NOAEL Studies
Cosmetic Ingredient
Benzophenone-2 NOAEL Studies
INCI: BENZOPHENONE-2
CAS: 131-55-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP_ICE_adme_parameters 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Clint | 19.2 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=2176; Record_ID=adme_parameters_709; Data_Type=Measured; DTXSID=DTXSID5041306; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=19.2; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_adme_parameters | Clint | 103 | uL/min/10^6 cells | Rat | - | - | Measured; httk, Rat Hepatic Intrinsic Clearance | sheet=Data; excel_row=2177; Record_ID=adme_parameters_709; Data_Type=Measured; DTXSID=DTXSID5041306; Assay=httk, Rat Hepatic Intrinsic Clearance; Endpoint=Clint; Response=103.0; Response_Unit=ul/min/10^6 cells; Species=Rat; Reference=httk2.3.1, Black 2021; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_adme_parameters | Fu | 0.0354 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=2175; Record_ID=adme_parameters_709; Data_Type=Measured; DTXSID=DTXSID5041306; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.0354; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wambaugh 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
NTP_ICE_endocrine 19 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | AC50 | 5.992535597 | uM | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=1548; RecordID=ARPathway2016_52; DatasetName=ARPathway2016; DTXSID=DTXSID5041306; Assay=AR Pathway Model, Agonist; Endpoint=AC50; Response=5.992535597; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | AC50 | 1.75364714262133 | uM | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1554; RecordID=ERPathway2016_167; DatasetName=ERPathway2016; DTXSID=DTXSID5041306; Assay=ER Pathway Model, Antagonist; Endpoint=AC50; Response=1.75364714262133; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | AC50/EC50/IC50 | 62700 | nM | - | - | - | In Vitro; AR Transactivation-Agonist | sheet=Data_invitro; excel_row=7891; Record_ID=endocrine_invitro_3481; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=AR Transactivation-Agonist; Endpoint=AC50/EC50/IC50; Reported_Response=62700; Reported_Response_Unit=nM; Response=62700; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Kunz and Fent 2006; 16911836; 10.1016/j.aquatox.2006.06.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | AC50/EC50/IC50 | 4900 | nM | - | - | - | In Vitro; AR Transactivation-Antagonist | sheet=Data_invitro; excel_row=13127; Record_ID=endocrine_invitro_4072; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=4900; Reported_Response_Unit=nM; Response=4900; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Ermler et al. 2011; 21945941; 10.1016/j.taap.2011.09.005; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | AC50/EC50/IC50 | 2500 | nM | - | - | - | In Vitro; AR Transactivation-Antagonist | sheet=Data_invitro; excel_row=13128; Record_ID=endocrine_invitro_4073; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=2500; Reported_Response_Unit=nM; Response=2500; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | AC50/EC50/IC50 | 1323 | nM | - | - | - | In Vitro; AR Transactivation-Antagonist | sheet=Data_invitro; excel_row=13285; Record_ID=endocrine_invitro_4117; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=1323; Reported_Response_Unit=nM; Response=1323; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Molina-Molina et al. 2008; 18706922; 10.1016/j.taap.2008.07.017; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | AC50/EC50/IC50 | 1530 | nM | - | - | - | In Vitro; AR Transactivation-Antagonist | sheet=Data_invitro; excel_row=13358; Record_ID=endocrine_invitro_4131; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=AR Transactivation-Antagonist; Endpoint=AC50/EC50/IC50; Reported_Response=1530; Reported_Response_Unit=nM; Response=1530; Response_Unit=nM; Reference=Kleinstreuer et al. 2016; 27933809; 10.1021/acs.chemrestox.6b00347|Suzuki et al. 2005; 15694459; 10.1016/j.taap.2004.07.005; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | ACC | 10.53998791 | uM | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=1549; RecordID=ARPathway2016_52; DatasetName=ARPathway2016; DTXSID=DTXSID5041306; Assay=AR Pathway Model, Agonist; Endpoint=ACC; Response=10.53998791; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | ACC | 0.94227658039805 | uM | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1555; RecordID=ERPathway2016_167; DatasetName=ERPathway2016; DTXSID=DTXSID5041306; Assay=ER Pathway Model, Antagonist; Endpoint=ACC; Response=0.94227658039805; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | LOEL | 200 | mg/kg bw/day | Rat | Subcutaneous | Treatment_Duration=3 days; Age_at_First_Dose=PND 19; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=3 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=777; Record_ID=endocrine_invivo_55; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=Uterotrophic-Agonist; Endpoint=LOEL; Response=200; Response_Unit=mg/kg/day; Species=Rat; Reported_Strain=Crj:CD(SD); Strain=Sprague-Dawley; Sex=Female; Route=Subcutaneous; Maximum_Dose=800; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Ethinylestradiol; Reference=Yamasaki et al. 2003; 12765246; 10.1016/s0378-4274(03)00019-5|Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | LOEL | 1000 | mg/kg bw/day | Mouse | Oral | Treatment_Duration=7 days; Age_at_First_Dose=PND 56; Age_Ovariectomized_or_Castrated=6 weeks; Time_Elapsed_Between_Surgery_and_Treatment=2 weeks; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=4 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=779; Record_ID=endocrine_invivo_57; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=Uterotrophic-Agonist; Endpoint=LOEL; Response=1000; Response_Unit=mg/kg/day; Species=Mouse; Reported_Strain=C57BL/6J; Strain=C57BL/6; Sex=Female (ovariectomized); Route=Oral; Maximum_Dose=1000; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Ethinylestradiol; Reference=Ohta et al. 2012; 23037998; 10.2131/jts.37.879|Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | LOEL | 229.8 | mg/kg bw/day | Rat | Subcutaneous | Treatment_Duration=3 days; Age_at_First_Dose=PND 20; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=3 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=784; Record_ID=endocrine_invivo_61; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=Uterotrophic-Agonist; Endpoint=LOEL; Response=229.8; Response_Unit=mg/kg/day; Species=Rat; Reported_Strain=Crj:CD(SD)IGS; Strain=Sprague-Dawley; Sex=Female; Route=Subcutaneous; Maximum_Dose=1000.0; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Ethinylestradiol; Reference=Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | LOEL | 300 | mg/kg bw/day | Mouse | Subcutaneous | Treatment_Duration=7 days; Age_at_First_Dose=PND 56; Age_Ovariectomized_or_Castrated=6 weeks; Time_Elapsed_Between_Surgery_and_Treatment=2 weeks; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=4 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=788; Record_ID=endocrine_invivo_63; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=Uterotrophic-Agonist; Endpoint=LOEL; Response=300; Response_Unit=mg/kg/day; Species=Mouse; Reported_Strain=C57BL/6J; Strain=C57BL/6; Sex=Female (ovariectomized); Route=Subcutaneous; Maximum_Dose=1000; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Ethinylestradiol; Reference=Ohta et al. 2012; 23037998; 10.2131/jts.37.879|Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | Model Score | 0.448 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1550; RecordID=ARPathway2016_52; DatasetName=ARPathway2016; DTXSID=DTXSID5041306; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0.448; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | Model Score | 0.00909 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=1551; RecordID=ARPathway2016_52; DatasetName=ARPathway2016; DTXSID=DTXSID5041306; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0.00909; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | Model Score | 0.397 | unitless | - | - | - | ERPathway2016; ER Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=1556; RecordID=ERPathway2016_167; DatasetName=ERPathway2016; DTXSID=DTXSID5041306; Assay=ER Pathway Model, Agonist; Endpoint=Model Score; Response=0.397; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ERPathway2016; ER Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=1557; RecordID=ERPathway2016_167; DatasetName=ERPathway2016; DTXSID=DTXSID5041306; Assay=ER Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | NOEL | 400 | mg/kg bw/day | Rat | Oral | Treatment_Duration=10 days; Age_at_First_Dose=PND 56; Age_Ovariectomized_or_Castrated=PND 42; Time_Elapsed_Between_Surgery_and_Treatment=14 days; Time_Elapsed_Between_Last_Dose_and_Necropsy=18 to 36 hours; Number_of_Doses_Tested=6 | In Vivo; Hershberger-Agonist | sheet=Data_invivo; excel_row=2150; Record_ID=endocrine_invivo_923; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=Hershberger-Agonist; Endpoint=NOEL; Response=400; Response_Unit=mg/kg/day; Species=Rat; Reported_Strain=Sprague-Dawley; Strain=Sprague-Dawley; Sex=Male (castrated); Route=Oral; Reference_Hormone=Testosterone propionate; Reference_Hormone_Dose=0.2; Reference_Hormone_Dose_Units=mg/kg/day; Reference_Hormone_Route=Subcutaneous; Additional_Information=Browne et al. 2018 unique record identifier 253; Reference=Yamasaki et al. 2003; 12504345; 10.1016/s0300-483x(02)00445-6|Browne et al. 2018; 30205136; 10.1016/j.reprotox.2018.08.016; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
| NTP_ICE_endocrine | Uterine weight increase vs control | 230 | % | Rat | Subcutaneous | Treatment_Duration=3 days; Age_at_First_Dose=PND 19; Time_Elapsed_Between_Last_Dose_and_Necropsy=24 hours; Number_of_Doses_Tested=3 | In Vivo; Uterotrophic-Agonist | sheet=Data_invivo; excel_row=2239; Record_ID=endocrine_invivo_55; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID5041306; Assay=Uterotrophic-Agonist; Endpoint=Uterine weight increase vs control; Response=230; Response_Unit=%; Species=Rat; Reported_Strain=Crj:CD(SD); Strain=Sprague-Dawley; Sex=Female; Route=Subcutaneous; Maximum_Dose=800.0; Maximum_Dose_Units=mg/kg/day; Reference_Hormone=Ethinylestradiol; Reference=Kleinstreuer et al. 2016; 26431337; 10.1289/ehp.1510183; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5041306 |
SCCS_vision_codex 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | - | NOAEL study | {"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Sunscreen lotion | 0.069 | 620 | 8986","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_005"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | - | NOAEL study | {"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Sunscreen lotion | 0.069 | 620 | 8986","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_005"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | - | NOAEL study | {"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Sunscreen lotion | 0.069 | 620 | 8986","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_005"} |
| SCCS_vision_codex | NOAEL | =1239 | mg/kg bw/day | rat | oral | 90-day | repeated dose toxicity | {"dose":"3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4.","effect":"sensitisation potential to BP-4, the risk of sensitisation to humans can be regarded as very low. 3.6.4 Acute toxicity The studies referred to in the SCCS Opinion (SCCS/1660/23) pointed to low or no acute toxicity of benzophenone-4 in animals. However, as indicated in the SCCS Notes of Guidance, acute toxicity studies are not mandatory for risk assessment of cosmetic ingredients. 3.6.5 Repeated dose toxicity From the 90-day repeat dose oral toxicity study in rats, referred to in the SCCS Opinion (SCCS/1660/23) a NOAEL of 1239 mg/kg bw/day could be derived for BP-4. 3.6.6 Reproductive toxicity The OECD TG 422 study, referred to in the SCCS Opinion (SCCS/1660/23) for BP-4, showed no treatment related changes up to 1250 mg/kg bw /day. 3.6.7 Mutagenicity / genotoxicity Benzophenone-4 has no in vitro genotoxic potential. 3.6.8 Carcinogenicity No data available. 3.6.9 Photo-induced toxicity Benzophenone-4 is not phototoxic, not photosensitising, not photomutagenic and not photoclastogenic. 3.6.10 Human data Considering the avail","page":38,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_001"} |
| SCCS_vision_codex | NOAEL | =5 | % | - | oral | - | NOAEL study | {"dose":"The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23).","effect":"iders it appropriate to use the available toxicological data on BP-4 for read-across to BP-5. The calculation of the systemic exposure dose (SED), the margin of safety (MOS), and the selection of Point of Departure (PoD) for BP-5 are therefore the taken as the same for BP-4, which has already been assessed in the SCCS Opinion (SCCS/1660/23). Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across from BP-4 when used in cosmetic products at 5%. Product type SED (mg/kg bw/day) Adjusted NOAEL (mg/kg bw/day) MoS Dermal exposure: Sunscreen lotion 0.069 620 8986 Face cream* 0.006 620 103333 Hand cream* 0.008 620 77500 Oral exposure: Lip stick* 0.045 620 13778 Inhalatory exposure: Sunscreen propellant spray* 0.088 620 7046 Sunscreen pump spray 0.001 620 620000 Overall aggregate* (deterministic) 0.147 620 4218 *Aggregate exposure has been calculated from face cream, hand cream, lipstick and sunscreen propellant spray (only one sunscreen was considered for the worst-case scenario) The calculation","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_002"} |
| SCCS_vision_codex | NOAEL | =7 | - | - | - | - | NOAEL study | {"dose":"Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Product type | SED (mg/kg bw/day) | Adjusted NOAEL (mg/kg bw/day) | MoS","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_004"} |
| SCCS_vision_codex | NOAEL | =620 | - | - | - | - | NOAEL study | {"effect":"Table 7: Margins of Safety (MoS) calculation for benzophenone-5 based on read-across: Sunscreen lotion | 0.069 | 620 | 8986","page":39,"pdf":"sccs_o_301.pdf","row_type":"noael_study","study_id":"sccs_o_301_noael_005"} |
ToxValDB_Uterotrophic_Hershberger_DB 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =185 | mg/kg bw/day | Rat | oral | subchronic; 90 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=0; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB:15713398:-:--; 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_1268983598d429ff0f2904f87e422c89 |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =100 | mg/kg bw/day | Rat | oral | short-term; 5 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=0; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB_dup_-_15713607_15713654:-:--; 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_df5bd405be9bbc0a00c284a08da07e7b |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =200 | mg/kg bw/day | Rat | injection | short-term; 3 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=1; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB_dup_-_15713613_15713641_15714027:-:--; 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_bd8f08fa3a82dfc1469c6aea3460922c |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =250 | mg/kg bw/day | Rat | oral | short-term; 5 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=0; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB_dup_-_15713607_15713654:-:--; 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_2fd820def9fad4989295fd63e4aee0c8 |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =300 | mg/kg bw/day | Mouse | injection | short-term; 7 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=1; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB:15713661:-:--; 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_070ea5d03ccf48a81940796647512fbf |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =1000 | mg/kg bw/day | Mouse | oral | short-term; 7 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=1; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB:15713685:-:--; 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_982e9c3cfd267df26518c942f48f4560 |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =229.784 | mg/kg bw/day | Rat | injection | short-term; 3 days | uterotrophic | LONG_REF=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124 2106, https://doi.org/10.1289/ehp.1510183; TITLE=A Curated Database of Rodent Uterotrophic Bioactivity; AUTHOR=Kleinstreuer et al., A Curated Database of Rodent Uterotrophic Bioactivity, EHP Vol 124; DOI=10.1289/ehp.1510183; GUIDELINE=1; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759abc7e4b0a7c65d37b40c; RECORD_SOURCE_LEVEL=Extraction document; TOXICOLOGICAL_EFFECT=Active; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=Uterotrophic Hershberger DB_dup_-_15713613_15713641_15714027:-:--; 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_8350e0ac2dc271d9c637ee78dd8c3b57 |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | PRR8K3H9VN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H10O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PRR8K3H9VN"} |
| openFDA substances | FDA UNII substance identifier | PRR8K3H9VN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H10O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PRR8K3H9VN"} |
| openFDA substances | FDA UNII substance identifier | PRR8K3H9VN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H10O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PRR8K3H9VN"} |
| openFDA substances | FDA UNII substance identifier | PRR8K3H9VN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C13H10O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"PRR8K3H9VN"} |