NOAEL Studies
Preservative
Benzisothiazolinone NOAEL Studies
INCI: BENZISOTHIAZOLINONE
CAS: 2634-33-5
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =10 | mg/kg bw/day | Rat | oral: gavage | 90 days | subchronic | EFSA AFC - 2007 - OutputID 307 - histopathology non neoplastic - systemic - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the presence of 1,2-Benzisothiazolin-3-one as an impurity in saccharin used as a food additive - doi:10.2903/j.efsa.2007.416 |
| EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx | NOAEL | =10 | mg/kg bw/day | Rat | oral: gavage | 90 days | subchronic | EFSA AFC - 2007 - OutputID 307 - histopathology non neoplastic - systemic - Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the presence of 1,2-Benzisothiazolin-3-one as an impurity in saccharin used as a food additive - doi:10.2903/j.efsa.2007.416 |
NTP_ICE_acute_dermal 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_dermal | EPA classification | 3 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=1416; Record_ID=acute_dermal_6; Data_Type=In Vivo; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=3.75; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=3.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_dermal | EPA classification | 4 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=1426; Record_ID=acute_dermal_394; Data_Type=In Vivo; Formulation_ID=MIX388; Formulation_Name=Nuosept Bit; Percent_Active_Ingredient=84.0; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=4.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_dermal | GHS classification | 5 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=1420; Record_ID=acute_dermal_367; Data_Type=In Vivo; Formulation_ID=MIX360; Formulation_Name=Preventol BIT 20N; Percent_Active_Ingredient=20.5; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Dermal Toxicity; Endpoint=GHS classification; Response=5.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_dermal | LD50 | >5000 | mg/kg | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=1415; Record_ID=acute_dermal_367; Data_Type=In Vivo; Formulation_ID=MIX360; Formulation_Name=Preventol BIT 20N; Percent_Active_Ingredient=20.5; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=5000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_dermal | LD50 | >2000 | mg/kg | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=1419; Record_ID=acute_dermal_316; Data_Type=In Vivo; Formulation_ID=MIX309; Formulation_Name=Mergal K10N; Percent_Active_Ingredient=9.68; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Dermal Toxicity; Endpoint=LD50; Response_Modifier=>; Response=2000.0; Response_Unit=mg/kg; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_acute_inhalation 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | GHS Classification | 3 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3107; Record_ID=acute_inhalation_26; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=3.75; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Inhalation Toxicity; Endpoint=GHS Classification; Response=3; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_inhalation | GHS Classification | 2 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3108; Record_ID=acute_inhalation_292; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX360; Formulation_Name=Preventol BIT 20N; Percent_Active_Ingredient=20.5; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Inhalation Toxicity; Endpoint=GHS Classification; Response=2; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_inhalation | LC50 | 0.73 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3111; Record_ID=acute_inhalation_26; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=3.75; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.73; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_acute_inhalation | LC50 | >0.5 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=3112; Record_ID=acute_inhalation_292; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX360; Formulation_Name=Preventol BIT 20N; Percent_Active_Ingredient=20.5; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=>; Response=0.5; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_acute_oral 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12803; row=9131; data_type=In Vivo; mixture=Mixture; formulation_id=MIX388; formulation_name=Nuosept Bit; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=84.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12859; row=9133; data_type=In Vivo; mixture=Mixture; formulation_id=MIX360; formulation_name=Preventol BIT 20N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=20.5; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12729; row=9135; data_type=In Vivo; mixture=Mixture; formulation_id=MIX309; formulation_name=Mergal K10N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=9.68; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12197; row=9138; data_type=In Vivo; mixture=Mixture; formulation_id=MIX11; formulation_name=Acticide SR 8213 C; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13156; row=9139; data_type=In Vivo; mixture=Mixture; formulation_id=MIX663; formulation_name=Acticide CBM 2; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12185; row=9140; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=3.75; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =3 | Unitless | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13062; row=9142; data_type=In Vivo; mixture=Mixture; formulation_id=MIX518; formulation_name=Troysan 680; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.4; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =5 | Unitless | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13062; row=9124; data_type=In Vivo; mixture=Mixture; formulation_id=MIX518; formulation_name=Troysan 680; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.4; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13063; row=9128; data_type=In Vivo; mixture=Mixture; formulation_id=MIX518; formulation_name=Troysan 680; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.4; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =5 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12185; row=9144; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=3.75; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13156; row=9145; data_type=In Vivo; mixture=Mixture; formulation_id=MIX663; formulation_name=Acticide CBM 2; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12197; row=9146; data_type=In Vivo; mixture=Mixture; formulation_id=MIX11; formulation_name=Acticide SR 8213 C; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =5 | Unitless | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12727; row=9149; data_type=In Vivo; mixture=Mixture; formulation_id=MIX309; formulation_name=Mergal K10N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=9.68; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12729; row=9151; data_type=In Vivo; mixture=Mixture; formulation_id=MIX309; formulation_name=Mergal K10N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=9.68; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =5 | Unitless | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12800; row=9152; data_type=In Vivo; mixture=Mixture; formulation_id=MIX388; formulation_name=Nuosept Bit; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=84.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Male/Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12802; row=9153; data_type=In Vivo; mixture=Mixture; formulation_id=MIX388; formulation_name=Nuosept Bit; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=84.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | GHS classification | =4 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12859; row=9156; data_type=In Vivo; mixture=Mixture; formulation_id=MIX360; formulation_name=Preventol BIT 20N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=20.5; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1367 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13063; row=9123; data_type=In Vivo; mixture=Mixture; formulation_id=MIX518; formulation_name=Troysan 680; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.4; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2342 | mg/kg bw | Rat (Male/Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12728; row=9125; data_type=In Vivo; mixture=Mixture; formulation_id=MIX309; formulation_name=Mergal K10N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=9.68; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =3127 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12727; row=9126; data_type=In Vivo; mixture=Mixture; formulation_id=MIX309; formulation_name=Mergal K10N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=9.68; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | >2000 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12185; row=9127; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=3.75; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1759 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12729; row=9129; data_type=In Vivo; mixture=Mixture; formulation_id=MIX309; formulation_name=Mergal K10N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=9.68; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1020 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM Hazardous Substances Data Bank (undated); record_id=acute_oral_4759; row=9130; data_type=In Vivo; mixture=Chemical; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; dtxsid=DTXSID5032523; url=https://pubchem.ncbi.nlm.nih.gov/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | >2000 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_13062; row=9141; data_type=In Vivo; mixture=Mixture; formulation_id=MIX518; formulation_name=Troysan 680; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=10.4; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1030 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12859; row=9147; data_type=In Vivo; mixture=Mixture; formulation_id=MIX360; formulation_name=Preventol BIT 20N; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=20.5; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1050 | mg/kg bw | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12803; row=9148; data_type=In Vivo; mixture=Mixture; formulation_id=MIX388; formulation_name=Nuosept Bit; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=84.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =1450 | mg/kg bw | Rat (Male/Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12802; row=9155; data_type=In Vivo; mixture=Mixture; formulation_id=MIX388; formulation_name=Nuosept Bit; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=84.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | LD50 | =2100 | mg/kg bw | Rat (Male) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12800; row=9157; data_type=In Vivo; mixture=Mixture; formulation_id=MIX388; formulation_name=Nuosept Bit; chemical_name=1,2-Benzisothiazolin-3-one; preferred_name=1,2-Benzisothiazolin-3-one; percent_active_ingredient=84.0; dtxsid=DTXSID5032523; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523; 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 | 34.74 | uL/min/10^6 cells | Human | - | - | Measured; httk, Human Hepatic Intrinsic Clearance | sheet=Data; excel_row=2122; Record_ID=adme_parameters_302; Data_Type=Measured; DTXSID=DTXSID5032523; Assay=httk, Human Hepatic Intrinsic Clearance; Endpoint=Clint; Response=34.74; Response_Unit=ul/min/10^6 cells; Species=Human; Reference=httk2.3.1, Wetmore 2015; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_adme_parameters | Fu | 0 | fraction | Human | - | - | Measured; httk, Human Plasma Fraction Unbound | sheet=Data; excel_row=2123; Record_ID=adme_parameters_302; Data_Type=Measured; DTXSID=DTXSID5032523; Assay=httk, Human Plasma Fraction Unbound; Endpoint=Fu; Response=0.0; Response_Unit=Unitless Fraction; Species=Human; Reference=httk2.3.1, Wetmore 2015; URL=https://cran.r-project.org/web/packages/httk/index.html; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_dart 10 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=87718; Record_ID=dart_4277; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, In life observation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Female; Life_Stage=Adult; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0005910;CUI;Body Weight|UMLS;C3540840;CUI;Sign or Symptom|UMLS;C0043094;CUI;Weight Gain; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87719; Record_ID=dart_4384; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C4086922;CUI;Unossified; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87720; Record_ID=dart_4383; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C4086922;CUI;Unossified; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=87721; Record_ID=dart_4294; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, In life observation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0005910;CUI;Body Weight|UMLS;C3540840;CUI;Sign or Symptom|UMLS;C0751992;CUI;Fetal Weight; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87722; Record_ID=dart_4291; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C4086922;CUI;Unossified; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87723; Record_ID=dart_4289; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C4086922;CUI;Unossified; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87724; Record_ID=dart_4287; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C1282719;CUI;Incomplete ossification; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=87725; Record_ID=dart_4282; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, In life observation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Female; Life_Stage=Adult; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C2983605;CUI;Food Consumption|UMLS;C3540840;CUI;Sign or Symptom|UMLS;C2983605;CUI;Food Consumption; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87726; Record_ID=dart_4386; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C4086922;CUI;Unossified; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_dart | LOEL | 100 | mg/kg bw/day | Rat | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=87727; Record_ID=dart_4385; Data_Type=In Vivo; DTXSID=DTXSID5032523; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=100; Response_Unit=mg/kg/day; Species=Rat; Strain=Alpk:APfSD; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0265509;CUI;Congenital anomaly of skeletal bone|UMLS;C4086922;CUI;Unossified; Reference=ToxRefDB v2 , ID = 6576; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_endocrine 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | AC50 | 52.0485260077318 | uM | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=448; RecordID=ARPathway2016_132; DatasetName=ARPathway2016; DTXSID=DTXSID5032523; Assay=AR Pathway Model, Agonist; Endpoint=AC50; Response=52.0485260077318; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_endocrine | ACC | 37.2171294089622 | uM | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=449; RecordID=ARPathway2016_132; DatasetName=ARPathway2016; DTXSID=DTXSID5032523; Assay=AR Pathway Model, Agonist; Endpoint=ACC; Response=37.2171294089622; Response_Unit=uM; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_endocrine | Model Score | 0.121 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=450; RecordID=ARPathway2016_132; DatasetName=ARPathway2016; DTXSID=DTXSID5032523; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0.121; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Agonist | sheet=Integrated_approaches; excel_row=451; RecordID=ARPathway2016_132; DatasetName=ARPathway2016; DTXSID=DTXSID5032523; Assay=AR Pathway Model, Agonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_eye_irritation 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_eye_irritation | EPA Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=1691; Record_ID=eye_irritation_252; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID52; Formulation_Name=Acticide SR 8213 C; Percent_Active_Ingredient=10.0; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_skin_irritation 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_irritation | Breakthrough Time | 240 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=4077; Record_ID=skin_irritation_invitro_140; Data_Type=In Vitro; Formulation_ID=MIX795; Formulation_Name=Proxel AB; Percent_Active_Ingredient=33; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Corrositex; Endpoint=Breakthrough Time; Response=240; Response_Unit=min; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | EPA classification | 3 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1124; Record_ID=skin_irritation_invivo_172; Data_Type=In Vivo; Formulation_ID=MIX388; Formulation_Name=Nuosept Bit; Percent_Active_Ingredient=84; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=3; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | EPA classification | 4 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1125; Record_ID=skin_irritation_invivo_431; Data_Type=In Vivo; Formulation_ID=MIX518; Formulation_Name=Troysan 680; Percent_Active_Ingredient=10.4; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=4; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | EPA classification | 1 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1126; Record_ID=skin_irritation_invivo_519; Data_Type=In Vivo; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=3.75; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=1; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | EPA classification | 2 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1129; Record_ID=skin_irritation_invivo_755; Data_Type=In Vivo; Formulation_ID=MIX360; Formulation_Name=Preventol BIT 20N; Percent_Active_Ingredient=20.5; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=2; Response_Unit=Unitless; Species=Rabbit; Reported_Strain=New Zealand White; Strain=New Zealand White; Sex=Male; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | TER | 9.4 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=4068; Record_ID=skin_irritation_invitro_2518; Data_Type=In Vitro; Formulation_ID=MIX796; Formulation_Name=Proxel BD; Percent_Active_Ingredient=33; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=TER Corrosion; Endpoint=TER; Response=9.4; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | TER | 10.5 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=4069; Record_ID=skin_irritation_invitro_2517; Data_Type=In Vitro; Formulation_ID=MIX796; Formulation_Name=Proxel BD; Percent_Active_Ingredient=33; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=TER Corrosion; Endpoint=TER; Response=10.5; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_irritation | TER | 11 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=4076; Record_ID=skin_irritation_invitro_2515; Data_Type=In Vitro; Formulation_ID=MIX795; Formulation_Name=Proxel AB; Percent_Active_Ingredient=33; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=TER Corrosion; Endpoint=TER; Response=11; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
NTP_ICE_skin_sensitization 27 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | CD54, EC200 | 0.55 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2069; Record_ID=skin_sensitization_invitro_515; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=0.55000000000000004; Reported_Response_Unit=ug/mL; Response=0.55; 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/DTXSID5032523 |
| NTP_ICE_skin_sensitization | CD54, EC200 | 0.54 | ug/mL | - | Dermal | - | In Vitro; hCLAT2015; h-CLAT | sheet=Data_invitro; excel_row=3642; Record_ID=skin_sensitization_invitro_834; Data_Type=In Vitro; Internal_Data_Source=hCLAT2015; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=h-CLAT; Endpoint=CD54, EC200; Reported_Response=0.54; Reported_Response_Unit=ug/mL; Response=0.54; Response_Unit=ug/mL; Reference=Ashikaga et al. 2010; 20822320; 10.1177/026119291003800403|Nukada et al. 2012; 22796097; 10.1016/j.tiv.2012.07.001|Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 0.55 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; U-SENS | sheet=Data_invitro; excel_row=8257; Record_ID=skin_sensitization_invitro_2280; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=3.637566138; Reported_Response_Unit=uM; Conversion_Factor_Value=151.18; Conversion_Factor_Source=EPA Dashboard; Converted_Response=0.55; Converted_Response_Unit=ug/mL; Response=0.55; 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/DTXSID5032523 |
| NTP_ICE_skin_sensitization | CD86, EC150 | 0.39 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8550; Record_ID=skin_sensitization_invitro_2359; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=U-SENS; Endpoint=CD86, EC150; Reported_Response=0.39; Reported_Response_Unit=ug/mL; Response=0.39; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | CV70 | 3.43 | ug/mL | - | Dermal | - | In Vitro; CE_USENSE2018; U-SENS | sheet=Data_invitro; excel_row=8552; Record_ID=skin_sensitization_invitro_2359; Data_Type=In Vitro; Internal_Data_Source=CE_USENSE2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=U-SENS; Endpoint=CV70; Reported_Response=3.43; Reported_Response_Unit=ug/mL; Response=3.43; Response_Unit=ug/mL; Reference=Piroird et al. 2015; 25820135; 10.1016/j.tiv.2015.03.009; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | CV75 | 1.83 | ug/mL | - | Dermal | - | In Vitro; CE_hCLAT2018; h-CLAT | sheet=Data_invitro; excel_row=2070; Record_ID=skin_sensitization_invitro_515; Data_Type=In Vitro; Internal_Data_Source=CE_hCLAT2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=h-CLAT; Endpoint=CV75; Reported_Response=1.83; Reported_Response_Unit=ug/mL; Response=1.83; 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/DTXSID5032523 |
| NTP_ICE_skin_sensitization | Depletion Cys | 97.7 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=341; Record_ID=skin_sensitization_invitro_109; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=97.7; Reported_Response_Unit=%; Response=97.7; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | Depletion Lys | 9.7 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=340; Record_ID=skin_sensitization_invitro_109; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=9.6999999999999993; Reported_Response_Unit=%; Response=9.7; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 50 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=342; Record_ID=skin_sensitization_invitro_109; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=50; Reported_Response_Unit=%; Response=50; Response_Unit=%; Reference=Nukada et al. 2013; 23149339; 10.1016/j.tiv.2012.11.006|Nukada personal communication (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | Depletion Lys + Cys | 53.7 | % | - | Dermal | - | In Vitro; DPRA2015; DPRA | sheet=Data_invitro; excel_row=349; Record_ID=skin_sensitization_invitro_111; Data_Type=In Vitro; Internal_Data_Source=DPRA2015; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=DPRA; Endpoint=Depletion Lys + Cys; Reported_Response=53.7; Reported_Response_Unit=%; Response=53.7; Response_Unit=%; Reference=Gerberick et al. 2007; 15254333; 10.1093/toxsci/kfh213|Jaworska 2011; 23670904; 10.1002/jat.2869|Natsch et al. 2013; 23576290; 10.1002/jat.2868; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC1.5 | 3.156 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8781; Record_ID=skin_sensitization_invitro_2433; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=3.1560000000000001; Reported_Response_Unit=uM; Response=3.156; 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|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 14.773 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8782; Record_ID=skin_sensitization_invitro_2433; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=KeratinoSens; Endpoint=EC3; Reported_Response=14.773; Reported_Response_Unit=uM; Response=14.773; 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|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 2.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13589; Record_ID=skin_sensitization_invivo_3816; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=2.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 32.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13599; Record_ID=skin_sensitization_invivo_3826; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=32.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 4.8 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13610; Record_ID=skin_sensitization_invivo_3846; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=4.8; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 2.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13589; Record_ID=skin_sensitization_invivo_3816; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=2.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 32.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13599; Record_ID=skin_sensitization_invivo_3826; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=32.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 4.8 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13610; Record_ID=skin_sensitization_invivo_3846; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=4.8; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 2.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13589; Record_ID=skin_sensitization_invivo_3816; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=2.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 32.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13599; Record_ID=skin_sensitization_invivo_3826; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=32.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 4.8 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13610; Record_ID=skin_sensitization_invivo_3846; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=4.8; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 2.3 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13589; Record_ID=skin_sensitization_invivo_3816; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=2.3; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Gerberick et al. 2005; 16536334; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 32.4 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13599; Record_ID=skin_sensitization_invivo_3826; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=32.4; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | EC3 | 4.8 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13610; Record_ID=skin_sensitization_invivo_3846; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=LLNA; Endpoint=EC3; Response=4.8; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Botham et al. 1991; 1782769; 10.1111/j.1600-0536.1991.tb01823.x; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | GHS Classification | 1 | unitless | Guinea pig | Dermal | - | In Vivo; SkinSensitization6pack; Guinea Pig Maximization/Buehler | sheet=Data_invivo; excel_row=1401; Record_ID=skin_sensitization_invivo_432; Data_Type=In Vivo; Internal_Data_Source=SkinSensitization6pack; Formulation_ID=MIX518; Formulation_Name=Troysan 680; Percent_Active_Ingredient=10.4; Mixture=Mixture; DTXSID=DTXSID5032523; Assay=Guinea Pig Maximization/Buehler; Endpoint=GHS Classification; Response=1; Response_Unit=Unitless; Species=Guinea pig; Route=Dermal; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | IC50 | 50.87 | uM | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8783; Record_ID=skin_sensitization_invitro_2433; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=50.87; Reported_Response_Unit=uM; Response=50.87; 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|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
| NTP_ICE_skin_sensitization | Imax | 23.96 | ratio | - | Dermal | - | In Vitro; CE_KeratinoSense2018; KeratinoSens | sheet=Data_invitro; excel_row=8784; Record_ID=skin_sensitization_invitro_2433; Data_Type=In Vitro; Internal_Data_Source=CE_KeratinoSense2018; Mixture=Chemical; DTXSID=DTXSID5032523; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=23.96; Reported_Response_Unit=Unitless; Response=23.96; 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|Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID5032523 |
SCCNFP_vision_codex 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 2","dose":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test s...","effect":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test substance and were not seen in the other groups. The NOAEL in this study was 15 mg/kg/day bw (12.63 mg a.i./kg/day). Ref.: 12 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity Guideline : OECD 408 Species/strain : Rat, Wistar Group size : Total 20; 10 male/10 female Test item : Benzisothiazolinone Batch no : G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity : 1,2-Benzisothiazolin-3-one, 84.29 %; water 15 %; purity of active ingredient on dry weight base 99.1 % Dose levels : 10,","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period.","effect":"ent related clinical signs. Food consumption was lower in females in weeks 2 and 4. There were some changes primarily in the non glandular stomach region both macroscopically and histologically which were considered treatment related and were reversible. These effects may have been due to the irritant nature to the test substance. At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period. The NOAEL in this study was 10 mg/kg/day/bw (8.42 mg a.i./kg/day). Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 2","dose":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test s...","effect":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test substance and were not seen in the other groups. The NOAEL in this study was 15 mg/kg/day bw (12.63 mg a.i./kg/day). Ref.: 12 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity Guideline : OECD 408 Species/strain : Rat, Wistar Group size : Total 20; 10 male/10 female Test item : Benzisothiazolinone Batch no : G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity : 1,2-Benzisothiazolin-3-one, 84.29 %; water 15 %; purity of active ingredient on dry weight base 99.1 % Dose levels : 10,","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period.","effect":"ent related clinical signs. Food consumption was lower in females in weeks 2 and 4. There were some changes primarily in the non glandular stomach region both macroscopically and histologically which were considered treatment related and were reversible. These effects may have been due to the irritant nature to the test substance. At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period. The NOAEL in this study was 10 mg/kg/day/bw (8.42 mg a.i./kg/day). Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 2","dose":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test s...","effect":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test substance and were not seen in the other groups. The NOAEL in this study was 15 mg/kg/day bw (12.63 mg a.i./kg/day). Ref.: 12 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity Guideline : OECD 408 Species/strain : Rat, Wistar Group size : Total 20; 10 male/10 female Test item : Benzisothiazolinone Batch no : G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity : 1,2-Benzisothiazolin-3-one, 84.29 %; water 15 %; purity of active ingredient on dry weight base 99.1 % Dose levels : 10,","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period.","effect":"ent related clinical signs. Food consumption was lower in females in weeks 2 and 4. There were some changes primarily in the non glandular stomach region both macroscopically and histologically which were considered treatment related and were reversible. These effects may have been due to the irritant nature to the test substance. At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period. The NOAEL in this study was 10 mg/kg/day/bw (8.42 mg a.i./kg/day). Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_002"} |
| SCCNFP_vision_codex | NOAEL | =15 | mg/kg/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 2","dose":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test s...","effect":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test substance and were not seen in the other groups. The NOAEL in this study was 15 mg/kg/day bw (12.63 mg a.i./kg/day). Ref.: 12 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity Guideline : OECD 408 Species/strain : Rat, Wistar Group size : Total 20; 10 male/10 female Test item : Benzisothiazolinone Batch no : G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity : 1,2-Benzisothiazolin-3-one, 84.29 %; water 15 %; purity of active ingredient on dry weight base 99.1 % Dose levels : 10,","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_001"} |
| SCCNFP_vision_codex | NOAEL | =10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 13 2","dose":"At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period.","effect":"ent related clinical signs. Food consumption was lower in females in weeks 2 and 4. There were some changes primarily in the non glandular stomach region both macroscopically and histologically which were considered treatment related and were reversible. These effects may have been due to the irritant nature to the test substance. At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period. The NOAEL in this study was 10 mg/kg/day/bw (8.42 mg a.i./kg/day). Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","page":8,"pdf":"out289_en.pdf","row_type":"noael_study","study_id":"out289_en_noael_002"} |
SCCS_vision_codex 40 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12","dose":"Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.","effect":"for females. Cumulative net weight gains were also significantly lower throughout the treatment and recovery period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Prom","page":19,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_001"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","effect":"higher in males and in females (weeks 15, 16 and 17) during the recovery period. There was a significant reduction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in","page":20,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_003"} |
| SCCS_vision_codex | NOAEL | =1482 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to da...","effect":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and...","effect":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.018 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"__________________________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"_________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound a","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_009"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/k...","effect":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound as a severe eye irritant. A guinea pig maximization test classified BIT as a mode","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_010"} |
| SCCS_vision_codex | NOAEL | =4115 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied.","effect":"tact dermatitis as required. Dermal absorption An in vitro study with human skin has been provided. The mean value + 1SD can be used for calculating the MOS. This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessme","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_011"} |
| SCCS_vision_codex | NOAEL | =8.42 | mg/kg bw/day | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively).","effect":"% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Reproductive Toxicity In a two generation study in rats with dietary administration benzisothiazolinone produced at 1000 ppm slight adult toxicity in the F1 generat","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_012"} |
| SCCS_vision_codex | NOAEL | =24 | mg/kg bw/day | - | - | - | genotoxicity | {"dose":"At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.","effect":"g ridge hyperplasia of the stomach together with incidences of squamous cell hyperplasia, forestomach gastritis, keratosis and erosion/ulcer. At this concentration, the growth of the offspring was slightly impaired and in the F2a offspring, there was a slight reduction in pup survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in v","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_013"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12","dose":"Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.","effect":"for females. Cumulative net weight gains were also significantly lower throughout the treatment and recovery period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Prom","page":19,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_001"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","effect":"higher in males and in females (weeks 15, 16 and 17) during the recovery period. There was a significant reduction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in","page":20,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_003"} |
| SCCS_vision_codex | NOAEL | =1482 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to da...","effect":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and...","effect":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.018 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"__________________________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"_________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound a","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_009"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/k...","effect":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound as a severe eye irritant. A guinea pig maximization test classified BIT as a mode","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_010"} |
| SCCS_vision_codex | NOAEL | =4115 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied.","effect":"tact dermatitis as required. Dermal absorption An in vitro study with human skin has been provided. The mean value + 1SD can be used for calculating the MOS. This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessme","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_011"} |
| SCCS_vision_codex | NOAEL | =8.42 | mg/kg bw/day | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively).","effect":"% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Reproductive Toxicity In a two generation study in rats with dietary administration benzisothiazolinone produced at 1000 ppm slight adult toxicity in the F1 generat","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_012"} |
| SCCS_vision_codex | NOAEL | =24 | mg/kg bw/day | - | - | - | genotoxicity | {"dose":"At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.","effect":"g ridge hyperplasia of the stomach together with incidences of squamous cell hyperplasia, forestomach gastritis, keratosis and erosion/ulcer. At this concentration, the growth of the offspring was slightly impaired and in the F2a offspring, there was a slight reduction in pup survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in v","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_013"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12","dose":"Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.","effect":"for females. Cumulative net weight gains were also significantly lower throughout the treatment and recovery period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Prom","page":19,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_001"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","effect":"higher in males and in females (weeks 15, 16 and 17) during the recovery period. There was a significant reduction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in","page":20,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_003"} |
| SCCS_vision_codex | NOAEL | =1482 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to da...","effect":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and...","effect":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.018 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"__________________________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"_________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound a","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_009"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/k...","effect":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound as a severe eye irritant. A guinea pig maximization test classified BIT as a mode","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_010"} |
| SCCS_vision_codex | NOAEL | =4115 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied.","effect":"tact dermatitis as required. Dermal absorption An in vitro study with human skin has been provided. The mean value + 1SD can be used for calculating the MOS. This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessme","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_011"} |
| SCCS_vision_codex | NOAEL | =8.42 | mg/kg bw/day | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively).","effect":"% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Reproductive Toxicity In a two generation study in rats with dietary administration benzisothiazolinone produced at 1000 ppm slight adult toxicity in the F1 generat","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_012"} |
| SCCS_vision_codex | NOAEL | =24 | mg/kg bw/day | - | - | - | genotoxicity | {"dose":"At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.","effect":"g ridge hyperplasia of the stomach together with incidences of squamous cell hyperplasia, forestomach gastritis, keratosis and erosion/ulcer. At this concentration, the growth of the offspring was slightly impaired and in the F2a offspring, there was a slight reduction in pup survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in v","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_013"} |
| SCCS_vision_codex | NOAEL | =15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | {"citation":"Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12","dose":"Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.","effect":"for females. Cumulative net weight gains were also significantly lower throughout the treatment and recovery period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Prom","page":19,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_001"} |
| SCCS_vision_codex | NOAEL | =10 | mg/kg bw/day | - | - | Chronic | genotoxicity | {"citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","effect":"higher in males and in females (weeks 15, 16 and 17) during the recovery period. There was a significant reduction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in","page":20,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_003"} |
| SCCS_vision_codex | NOAEL | =1482 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to da...","effect":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_006"} |
| SCCS_vision_codex | NOAEL | =25 | - | - | oral | 90-day | reproductive toxicity | {"citation":"Ref.: 14 3","dose":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and...","effect":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S","page":25,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_007"} |
| SCCS_vision_codex | NOAEL | =0.018 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"__________________________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_008"} |
| SCCS_vision_codex | NOAEL | =50 | % | rat | oral | - | dermal absorption | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","effect":"_________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound a","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_009"} |
| SCCS_vision_codex | NOAEL | =25 | mg/kg bw/d | rat | oral | - | dermal absorption | {"dose":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/k...","effect":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound as a severe eye irritant. A guinea pig maximization test classified BIT as a mode","page":26,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_010"} |
| SCCS_vision_codex | NOAEL | =4115 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | {"dose":"This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied.","effect":"tact dermatitis as required. Dermal absorption An in vitro study with human skin has been provided. The mean value + 1SD can be used for calculating the MOS. This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessme","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_011"} |
| SCCS_vision_codex | NOAEL | =8.42 | mg/kg bw/day | rat | oral | subacute | repeated dose toxicity | {"dose":"General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively).","effect":"% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Reproductive Toxicity In a two generation study in rats with dietary administration benzisothiazolinone produced at 1000 ppm slight adult toxicity in the F1 generat","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_012"} |
| SCCS_vision_codex | NOAEL | =24 | mg/kg bw/day | - | - | - | genotoxicity | {"dose":"At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.","effect":"g ridge hyperplasia of the stomach together with incidences of squamous cell hyperplasia, forestomach gastritis, keratosis and erosion/ulcer. At this concentration, the growth of the offspring was slightly impaired and in the F2a offspring, there was a slight reduction in pup survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in v","page":27,"pdf":"sccs_o_099.pdf","row_type":"noael_study","study_id":"sccs_o_099_noael_013"} |
ToxRefDB_ToxRefDB_v3_pod.csv 15 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =356 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 13 week | SUB | study_id=6069; toxval_study_source_id=studyid6069_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-infiltration cellular|pathology gross-stomach-thickened; dose_level=3; study_year=1990; study_citation=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =69 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 13 week | SUB | study_id=6069; toxval_study_source_id=studyid6069_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology microscopic-stomach-hyperplasia|pathology gross-stomach-thickened|in life observation-food consumption-food efficiency; dose_level=2; study_year=1990; study_citation=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =10 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 0 day to 92 day | SUB | study_id=6071; toxval_study_source_id=studyid6071_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-stomach-thickened|in life observation-clinical signs-oral discharge|in life observation-clinical signs-body temperature|in life observation-mortality-mortality|in life observation-clinical signs-defecation|clinical chemistry-albumin-albumin|clinical chemistry-globulins-globulins|clinical chemistry-protein-protein|in life observation-clinical signs-reduced activity|pathology gross-stomach-discolored|pathology microscopic-stomach-inflammation|in life observation-clinical signs-body surface staining|pathology microscopic-stomach-ulcer|pathology microscopic-larynx-necrosis|in life observation-clinical signs-abnormal respiratory sounds|pathology gross-stomach-distended|pathology microscopic-stomach-hemorrhage|pathology microscopic-trachea-necrosis|in life observation-body weight-body weight gain; dose_level=1; study_year=2007; study_citation=Roper, J. 2007. A 90-day oral (gavage) study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Report no. 06RC-075. MRID 47759801.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =89 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 day to 90 day | SUB | study_id=6072; toxval_study_source_id=studyid6072_Adult_F0_F_systemic; toxval_effect_list=in life observation-food consumption-food consumption|in life observation-body weight-body weight gain|in life observation-body weight-body weight; dose_level=3; study_year=2007; study_citation=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =106 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 day to 90 day | SUB | study_id=6072; toxval_study_source_id=studyid6072_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-body weight-body weight gain|in life observation-food consumption-food consumption; dose_level=3; study_year=2007; study_citation=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =50 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 70 days (premating) to 2 generation | MGR | study_id=6075; toxval_study_source_id=studyid6075_Juvenile_F1_F_developmental; toxval_effect_list=offspring survival late-viability index-viability index; dose_level=3; study_year=2007; study_citation=Stump, DG. 2007. An oral (gavage) two-generation reproductive toxicity study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Ashland, OH. Lab. project no. WIL-91028. Unpubished report.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =40 | mg/kg bw/day | rat (sprague dawley; Alpk: APfSD) | oral | 7 GD to 16 GD | DEV | study_id=6576; toxval_study_source_id=studyid6576_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-abnormal respiratory sounds|in life observation-food consumption-food consumption|pathology gross-stomach-irregular surface|in life observation-body weight-body weight gain; dose_level=2; study_year=1988; study_citation=Pigott GH and ME Burt. (1988) PROXEL Press Paste: Teratology Study in the Rat. Zeneca, Study No CTL/P/2297. MRID 40961201.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | LOAEL | =100 | mg/kg bw/day | rat (sprague dawley; Alpk: APfSD) | oral | 7 GD to 16 GD | DEV | study_id=6576; toxval_study_source_id=studyid6576_Adult_F0_F_systemic; toxval_effect_list=in life observation-food consumption-food consumption|in life observation-body weight-body weight gain; dose_level=3; study_year=1988; study_citation=Pigott GH and ME Burt. (1988) PROXEL Press Paste: Teratology Study in the Rat. Zeneca, Study No CTL/P/2297. MRID 40961201.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =78.3 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 13 week | SUB | study_id=6069; toxval_study_source_id=studyid6069_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology microscopic-stomach-hyperplasia|pathology gross-stomach-thickened|pathology microscopic-stomach-infiltration cellular; dose_level=2; study_year=1990; study_citation=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =15.3 | mg/kg bw/day | rat (sprague dawley; Alpk: APSD) | oral | 0 week to 13 week | SUB | study_id=6069; toxval_study_source_id=studyid6069_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight|pathology microscopic-stomach-hyperplasia|pathology gross-stomach-thickened|in life observation-food consumption-food efficiency; dose_level=1; study_year=1990; study_citation=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | >0 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 0 day to 92 day | SUB | study_id=6071; toxval_study_source_id=studyid6071_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-reduced activity|pathology gross-stomach-discolored|pathology microscopic-stomach-ulcer|pathology microscopic-larynx-necrosis|in life observation-clinical signs-abnormal respiratory sounds|pathology microscopic-stomach-inflammation|in life observation-clinical signs-body surface staining|pathology gross-stomach-distended|in life observation-body weight-body weight gain|pathology microscopic-stomach-hemorrhage|pathology microscopic-trachea-necrosis|in life observation-clinical signs-oral discharge|pathology microscopic-stomach-thickened|in life observation-clinical signs-body temperature|in life observation-clinical signs-defecation|clinical chemistry-albumin-albumin|in life observation-mortality-mortality|clinical chemistry-globulins-globulins|clinical chemistry-protein-protein; dose_level=0; study_year=2007; study_citation=Roper, J. 2007. A 90-day oral (gavage) study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Report no. 06RC-075. MRID 47759801.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =38 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 day to 90 day | SUB | study_id=6072; toxval_study_source_id=studyid6072_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-body weight-body weight gain|in life observation-food consumption-food consumption; dose_level=2; study_year=2007; study_citation=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =37 | mg/kg bw/day | dog (beagle; beagle) | oral | 0 day to 90 day | SUB | study_id=6072; toxval_study_source_id=studyid6072_Adult_F0_M_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-food consumption-food consumption|in life observation-body weight-body weight gain; dose_level=2; study_year=2007; study_citation=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; dsstox_substance_id=DTXSID5032523; admin_method=Feed; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =25 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 70 days (premating) to 2 generation | MGR | study_id=6075; toxval_study_source_id=studyid6075_Juvenile_F1_F_developmental; toxval_effect_list=offspring survival late-viability index-viability index; dose_level=2; study_year=2007; study_citation=Stump, DG. 2007. An oral (gavage) two-generation reproductive toxicity study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Ashland, OH. Lab. project no. WIL-91028. Unpubished report.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
| ToxRefDB_ToxRefDB_v3_pod.csv | NEL | =10 | mg/kg bw/day | rat (sprague dawley; Alpk: APfSD) | oral | 7 GD to 16 GD | DEV | study_id=6576; toxval_study_source_id=studyid6576_Adult_F0_F_systemic; toxval_effect_list=pathology gross-stomach-irregular surface|in life observation-food consumption-food consumption|in life observation-clinical signs-abnormal respiratory sounds|in life observation-body weight-body weight gain; dose_level=1; study_year=1988; study_citation=Pigott GH and ME Burt. (1988) PROXEL Press Paste: Teratology Study in the Rat. Zeneca, Study No CTL/P/2297. MRID 40961201.; dsstox_substance_id=DTXSID5032523; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
ToxValDB_ECHA_IUCLID 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LOAEL | =20 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf8e4b0a7c65d1c6cbe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22961/7/6/2?documentUUID=edfd03d9-4515-43bd-aa36-0223d7a8ece1; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15836433_15849349: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_f214ba958b12eb0a98f468c1f4e5b1ee |
| ToxValDB_ECHA_IUCLID | NOAEL | =150 | mg/kg bw/day | Rat | oral | short-term; 4 weeks | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf8e4b0a7c65d1c6cbb; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22961/7/6/2?documentUUID=edfd03d9-4515-43bd-aa36-0223d7a8ece1; YEAR=2009; ORIGINAL_YEAR=2009; STUDY_GROUP=ECHA IUCLID:15849348:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_82a1b461457388ec3f7d012a0c9f6c43 |
| ToxValDB_ECHA_IUCLID | NOAEL | =5 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf8e4b0a7c65d1c6cbe; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22961/7/6/2?documentUUID=edfd03d9-4515-43bd-aa36-0223d7a8ece1; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15836433_15849349:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_ea6ab1171f9dcdf5e373eeafe3392b94 |
| ToxValDB_ECHA_IUCLID | NOAEL | =69 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eadf9e4b0a7c65d1c6cc4; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22961/7/6/2?documentUUID=edfd03d9-4515-43bd-aa36-0223d7a8ece1; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=body weight and weight gain|food consumption and compound intake; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ECHA IUCLID:15849350:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_18877f03565ee937984a2b480226a79c |
| ToxValDB_ECHA_IUCLID | NOAEL | =112 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaadfe4b0a7c65d1b7d03; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22961/7/9/2?documentUUID=edfd03d9-4515-43bd-aa36-0223d7a8ece1; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=P0: clinical signs|P0: body weight and weight gain | P0: reproductive function (oestrouscycle) | P0: reproductivefunction (sperm measures) | P0: reproductive performance; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|reproduction; STUDY_GROUP=ECHA IUCLID:15860717:M/F:P0-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_6387bfecb94261513079bbeb69fbbbb6 |
| ToxValDB_ECHA_IUCLID | NOAEL | =56.6 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaadfe4b0a7c65d1b7d03; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/22961/7/9/2?documentUUID=edfd03d9-4515-43bd-aa36-0223d7a8ece1; YEAR=2009; ORIGINAL_YEAR=2009; TOXICOLOGICAL_EFFECT=F2: viability|F2: body weight and weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|reproduction; STUDY_GROUP=ECHA IUCLID:15862763:M/F:F2-; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_87ffe7c66585c4b95a3d807ede2791e7 |
ToxValDB_ECOTOX 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =100 | ppm | Rat | oral | acute; 0.0417 days | acute | LONG_REF=Pharmacol. Res. Commun.3(4): 385-400 Bertaccini,G., M. Impicciatore, and T. Vitali Pharmacological Activities of Benzisothiazolone and Benzisoxazolone 1971; TITLE=Pharmacological Activities of Benzisothiazolone and Benzisoxazolone; AUTHOR=Bertaccini,G., M. Impicciatore, and T. Vitali; DOI=10.1016/0031-6989(71)90011-7; QUALITY=Control type: Concurrent control; EXTERNAL_SOURCE_ID=81165; 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=1971; ORIGINAL_YEAR=1971; TOXICOLOGICAL_EFFECT=Behavior: Response time to a stimulus; TOXICOLOGICAL_EFFECT_CATEGORY=neurobehavior; STUDY_GROUP=ECOTOX:15601058:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=7cba0641f0a0e957b153d210d9878316 |
| ToxValDB_ECOTOX | NOEL | =90 | mg/kg bw/day | Rat | oral | acute; 0.5 days | acute | LONG_REF=J. Occup. Health40(3): 198-202 Hellman,B., M. Sjoquist, H. Anundi, and C. Edling No Evidence for a Diuretic Effect of Benzisothiazolinone (BIT) in an Experimental Animal Model Employing Anaesthetised Rats 1998; TITLE=No Evidence for a Diuretic Effect of Benzisothiazolinone (BIT) in an Experimental Animal Model Employing Anaesthetised Rats; AUTHOR=Hellman,B., M. Sjoquist, H. Anundi, and C. Edling; DOI=10.1539/joh.40.198; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=81347; EXTERNAL_SOURCE_ID_DESC=ECOTOX Reference Number; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6759bce8e4b0a7c65d37bc5f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://cfpub.epa.gov/ecotox/; YEAR=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=Physiology: Blood pressure; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECOTOX:15605080:M:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=d37b4d74acffe72e6d764bb33158925e |
ToxValDB_EFSA 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_EFSA | NOAEL | =10 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | LONG_REF=EFSA AFC (2007). Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the presence of 1,2-Benzisothiazolin-3-one as an impurity in saccharin used as a food additive. doi:10.2903/j.efsa.2007.416.; TITLE=Opinion of the Scientific Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on the presence of 1,2-Benzisothiazolin-3-one as an impurity in saccharin used as a food additive; AUTHOR=EFSA AFC; DOI=doi:10.2903/j.efsa.2007.416; 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=histopathology: nonneoplastic; STUDY_GROUP=EFSA:15614272: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_170a5a52bc413e62f93314c110ec4bee |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =6.81 | 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:15630018:-:--; 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_c0e6f0fbad8a1d0fe950ce2507e2ac4e |
ToxValDB_ToxRefDB 13 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ToxRefDB | LEL | =356 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; TITLE=PROXEL Press Paste: 90-day feeding study in rats; AUTHOR=Whiles, AJ; EXTERNAL_SOURCE_ID=6069; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-infiltration cellular|systemic: pathology gross-stomach-thickened|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-stomach-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|gross pathology|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710792_15710793_15710794_15710795:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_79d232c08b593acb5cb207d0c58b206f |
| ToxValDB_ToxRefDB | LEL | =10 | mg/kg bw/day | Rat | oral | chronic; 92 days | chronic | LONG_REF=Roper, J. 2007. A 90-day oral (gavage) study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Report no. 06RC-075. MRID 47759801.; TITLE=A 90-day oral (gavage) study of 1,2-benzisothiazolin-3-one in rats; AUTHOR=Roper, J; EXTERNAL_SOURCE_ID=6071; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-thickened|systemic: in life observation-mortality-mortality|systemic: in life observation-clinical signs-oral discharge|systemic: pathology gross-stomach-distended|systemic: in life observation-clinical signs-reduced activity|systemic: in life observation-clinical signs-defecation|systemic: clinical chemistry-albumin-albumin|systemic: pathology gross-stomach-discolored|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-stomach-hemorrhage|systemic: in life observation-clinical signs-body surface staining|systemic: pathology microscopic-trachea-necrosis|systemic: in life observation-clinical signs-body temperature|systemic: pathology microscopic-stomach-ulcer|systemic: in life observation-body weight-body weight gain|systemic: clinical chemistry-globulins-globulins|systemic: pathology microscopic-larynx-necrosis|systemic: in life observation-clinical signs-abnormal respiratory sounds|systemic: clinical chemistry-protein-protein; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|gross pathology|mortality/survival|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710800_15710801:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7bd870ef41a994e776fd0ec25ef30e62 |
| ToxValDB_ToxRefDB | LEL | =89 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | LONG_REF=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; TITLE=A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs; AUTHOR=Roper, JM; EXTERNAL_SOURCE_ID=6072; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain|systemic: in life observation-food consumption-food consumption|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15710804_15710805_15710806_15710807:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_3c2d9f6af702bd2eff768891363d83a4 |
| ToxValDB_ToxRefDB | LEL | =106 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | LONG_REF=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; TITLE=A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs; AUTHOR=Roper, JM; EXTERNAL_SOURCE_ID=6072; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15710808_15710809_15710810_15710811:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6e5e1cd9623443eb7ca7fde845f543e8 |
| ToxValDB_ToxRefDB | LEL | =50 | mg/kg bw/day | Rat | oral | chronic (developmental) | developmental | LONG_REF=Stump, DG. 2007. An oral (gavage) two-generation reproductive toxicity study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Ashland, OH. Lab. project no. WIL-91028. Unpubished report.; TITLE=An oral (gavage) two-generation reproductive toxicity study of 1,2-benzisothiazolin-3-one in rats; AUTHOR=Stump, DG; EXTERNAL_SOURCE_ID=6075; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=developmental: offspring survival late-viability index-viability index; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ToxRefDB_dup_-_15710820_15710821_15710822_15710823:F:F1juvenile; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_5c4b04b2387b82136de708a53377f1b0 |
| ToxValDB_ToxRefDB | LEL | =40 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | reproduction developmental | LONG_REF=Pigott GH and ME Burt. (1988) PROXEL Press Paste: Teratology Study in the Rat. Zeneca, Study No CTL/P/2297. MRID 40961201.; TITLE=PROXEL Press Paste: Teratology Study in the Rat; AUTHOR=Pigott GH and ME Burt; EXTERNAL_SOURCE_ID=6576; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-abnormal respiratory sounds|systemic: pathology gross-stomach-irregular surface|systemic: in life observation-body weight-body weight gain|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology; STUDY_GROUP=ToxRefDB_dup_-_15712300_15712301_15712302_15712303:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_969be76c7e1c9b0a904398eac5cce653 |
| ToxValDB_ToxRefDB | LOAEL | =100 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | reproduction developmental | LONG_REF=Pigott GH and ME Burt. (1988) PROXEL Press Paste: Teratology Study in the Rat. Zeneca, Study No CTL/P/2297. MRID 40961201.; TITLE=PROXEL Press Paste: Teratology Study in the Rat; AUTHOR=Pigott GH and ME Burt; EXTERNAL_SOURCE_ID=6576; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight gain|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15712300_15712301_15712302_15712303:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6324ff093da611af743114836ea6c630 |
| ToxValDB_ToxRefDB | NEL | =78.3 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; TITLE=PROXEL Press Paste: 90-day feeding study in rats; AUTHOR=Whiles, AJ; EXTERNAL_SOURCE_ID=6069; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology gross-stomach-thickened|systemic: pathology microscopic-stomach-infiltration cellular; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|gross pathology|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710792_15710793_15710794_15710795:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_df0405b7dc6d5646458f3adc1e0ce248 |
| ToxValDB_ToxRefDB | NEL | =15.3 | mg/kg bw/day | Rat | oral | subchronic; 13 weeks | subchronic | LONG_REF=Whiles, AJ. 1990. PROXEL Press Paste: 90-day feeding study in rats. ICI Central Tox Lab., Study no. PR0798. MRID 41910401.; TITLE=PROXEL Press Paste: 90-day feeding study in rats; AUTHOR=Whiles, AJ; EXTERNAL_SOURCE_ID=6069; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1990; ORIGINAL_YEAR=1990; TOXICOLOGICAL_EFFECT=systemic: pathology gross-stomach-thickened|systemic: in life observation-food consumption-food efficiency|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-stomach-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|gross pathology|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15710796_15710797_15710798_15710799:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_616a941e67ca4f912aa8e6a3cd155377 |
| ToxValDB_ToxRefDB | NEL | =38 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | LONG_REF=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; TITLE=A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs; AUTHOR=Roper, JM; EXTERNAL_SOURCE_ID=6072; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food consumption|systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15710804_15710805_15710806_15710807:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_04d6dd7e4cf4dab9a20f62fbfa14aeb8 |
| ToxValDB_ToxRefDB | NEL | =37 | mg/kg bw/day | Dog | oral | subchronic; 90 days | subchronic | LONG_REF=Roper, JM. 2007. A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs. WIL Research Labs, LLC, Lab report no. WIL-91030. MRID 47759802.; TITLE=A 90-day dietary toxicity study of 1,2 Benzisothiazolin-3-one in Beagle dogs; AUTHOR=Roper, JM; EXTERNAL_SOURCE_ID=6072; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=systemic: in life observation-food consumption-food consumption|systemic: in life observation-body weight-body weight gain|systemic: in life observation-body weight-body weight; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15710808_15710809_15710810_15710811:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_1c3cce0c8aa5ff929341e66395335a4d |
| ToxValDB_ToxRefDB | NEL | =25 | mg/kg bw/day | Rat | oral | chronic (developmental) | developmental | LONG_REF=Stump, DG. 2007. An oral (gavage) two-generation reproductive toxicity study of 1,2-benzisothiazolin-3-one in rats. WIL Research Labs, LLC, Ashland, OH. Lab. project no. WIL-91028. Unpubished report.; TITLE=An oral (gavage) two-generation reproductive toxicity study of 1,2-benzisothiazolin-3-one in rats; AUTHOR=Stump, DG; EXTERNAL_SOURCE_ID=6075; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=2007; ORIGINAL_YEAR=2007; TOXICOLOGICAL_EFFECT=developmental: offspring survival late-viability index-viability index; TOXICOLOGICAL_EFFECT_CATEGORY=reproduction; STUDY_GROUP=ToxRefDB_dup_-_15710820_15710821_15710822_15710823:F:F1juvenile; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_72c0c856f5a99173bb6c6d9a41a0f0c2 |
| ToxValDB_ToxRefDB | NEL | =10 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | developmental | LONG_REF=Pigott GH and ME Burt. (1988) PROXEL Press Paste: Teratology Study in the Rat. Zeneca, Study No CTL/P/2297. MRID 40961201.; TITLE=PROXEL Press Paste: Teratology Study in the Rat; AUTHOR=Pigott GH and ME Burt; EXTERNAL_SOURCE_ID=6576; EXTERNAL_SOURCE_ID_DESC=ToxRefDB Study ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66bca4a3e4b0a7c65d2a792a; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://github.com/USEPA/CompTox-ToxRefDB; YEAR=1988; ORIGINAL_YEAR=1988; TOXICOLOGICAL_EFFECT=developmental: developmental malformation-bone-unossified|developmental: developmental malformation-bone-incomplete ossification; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ToxRefDB_dup_-_15712304_15712305_15712306_15712307:M/F:fetusfetal; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8427ad6aab62bcaec0f3434079d75a59 |
UnifiedCodex:SCCNFP:beta.noael_studies 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCNFP:beta.noael_studies | developmental toxicity | 10 | mg/kg/day | rat | - | 90 day | developmental toxicity | SOURCE_SUBDIR=out289_en; REPORT_TITLE=OPINION CONCERNING BENZISOTHIAZOLINONE COLIPA n° P 96; OPINION_NUMBER=SCCNFP/0811/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 1 July 2004; VALUE_TEXT=10; DOSE=Conclusions The NOAEL was set at 10 mg/kg/day/bw (90 day study in the rat).; EFFECT=SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 19 NOT APPLICABLE 2.12. Conclusions The NOAEL was set at 10 mg/kg/day/bw (90 day study in the rat). No data on embryotoxicity and developmental toxicity were provided. Benzisothiazolinone is moderately irritating to the skin and severely irritating to the rabbit eye. It is a moderate contact sensitizer. No data on percutaneous absorption were provided. Benzisothiazolinone has been tested for the induction of gene mutation on bacterial and mammalian cells treated in vitro, for clastogenicity on mammalian cells treated in vitro, for the induction of Micronu; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"Conclusions The NOAEL was set at 10 mg/kg/day/bw (90 day study in the rat).","duration":"90 day","effect":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 19 NOT APPLICABLE 2.12. Conclusions The NOAEL was set at 10 mg/kg/day/bw (90 day study in the rat). No data on embryotoxicity and developmental toxicity were provided. Benzisothiazolinone is moderately irritating to the skin and severely irritating to the rabbit eye. It is a moderate contact sensitizer. No data on percutaneous absorption were provided. Benzisothiazolinone has been tested for the induction of gene mutation on bacterial and mammalian cells treated in vitro, for clastogenicity on mammalian cells treated in vitro, for the induction of Micronu","endpoint":"developmental toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":19,"route":"","species":"rat","study_id":"out289_en_noael_003"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 15 | mg/kg/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out289_en; REPORT_TITLE=OPINION CONCERNING BENZISOTHIAZOLINONE COLIPA n° P 96; OPINION_NUMBER=SCCNFP/0811/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 1 July 2004; VALUE_TEXT=15; DOSE=SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test s...; EFFECT=SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test substance and were not seen in the other groups. The NOAEL in this study was 15 mg/kg/day bw (12.63 mg a.i./kg/day). Ref.: 12 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity Guideline : OECD 408 Species/strain : Rat, Wistar Group size : Total 20; 10 male/10 female Test item : Benzisothiazolinone Batch no : G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity : 1,2-Benzisothiazolin-3-one, 84.29 %; water 15 %; purity of active ingredient on dry weight base 99.1 % Dose levels : 10,; CITATION=Ref.: 12 2; CITATION_NUMBERS=[12,2]; REFERENCE=Ref.: 12 2; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 12 2","dose":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test s...","duration":"Sub-chronic","effect":"SCCNFP/0811/04 Evaluation and opinion on Benzisothiazolinone ____________________________________________________________________________________________ 8 The only treatment related effect seen in the 45-mg/kg/day group was that lesions were seen in the non-glandular stomach, which could be related to the irritant/corrosive effect of the test substance and were not seen in the other groups. The NOAEL in this study was 15 mg/kg/day bw (12.63 mg a.i./kg/day). Ref.: 12 2.3.5. Repeated dose dermal toxicity No data 2.3.6. Repeated dose inhalation toxicity No data 2.3.7. Sub-chronic oral toxicity Guideline : OECD 408 Species/strain : Rat, Wistar Group size : Total 20; 10 male/10 female Test item : Benzisothiazolinone Batch no : G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity : 1,2-Benzisothiazolin-3-one, 84.29 %; water 15 %; purity of active ingredient on dry weight base 99.1 % Dose levels : 10,","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"15","page":8,"route":"oral","species":"rat","study_id":"out289_en_noael_001"} |
| UnifiedCodex:SCCNFP:beta.noael_studies | repeated dose toxicity | 10 | mg/kg/day | - | dermal | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=out289_en; REPORT_TITLE=OPINION CONCERNING BENZISOTHIAZOLINONE COLIPA n° P 96; OPINION_NUMBER=SCCNFP/0811/04; COMMITTEE=SCCNFP; REPORT_DATE=Adopted by the SCCNFP on 1 July 2004; VALUE_TEXT=10; DOSE=At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period.; EFFECT=ent related clinical signs. Food consumption was lower in females in weeks 2 and 4. There were some changes primarily in the non glandular stomach region both macroscopically and histologically which were considered treatment related and were reversible. These effects may have been due to the irritant nature to the test substance. At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period. The NOAEL in this study was 10 mg/kg/day/bw (8.42 mg a.i./kg/day). Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data; CITATION=Ref.: 13 2; CITATION_NUMBERS=[13,2]; REFERENCE=Ref.: 13 2; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 13 2","dose":"At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period.","duration":"Sub-chronic","effect":"ent related clinical signs. Food consumption was lower in females in weeks 2 and 4. There were some changes primarily in the non glandular stomach region both macroscopically and histologically which were considered treatment related and were reversible. These effects may have been due to the irritant nature to the test substance. At 75 mg/kg/day (63.15 mg a.i./kg/day) there was a significant reduction in food consumption in males and less so in females, which returned to control levels in the recovery period. The NOAEL in this study was 10 mg/kg/day/bw (8.42 mg a.i./kg/day). Ref.: 13 2.3.8. Sub-chronic dermal toxicity No data","endpoint":"repeated dose toxicity","ingredient":"codes","loael_value":"","noael_unit":"mg/kg/day","noael_value":"10","page":8,"route":"dermal","species":"","study_id":"out289_en_noael_002"} |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 14 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.018 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT== 0.018; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...; EFFECT=__________________________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","duration":"","effect":"__________________________________________________________________________________________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant","endpoint":"dermal absorption","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 0.018","page":26,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | 50 | % | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=50; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...; EFFECT=_________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.0...","duration":"","effect":"_________ 26 3.3.12. Special investigations No data submitted 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound a","endpoint":"dermal absorption","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"%","noael_value":"50","page":26,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =25 | mg/kg bw/d | rat | oral | - | dermal absorption | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT== 25; DOSE=evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/k...; EFFECT=evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound as a severe eye irritant. A guinea pig maximization test classified BIT as a mode; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/k...","duration":"","effect":"evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Benzisothiazolinone Daily exposure to all cosmetic products (excl. sunscreens) = 17.4 g/d Concentration Benzisothiazolinone (BIT) = 0.01% Daily exposure BIT = 1.74 mg Dermal absorption = 61.9% Typical body weight of human = 60 kg Systemic exposure dose = 0.018 mg/kg bw/d No Observed Adverse Effect Level = 50 mg/kg bw/d (2-generation-study, oral, rat) NOAEL corrected for 50% oral bioavailability = 25 mg/kg bw/d Margin of Safety NOAEL/SED = 1392 3.3.14. Discussion Physico-chemical properties Benzisothiazolinone is an off-white to yellowish solid that is soluble in water (1.1 g/L at 20°C); its log Pow shows a significant dependence on the pH. No data on stability are provided. Irritation, sensitisation According to a study conducted in rabbits benzisothiazolinone (BIT) can be classified as a moderate irritant to skin. A study in rabbits classified the compound as a severe eye irritant. A guinea pig maximization test classified BIT as a mode","endpoint":"dermal absorption","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 25","page":26,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=10; DOSE=The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).; EFFECT=higher in males and in females (weeks 15, 16 and 17) during the recovery period. There was a significant reduction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in; CITATION=Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8; CITATION_NUMBERS=[13,10,8]; REFERENCE=Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","duration":"Chronic","effect":"higher in males and in females (weeks 15, 16 and 17) during the recovery period. There was a significant reduction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in","endpoint":"genotoxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":20,"route":"","species":"","study_id":"sccs_o_099_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=10; DOSE=The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).; EFFECT=duction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/08441/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/stra; CITATION=Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8; CITATION_NUMBERS=[13,10,8]; REFERENCE=Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","duration":"Chronic","effect":"duction in food consumption in males (weeks 1, 2, 7, 8, 12 and 13) and in females (weeks 1, 2 and 4), which returned to control levels in the recovery period. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/08441/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/stra","endpoint":"genotoxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":20,"route":"","species":"","study_id":"sccs_o_099_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 10 | mg/kg bw/day | - | - | Chronic | genotoxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=10; DOSE=The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).; EFFECT=landular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/08441/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA1537, TA100, TA1535 Escherichia coli WP2uvrA pkM 101 Test substance: Promex BIT 1,2–Benzisothiazolin-3-one Batch: 2001 014 Lot number: KP 070601 Purity: 99.02% Concentrations: 0, 20, 35; CITATION=Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8; CITATION_NUMBERS=[13,10,8]; REFERENCE=Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8","dose":"The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day).","duration":"Chronic","effect":"landular stomach (hyperkera- tosis, epithelial hyperplasia, ulceration, keratin cysts) were observed in males and females. The severity of the lesions was reduced in the recovery group. The NOAEL in this study was 10 mg/kg bw/day (8.42 mg a.i./kg bw/day). Ref.: 13 Comment The SCCS noted that the NOAEL of 10 mg/kg bw/day (8.42 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. Therefore, the NOAEL is 25.26 mg a.i./kg bw/day based on systemic effects. 3.3.5.3. Chronic (> 12 months) toxicity No data submitted 3.3.6. Mutagenicity / Genotoxicity 3.3.6.1 Mutagenicity / Genotoxicity in vitro Taken from SCCNFP/08441/04 Bacterial Reverse Mutation Assay Guideline: OECD 471 (1997) Species/strain: Salmonella typhimurium TA98, TA1537, TA100, TA1535 Escherichia coli WP2uvrA pkM 101 Test substance: Promex BIT 1,2–Benzisothiazolin-3-one Batch: 2001 014 Lot number: KP 070601 Purity: 99.02% Concentrations: 0, 20, 35","endpoint":"genotoxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"10","page":20,"route":"","species":"","study_id":"sccs_o_099_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 24 | mg/kg bw/day | - | - | - | genotoxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=24; DOSE=At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.; EFFECT=g ridge hyperplasia of the stomach together with incidences of squamous cell hyperplasia, forestomach gastritis, keratosis and erosion/ulcer. At this concentration, the growth of the offspring was slightly impaired and in the F2a offspring, there was a slight reduction in pup survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in v; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.","duration":"","effect":"g ridge hyperplasia of the stomach together with incidences of squamous cell hyperplasia, forestomach gastritis, keratosis and erosion/ulcer. At this concentration, the growth of the offspring was slightly impaired and in the F2a offspring, there was a slight reduction in pup survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in v","endpoint":"genotoxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"24","page":27,"route":"","species":"","study_id":"sccs_o_099_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | genotoxicity | 24 | mg/kg bw/day | rat | - | - | genotoxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=24; DOSE=At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.; EFFECT=survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in vitro, for clastogenicity on mammalian cells treated in vitro, for the induction of micronuclei in mice and for the induction of UDS in rats treated in vivo. The study on the induction of gene mutations on bacterial cells is inadequate due to the toxicity of the test item. The; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only.","duration":"","effect":"survival. At 500 ppm, there were incidences of limiting ridge hyperplasia in the stomach only. There were no adverse effects of treatment at 250 ppm, equivalent to an approximate overall mean intake of 24 mg/kg bw/day (active ingredient). The NOAEL was based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Therefore, the NOAEL of 50 mg a.i./kg bw/day for the systemic effects of benzisothiazolinone will be used for the safety assessment. Mutagenicity Benzisothiazolinone has been tested for the induction of gene mutation in bacterial and mammalian cells treated in vitro, for clastogenicity on mammalian cells treated in vitro, for the induction of micronuclei in mice and for the induction of UDS in rats treated in vivo. The study on the induction of gene mutations on bacterial cells is inadequate due to the toxicity of the test item. The","endpoint":"genotoxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"24","page":27,"route":"","species":"rat","study_id":"sccs_o_099_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=15; DOSE=Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.; EFFECT=for females. Cumulative net weight gains were also significantly lower throughout the treatment and recovery period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Prom; CITATION=Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12; CITATION_NUMBERS=[12,15]; REFERENCE=Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12","dose":"Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.","duration":"Sub-chronic","effect":"for females. Cumulative net weight gains were also significantly lower throughout the treatment and recovery period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Prom","endpoint":"repeated dose toxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":19,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 15 | mg/kg bw/day | rat | oral | Sub-chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=15; DOSE=Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.; EFFECT=period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Promex-BIT) Batch: G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity: 1,2-Benzisothiazolin-3-one, 84.29%;; CITATION=Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12; CITATION_NUMBERS=[12,15]; REFERENCE=Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12","dose":"Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females.","duration":"Sub-chronic","effect":"period in males and females with the exception of the first week where it was not statistically significant. Increased incidences of histopathological lesions in the non-glandular stomach (hyperkeratosis, epithelial hyperplasia, ulceration) were observed in mid- (45 mg/kg bw/day) and high-dose (135 mg/kg bw/day) males and females. The severity of the lesions was reduced in the high-dose recovery group. The NOAEL in this study was 15 mg/kg bw/day (12.63 mg a.i./kg bw/day). Ref.: 12 Comment The SCCS noted that the NOAEL of 15 mg/kg bw/day (12.63 mg a.i./kg bw/day) was based on the histopathological lesions observed in the non-glandular stomach, which are most likely due to the irritant property of the test substance. 3.3.5.2. Sub-chronic (90 days) toxicity (oral, dermal) Taken from SCCNFP/08441/04 Guideline: OECD 408 Species/strain: Rat, Wistar Group size: Total 20; 10 male/10 female Test item: Benzisothiazolinone (Promex-BIT) Batch: G00Z-0600-1907-13//072/1.PBP//2001 014//KP 070601 Purity: 1,2-Benzisothiazolin-3-one, 84.29%;","endpoint":"repeated dose toxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"15","page":19,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 4115 | mg/kg bw | rat | oral | subacute | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=4115; DOSE=This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied.; EFFECT=tact dermatitis as required. Dermal absorption An in vitro study with human skin has been provided. The mean value + 1SD can be used for calculating the MOS. This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessme; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied.","duration":"subacute","effect":"tact dermatitis as required. Dermal absorption An in vitro study with human skin has been provided. The mean value + 1SD can be used for calculating the MOS. This was 61.9% of the applied dose (1.29 μg/cm2) when 0.01% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessme","endpoint":"repeated dose toxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw","noael_value":"4115","page":27,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 8.42 | mg/kg bw/day | rat | oral | subacute | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=8.42; DOSE=General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively).; EFFECT=% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Reproductive Toxicity In a two generation study in rats with dietary administration benzisothiazolinone produced at 1000 ppm slight adult toxicity in the F1 generat; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"2634-33-5","citation":"","dose":"General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively).","duration":"subacute","effect":"% benzisothiazolinone aqueous was applied. The dermal absorption studies had not been performed with representative cosmetic formulations. General toxicity The acute toxicity of benzisothiazolinone upon oral or dermal administration to rats is low (LD50 of 1193 and 4115 mg/kg bw, respectively). The NOAEL derived from a subacute 28 day oral (gavage) toxicity study in rats was 12.63 mg a.i./kg bw/day. Subchronic toxicity was evaluated in a 90 day oral (gavage) study (according to OECD guideline 408) and provided a NOAEL of 8.42 mg/kg bw/day for the active ingredient. The NOAELs in the 28- day and 90-day studies were based on histopathological lesions observed in the non- glandular stomach, which are most likely due to the irritant property of the test substance and are therefore, not relevant for the safety assessment of benzisothiazolinone as a cosmetic ingredient. Reproductive Toxicity In a two generation study in rats with dietary administration benzisothiazolinone produced at 1000 ppm slight adult toxicity in the F1 generat","endpoint":"repeated dose toxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"8.42","page":27,"route":"oral","species":"rat","study_id":"sccs_o_099_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 1482 | - | - | oral | 90-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=unclear:SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake; DOSE=SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to da...; EFFECT=SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 14 3","dose":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to da...","duration":"90-day","effect":"SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake","endpoint":"reproductive toxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"","noael_value":"unclear:SCCS/1482/12 Opinion on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake","page":25,"route":"oral","species":"","study_id":"sccs_o_099_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 25 | - | - | oral | 90-day | reproductive toxicity | SOURCE_SUBDIR=sccs_o_099; REPORT_TITLE=OPINION ON Benzisothiazolinone COLIPA n° P96; OPINION_NUMBER=SCCS/1482/12; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=adopted 1 July 2004; VALUE_TEXT=unclear:n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S; DOSE=n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and...; EFFECT=n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S; CITATION=Ref.: 14 3; CITATION_NUMBERS=[14,3]; REFERENCE=Ref.: 14 3; DETAILS_JSON={"cas_number":"2634-33-5","citation":"Ref.: 14 3","dose":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and...","duration":"90-day","effect":"n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S","endpoint":"reproductive toxicity","ingredient":"benzisothiazolinone is currently not listed in Annex VI of the Cosmetics Directive and","loael_value":"","noael_unit":"","noael_value":"unclear:n on benzisothiazolinone ___________________________________________________________________________________________ 25 Comments No significant effects were reported for the reproductive parameters at any dose level and only slight effects were noted in the offspring at the highest dose level (slightly lower pup survival to day 4 post-partum and slightly lower mean pup weight gain). Based on this study, a NOAEL of approximately 50 mg a.i./kg bw/day is used as a conservative estimate for the MOS calculation. This NOAEL is lower than the lowest LOAEL for systemic effects (63 mg a.i./kg bw/day) in the 90-day study. 3.3.8.2. Teratogenicity No evidence for teratogenicity in the two-generation oral reprotoxicity study Ref.: 14 3.3.9. Toxicokinetics No data provided. 3.3.10. Photo-induced toxicity 3.3.10.1. Phototoxicity / photoirritation and photosensitisation Guideline: OECD Test guideline 432 Test: Neutral Red uptake phototoxicity test with Balb/c 3T3 cells Test substance: 1,2–Benzisothiazolin-3-one Batch: LMS 414, CH-0405-S","page":25,"route":"oral","species":"","study_id":"sccs_o_099_noael_007"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | HRA0F1A4R3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HRA0F1A4R3"} |
| openFDA substances | FDA UNII substance identifier | HRA0F1A4R3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HRA0F1A4R3"} |
| openFDA substances | FDA UNII substance identifier | HRA0F1A4R3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HRA0F1A4R3"} |
| openFDA substances | FDA UNII substance identifier | HRA0F1A4R3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C7H5NOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"HRA0F1A4R3"} |