only present in 2 litters and not at the higher dosages. Historical control data for the years 1993-1999 (Instituto di Ricerche Biomediche, 2000) showed,","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":92,"route":"","species":"","study_id":"sccp_o_122_noael_020"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	200	mg/kg bw/d	rabbit	dermal	6 days	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=200; DOSE=gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.; EFFECT=gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965; 1966a) or 50 mg/kg bw/d as 2.5% solution on the intact skin for 13 weeks (Procter & Gamble, 1966b). In both studies there were no statistically significant differences compared to controls in growth, organ/body; CITATION=Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available; CITATION_NUMBERS=[2003]; REFERENCE=Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available; DETAILS_JSON={"cas_number":"7722-84-1","citation":"Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available","dose":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.","duration":"6 days","effect":"gated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965; 1966a) or 50 mg/kg bw/d as 2.5% solution on the intact skin for 13 weeks (Procter & Gamble, 1966b). In both studies there were no statistically significant differences compared to controls in growth, organ/body","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":90,"route":"dermal","species":"rabbit","study_id":"sccp_o_122_noael_018"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1000	mg/kg bw/d	-	oral	8 days	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=1000; DOSE=In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.; EFFECT=number of platelets was statistically significantly increased. The spleen size and spleenic parenchyma were reduced. In contrast in the Dufour-study, (with 8 days duration instead of 28 days in the Degussa study) no changes in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of paramete; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.","duration":"8 days","effect":"number of platelets was statistically significantly increased. The spleen size and spleenic parenchyma were reduced. In contrast in the Dufour-study, (with 8 days duration instead of 28 days in the Degussa study) no changes in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of paramete","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":90,"route":"oral","species":"","study_id":"sccp_o_122_noael_015"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1000	mg/kg bw/d	-	oral	15 days	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=1000; DOSE=In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.; EFFECT=ges in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate t; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested.","duration":"15 days","effect":"ges in blood cell parameters were observed during the study but haemoglobin and haematocrit were increased up to 15 days after the end of the application. This was explained by depression of haematopoiesis during the study and overregulation at the termination of the application. In conclusion the NOEL for these endpoints is below the dose of 1000 mg/kg bw/d tested. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate t","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":90,"route":"oral","species":"","study_id":"sccp_o_122_noael_016"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	-	1000	mg/kg bw/d	rabbit	oral	28-day	-	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=1000; DOSE=From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.; EFFECT=sted. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965;; CITATION=Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available; CITATION_NUMBERS=[2003]; REFERENCE=Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available; DETAILS_JSON={"cas_number":"7722-84-1","citation":"Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available","dose":"From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system.","duration":"28-day","effect":"sted. Comment Effects after oral application of sodium perborate can be attributed to the degradation products. From the 28-day study from Degussa (1989) a NOAEL cannot be derived, because the only dose investigated was 1000 mg/kg bw/d which showed effects on the stomach, spleen and the haematopoietic system. No effects were recorded in the study of Dufour (1971). This study was only for 6 days with 3 days of recovery and only a limited number of parameters have been investigated. Therefore also from this study a NOAEL cannot be derived. Systemic effects, which have to be considered, are the effects on the haematopoietic system. Thus the LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) and no NOAEL can be derived. Ref.: ECB (2003) Dermal Two dermal studies, both on sodium perborate tetrahydrate, with limited reporting of the results are available. New Zealand white rabbits received either a dermal dose of 200 mg/kg bw/d in 10% aqueous solution on the abraded skin for 3 weeks (Proctor & Gamble, 1965;","endpoint":"","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":90,"route":"oral","species":"rabbit","study_id":"sccp_o_122_noael_017"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	carcinogenicity	5	%	mouse	oral	25 weeks	carcinogenicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=5; EFFECT=ur frequency was 5% in Sencar mice after initiation with the initiator DMBA followed skin painting with hydrogen peroxide for 25 weeks corresponding to about 0.47 mg/cm2/day. The peak exposure in the saliva after teeth bleaching with 5% Whitestrip was 0.1% hydrogen peroxide (Hannig et al., 2003) corresponding to about 5 µg/cm2 which is only about 100 times lower that the concentration inducing a tumour frequency of 5% in the mice skin painting study. Mahony et al (2006) claim that 0.71 and 0.41 mg/cm2 represent a NOEL for tumour promotion in mouse skin and hamster cheek, respectively. Based on an assumed maximal human exposure of 1.5 µg/cm2, they calculated a MOS of 473 and 287 based on the mouse and hamster study, respectively. Based on the results of Klein-Szanto and Slaga (1982) as discussed above, these calculations can be questioned. Munro et al. (2006a,b) are of the opinion that the available genetic toxicity and animal toxicology data do not indicate that hydrogen peroxide poses a carcinogenic risk to the human oral muc; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"","duration":"25 weeks","effect":"ur frequency was 5% in Sencar mice after initiation with the initiator DMBA followed skin painting with hydrogen peroxide for 25 weeks corresponding to about 0.47 mg/cm2/day. The peak exposure in the saliva after teeth bleaching with 5% Whitestrip was 0.1% hydrogen peroxide (Hannig et al., 2003) corresponding to about 5 µg/cm2 which is only about 100 times lower that the concentration inducing a tumour frequency of 5% in the mice skin painting study. Mahony et al (2006) claim that 0.71 and 0.41 mg/cm2 represent a NOEL for tumour promotion in mouse skin and hamster cheek, respectively. Based on an assumed maximal human exposure of 1.5 µg/cm2, they calculated a MOS of 473 and 287 based on the mouse and hamster study, respectively. Based on the results of Klein-Szanto and Slaga (1982) as discussed above, these calculations can be questioned. Munro et al. (2006a,b) are of the opinion that the available genetic toxicity and animal toxicology data do not indicate that hydrogen peroxide poses a carcinogenic risk to the human oral muc","endpoint":"carcinogenicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"%","noael_value":"5","page":34,"route":"oral","species":"mouse","study_id":"sccp_o_122_noael_009"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	100	mg/kg bw/d	-	-	developmental	developmental toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=The malformations were different from those observed at 100 mg/kg bw/d.; EFFECT=increased. The malformation included hydroneprhrosis and hypoplasia. Other viscereal malformations were microphtalmia or anophthalmia, vascular ring, displaced or double aortic arch, displaced botallus duct. The malformations were different from those observed at 100 mg/kg bw/d. Furthermore, at 300 and 1000 mg/kg bw/d dose-related increases of post implantation losses and early resorptions and dose-related lower mean foetal and placental weights were observed. The authors of the study considered 100 mg/kg bw/d as NOAEL for foetal effects. Comment In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity. Although reduced maternal weight gain as measure of maternal toxicity may partly be due to an increased number of resorptions and reduced foetal weights, other toxicological studies support the view that doses above 100 mg/kg bw/d via gavag; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"The malformations were different from those observed at 100 mg/kg bw/d.","duration":"developmental","effect":"increased. The malformation included hydroneprhrosis and hypoplasia. Other viscereal malformations were microphtalmia or anophthalmia, vascular ring, displaced or double aortic arch, displaced botallus duct. The malformations were different from those observed at 100 mg/kg bw/d. Furthermore, at 300 and 1000 mg/kg bw/d dose-related increases of post implantation losses and early resorptions and dose-related lower mean foetal and placental weights were observed. The authors of the study considered 100 mg/kg bw/d as NOAEL for foetal effects. Comment In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity. Although reduced maternal weight gain as measure of maternal toxicity may partly be due to an increased number of resorptions and reduced foetal weights, other toxicological studies support the view that doses above 100 mg/kg bw/d via gavag","endpoint":"developmental toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":92,"route":"","species":"","study_id":"sccp_o_122_noael_021"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	developmental toxicity	100	mg/kg bw/d	-	oral	developmental	developmental toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=ifferent from those observed at 100 mg/kg bw/d.; EFFECT=ifferent from those observed at 100 mg/kg bw/d. Furthermore, at 300 and 1000 mg/kg bw/d dose-related increases of post implantation losses and early resorptions and dose-related lower mean foetal and placental weights were observed. The authors of the study considered 100 mg/kg bw/d as NOAEL for foetal effects. Comment In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity. Although reduced maternal weight gain as measure of maternal toxicity may partly be due to an increased number of resorptions and reduced foetal weights, other toxicological studies support the view that doses above 100 mg/kg bw/d via gavage are toxic to the dams. Critical is the evaluation of the external malformations at 100 mg/kg bw/d. They were statistically significant but considered incidental due to lack of dose response by the authors; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"ifferent from those observed at 100 mg/kg bw/d.","duration":"developmental","effect":"ifferent from those observed at 100 mg/kg bw/d. Furthermore, at 300 and 1000 mg/kg bw/d dose-related increases of post implantation losses and early resorptions and dose-related lower mean foetal and placental weights were observed. The authors of the study considered 100 mg/kg bw/d as NOAEL for foetal effects. Comment In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity. Although reduced maternal weight gain as measure of maternal toxicity may partly be due to an increased number of resorptions and reduced foetal weights, other toxicological studies support the view that doses above 100 mg/kg bw/d via gavage are toxic to the dams. Critical is the evaluation of the external malformations at 100 mg/kg bw/d. They were statistically significant but considered incidental due to lack of dose response by the authors","endpoint":"developmental toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":92,"route":"oral","species":"","study_id":"sccp_o_122_noael_022"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	genotoxicity	200	mg/kg bw/d	-	oral	-	genotoxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=200; DOSE=SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 91 perborate is not taken up by the skin very efficiently the NOAEL of this study of 200 mg/kg bw/d, which was the highest dose tested, may be too low.; EFFECT=SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 91 perborate is not taken up by the skin very efficiently the NOAEL of this study of 200 mg/kg bw/d, which was the highest dose tested, may be too low. Ref.: ECB (2003) 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The mutagenic potential of sodium perborate was investigated in three different assays which included the induction of DNA damage, of point mutations, and of chromosomal aberrations. The results indicated that sodium perborate was capable of producing mutagenic changes in a number of in vitro test systems. In an assay which was tail; CITATION=Ref.: ECB (2003) 3; CITATION_NUMBERS=[2003,3]; REFERENCE=Ref.: ECB (2003) 3; DETAILS_JSON={"cas_number":"7722-84-1","citation":"Ref.: ECB (2003) 3","dose":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 91 perborate is not taken up by the skin very efficiently the NOAEL of this study of 200 mg/kg bw/d, which was the highest dose tested, may be too low.","duration":"","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 91 perborate is not taken up by the skin very efficiently the NOAEL of this study of 200 mg/kg bw/d, which was the highest dose tested, may be too low. Ref.: ECB (2003) 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1. Mutagenicity / Genotoxicity in vitro The mutagenic potential of sodium perborate was investigated in three different assays which included the induction of DNA damage, of point mutations, and of chromosomal aberrations. The results indicated that sodium perborate was capable of producing mutagenic changes in a number of in vitro test systems. In an assay which was tail","endpoint":"genotoxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":91,"route":"oral","species":"","study_id":"sccp_o_122_noael_019"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	0.15	%	mouse	oral	Sub-chronic	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=0.15; DOSE=top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels.; EFFECT=top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels. Control animals did not exhibit changes. The nasal localisation of the primary injury by peroxide is what can be expected from a water soluble oxidant vapour. As regards pathology in the lungs, the authors of the study considered it unlikely that the effects were treatment related due to the absence of a relationship with exposure concentration and the low incidence, and hence the NOAEL of the study would be 2.9 mg/m3 (CEFIC, 2002) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Oral Hydrogen peroxide Mice Study 1 Mice drinking 0.15% hydrogen peroxide (about 150 mg/kg/day) ad libitum grew normally and developed no visible abnormalities during a 35-week test period (FDA, 1983). Necropsy results show changes in the liver, kidney and stomach and small intestine. Hydrogen peroxide solutions at >1% (> 1 g/kg/day) caused pronounced weight loss and death of mice within 2 weeks (FD; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels.","duration":"Sub-chronic","effect":"top dose group exhibited perivascular neutrophil infiltration, and there was haemorrhage in some animals at the two lower dose levels. Control animals did not exhibit changes. The nasal localisation of the primary injury by peroxide is what can be expected from a water soluble oxidant vapour. As regards pathology in the lungs, the authors of the study considered it unlikely that the effects were treatment related due to the absence of a relationship with exposure concentration and the low incidence, and hence the NOAEL of the study would be 2.9 mg/m3 (CEFIC, 2002) 3.3.5.2. Sub-chronic (90 days) oral / dermal / inhalation toxicity Oral Hydrogen peroxide Mice Study 1 Mice drinking 0.15% hydrogen peroxide (about 150 mg/kg/day) ad libitum grew normally and developed no visible abnormalities during a 35-week test period (FDA, 1983). Necropsy results show changes in the liver, kidney and stomach and small intestine. Hydrogen peroxide solutions at >1% (> 1 g/kg/day) caused pronounced weight loss and death of mice within 2 weeks (FD","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"%","noael_value":"0.15","page":19,"route":"oral","species":"mouse","study_id":"sccp_o_122_noael_001"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	20	mg/kg bw/day	rat	oral	Chronic	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.; EFFECT=whitening products 21 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7 Carcinogenicity 3.3.5.4. Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study (Rat study 2), a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day may be used for calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity Hydrogen peroxide The in vitro and in vivo genotoxic potential of H2O2 is summarised in Table 3.1 and 3.2, respectively.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.","duration":"Chronic","effect":"whitening products 21 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7 Carcinogenicity 3.3.5.4. Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study (Rat study 2), a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day may be used for calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity Hydrogen peroxide The in vitro and in vivo genotoxic potential of H2O2 is summarised in Table 3.1 and 3.2, respectively.","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":21,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_007"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	20	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=mary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.; EFFECT=mary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study (Rat study 2), a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day may be used for calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity Hydrogen peroxide The in vitro and in vivo genotoxic potential of H2O2 is summarised in Table 3.1 and 3.2, respectively.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"mary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.","duration":"90 day","effect":"mary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study (Rat study 2), a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day may be used for calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity Hydrogen peroxide The in vitro and in vivo genotoxic potential of H2O2 is summarised in Table 3.1 and 3.2, respectively.","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":21,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_008"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	20	mg/kg bw/day	rat	oral	100 days	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=However, adverse effects have been observed in repeated dose studies in animals, allowing calculation of a MoS for systemic toxicity.; EFFECT=ulation of MoS SCCP is of the opinion that the risk of systemic effects is low. This is supported by the fact that hydrogen peroxide which may enter into the bloodstream is rapidly metabolised. However, adverse effects have been observed in repeated dose studies in animals, allowing calculation of a MoS for systemic toxicity. Irritating effects both due to a direct effect in the oral cavity and in the gastrointestinal system after swallowing are of concern. Toothpastes and mouth-rinses Repeated dose toxicity A NOAEL of 20 mg/kg bw/day of hydrogen peroxide has been obtained from a 100 days rat gavage study based on a significantly reduced plasma catalase level at higher dose levels Estimated daily exposure (SCCP, 2007): Toothpaste: 480 mg/day Mouth-rinses: 3000 mg/day Amount of hydrogen peroxide at 0.1% hydrogen peroxide Toothpaste: 0.48 mg/day, Systemic exposure (0.48/60) 0.008 mg/kg bw/d MOS = (20/0.008) 2500 Mouth-rinse: 3.0 mg/d, Systemic exposure (3.0/60) 0.05 mg/kg bw/d MOS = (20/0.05) 400 Conclusion The calculated; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"However, adverse effects have been observed in repeated dose studies in animals, allowing calculation of a MoS for systemic toxicity.","duration":"100 days","effect":"ulation of MoS SCCP is of the opinion that the risk of systemic effects is low. This is supported by the fact that hydrogen peroxide which may enter into the bloodstream is rapidly metabolised. However, adverse effects have been observed in repeated dose studies in animals, allowing calculation of a MoS for systemic toxicity. Irritating effects both due to a direct effect in the oral cavity and in the gastrointestinal system after swallowing are of concern. Toothpastes and mouth-rinses Repeated dose toxicity A NOAEL of 20 mg/kg bw/day of hydrogen peroxide has been obtained from a 100 days rat gavage study based on a significantly reduced plasma catalase level at higher dose levels Estimated daily exposure (SCCP, 2007): Toothpaste: 480 mg/day Mouth-rinses: 3000 mg/day Amount of hydrogen peroxide at 0.1% hydrogen peroxide Toothpaste: 0.48 mg/day, Systemic exposure (0.48/60) 0.008 mg/kg bw/d MOS = (20/0.008) 2500 Mouth-rinse: 3.0 mg/d, Systemic exposure (3.0/60) 0.05 mg/kg bw/d MOS = (20/0.05) 400 Conclusion The calculated","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":61,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_010"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	20	mg/kg bw/day	rat	oral	100 days	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=MOS calculation Estimated daily exposure from tooth whitening products containing 6% hydrogen peroxide is estimated to 0.2 mg/kg bw/d (see discussion) Repeated dose toxicity A NOAEL of 20 mg/kg bw/day of hydrogen peroxide has been obtained from a 100 days rat gavage study based on a significantly reduced plasma catalase level at higher dose leve...; EFFECT=free form or when released when used in oral hygiene products. Tooth whitening products Safety calculation of tooth whitening products due to hydrogen peroxide may be performed by MOS calculations based on the systemic exposure or by comparing the exposure in µg/cm2 caused by tooth whitening products with that causing an adverse effect. MOS calculation Estimated daily exposure from tooth whitening products containing 6% hydrogen peroxide is estimated to 0.2 mg/kg bw/d (see discussion) Repeated dose toxicity A NOAEL of 20 mg/kg bw/day of hydrogen peroxide has been obtained from a 100 days rat gavage study based on a significantly reduced plasma catalase level at higher dose levels MOS = (20/0.2) 100 Conclusion The calculated MOS for repeated dose toxicity is on the borderline of that considered to give sufficient protection in relation to the use of 6% hydrogen; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"MOS calculation Estimated daily exposure from tooth whitening products containing 6% hydrogen peroxide is estimated to 0.2 mg/kg bw/d (see discussion) Repeated dose toxicity A NOAEL of 20 mg/kg bw/day of hydrogen peroxide has been obtained from a 100 days rat gavage study based on a significantly reduced plasma catalase level at higher dose leve...","duration":"100 days","effect":"free form or when released when used in oral hygiene products. Tooth whitening products Safety calculation of tooth whitening products due to hydrogen peroxide may be performed by MOS calculations based on the systemic exposure or by comparing the exposure in µg/cm2 caused by tooth whitening products with that causing an adverse effect. MOS calculation Estimated daily exposure from tooth whitening products containing 6% hydrogen peroxide is estimated to 0.2 mg/kg bw/d (see discussion) Repeated dose toxicity A NOAEL of 20 mg/kg bw/day of hydrogen peroxide has been obtained from a 100 days rat gavage study based on a significantly reduced plasma catalase level at higher dose levels MOS = (20/0.2) 100 Conclusion The calculated MOS for repeated dose toxicity is on the borderline of that considered to give sufficient protection in relation to the use of 6% hydrogen","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":61,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_011"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	20	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.; EFFECT=hitening products 63 substance may enter into blood circulation. Moreover, the red blood cells have an immense metabolic capacity to degrade hydrogen peroxide. Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day of hydrogen peroxide may be used for calculation of MOS for repeated dose toxicity. Mutagenicity / Genotoxicity Hydrogen peroxide is a mutagenic and genotoxic in a variety of in vitro test systems. The responses observed were modified by the presence of degrading enzymes (catalase), the extent of formation of hydroxyl radicals by Fenton reaction, and the cells repair abilities. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.","duration":"90 day","effect":"hitening products 63 substance may enter into blood circulation. Moreover, the red blood cells have an immense metabolic capacity to degrade hydrogen peroxide. Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day of hydrogen peroxide may be used for calculation of MOS for repeated dose toxicity. Mutagenicity / Genotoxicity Hydrogen peroxide is a mutagenic and genotoxic in a variety of in vitro test systems. The responses observed were modified by the presence of degrading enzymes (catalase), the extent of formation of hydroxyl radicals by Fenton reaction, and the cells repair abilities. The","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":63,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_013"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	20	mg/kg bw/day	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=20; DOSE=Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.; EFFECT=metabolic capacity to degrade hydrogen peroxide. Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day of hydrogen peroxide may be used for calculation of MOS for repeated dose toxicity. Mutagenicity / Genotoxicity Hydrogen peroxide is a mutagenic and genotoxic in a variety of in vitro test systems. The responses observed were modified by the presence of degrading enzymes (catalase), the extent of formation of hydroxyl radicals by Fenton reaction, and the cells repair abilities. The available studies are not in support of a significant genotoxicity/mutagenicity for hydrogen peroxide under in vi; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.","duration":"90 day","effect":"metabolic capacity to degrade hydrogen peroxide. Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day of hydrogen peroxide may be used for calculation of MOS for repeated dose toxicity. Mutagenicity / Genotoxicity Hydrogen peroxide is a mutagenic and genotoxic in a variety of in vitro test systems. The responses observed were modified by the presence of degrading enzymes (catalase), the extent of formation of hydroxyl radicals by Fenton reaction, and the cells repair abilities. The available studies are not in support of a significant genotoxicity/mutagenicity for hydrogen peroxide under in vi","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"20","page":63,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_014"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	100	ppm	rat	oral	Chronic	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.; EFFECT=SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 21 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7 Carcinogenicity 3.3.5.4. Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study (Rat study 2), a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day may be used for calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity Hydrogen peroxide The in vitro and in; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.","duration":"Chronic","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 21 3.3.5.3. Chronic (> 12 months) toxicity See section 3.3.7 Carcinogenicity 3.3.5.4. Summary / Comment on Repeated dose toxicity In a 90 day study in mice (Mouse study 2) with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study (Rat study 2), a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day may be used for calculation of MOS. 3.3.6. Mutagenicity / Genotoxicity Hydrogen peroxide The in vitro and in","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"ppm","noael_value":"100","page":21,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_006"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	100	ppm	rat	oral	90 day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.; EFFECT=SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 63 substance may enter into blood circulation. Moreover, the red blood cells have an immense metabolic capacity to degrade hydrogen peroxide. Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day of hydrogen peroxide may be used for calculation of MOS for repeated dose toxicity. Mutagenicity / Genotoxicity Hydrogen perox; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia.","duration":"90 day","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 63 substance may enter into blood circulation. Moreover, the red blood cells have an immense metabolic capacity to degrade hydrogen peroxide. Repeated dose toxicity In a 90 day study in mice with hydrogen peroxide in the drinking water, a NOAEL of 100 ppm was found based on dose-related reductions in food and water consumption, and on the observation of duodenal mucosal hyperplasia. This corresponds to 26 and 37 mg/kg bw/day for males and females, respectively. In a 100 days rat gavage study a NOAEL of 20 mg/kg bw/day was found based a significantly reduced plasma catalase level at higher dose levels. A NOAEL of 20 mg/kg bw/day of hydrogen peroxide may be used for calculation of MOS for repeated dose toxicity. Mutagenicity / Genotoxicity Hydrogen perox","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"ppm","noael_value":"100","page":63,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_012"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	repeated dose toxicity	200	mg/kg bw/d	rat	oral	28 day	repeated dose toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=200; DOSE=Repeated dose toxicity Effects after oral application of sodium perborate to rats can be attributed to the degradation products.; EFFECT=ising in a Buehler test. Dermal / percutaneous absorption There are no valid quantitative data on the absorption of sodium perborate following dermal exposure. Repeated dose toxicity Effects after oral application of sodium perborate to rats can be attributed to the degradation products. Systemic effects, which have to be considered on the basis of a 28 day study, are the effects on the haematopoietic system. The LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) (only dose tested). The NOAEL from a 3 week skin painting study on rabbits is 200 mg/kg bw/d, which was the highest dose tested.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Repeated dose toxicity Effects after oral application of sodium perborate to rats can be attributed to the degradation products.","duration":"28 day","effect":"ising in a Buehler test. Dermal / percutaneous absorption There are no valid quantitative data on the absorption of sodium perborate following dermal exposure. Repeated dose toxicity Effects after oral application of sodium perborate to rats can be attributed to the degradation products. Systemic effects, which have to be considered on the basis of a 28 day study, are the effects on the haematopoietic system. The LOAEL is 1000 mg sodium perborate tetrahydrate/kg bw/d (70 mg boron/kg bw/d) (only dose tested). The NOAEL from a 3 week skin painting study on rabbits is 200 mg/kg bw/d, which was the highest dose tested.","endpoint":"repeated dose toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"200","page":94,"route":"oral","species":"rat","study_id":"sccp_o_122_noael_024"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	100	mg/kg bw/d	human	oral	developmental	reproductive toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=100; DOSE=Reproductive toxicity In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity.; EFFECT=n its free form or when released, in oral hygiene products and tooth whitening products 95 Mutagenicity / Genotoxicity The in vitro studies on sodium perborate show a genotoxic potential, which may be due to the generation of H2O2. No in vivo studies are available. Carcinogenicity No data found. Reproductive toxicity In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity. It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility. Toxicokinetics No data found. Human data Sodium perborate has been used in vital tooth bleaching systems (e.g. Supersmile Whitening Toothpase, Vitint Tooth Gel, Vitint Mouth Contitioner, Vitint Irresistible, Vitint Safe & White Whitening Gel, Vitint System A [for use by d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"7722-84-1","citation":"","dose":"Reproductive toxicity In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity.","duration":"developmental","effect":"n its free form or when released, in oral hygiene products and tooth whitening products 95 Mutagenicity / Genotoxicity The in vitro studies on sodium perborate show a genotoxic potential, which may be due to the generation of H2O2. No in vivo studies are available. Carcinogenicity No data found. Reproductive toxicity In a study on developmental effects of sodium perborate tetrahydrate according to OECD Guideline 414, 100 mg/kg bw/d of sodium perborate tetrahydrate was regarded by the authors of the study as the NOAEL for both maternal and developmental toxicity. It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility. Toxicokinetics No data found. Human data Sodium perborate has been used in vital tooth bleaching systems (e.g. Supersmile Whitening Toothpase, Vitint Tooth Gel, Vitint Mouth Contitioner, Vitint Irresistible, Vitint Safe & White Whitening Gel, Vitint System A [for use by d","endpoint":"reproductive toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"100","page":95,"route":"oral","species":"human","study_id":"sccp_o_122_noael_025"}
UnifiedCodex:SCCS_SHADOW:beta.noael_studies	reproductive toxicity	1129	-	human	oral	developmental	reproductive toxicity	SOURCE_SUBDIR=sccp_o_122; REPORT_TITLE=OPINION ON Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products; OPINION_NUMBER=SCCP/1129/07; COMMITTEE=Scientific Committee on Consumer Products (SCCP); REPORT_DATE=18 December 2007; VALUE_TEXT=unclear:SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe; DOSE=This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found.; EFFECT=SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe; CITATION=Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; CITATION_NUMBERS=[2003,2]; REFERENCE=Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; DETAILS_JSON={"cas_number":"7722-84-1","citation":"Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2","dose":"This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found.","duration":"developmental","effect":"SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe","endpoint":"reproductive toxicity","ingredient":"s) is considered safe","loael_value":"","noael_unit":"","noael_value":"unclear:SCCP/1129/07 Opinion on Hydrogen peroxide, in its free form or when released, in oral hygiene products and tooth whitening products 93 of the study. This is supported by the fact that with other boron compounds which have very similar developmental effects as sodium perborate at higher dose levels, this type of effect was not found. A final decision on the NOAEL or LOAEL for the teratogenicity of sodium perborate will be made after the targeted evaluation of the boron compounds. Ref.: ECB (2003) It is proposed by ECB that sodium perborate should be classified as toxic to reproduction category 2; R61 May cause harm to the unborn child and category 3; R62 Possible risk of impaired fertility (http://ecb.jrc.it/classification-labelling/search-classlab/ (Search Working Database)). 3.3.9. Toxicokinetics / 3.3.10. Photo-induced toxicity / 3.3.11. Human data / 3.3.12. Spe","page":93,"route":"oral","species":"human","study_id":"sccp_o_122_noael_023"}

openFDA substances 4 endpoints

Source	Endpoint Type	Value	Unit	Species	Route	Duration	Study Type	Reference
openFDA substances	FDA UNII substance identifier	BBX060AN9V	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BBX060AN9V"}
openFDA substances	FDA UNII substance identifier	BBX060AN9V	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BBX060AN9V"}
openFDA substances	FDA UNII substance identifier	BBX060AN9V	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BBX060AN9V"}
openFDA substances	FDA UNII substance identifier	BBX060AN9V	UNII	-	-	-	chemical	{"approval_status":null,"molecular_formula":"H2O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"BBX060AN9V"}