NOAEL Studies
Preservative
Benzoic Acid NOAEL Studies
INCI: BENZOIC ACID
CAS: 65-85-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS_DB 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS_DB | LOAEL | 25 | mg/kg bw/day | rat | oral | 5-16 Gestation day | Developmental | PAFA; SBJ |
| COSMOS_DB | NOAEL | 80 | mg/kg bw/day | mouse | oral | 240 day | Chronic | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 175 | mg/kg bw/day | mouse | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 300 | mg/kg bw/day | hamster | oral | 5 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 250 | mg/kg bw/day | rabbit | oral | 13 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS_DB | NOAEL | 25 | mg/kg bw/day | rat | oral | 10 day | Developmental | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =500 | mg/kg bw/day | Rat | oral: feed | 730 days | chronic/long term toxicity | EFSA - 2016 - OutputID 2899 - other - systemic - Peer review of the pesticide risk assessment of the active substance benzoic acid - doi:10.2903/j.efsa.2016.4657 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =1310 | mg/kg bw/day | Rat | oral: feed | - | reproduction toxicity | EFSA ANS - 2016 - OutputID 2794 - no adverse effect observed at single/highest dose - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =500 | mg/kg bw/day | Rat | oral: feed | 730 days | chronic/long term toxicity | EFSA - 2016 - OutputID 2899 - other - systemic - Peer review of the pesticide risk assessment of the active substance benzoic acid - doi:10.2903/j.efsa.2016.4657 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =1310 | mg/kg bw/day | Rat | oral: feed | - | reproduction toxicity | EFSA ANS - 2016 - OutputID 2794 - no adverse effect observed at single/highest dose - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433 |
EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =5 | mg/kg bw/day | Consumers | - | - | ADI | EFSA - 2016 - OutputID 2899 - Consumers - Peer review of the pesticide risk assessment of the active substance benzoic acid - doi:10.2903/j.efsa.2016.4657 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =300 | mg/person/day | Consumers | - | - | ADI | EFSA FEEDAP - 2012 - OutputID 246 - Consumers - Scientific Opinion on safety and efficacy of CRINA Poultry Plus (preparation of benzoic acid and essential oil compounds) as feed additive for chickens for fattening - doi:10.2903/j.efsa.2012.2620 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =5 | mg/kg bw/day | Consumers | - | - | ADI | EFSA - 2016 - OutputID 2899 - Consumers - Peer review of the pesticide risk assessment of the active substance benzoic acid - doi:10.2903/j.efsa.2016.4657 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI | =300 | mg/person/day | Consumers | - | - | ADI | EFSA FEEDAP - 2012 - OutputID 246 - Consumers - Scientific Opinion on safety and efficacy of CRINA Poultry Plus (preparation of benzoic acid and essential oil compounds) as feed additive for chickens for fattening - doi:10.2903/j.efsa.2012.2620 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI (group) | =5 | mg/kg bw/day | Consumers | - | - | ADI (group) | EFSA ANS - 2016 - OutputID 2794 - Consumers - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433 |
| EFSA_OpenFoodTox_EFSA_ReferenceValues.xlsx | ADI (group) | =5 | mg/kg bw/day | Consumers | - | - | ADI (group) | EFSA ANS - 2016 - OutputID 2794 - Consumers - Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives - doi:10.2903/j.efsa.2016.4433 |
EPA_IRIS_iris_rfd_systems.csv 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EPA_IRIS_iris_rfd_systems.csv | NOAEL | =4.4 | mg/kg/day | - | oral | chronic | IRIS chronic oral RfD system PoD | row_hash=bca8fc84025ed602; file=iris_rfd_systems.csv; kind=point_of_departure; raw_column=point_of_departure; raw_value=NOAEL : 4.4 mg/kg-day; system=Other; basis=No adverse effects observed; point_of_departure=NOAEL : 4.4 mg/kg-day; composite_uf=1; confidence=Medium; dtxsid=DTXSID6020143; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=355; rfd_last_updated=09/07/1988; rfd_pdf_url=https://iris.epa.gov/static/pdfs/0355_summary.pdf |
| EPA_IRIS_iris_rfd_systems.csv | RfD | =4 | mg/kg/day | - | oral | chronic | IRIS chronic oral RfD system | row_hash=db9403bf0c77df73; file=iris_rfd_systems.csv; kind=reference_value; raw_column=rfd_mg_per_kg_day; raw_value=4; system=Other; basis=No adverse effects observed; point_of_departure=NOAEL : 4.4 mg/kg-day; composite_uf=1; confidence=Medium; dtxsid=DTXSID6020143; detail_url=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=355; rfd_last_updated=09/07/1988; rfd_pdf_url=https://iris.epa.gov/static/pdfs/0355_summary.pdf |
INCHEM_WHO_cicads_cicads_cicad26 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| INCHEM_WHO_cicads_cicads_cicad26 | NOAEL | ~500 | mg/kg bw/day | - | - | - | Reproductive toxicity | document_id=cicads_cicads_cicad26; title=BENZOIC ACID AND SODIUM BENZOATE; path=mirror/documents/cicads/cicads/cicad26.htm; row_hash=7e7bb2f770df14c8; raw_unit=mg/kg body weight per day; context=From a limited four-generation study, only a preliminary no-observed-(adverse-)effect level (NO(A)EL) of about 500 mg/kg body weight per day can be derived. |
| INCHEM_WHO_cicads_cicads_cicad26 | NOAEL | ~1310 | mg/kg bw | Rat | oral | - | Toxicology study | document_id=cicads_cicads_cicad26; title=BENZOIC ACID AND SODIUM BENZOATE; path=mirror/documents/cicads/cicads/cicad26.htm; row_hash=bf42f7715d8d6de5; raw_unit=mg/kg body weight; context=In a dietary study in rats, a NO(A)EL of about 1310 mg/kg body weight was established. |
| INCHEM_WHO_cicads_cicads_cicad26 | NOAEL | ~1310 | mg/kg bw/day | - | - | - | Toxicology study | document_id=cicads_cicads_cicad26; title=BENZOIC ACID AND SODIUM BENZOATE; path=mirror/documents/cicads/cicads/cicad26.htm; row_hash=493f2ff973bfd635; raw_unit=mg/kg body weight per day; context=From this study, a NO(A)EL of about 1310 mg/kg body weight per day can be derived. |
NTP_ICE_acute_inhalation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | >0.026 | mg/L | - | Inhalation | Duration=1 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3268; Record_ID=acute_inhalation_2767; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.026; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
NTP_ICE_acute_oral 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | LD50 | =2742 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_9000; row=9899; data_type=In Vivo; mixture=Chemical; chemical_name=Benzoic acid; preferred_name=Benzoic acid; dtxsid=DTXSID6020143; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6020143; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1700 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_8997; row=9900; data_type=In Vivo; mixture=Chemical; chemical_name=Benzoic acid; preferred_name=Benzoic acid; dtxsid=DTXSID6020143; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6020143; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2360 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_8998; row=9901; data_type=In Vivo; mixture=Chemical; chemical_name=Benzoic acid; preferred_name=Benzoic acid; dtxsid=DTXSID6020143; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6020143; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2565 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | ECHA ChemProp (undated); record_id=acute_oral_8999; row=9902; data_type=In Vivo; mixture=Chemical; chemical_name=Benzoic acid; preferred_name=Benzoic acid; dtxsid=DTXSID6020143; url=https://echa.europa.eu/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; url_cebs=https://doi.org/10.22427/NTP-DATA-DTXSID6020143; source_file=acute_oral.xlsx |
NTP_ICE_adme_parameters 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_adme_parameters | Clint | 0.78 | uL/min/10^6 cells | Rat | - | - | Measured; httk, Rat Hepatic Intrinsic Clearance | sheet=Data; excel_row=2305; Record_ID=adme_parameters_1364; Data_Type=Measured; DTXSID=DTXSID6020143; Assay=httk, Rat Hepatic Intrinsic Clearance; Endpoint=Clint; Response=0.78; Response_Unit=ul/min/10^6 cells; Species=Rat; Reference=httk2.3.1, Honda 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_adme_parameters | Fu | 0.422 | fraction | Rat | - | - | Measured; httk, Rat Plasma Fraction Unbound | sheet=Data; excel_row=2306; Record_ID=adme_parameters_1364; Data_Type=Measured; DTXSID=DTXSID6020143; Assay=httk, Rat Plasma Fraction Unbound; Endpoint=Fu; Response=0.422; Response_Unit=Unitless Fraction; Species=Rat; Reference=httk2.3.1, Honda 2019; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=5340; RecordID=ARPathway2016_1453; DatasetName=ARPathway2016; DTXSID=DTXSID6020143; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
NTP_ICE_skin_sensitization 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD86, EC150 | >854.861 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8171; Record_ID=skin_sensitization_invitro_2194; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=U-SENS; Endpoint=CD86, EC150; Response_Modifier=>; Reported_Response_Modifier=>; Reported_Response=7000; Reported_Response_Unit=uM; Conversion_Factor_Value=122.123; Conversion_Factor_Source=EPA Dashboard; Converted_Response_Modifier=>; Converted_Response=854.861; Converted_Response_Unit=ug/mL; Response=854.861; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | CV75 | 1000 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3800; Record_ID=skin_sensitization_invitro_864; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=h-CLAT; Endpoint=CV75; Reported_Response=1000; Reported_Response_Unit=ug/mL; Response=1000; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Depletion Cys | 16.2 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1464; Record_ID=skin_sensitization_invitro_390; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=16.2; Reported_Response_Unit=%; Response=16.2; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Depletion Cys | 22.6 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1468; Record_ID=skin_sensitization_invitro_391; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=22.6; Reported_Response_Unit=%; Response=22.6; Response_Unit=%; Reference=Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Depletion Lys | 68.1 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1463; Record_ID=skin_sensitization_invitro_390; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=68.099999999999994; Reported_Response_Unit=%; Response=68.1; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Depletion Lys | 23.4 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1467; Record_ID=skin_sensitization_invitro_391; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=23.4; Reported_Response_Unit=%; Response=23.4; Response_Unit=%; Reference=Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 42.2 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1465; Record_ID=skin_sensitization_invitro_390; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=42.2; Reported_Response_Unit=%; Response=42.2; Response_Unit=%; Reference=Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 23 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=1469; Record_ID=skin_sensitization_invitro_391; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=23; Reported_Response_Unit=%; Response=23; Response_Unit=%; Reference=Jaworska 2011; 23670904; 10.1002/jat.2869; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | EC1.5 | >2000 | uM | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6398; Record_ID=skin_sensitization_invitro_1515; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=KeratinoSens; Endpoint=EC1.5; Response_Modifier=>; Reported_Response=No induction; Reported_Response_Unit=Unitless; Conversion_Factor=Text to numeric; Conversion_Factor_Value=No induction assumed >2000 uM; Conversion_Factor_Source=Manually calculated; Converted_Response_Modifier=>; Converted_Response=2000; Converted_Response_Unit=uM; Response=2000; Response_Unit=uM; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Imax | 1.1 | ratio | - | Dermal | - | In Vitro; KeratinoSens2015; KeratinoSens | sheet=Data_invitro; excel_row=6401; Record_ID=skin_sensitization_invitro_1515; Data_Type=In Vitro; Internal_Data_Source=KeratinoSens2015; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=1.1000000000000001; Reported_Response_Unit=Unitless; Response=1.1; Response_Unit=Ratio; Reference=Emter et al. 2010; 20307559; 10.1016/j.taap.2010.03.009|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9284; Record_ID=skin_sensitization_invivo_2055; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Human Maximization Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Kligman 1977: report to RIFM|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80012-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 1350 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9282; Record_ID=skin_sensitization_invivo_2055; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=1350; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Kligman 1977: report to RIFM|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80012-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 3750 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9290; Record_ID=skin_sensitization_invivo_2057; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=5.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Human Maximization Test; Endpoint=Induction dose per skin area; Response=3750; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Leyden and Kligman 1977; 145346; 10.1111/j.1600-0536.1977.tb03674.x|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80012-8; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Relative reliability score | 3 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9288; Record_ID=skin_sensitization_invivo_2055; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=2.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=3; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Kligman 1977: report to RIFM|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80012-7; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Relative reliability score | 2 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Maximization Test | sheet=Data_invivo; excel_row=9296; Record_ID=skin_sensitization_invivo_2057; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=5.0; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Human Maximization Test; Endpoint=Relative reliability score; Response=2; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Leyden and Kligman 1977; 145346; 10.1111/j.1600-0536.1977.tb03674.x|Anonymous 1979; Not available; 10.1016/S0015-6264(79)80012-8; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
| NTP_ICE_skin_sensitization | Relative reliability score | 5 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=9303; Record_ID=skin_sensitization_invivo_2059; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Mixture=Chemical; DTXSID=DTXSID6020143; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=5; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Gad et al. 1986; 3715870; 10.1016/0041-008X(86)90419-9; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6020143; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID6020143 |
SCCNFP_vision_codex 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | dermal absorption | {"citation":"Ref. : 41 2","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"id was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approx. 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL : 500 mg/kg bw Ref. : 41 2.7. Toxicokinetics (incl. Percutaneous Absorption) Benzoic acid 14C-labelled benzoic acid (4 - 40 µg/cm2 dissolved in acetone) was applied to excised human skin in a static diffusion chamber. Samples of penetrated amounts were measured in 1- 2 hr interval over the first 24 hrs and 3-6 hrs interval over the remaining days. A median of 44.9 % of the applied benzoic acid was found in the receptor phase 48 hrs after application. Ref. : 34 Percutaneous absorption of benzoic acid was studied in","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | intravenous | 16 months | NOAEL study | {"citation":"Ref. : 42 2","dose":"However no differences in mortality rates between treated and control group was seen.","effect":"ring the first 16 months, except for myeloproliferative disorder developed in one female control rat, all other dead animals showed pneumonia with abscess. Around 100 rats including those of the control group died after 16 months of hemorrhagic pneumonia with edema. However no differences in mortality rates between treated and control group was seen. Although a variety of tumours occurred among test and control rats of each sex, tumours in treated rats were similar in type and number of those of the control group. NOEL: 1000 mg/kg bw/d Ref. : 42 2.10. Special investigations Serious metabolic disturbances in premature neonates given intravenous fluids with benzyl alcohol have been attributed to the accumulation of benzoic acid metabolites of the benzyl alcohol. This risk has led to the recommendation that the CNS stimulant, caffeine and sodium benzoate injection should not be given to neonates. Ref. : AR 10 Benzoic acid can also displace bound bilirubin from albumin, putting neonates at risk from kernicterus. Ref. : AR 11 Sodium","page":15,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"ox. 1 g/kg bw/d) in the diet is tolerated by rats. In an oral subacute toxicity study in mice (35 days) 2 % sodium benzoate in drinking water was taken to be the no-observed-effect-level (approx. 6 g/kg bw/d). An oral subchronic toxicity study in mice (90 days) showed a minimal effect level of 80 mg benzoic acid/kg bw/d. Data are not sufficient to justify conclusion. In a 90-day feeding study in rats the no-observed-effect-level was 2.6 g sodium benzoate/kg bw/d, compared with other studies this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the hig","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg | rat | oral | chronic | developmental toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the highest dose of 500 mg/kg body weight per day. However data presented are summarised results and very old (1960. There was no influence on reproduction after application of up to 1 % (approx. 0.5 g/kg bw/d) in the diet. Sodium benzoate in two long-term studies with rats and mice did not show evidence of carcinogenicity. No carcinogenic data for benzoic acid was given. There are no adequate studies available on inhalation exposure. Benzoic acid is a skin and eye irritant in rabbits. It causes irri","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =250 | mg/kg bw | rabbit | - | - | NOAEL study | {"dose":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","effect":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_012"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | dermal absorption | {"citation":"Ref. : 41 2","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"id was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approx. 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL : 500 mg/kg bw Ref. : 41 2.7. Toxicokinetics (incl. Percutaneous Absorption) Benzoic acid 14C-labelled benzoic acid (4 - 40 µg/cm2 dissolved in acetone) was applied to excised human skin in a static diffusion chamber. Samples of penetrated amounts were measured in 1- 2 hr interval over the first 24 hrs and 3-6 hrs interval over the remaining days. A median of 44.9 % of the applied benzoic acid was found in the receptor phase 48 hrs after application. Ref. : 34 Percutaneous absorption of benzoic acid was studied in","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | intravenous | 16 months | NOAEL study | {"citation":"Ref. : 42 2","dose":"However no differences in mortality rates between treated and control group was seen.","effect":"ring the first 16 months, except for myeloproliferative disorder developed in one female control rat, all other dead animals showed pneumonia with abscess. Around 100 rats including those of the control group died after 16 months of hemorrhagic pneumonia with edema. However no differences in mortality rates between treated and control group was seen. Although a variety of tumours occurred among test and control rats of each sex, tumours in treated rats were similar in type and number of those of the control group. NOEL: 1000 mg/kg bw/d Ref. : 42 2.10. Special investigations Serious metabolic disturbances in premature neonates given intravenous fluids with benzyl alcohol have been attributed to the accumulation of benzoic acid metabolites of the benzyl alcohol. This risk has led to the recommendation that the CNS stimulant, caffeine and sodium benzoate injection should not be given to neonates. Ref. : AR 10 Benzoic acid can also displace bound bilirubin from albumin, putting neonates at risk from kernicterus. Ref. : AR 11 Sodium","page":15,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"ox. 1 g/kg bw/d) in the diet is tolerated by rats. In an oral subacute toxicity study in mice (35 days) 2 % sodium benzoate in drinking water was taken to be the no-observed-effect-level (approx. 6 g/kg bw/d). An oral subchronic toxicity study in mice (90 days) showed a minimal effect level of 80 mg benzoic acid/kg bw/d. Data are not sufficient to justify conclusion. In a 90-day feeding study in rats the no-observed-effect-level was 2.6 g sodium benzoate/kg bw/d, compared with other studies this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the hig","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg | rat | oral | chronic | developmental toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the highest dose of 500 mg/kg body weight per day. However data presented are summarised results and very old (1960. There was no influence on reproduction after application of up to 1 % (approx. 0.5 g/kg bw/d) in the diet. Sodium benzoate in two long-term studies with rats and mice did not show evidence of carcinogenicity. No carcinogenic data for benzoic acid was given. There are no adequate studies available on inhalation exposure. Benzoic acid is a skin and eye irritant in rabbits. It causes irri","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =250 | mg/kg bw | rabbit | - | - | NOAEL study | {"dose":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","effect":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_012"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | dermal absorption | {"citation":"Ref. : 41 2","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"id was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approx. 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL : 500 mg/kg bw Ref. : 41 2.7. Toxicokinetics (incl. Percutaneous Absorption) Benzoic acid 14C-labelled benzoic acid (4 - 40 µg/cm2 dissolved in acetone) was applied to excised human skin in a static diffusion chamber. Samples of penetrated amounts were measured in 1- 2 hr interval over the first 24 hrs and 3-6 hrs interval over the remaining days. A median of 44.9 % of the applied benzoic acid was found in the receptor phase 48 hrs after application. Ref. : 34 Percutaneous absorption of benzoic acid was studied in","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | intravenous | 16 months | NOAEL study | {"citation":"Ref. : 42 2","dose":"However no differences in mortality rates between treated and control group was seen.","effect":"ring the first 16 months, except for myeloproliferative disorder developed in one female control rat, all other dead animals showed pneumonia with abscess. Around 100 rats including those of the control group died after 16 months of hemorrhagic pneumonia with edema. However no differences in mortality rates between treated and control group was seen. Although a variety of tumours occurred among test and control rats of each sex, tumours in treated rats were similar in type and number of those of the control group. NOEL: 1000 mg/kg bw/d Ref. : 42 2.10. Special investigations Serious metabolic disturbances in premature neonates given intravenous fluids with benzyl alcohol have been attributed to the accumulation of benzoic acid metabolites of the benzyl alcohol. This risk has led to the recommendation that the CNS stimulant, caffeine and sodium benzoate injection should not be given to neonates. Ref. : AR 10 Benzoic acid can also displace bound bilirubin from albumin, putting neonates at risk from kernicterus. Ref. : AR 11 Sodium","page":15,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"ox. 1 g/kg bw/d) in the diet is tolerated by rats. In an oral subacute toxicity study in mice (35 days) 2 % sodium benzoate in drinking water was taken to be the no-observed-effect-level (approx. 6 g/kg bw/d). An oral subchronic toxicity study in mice (90 days) showed a minimal effect level of 80 mg benzoic acid/kg bw/d. Data are not sufficient to justify conclusion. In a 90-day feeding study in rats the no-observed-effect-level was 2.6 g sodium benzoate/kg bw/d, compared with other studies this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the hig","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg | rat | oral | chronic | developmental toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the highest dose of 500 mg/kg body weight per day. However data presented are summarised results and very old (1960. There was no influence on reproduction after application of up to 1 % (approx. 0.5 g/kg bw/d) in the diet. Sodium benzoate in two long-term studies with rats and mice did not show evidence of carcinogenicity. No carcinogenic data for benzoic acid was given. There are no adequate studies available on inhalation exposure. Benzoic acid is a skin and eye irritant in rabbits. It causes irri","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =250 | mg/kg bw | rabbit | - | - | NOAEL study | {"dose":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","effect":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_012"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | dermal absorption | {"citation":"Ref. : 41 2","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"id was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approx. 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL : 500 mg/kg bw Ref. : 41 2.7. Toxicokinetics (incl. Percutaneous Absorption) Benzoic acid 14C-labelled benzoic acid (4 - 40 µg/cm2 dissolved in acetone) was applied to excised human skin in a static diffusion chamber. Samples of penetrated amounts were measured in 1- 2 hr interval over the first 24 hrs and 3-6 hrs interval over the remaining days. A median of 44.9 % of the applied benzoic acid was found in the receptor phase 48 hrs after application. Ref. : 34 Percutaneous absorption of benzoic acid was studied in","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_006"} |
| SCCNFP_vision_codex | NOAEL | =1000 | mg/kg bw/d | rat | intravenous | 16 months | NOAEL study | {"citation":"Ref. : 42 2","dose":"However no differences in mortality rates between treated and control group was seen.","effect":"ring the first 16 months, except for myeloproliferative disorder developed in one female control rat, all other dead animals showed pneumonia with abscess. Around 100 rats including those of the control group died after 16 months of hemorrhagic pneumonia with edema. However no differences in mortality rates between treated and control group was seen. Although a variety of tumours occurred among test and control rats of each sex, tumours in treated rats were similar in type and number of those of the control group. NOEL: 1000 mg/kg bw/d Ref. : 42 2.10. Special investigations Serious metabolic disturbances in premature neonates given intravenous fluids with benzyl alcohol have been attributed to the accumulation of benzoic acid metabolites of the benzyl alcohol. This risk has led to the recommendation that the CNS stimulant, caffeine and sodium benzoate injection should not be given to neonates. Ref. : AR 10 Benzoic acid can also displace bound bilirubin from albumin, putting neonates at risk from kernicterus. Ref. : AR 11 Sodium","page":15,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_007"} |
| SCCNFP_vision_codex | NOAEL | =300 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"ox. 1 g/kg bw/d) in the diet is tolerated by rats. In an oral subacute toxicity study in mice (35 days) 2 % sodium benzoate in drinking water was taken to be the no-observed-effect-level (approx. 6 g/kg bw/d). An oral subchronic toxicity study in mice (90 days) showed a minimal effect level of 80 mg benzoic acid/kg bw/d. Data are not sufficient to justify conclusion. In a 90-day feeding study in rats the no-observed-effect-level was 2.6 g sodium benzoate/kg bw/d, compared with other studies this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the hig","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_008"} |
| SCCNFP_vision_codex | NOAEL | =500 | mg/kg | rat | oral | chronic | developmental toxicity | {"dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","effect":"this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the highest dose of 500 mg/kg body weight per day. However data presented are summarised results and very old (1960. There was no influence on reproduction after application of up to 1 % (approx. 0.5 g/kg bw/d) in the diet. Sodium benzoate in two long-term studies with rats and mice did not show evidence of carcinogenicity. No carcinogenic data for benzoic acid was given. There are no adequate studies available on inhalation exposure. Benzoic acid is a skin and eye irritant in rabbits. It causes irri","page":16,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_009"} |
| SCCNFP_vision_codex | NOAEL | =250 | mg/kg bw | rabbit | - | - | NOAEL study | {"dose":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","effect":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","page":12,"pdf":"out166_en.pdf","row_type":"noael_study","study_id":"out166_en_noael_012"} |
SCCS_vision_codex 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days","dose":"45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days.","effect":"e not sufficient to justify conclusion. Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased with histopathological changes in liver and kidney (7/16). Data are insufficient to justify a NOAEL of 4 % in the diet (2.6 g/kg bw/d). Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref.: 45 10 male and 10 female rats received 4","page":16,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | NOAEL study | {"citation":"Ref.: 41 3","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approximately 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL: 500 mg/kg bw. Ref.: 41 3.3.8.2. Teratogenicity Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 on pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. The data was considered inadequate, since only a single dose was used. Ref.: 46 Sodium benzoate Sodium benzoate at doses of 0, 1.75, 8, 38 and 175 mg/kg bw was administered by gavage to groups of at","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_002"} |
| SCCS_vision_codex | NOAEL | =175 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 47","dose":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.","effect":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"w on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_005"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_006"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | human | - | - | NOAEL study | {"dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","effect":"e-products (ep): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","page":23,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"citation":"Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity","dose":"There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.","effect":"oncluded that the data reviewed for compounds in this group were sufficient to demonstrate lack of teratogenic, reproductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic","page":24,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_010"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days","dose":"45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days.","effect":"e not sufficient to justify conclusion. Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased with histopathological changes in liver and kidney (7/16). Data are insufficient to justify a NOAEL of 4 % in the diet (2.6 g/kg bw/d). Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref.: 45 10 male and 10 female rats received 4","page":16,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | NOAEL study | {"citation":"Ref.: 41 3","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approximately 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL: 500 mg/kg bw. Ref.: 41 3.3.8.2. Teratogenicity Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 on pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. The data was considered inadequate, since only a single dose was used. Ref.: 46 Sodium benzoate Sodium benzoate at doses of 0, 1.75, 8, 38 and 175 mg/kg bw was administered by gavage to groups of at","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_002"} |
| SCCS_vision_codex | NOAEL | =175 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 47","dose":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.","effect":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"w on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_005"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_006"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | human | - | - | NOAEL study | {"dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","effect":"e-products (ep): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","page":23,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"citation":"Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity","dose":"There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.","effect":"oncluded that the data reviewed for compounds in this group were sufficient to demonstrate lack of teratogenic, reproductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic","page":24,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_010"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days","dose":"45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days.","effect":"e not sufficient to justify conclusion. Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased with histopathological changes in liver and kidney (7/16). Data are insufficient to justify a NOAEL of 4 % in the diet (2.6 g/kg bw/d). Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref.: 45 10 male and 10 female rats received 4","page":16,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | NOAEL study | {"citation":"Ref.: 41 3","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approximately 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL: 500 mg/kg bw. Ref.: 41 3.3.8.2. Teratogenicity Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 on pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. The data was considered inadequate, since only a single dose was used. Ref.: 46 Sodium benzoate Sodium benzoate at doses of 0, 1.75, 8, 38 and 175 mg/kg bw was administered by gavage to groups of at","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_002"} |
| SCCS_vision_codex | NOAEL | =175 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 47","dose":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.","effect":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"w on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_005"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_006"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | human | - | - | NOAEL study | {"dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","effect":"e-products (ep): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","page":23,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"citation":"Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity","dose":"There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.","effect":"oncluded that the data reviewed for compounds in this group were sufficient to demonstrate lack of teratogenic, reproductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic","page":24,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_010"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | 90 days | NOAEL study | {"citation":"Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days","dose":"45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days.","effect":"e not sufficient to justify conclusion. Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased with histopathological changes in liver and kidney (7/16). Data are insufficient to justify a NOAEL of 4 % in the diet (2.6 g/kg bw/d). Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref.: 45 10 male and 10 female rats received 4","page":16,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_001"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw | rat | oral | 16 weeks | NOAEL study | {"citation":"Ref.: 41 3","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","effect":"conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approximately 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL: 500 mg/kg bw. Ref.: 41 3.3.8.2. Teratogenicity Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 on pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. The data was considered inadequate, since only a single dose was used. Ref.: 46 Sodium benzoate Sodium benzoate at doses of 0, 1.75, 8, 38 and 175 mg/kg bw was administered by gavage to groups of at","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_002"} |
| SCCS_vision_codex | NOAEL | =175 | mg/kg bw | rat | oral | - | NOAEL study | {"citation":"Ref.: 47","dose":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.","effect":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_003"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"w on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_005"} |
| SCCS_vision_codex | NOAEL | =250 | mg/kg bw | rat | - | - | NOAEL study | {"citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","effect":"Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","page":21,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_006"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/d | human | - | - | NOAEL study | {"dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","effect":"e-products (ep): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","page":23,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_007"} |
| SCCS_vision_codex | NOAEL | =500 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | {"citation":"Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity","dose":"There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.","effect":"oncluded that the data reviewed for compounds in this group were sufficient to demonstrate lack of teratogenic, reproductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic","page":24,"pdf":"sccp_o_015.pdf","row_type":"noael_study","study_id":"sccp_o_015_noael_010"} |
ToxValDB_Alaska_DEC 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_Alaska_DEC | RfD | =4 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/610038e1e4b01a90a3f9ae63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://dec.alaska.gov/spar/csp/; STUDY_GROUP=Alaska DEC:15446024:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=00128bf1cd04ccc97b9bcc07ad822af5 |
| ToxValDB_Alaska_DEC | RfD | =4 | mg/kg bw/day | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/610038e1e4b01a90a3f9ae63; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://dec.alaska.gov/spar/csp/; STUDY_GROUP=Alaska DEC:15446024:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=00128bf1cd04ccc97b9bcc07ad822af5 |
ToxValDB_ECHA_IUCLID 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | =340 | mg/kg bw/day | Cat | oral | short-term; 15 days | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb54e4b0a7c65d225b62; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10053/7/6/2?documentUUID=a97a5c25-b1ff-482d-9c06-e11a40bfd00c; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15835622_15835623_15836064_15836065: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_6526e12b8c404c2740e465df9e9899e3 |
| ToxValDB_ECHA_IUCLID | LOAEL | =2500 | mg/kg bw/day | Rat | oral | subchronic; 5 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadd4e4b0a7c65d1c61e6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15838076_15838077: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_05e19aafd4d0c7ea9309146be7b826c3 |
| ToxValDB_ECHA_IUCLID | NOAEL | >2500 | mg/kg bw/day | Rabbit | dermal | acute; 6 hours | acute | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c61e7ce4b096bca8779dc7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10053/7/6/4?documentUUID=a97a5c25-b1ff-482d-9c06-e11a40bfd00c; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID:15826526: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_9ee7446d62dae9b68fc57e09c28889fc |
| ToxValDB_ECHA_IUCLID | NOAEL | =200 | mg/kg bw/day | Cat | oral | short-term; 15 days | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cb54e4b0a7c65d225b62; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/10053/7/6/2?documentUUID=a97a5c25-b1ff-482d-9c06-e11a40bfd00c; YEAR=1982; ORIGINAL_YEAR=1982; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15835622_15835623_15836064_15836065: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_176f41eb459a676bca0176e135fdf5f7 |
| ToxValDB_ECHA_IUCLID | NOAEL | =648 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadd4e4b0a7c65d1c61d7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15835795_15842960:-:--; 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_e4bc7e85ce6c850559596828b5dc8565 |
| ToxValDB_ECHA_IUCLID | NOAEL | =500 | mg/kg bw/day | Rat | oral | subchronic; 5 weeks | subchronic | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadd4e4b0a7c65d1c61e6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15838076_15838077: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_49325165e836f30a5f3ba72974ad1ed6 |
| ToxValDB_ECHA_IUCLID | NOEL | =1000 | mg/kg bw/day | Rat | oral | short-term; 2 weeks | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cad6e4b0a7c65d223ab3; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/24934/7/6/2?documentUUID=11d691ad-8c1b-4c0d-9f47-9c18d29c10a5; YEAR=1976; ORIGINAL_YEAR=1976; STUDY_GROUP=ECHA IUCLID:15834733: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_154513ef75a75d87286d56540a020f29 |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =15.2 | g/org-day | Rat | oral | chronic; 224 days | chronic | LONG_REF=Carcinogenesis14(2): 275-280 Shibata,M.A., M. Hirose, M. Kagawa, P. Boonyaphiphat, and N. Ito Enhancing Effect of Concomitant L-Ascorbic Acid Administration on BHA-Induced Forestomach Carcinogenesis in Rats 1993; TITLE=Enhancing Effect of Concomitant L-Ascorbic Acid Administration on BHA-Induced Forestomach Carcinogenesis in Rats; AUTHOR=Shibata,M.A., M. Hirose, M. Kagawa, P. Boonyaphiphat, and N. Ito; DOI=10.1093/carcin/14.2.275; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75903; 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=1993; ORIGINAL_YEAR=1993; TOXICOLOGICAL_EFFECT=Growth: Weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight; STUDY_GROUP=ECOTOX:15599259:unknown:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=b2231851c484aaaeafef9cd7fd49510d |
| ToxValDB_ECOTOX | NOEL | =1000 | mg/kg bw/day | Mouse | oral | acute; 1 days | acute | LONG_REF=Mutat. Res.519(1/2): 103-119 Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives 2002; TITLE=The Comet Assay with 8 Mouse Organs: Results with 39 Currently Used Food Additives; AUTHOR=Sasaki,Y.F., S. Kawaguchi, A. Kamaya, M. Ohshita, K. Kabasawa, K. Iwama, K. Taniguchi, and S. Tsuda; DOI=10.1016/s1383-5718(02)00128-6; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=75840; 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=2002; ORIGINAL_YEAR=2002; TOXICOLOGICAL_EFFECT=Genetics: Damage; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15597280:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=52377f612c3fb4f79116f6d28b0039e7 |
ToxValDB_EFSA 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | LEL | =10000 | mg/kg bw/day | Pig | oral | - | repeat dose other | LONG_REF=EFSA FEEDAP (2005). Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product VevoVitall as a feed additive for weaned piglets in accordance with Regulation (EC) No 1831/2003. doi:10.2903/j.efsa.2005.290.; TITLE=Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of the product VevoVitall as a feed additive for weaned piglets in accordance with Regulation (EC) No 1831/2003; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2005.290; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2005; ORIGINAL_YEAR=2005; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; STUDY_GROUP=EFSA_dup_-_15614171_15614172:-:--; 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_0dea15e2a1074e82305f90c52fc3f1da |
| ToxValDB_EFSA | LEL | =20000 | mg/kg bw/day | Pig | oral | subchronic; 84 days | subchronic | LONG_REF=EFSA FEEDAP (2007). Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of VevoVitall (benzoic acid) as feed additive for pigs for fattening. doi:10.2903/j.efsa.2007.457.; TITLE=Opinion of the Scientific Panel on Additives and Products or Substances used in Animal Feed on the safety and efficacy of VevoVitall (benzoic acid) as feed additive for pigs for fattening; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2007.457; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=organ weight; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=EFSA:15614173:-:--; 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_e980ceb23c80cfdc58b213cb86d028e7 |
| ToxValDB_EFSA | LEL | =5000 | mg/kg bw/day | Pig | oral | subchronic; 42 days | subchronic | LONG_REF=EFSA FEEDAP (2018). Safety and efficacy of benzoic acid for pigs and poultry. doi:10.2903/j.efsa.2018.5210.; TITLE=Safety and efficacy of benzoic acid for pigs and poultry; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2018.5210; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614186: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_b04b93ba97b94befa6d1291eeb08949c |
| ToxValDB_EFSA | LEL | =1500 | mg/kg bw/day | Chicken | oral | subchronic; 36 days | subchronic | LONG_REF=EFSA FEEDAP (2018). Safety and efficacy of benzoic acid for pigs and poultry. doi:10.2903/j.efsa.2018.5210.; TITLE=Safety and efficacy of benzoic acid for pigs and poultry; AUTHOR=EFSA FEEDAP; DOI=doi:10.2903/j.efsa.2018.5210; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2018; ORIGINAL_YEAR=2018; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614187: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_1cf7ce6c1ead0cde1795647f52dadd6c |
| ToxValDB_EFSA | NOAEL | =1310 | mg/kg bw/day | Rat | oral | - | reproduction developmental | LONG_REF=EFSA ANS (2016). Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives. doi:10.2903/j.efsa.2016.4433.; TITLE=Scientific Opinion on the re-evaluation of benzoic acid (E 210), sodium benzoate (E 211), potassium benzoate (E 212) and calcium benzoate (E 213) as food additives; AUTHOR=EFSA ANS; DOI=doi:10.2903/j.efsa.2016.4433; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=EFSA:15614175:-:--; 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_9a1999b2b3aebec7d35a2d4c6ddb626e |
| ToxValDB_EFSA | NOAEL | =500 | mg/kg bw/day | Rat | oral | chronic; 16 weeks | chronic | LONG_REF=EFSA (2016). Peer review of the pesticide risk assessment of the active substance benzoic acid. doi:10.2903/j.efsa.2016.4657.; TITLE=Peer review of the pesticide risk assessment of the active substance benzoic acid; AUTHOR=EFSA; DOI=doi:10.2903/j.efsa.2016.4657; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2016; ORIGINAL_YEAR=2016; TOXICOLOGICAL_EFFECT=histopathology: nonneoplastic; STUDY_GROUP=EFSA:15614181:-:--; 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_a4356e33e211cbee405942b7f8f699e3 |
ToxValDB_GESTIS_DNEL 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL local | =0.1 | 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_dup_-_15630024_15630025:-:--; 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_3747f40811ad6264a478f99892b353a0 |
| ToxValDB_GESTIS_DNEL | DNEL systemic | =3 | 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_dup_-_15630024_15630025:-:--; 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_b26027aef50fa7af1e9023a7f30378a8 |
ToxValDB_IRIS 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_IRIS | NOAEL | =4.4 | mg/kg bw/day | Human | oral | - | epidemiologic | LONG_REF=FDA (Food and Drug Administration). 1973. Evaluation of the Health Aspects of Benzoic Acid and Sodium Benzoate as Food Ingredients. DHEW, Washington, DC. Report No. SCOGS-7. NTIS PB-223837/6.; TITLE=Evaluation of the Health Aspects of Benzoic Acid and Sodium Benzoate as Food Ingredients; AUTHOR=FDA (Food and Drug Administration); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/652e8a3be4b045b9ff7a57a4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/iris; SUBSOURCE_URL=https://iris.epa.gov/ChemicalLanding/&substance_nmbr=355; TOXICOLOGICAL_EFFECT=no effects; STUDY_GROUP=IRIS:15644411:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_943cf6a96653374cb5cca29933c1340e |
ToxValDB_PPRTV_(CPHEA) 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_PPRTV_(CPHEA) | LOAEL (HEC) | =1.9 | mg/m3 | Rat | inhalation | short-term; 4 weeks | short-term | LONG_REF=IRDC 1981; AUTHOR=IRDC; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b355; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1589; TOXICOLOGICAL_EFFECT=pulmonary effects; STUDY_GROUP=PPRTV (CPHEA):15653423:M/F:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_503ff266725b1de1cd43b11aebecc898 |
| ToxValDB_PPRTV_(CPHEA) | RfC (provisional) | =0.002 | mg/m3 | Human | inhalation | - | Toxicity Value | LONG_REF=IRDC 1981; AUTHOR=IRDC; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/640754bee4b08a6b3934b355; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.epa.gov/pprtv/basic-information-about-provisional-peer-reviewed-toxicity-values-pprtvs; SUBSOURCE_URL=https://cfpub.epa.gov/ncea/pprtv/chemicalLanding.cfm?pprtv_sub_id=1589; TOXICOLOGICAL_EFFECT=Pulmonary effects in male/female rats; STUDY_GROUP=PPRTV (CPHEA):15653422:-:--; QC_CATEGORY=Manually extracted from unstructured data source; Source overall passed QC, and this record was manually checked; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c14b748d583a1d3f623eb9c0d2422e85 |
ToxValDB_Uterotrophic_Hershberger_DB 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =1 | ug/100 g | Mouse | 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=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:15713785:-:--; 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_472db6563131ccf67e4fb92e69405abf |
| ToxValDB_Uterotrophic_Hershberger_DB | LEL | =10 | ug/100 g BW | Mouse | 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=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:15713788:-:--; 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_ea863a56fb9e785a6d14e3ab67278a02 |
ToxValDB_WHO_JECFA_ADI 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_WHO_JECFA_ADI | ADI | <=20 | mg/kg | Human | oral | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/650afa11e4b0d99f5a878f74; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/; SUBSOURCE_URL=https://apps.who.int/food-additives-contaminants-jecfa-database/Home/Chemical/1754; YEAR=2021; ORIGINAL_YEAR=2021; STUDY_GROUP=WHO JECFA ADI:15715339:-:--; 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_982e23b482dfb8d3e6dba6294c378567 |
UnifiedCodex:SCCNFP:beta.noael_studies 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 4 | % | rat | oral | 90 days | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=4; DOSE=4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased.; EFFECT=e quality of the data are not sufficient to be conclusive. Ref. : 38 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate (0.6, 1.3, 2.6 and 6.3 g/kg bw/d) in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased. Moreover, frequent pathological lesion were noted (7/16). Data are insufficient to justify NOAEL 4 % in the diet (2.6 g/kg bw/d). Ref. : 6 2.3.7. Chronic toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref. : 38 10 male and 10 female rats received 40 mg benzoic acid/kg; CITATION=Ref. : 38 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate (0; CITATION_NUMBERS=[38,4,5,1,2,8]; REFERENCE=Ref. : 38 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate (0; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 38 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate (0","dose":"4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased.","duration":"90 days","effect":"e quality of the data are not sufficient to be conclusive. Ref. : 38 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate (0.6, 1.3, 2.6 and 6.3 g/kg bw/d) in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased. Moreover, frequent pathological lesion were noted (7/16). Data are insufficient to justify NOAEL 4 % in the diet (2.6 g/kg bw/d). Ref. : 6 2.3.7. Chronic toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref. : 38 10 male and 10 female rats received 40 mg benzoic acid/kg","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"%","noael_value":"4","page":8,"route":"oral","species":"rat","study_id":"out166_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 175 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=175; DOSE=The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.; EFFECT=SCCNFP/0532/01, final Evaluation and opinion on : Benzoic acid and sodium benzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four; CITATION=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; CITATION_NUMBERS=[39,510,7,9]; REFERENCE=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","duration":"","effect":"SCCNFP/0532/01, final Evaluation and opinion on : Benzoic acid and sodium benzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"175","page":12,"route":"","species":"rat","study_id":"out166_en_noael_002"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 175 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=175; DOSE=The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.; EFFECT=al Evaluation and opinion on : Benzoic acid and sodium benzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four generation study with benzoic acid was conducted in rats. Males and females of the first and sec; CITATION=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; CITATION_NUMBERS=[39,510,7,9]; REFERENCE=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","duration":"","effect":"al Evaluation and opinion on : Benzoic acid and sodium benzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four generation study with benzoic acid was conducted in rats. Males and females of the first and sec","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"175","page":12,"route":"","species":"rat","study_id":"out166_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 300 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=300; DOSE=The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.; EFFECT=: Benzoic acid and sodium benzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four generation study with benzoic acid was conducted in rats. Males and females of the first and second generation were fed 0.5 o; CITATION=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; CITATION_NUMBERS=[39,510,7,9]; REFERENCE=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","duration":"","effect":": Benzoic acid and sodium benzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four generation study with benzoic acid was conducted in rats. Males and females of the first and second generation were fed 0.5 o","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":12,"route":"","species":"rat","study_id":"out166_en_noael_004"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 250 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=250; DOSE=The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.; EFFECT=nzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four generation study with benzoic acid was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the; CITATION=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; CITATION_NUMBERS=[39,510,7,9]; REFERENCE=Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestati","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","duration":"","effect":"nzoate ____________________________________________________________________________________________ 12 There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies were in all species identical with the highest dose tested : mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref. : 39 Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. Ref. : 40 2.6.1. Multi-generation reproduction toxicity Benzoic acid A four generation study with benzoic acid was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":12,"route":"","species":"rat","study_id":"out166_en_noael_005"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 1000 | mg/kg bw/d | rat | intravenous | 16 months | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=1000; DOSE=However no differences in mortality rates between treated and control group was seen.; EFFECT=ring the first 16 months, except for myeloproliferative disorder developed in one female control rat, all other dead animals showed pneumonia with abscess. Around 100 rats including those of the control group died after 16 months of hemorrhagic pneumonia with edema. However no differences in mortality rates between treated and control group was seen. Although a variety of tumours occurred among test and control rats of each sex, tumours in treated rats were similar in type and number of those of the control group. NOEL: 1000 mg/kg bw/d Ref. : 42 2.10. Special investigations Serious metabolic disturbances in premature neonates given intravenous fluids with benzyl alcohol have been attributed to the accumulation of benzoic acid metabolites of the benzyl alcohol. This risk has led to the recommendation that the CNS stimulant, caffeine and sodium benzoate injection should not be given to neonates. Ref. : AR 10 Benzoic acid can also displace bound bilirubin from albumin, putting neonates at risk from kernicterus. Ref. : AR 11 Sodium; CITATION=Ref. : 42 2; CITATION_NUMBERS=[42,2]; REFERENCE=Ref. : 42 2; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 42 2","dose":"However no differences in mortality rates between treated and control group was seen.","duration":"16 months","effect":"ring the first 16 months, except for myeloproliferative disorder developed in one female control rat, all other dead animals showed pneumonia with abscess. Around 100 rats including those of the control group died after 16 months of hemorrhagic pneumonia with edema. However no differences in mortality rates between treated and control group was seen. Although a variety of tumours occurred among test and control rats of each sex, tumours in treated rats were similar in type and number of those of the control group. NOEL: 1000 mg/kg bw/d Ref. : 42 2.10. Special investigations Serious metabolic disturbances in premature neonates given intravenous fluids with benzyl alcohol have been attributed to the accumulation of benzoic acid metabolites of the benzyl alcohol. This risk has led to the recommendation that the CNS stimulant, caffeine and sodium benzoate injection should not be given to neonates. Ref. : AR 10 Benzoic acid can also displace bound bilirubin from albumin, putting neonates at risk from kernicterus. Ref. : AR 11 Sodium","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"1000","page":15,"route":"intravenous","species":"rat","study_id":"out166_en_noael_007"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 175 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=175; DOSE=Visible table on page 12: mice and rats | NOEL | 175 mg/kg bw; EFFECT=Visible table on page 12: mice and rats | NOEL | 175 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Visible table on page 12: mice and rats | NOEL | 175 mg/kg bw","duration":"","effect":"Visible table on page 12: mice and rats | NOEL | 175 mg/kg bw","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"175","page":12,"route":"","species":"rat","study_id":"out166_en_noael_010"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 300 | mg/kg bw | - | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=300; DOSE=Visible table on page 12: hamsters | NOEL | 300 mg/kg bw; EFFECT=Visible table on page 12: hamsters | NOEL | 300 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Visible table on page 12: hamsters | NOEL | 300 mg/kg bw","duration":"","effect":"Visible table on page 12: hamsters | NOEL | 300 mg/kg bw","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":12,"route":"","species":"","study_id":"out166_en_noael_011"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | - | 250 | mg/kg bw | rabbit | - | - | - | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=250; DOSE=Visible table on page 12: rabbits | NOEL | 250 mg/kg bw; EFFECT=Visible table on page 12: rabbits | NOEL | 250 mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","duration":"","effect":"Visible table on page 12: rabbits | NOEL | 250 mg/kg bw","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":12,"route":"","species":"rabbit","study_id":"out166_en_noael_012"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | dermal absorption | 500 | mg/kg bw | rat | oral | 16 weeks | dermal absorption | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=500; DOSE=The third generation was treated for 16 weeks and generation 4 was treated until breeding.; EFFECT=id was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approx. 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL : 500 mg/kg bw Ref. : 41 2.7. Toxicokinetics (incl. Percutaneous Absorption) Benzoic acid 14C-labelled benzoic acid (4 - 40 µg/cm2 dissolved in acetone) was applied to excised human skin in a static diffusion chamber. Samples of penetrated amounts were measured in 1- 2 hr interval over the first 24 hrs and 3-6 hrs interval over the remaining days. A median of 44.9 % of the applied benzoic acid was found in the receptor phase 48 hrs after application. Ref. : 34 Percutaneous absorption of benzoic acid was studied in; CITATION=Ref. : 41 2; CITATION_NUMBERS=[41,2]; REFERENCE=Ref. : 41 2; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref. : 41 2","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","duration":"16 weeks","effect":"id was conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approx. 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL : 500 mg/kg bw Ref. : 41 2.7. Toxicokinetics (incl. Percutaneous Absorption) Benzoic acid 14C-labelled benzoic acid (4 - 40 µg/cm2 dissolved in acetone) was applied to excised human skin in a static diffusion chamber. Samples of penetrated amounts were measured in 1- 2 hr interval over the first 24 hrs and 3-6 hrs interval over the remaining days. A median of 44.9 % of the applied benzoic acid was found in the receptor phase 48 hrs after application. Ref. : 34 Percutaneous absorption of benzoic acid was studied in","endpoint":"dermal absorption","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"500","page":12,"route":"oral","species":"rat","study_id":"out166_en_noael_006"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 500 | mg/kg | rat | oral | chronic | developmental toxicity | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=500; DOSE=Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.; EFFECT=this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the highest dose of 500 mg/kg body weight per day. However data presented are summarised results and very old (1960. There was no influence on reproduction after application of up to 1 % (approx. 0.5 g/kg bw/d) in the diet. Sodium benzoate in two long-term studies with rats and mice did not show evidence of carcinogenicity. No carcinogenic data for benzoic acid was given. There are no adequate studies available on inhalation exposure. Benzoic acid is a skin and eye irritant in rabbits. It causes irri; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","duration":"chronic","effect":"this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the highest dose of 500 mg/kg body weight per day. However data presented are summarised results and very old (1960. There was no influence on reproduction after application of up to 1 % (approx. 0.5 g/kg bw/d) in the diet. Sodium benzoate in two long-term studies with rats and mice did not show evidence of carcinogenicity. No carcinogenic data for benzoic acid was given. There are no adequate studies available on inhalation exposure. Benzoic acid is a skin and eye irritant in rabbits. It causes irri","endpoint":"developmental toxicity","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg","noael_value":"500","page":16,"route":"oral","species":"rat","study_id":"out166_en_noael_009"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 300 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | SOURCE_SUBDIR=out166_en; REPORT_TITLE=OPINION OF THE SCIENTIFIC COMMITTEE ON COSMETIC PRODUCTS AND NON-FOOD PRODUCTS INTENDED FOR CONSUMERS CONCERNING BENZOIC ACID AND SODIUM BENZOATE; OPINION_NUMBER=SCCNFP/0532/01; COMMITTEE=SCCNFP; REPORT_DATE=4 June 2002; VALUE_TEXT=300; DOSE=Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.; EFFECT=ox. 1 g/kg bw/d) in the diet is tolerated by rats. In an oral subacute toxicity study in mice (35 days) 2 % sodium benzoate in drinking water was taken to be the no-observed-effect-level (approx. 6 g/kg bw/d). An oral subchronic toxicity study in mice (90 days) showed a minimal effect level of 80 mg benzoic acid/kg bw/d. Data are not sufficient to justify conclusion. In a 90-day feeding study in rats the no-observed-effect-level was 2.6 g sodium benzoate/kg bw/d, compared with other studies this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the hig; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw.","duration":"subacute","effect":"ox. 1 g/kg bw/d) in the diet is tolerated by rats. In an oral subacute toxicity study in mice (35 days) 2 % sodium benzoate in drinking water was taken to be the no-observed-effect-level (approx. 6 g/kg bw/d). An oral subchronic toxicity study in mice (90 days) showed a minimal effect level of 80 mg benzoic acid/kg bw/d. Data are not sufficient to justify conclusion. In a 90-day feeding study in rats the no-observed-effect-level was 2.6 g sodium benzoate/kg bw/d, compared with other studies this seemed an unlikely NOAEL. Data from a chronic study in rats are insufficient since no details of the study were given. Sodium benzoate was tested in mice, rats, rabbits and hamsters for its embryotoxic and teratogenic effects in doses up to 300 mg/kg bw. Based on the results of these studies the No- observed-effect-level can be considered to be 175 mg/kg bw (highest dose in rats and mice). A limited four generation study with benzoic acid was conducted in rats. Preliminary no- observed-(adverse-)effect level (NO(A)EL) derived from the hig","endpoint":"repeated dose toxicity","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":16,"route":"oral","species":"rat","study_id":"out166_en_noael_008"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 11 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 4 | % | rat | oral | 90 days | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=4; DOSE=45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days.; EFFECT=e not sufficient to justify conclusion. Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased with histopathological changes in liver and kidney (7/16). Data are insufficient to justify a NOAEL of 4 % in the diet (2.6 g/kg bw/d). Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref.: 45 10 male and 10 female rats received 4; CITATION=Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days; CITATION_NUMBERS=[45,4,5,1,2,8,640,1320,2620,6290,90]; REFERENCE=Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days","dose":"45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days.","duration":"90 days","effect":"e not sufficient to justify conclusion. Ref.: 45 Sodium benzoate Groups of 4-5 male and 4-5 female rats received 0, 1, 2, 4, and 8 % sodium benzoate equivalent to 640, 1320, 2620, and 6290 mg/kg bw/d in the diet for 90 days. 4/8 animals died (average 13 days to death) in the 8 % dose level group, the average weight gain of the surviving rats was reduced and the relative liver and kidney weight was significantly increased with histopathological changes in liver and kidney (7/16). Data are insufficient to justify a NOAEL of 4 % in the diet (2.6 g/kg bw/d). Ref.: 8 3.3.5.3. Chronic (> 12 months) toxicity Benzoic acid 25 male and 25 female mice were given 40 mg/kg bw/d for 17 months. Benzoic acid was fed in a paste prior to the main feed. The weight of liver, kidney and testes relative to body weight in mice sacrificed at the end of the test period were lower in the group receiving sorbic acid (40 mg/kg bw/d) than in the group treated with benzoic acid. No further details were given. Ref.: 45 10 male and 10 female rats received 4","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"%","noael_value":"4","page":16,"route":"oral","species":"rat","study_id":"sccp_o_015_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg bw | rat | oral | 16 weeks | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=500; DOSE=The third generation was treated for 16 weeks and generation 4 was treated until breeding.; EFFECT=conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approximately 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL: 500 mg/kg bw. Ref.: 41 3.3.8.2. Teratogenicity Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 on pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. The data was considered inadequate, since only a single dose was used. Ref.: 46 Sodium benzoate Sodium benzoate at doses of 0, 1.75, 8, 38 and 175 mg/kg bw was administered by gavage to groups of at; CITATION=Ref.: 41 3; CITATION_NUMBERS=[41,3]; REFERENCE=Ref.: 41 3; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 41 3","dose":"The third generation was treated for 16 weeks and generation 4 was treated until breeding.","duration":"16 weeks","effect":"conducted in rats. Males and females of the first and second generation were fed 0.5 or 1.0 % benzoic acid in the diet (approximately 0.25 or 0.5 g/kg bw d). The third generation was treated for 16 weeks and generation 4 was treated until breeding. There were no unfavourable side-effects on growth, food utilisation, duration of life, procreation, feeding of the offspring, weight of organs and histological pattern of organs in the 1 % dose group. In the 0.5 % group there was a significant prolongation of lifetime. NOAEL: 500 mg/kg bw. Ref.: 41 3.3.8.2. Teratogenicity Benzoic acid In a study to determine the teratologic effects, benzoic acid was administered in a single dose of 510 mg/kg bw to 7 on pregnant Wistar albino rats at day 9 of gestation. The malformations and resorption rates were comparable to those in control animals. The data was considered inadequate, since only a single dose was used. Ref.: 46 Sodium benzoate Sodium benzoate at doses of 0, 1.75, 8, 38 and 175 mg/kg bw was administered by gavage to groups of at","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"500","page":21,"route":"oral","species":"rat","study_id":"sccp_o_015_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 175 | mg/kg bw | rat | oral | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=175; DOSE=of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.; EFFECT=of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47; CITATION=Ref.: 47; CITATION_NUMBERS=[47]; REFERENCE=Ref.: 47; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 47","dose":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.","duration":"","effect":"of 10 Dutch-belted rabbits were artificially inseminated and then dosed by oral intubation with 0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"175","page":21,"route":"oral","species":"rat","study_id":"sccp_o_015_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 175 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=175; DOSE=0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.; EFFECT=0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47; CITATION=Ref.: 47; CITATION_NUMBERS=[47]; REFERENCE=Ref.: 47; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 47","dose":"0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18.","duration":"","effect":"0, 2.5, 12, 54 or 250 mg/kg bw on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"175","page":21,"route":"","species":"rat","study_id":"sccp_o_015_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 300 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=300; DOSE=The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.; EFFECT=w on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47; CITATION=Ref.: 47; CITATION_NUMBERS=[47]; REFERENCE=Ref.: 47; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","duration":"","effect":"w on gestation days 6 to 18. Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"300","page":21,"route":"","species":"rat","study_id":"sccp_o_015_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 250 | mg/kg bw | rat | - | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=250; DOSE=The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.; EFFECT=Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47; CITATION=Ref.: 47; CITATION_NUMBERS=[47]; REFERENCE=Ref.: 47; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 47","dose":"The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls.","duration":"","effect":"Caesareans were performed on mice, rats, hamsters and rabbits on days 17, 20, 14 and 29, respectively. There was no clearly discernible effect on nidation or on maternal or foetal survival. The number of abnormalities seen in either soft or skeletal tissues of the test groups did not differ from the number occurring spontaneously in the sham-treated controls. The NOEL in these studies was in all species identical with the highest dose tested: mice and rats NOEL : 175 mg/kg bw hamsters NOEL : 300 mg/kg bw rabbits NOEL : 250 mg/kg bw Ref.: 47","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw","noael_value":"250","page":21,"route":"","species":"rat","study_id":"sccp_o_015_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg bw/d | human | - | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=500; DOSE=Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):; EFFECT=e-products (ep): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","duration":"","effect":"e-products (ep): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":23,"route":"","species":"human","study_id":"sccp_o_015_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg bw/d | human | - | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=500; DOSE=Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):; EFFECT=f active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","duration":"","effect":"f active ingredient (a. I.) [%] 0.5 Exposure to eye-products E [g/day] 0.05 Maximum amount of a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":23,"route":"","species":"human","study_id":"sccp_o_015_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 500 | mg/kg bw/d | human | - | - | - | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=500; DOSE=Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):; EFFECT=a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"65-85-0","citation":"","dose":"Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS):","duration":"","effect":"a. I. applied Iep [mg/day] 0.25 Non rinse off-products (nro): Maximum content of active ingredient (a. I.) [%] 0.5 Exposure to non rinse-off-products E [g/day] 13.50 Maximum amount of a. I. applied Inro [mg/day] 67.50 Typical body weight (human) TBW [kg] 60 kg Exposure from all product groups: Systemic exposure dose SED [mg/kg bw/d] = [Ioh + Iro + Iep + Inro x A]/TBW = 2.43 No observed adverse effect level (NOAEL) from a 4-generation study 500 mg/kg bw/d (selected by SCF) MARGIN OF SAFETY (MOS): MOS (NOAEL/SED) 500 mg/kg bw/d / 2.43 mg/kg bw/d = 206","endpoint":"","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"500","page":23,"route":"","species":"human","study_id":"sccp_o_015_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 500 | mg/kg bw/day | - | oral | developmental | developmental toxicity | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=500; DOSE=There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.; EFFECT=oductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic activity on benzoic acid should no longer be required. On the basis of these data and the other types of study previ; CITATION=Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity; CITATION_NUMBERS=[56,2002,1994]; REFERENCE=Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity","dose":"There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.","duration":"developmental","effect":"oductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic activity on benzoic acid should no longer be required. On the basis of these data and the other types of study previ","endpoint":"developmental toxicity","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":24,"route":"oral","species":"","study_id":"sccp_o_015_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 500 | mg/kg bw/day | - | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccp_o_015; REPORT_TITLE=OPINION ON Benzoic Acid and Sodium Benzoate; OPINION_NUMBER=SCCP/0891/05; COMMITTEE=Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP); REPORT_DATE=21 June 2005; VALUE_TEXT=500; DOSE=There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.; EFFECT=oncluded that the data reviewed for compounds in this group were sufficient to demonstrate lack of teratogenic, reproductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic; CITATION=Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity; CITATION_NUMBERS=[56,2002,1994]; REFERENCE=Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity; DETAILS_JSON={"cas_number":"65-85-0","citation":"Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity","dose":"There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight.","duration":"developmental","effect":"oncluded that the data reviewed for compounds in this group were sufficient to demonstrate lack of teratogenic, reproductive or carcinogenic potential. Consequently, the Committee concluded that further studies were not required’ Ref.: 56 The conclusions of the SCF in 2002 were: ”The database is much more extensive than that considered by the Committee in 1994, both for developmental toxicity and for genotoxicity. There appear to be sufficient studies to conclude absence of teratogenic potential, with an overall NOAEL for developmental toxicity of 500 mg/kg bw/day, based on effects on foetal weight. The fact that this overall NOAEL takes into account gavage as well as dietary studies gives further reassurance. It is therefore concluded that a further teratogenicity study on benzoic acid should no longer be required. Similarly for genotoxicity, while some of the in vitro tests have been positive or equivocal, all the results from in vivo studies have been negative. It is therefore concluded that an in vivo study for clastogenic","endpoint":"reproductive toxicity","ingredient":"Benzoic acid (INCI name)","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"500","page":24,"route":"oral","species":"","study_id":"sccp_o_015_noael_010"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 8SKN0B0MIM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8SKN0B0MIM"} |
| openFDA substances | FDA UNII substance identifier | 8SKN0B0MIM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8SKN0B0MIM"} |
| openFDA substances | FDA UNII substance identifier | 8SKN0B0MIM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8SKN0B0MIM"} |
| openFDA substances | FDA UNII substance identifier | 8SKN0B0MIM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H6O2","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"8SKN0B0MIM"} |