NOAEL Studies
Preservative
Methylchloroisothiazolinone NOAEL Studies
INCI: METHYLCHLOROISOTHIAZOLINONE
CAS: 26172-55-4
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP_ICE_acute_dermal 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_dermal | EPA classification | 4 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=2573; Record_ID=acute_dermal_406; Data_Type=In Vivo; Formulation_ID=MIX400; Formulation_Name=Rocima 586; Percent_Active_Ingredient=0.78; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_acute_dermal | EPA classification | 2 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=2575; Record_ID=acute_dermal_285; Data_Type=In Vivo; Formulation_ID=MIX278; Formulation_Name=Kathon CF 400; Percent_Active_Ingredient=2.95; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Dermal Toxicity; Endpoint=EPA classification; Response=2.0; Response_Unit=Unitless; Species=Rat; Route=Dermal; Reference=FIFRA data; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_dermal | EPA classification | 3 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=2576; Record_ID=acute_dermal_6; Data_Type=In Vivo; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=0.465; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_acute_dermal | GHS classification | 5 | unitless | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=2570; Record_ID=acute_dermal_368; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_acute_dermal | LD50 | >5000 | mg/kg | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=2577; Record_ID=acute_dermal_368; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_acute_dermal | LD50 | >2000 | mg/kg | Rat | Dermal | - | In Vivo; Rat Acute Dermal Toxicity | sheet=Data; excel_row=2578; Record_ID=acute_dermal_8; Data_Type=In Vivo; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=1.95; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
NTP_ICE_acute_inhalation 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | EPA Classification | 3 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5290; Record_ID=acute_inhalation_293; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_inhalation | EPA Classification | 2 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5293; Record_ID=acute_inhalation_29; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=1.95; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=EPA Classification; Response=2; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_inhalation | GHS Classification | 4 | unitless | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5297; Record_ID=acute_inhalation_329; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX400; Formulation_Name=Rocima 586; Percent_Active_Ingredient=0.78; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=GHS Classification; Response=4; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_inhalation | LC50 | 0.73 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5287; Record_ID=acute_inhalation_26; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX6; Formulation_Name=Acticide CBM; Percent_Active_Ingredient=0.465; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.73; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_inhalation | LC50 | 0.21 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5288; Record_ID=acute_inhalation_29; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=1.95; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.21; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_inhalation | LC50 | 1.69 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5289; Record_ID=acute_inhalation_329; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX400; Formulation_Name=Rocima 586; Percent_Active_Ingredient=0.78; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=1.69; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_acute_inhalation | LC50 | range0.52 | mg/L | - | Inhalation | - | In Vivo; AcuteInhal6pack; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=5298; Record_ID=acute_inhalation_293; Data_Type=In Vivo; Internal_Data_Source=AcuteInhal6pack; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response_Modifier=range; Response=>0.52 and <2.05; Response_Unit=mg/L; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
NTP_ICE_acute_oral 15 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_12860; row=15990; data_type=In Vivo; mixture=Mixture; formulation_id=MIX361; formulation_name=Preventol P 91; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.8; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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=15994; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.465; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_13224; row=15996; data_type=In Vivo; mixture=Mixture; formulation_id=MIX278; formulation_name=Kathon CF 400; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=2.95; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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=16000; data_type=In Vivo; mixture=Mixture; formulation_id=MIX663; formulation_name=Acticide CBM 2; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=1.0; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_12959; row=16001; data_type=In Vivo; mixture=Mixture; formulation_id=MIX400; formulation_name=Rocima 586; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.78; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; source_file=acute_oral.xlsx |
| NTP_ICE_acute_oral | EPA classification | =2 | Unitless | Rat (Female) | oral | acute | Rat Acute Oral Toxicity | Studies submitted to EPA in support of pesticide registration applications (undated); record_id=acute_oral_12189; row=16004; data_type=In Vivo; mixture=Mixture; formulation_id=MIX8; formulation_name=Acticide LA 2605-F; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=1.95; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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=15991; data_type=In Vivo; mixture=Mixture; formulation_id=MIX663; formulation_name=Acticide CBM 2; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=1.0; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_12189; row=15992; data_type=In Vivo; mixture=Mixture; formulation_id=MIX8; formulation_name=Acticide LA 2605-F; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=1.95; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_13224; row=15993; data_type=In Vivo; mixture=Mixture; formulation_id=MIX278; formulation_name=Kathon CF 400; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=2.95; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_12959; row=15995; data_type=In Vivo; mixture=Mixture; formulation_id=MIX400; formulation_name=Rocima 586; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.78; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_12860; row=15997; data_type=In Vivo; mixture=Mixture; formulation_id=MIX361; formulation_name=Preventol P 91; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.8; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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=16003; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.465; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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=15998; data_type=In Vivo; mixture=Mixture; formulation_id=MIX6; formulation_name=Acticide CBM; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.465; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_12959; row=15999; data_type=In Vivo; mixture=Mixture; formulation_id=MIX400; formulation_name=Rocima 586; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.78; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; 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_12860; row=16002; data_type=In Vivo; mixture=Mixture; formulation_id=MIX361; formulation_name=Preventol P 91; chemical_name=5-Chloro-2-methyl-4-isothiazolin-3-one; preferred_name=5-Chloro-2-methyl-3(2H)-isothiazolone; percent_active_ingredient=0.8; dtxsid=DTXSID9034286; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286; source_file=acute_oral.xlsx |
NTP_ICE_dart 7 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=135747; Record_ID=dart_11329; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, In life observation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; 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;C0005910;CUI;Body Weight; Reference=ToxRefDB v2 , ID = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=135748; Record_ID=dart_11330; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, In life observation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; 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 = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=135749; Record_ID=dart_11331; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, In life observation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; Sex=Female; Life_Stage=Adult; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C3540840;CUI;Sign or Symptom|UMLS;C0011135;CUI;Defecation; Reference=ToxRefDB v2 , ID = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=135750; Record_ID=dart_11347; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, In life observation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; Sex=Female; Life_Stage=Adult; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C3540840;CUI;Sign or Symptom|UMLS;C0011991;CUI;Diarrhea; Reference=ToxRefDB v2 , ID = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=135751; Record_ID=dart_11349; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, In life observation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; 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 = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, In life observation | sheet=Data; excel_row=135752; Record_ID=dart_11348; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, In life observation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; Sex=Female; Life_Stage=Adult; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C3540840;CUI;Sign or Symptom|UMLS;C0011991;CUI;Diarrhea; Reference=ToxRefDB v2 , ID = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_dart | LOEL | 8 | mg/kg bw/day | Rabbit | Oral | - | In Vivo; DART, Developmental malformation | sheet=Data; excel_row=135753; Record_ID=dart_11354; Data_Type=In Vivo; DTXSID=DTXSID9034286; Assay=DART, Developmental malformation; Endpoint=LOEL; Response=8; Response_Unit=mg/kg/day; Species=Rabbit; Strain=New Zealand White; Sex=Male/Female; Life_Stage=Fetal; Route=Oral; Critical_Effect=Yes; Unified_Medical_Language_System=UMLS;C0000768;CUI;Congenital Abnormality|UMLS;C0205394;CUI;Other; Reference=ToxRefDB v2 , ID = 825; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
NTP_ICE_endocrine 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_endocrine | Model Score | 0 | unitless | - | - | - | ARPathway2016; AR Pathway Model, Antagonist | sheet=Integrated_approaches; excel_row=4294; RecordID=ARPathway2016_1068; DatasetName=ARPathway2016; DTXSID=DTXSID9034286; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
NTP_ICE_eye_irritation 4 endpoints
| 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=2919; Record_ID=eye_irritation_905; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID773; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_eye_irritation | EPA Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2919; Record_ID=eye_irritation_905; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID773; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_eye_irritation | EPA Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2919; Record_ID=eye_irritation_905; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID773; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_eye_irritation | EPA Classification | 1 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=2919; Record_ID=eye_irritation_905; Data_Type=In Vivo; Formulation_ID=EyeIrritation6pack_PID773; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
NTP_ICE_skin_irritation 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_irritation | EPA classification | 2 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1975; Record_ID=skin_irritation_invivo_378; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=2; Response_Unit=Unitless; Species=Rabbit; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_irritation | EPA classification | 1 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1976; Record_ID=skin_irritation_invivo_516; Data_Type=In Vivo; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=1.95; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_skin_irritation | EPA classification | 2 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1978; Record_ID=skin_irritation_invivo_751; Data_Type=In Vivo; Formulation_ID=MIX361; Formulation_Name=Preventol P 91; Percent_Active_Ingredient=0.8; Mixture=Mixture; DTXSID=DTXSID9034286; 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=Female; Reference=FIFRA (undated); URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_irritation | EPA classification | 1 | unitless | Rabbit | Dermal | - | In Vivo; Draize Skin Irritation/Corrosion Test | sheet=Data_invivo; excel_row=1979; Record_ID=skin_irritation_invivo_849; Data_Type=In Vivo; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=1.95; Mixture=Mixture; DTXSID=DTXSID9034286; Assay=Draize Skin Irritation/Corrosion Test; Endpoint=EPA classification; Response=1; 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/DTXSID9034286 |
NTP_ICE_skin_sensitization 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | Depletion Cys | 96.3 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=151; Record_ID=skin_sensitization_invitro_58; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=96.3; Reported_Response_Unit=%; Response=96.3; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_sensitization | Depletion Lys | 35.1 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=167; Record_ID=skin_sensitization_invitro_58; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=35.1; Reported_Response_Unit=%; Response=35.1; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_sensitization | EC1.5 | 2.3 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=8777; Record_ID=skin_sensitization_invitro_2432; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=KeratinoSens; Endpoint=EC1.5; Reported_Response=2.3; Reported_Response_Unit=uM; Response=2.3; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_sensitization | EC3 | 0.01 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13027; Record_ID=skin_sensitization_invivo_2990; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=LLNA; Endpoint=EC3; Response=0.01; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Basketter et al. 1999; 10439339; 10.1002/(sici)1099-1263(199907/08)19:4<255::aid-jat573>3.0.co;2-s; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_sensitization | EC3 | 0.009 | % | Mouse | Dermal | - | In Vivo; LLNAdb2013; LLNA | sheet=Data_invivo; excel_row=13028; Record_ID=skin_sensitization_invivo_2991; Data_Type=In Vivo; Internal_Data_Source=LLNAdb2013; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=LLNA; Endpoint=EC3; Response=9.00E-03; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Ashby et al. 1995; 8553361; 10.1016/0300-483x(95)03132-y; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_sensitization | GHS Classification | 1 | unitless | Guinea pig | Dermal | - | In Vivo; SkinSensitization6pack; Guinea Pig Maximization/Buehler | sheet=Data_invivo; excel_row=728; Record_ID=skin_sensitization_invivo_23; Data_Type=In Vivo; Internal_Data_Source=SkinSensitization6pack; Formulation_ID=MIX8; Formulation_Name=Acticide LA 2605-F; Percent_Active_Ingredient=1.95; Mixture=Mixture; DTXSID=DTXSID9034286; 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/DTXSID9034286 |
| NTP_ICE_skin_sensitization | IC50 | 16.9 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=8778; Record_ID=skin_sensitization_invitro_2432; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=KeratinoSens; Endpoint=IC50; Reported_Response=16.8999379; Reported_Response_Unit=uM; Response=16.9; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
| NTP_ICE_skin_sensitization | Imax | 7.248 | ratio | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; KeratinoSens | sheet=Data_invitro; excel_row=8779; Record_ID=skin_sensitization_invitro_2432; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID9034286; Assay=KeratinoSens; Endpoint=Imax; Reported_Response=7.24767612; Reported_Response_Unit=Unitless; Response=7.248; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID9034286 |
SCCS_vision_codex 80 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =2.6 | mg/kg/day | rat | oral | 90-day | repeated dose toxicity | {"citation":"Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic","dose":"Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid].","effect":"skin. There were no other differences in general behaviour or appearance. There were no treatment-related changes in haematological, biochemical, urinary parameters nor any pathology. Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid]. The No Observed Effect Level (NOEL) in this study was estimated to be greater than or equal to the highest dose tested (29.1 mg a.i. /kg/day). Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; 10/sex/dose reproduction) Test substance: Kathon 886 NAR (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0,","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | oral | 90 days | repeated dose toxicity | {"dose":"99.9 area% (HPLC) Vehicle: water Dose levels:","effect":"l- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0, 25, 75 or 225 ppm a.i. Route: drinking water Exposure: 90 days (subchronic), approximately 5 months (15 weeks up 21 postnatal day 21, reproduction) GLP: in compliance Study period 1981 Kathon 886 NAR, with magnesium salts, is given as 15.1% a.i. but there is no indication of the CMI/MI ratio. Dose levels were selected based on a range-finding study that indicated a no-observed- effect-level (NOEL) of 200 ppm a.i. after two weeks of CMI/MI administration in the drinking water. Rats were exposed to CMI/MI via their drinking water at concentrations of 25, 75 or 225 ppm a.i. for three months [equivalent to an average intake of 2.38, 6.28 and 16.3 mg/kg/day in males and 4.06, 10.8, and 24.7 mg/kg/day in females]. Two additional groups of rats (25/sex/group) were given tap water or tap water containing the inorganic ions present in the CMI/MI solution, at a concentration equal to that in the high dose group (225","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_002"} |
| SCCS_vision_codex | NOAEL | =75 | ppm | - | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"ted changes were seen. Reproductive organs at all doses were comparable to the controls. Reproductive Results Reproductive capability was similar in all groups. Litter size and survival at birth was also similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_003"} |
| SCCS_vision_codex | NOAEL | =225 | ppm | rat | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"lso similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and female","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_004"} |
| SCCS_vision_codex | NOAEL | =104 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","effect":"and atonia as well as eschar formation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","page":24,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.34 | - | - | - | Chronic | repeated dose toxicity | {"citation":"Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data","dose":"At the mid-dose, the only effect observed was a very slight incidence of rhinitis.","effect":"f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3","page":26,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_009"} |
| SCCS_vision_codex | NOAEL | =30 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","dose":"id and high dose groups.","effect":"id and high dose groups. Gastric irritation was the primary effect observed. No adverse effects on the histopathology of any other tissues/organs were observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_010"} |
| SCCS_vision_codex | NOAEL | =300 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth","dose":"Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.","effect":"ere observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepare","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_011"} |
| SCCS_vision_codex | NOAEL | =3.7 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"sia, hyperkeratosis, eschar, dermal inflammation, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazo","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_013"} |
| SCCS_vision_codex | NOAEL | =13.9 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"e histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N°","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_015"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | Developmental | reproductive toxicity | {"dose":"The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i.","effect":"r doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_024"} |
| SCCS_vision_codex | NOAEL | =19.6 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":"mg/kg/day in the P1 animals;","effect":"mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_026"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":">15 mg a.i./kg bw/day during organogenesis (highest dose tested).","effect":">15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_030"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | oral | Developmental | reproductive toxicity | {"citation":"(Ref 80)","dose":"2 mg/kg bw Developmental NOEL:","effect":"t Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P1 two generation reproductive toxicity study,(Ref 80), based on significantly reduced water intake","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_031"} |
| SCCS_vision_codex | NOAEL | =0.00038 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ith an aerosol of the test substance at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_032"} |
| SCCS_vision_codex | NOAEL | =2.8 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ce at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_033"} |
| SCCS_vision_codex | NOAEL | =100 | % | human | dermal | - | reproductive toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":": 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_034"} |
| SCCS_vision_codex | NOAEL | =0.0015 | % | - | - | subchronic | repeated dose toxicity | {"effect":", 10% magnesium chloride and 62% water. This seems to be a change in the manufacturing process, but there is no indication as to when this change was made. The CMI/MI formulations described in the dossier show variations in the CMI/MI ratio and several physicochemical parameters. Toxicity The value of the acute, subchronic and reproductive toxicity studies is limited as the test formulations are not properly characterised and there are other data gaps. For the calculation of the Margin of Safety, the parental P1 NOAEL of 2.8 mg a.i./kg bw/day from the Kathon MW two generation reproductive toxicity study was used. Skin/eye irritation and sensitisation P56, (5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1) is corrosive or irritating at high concentrations. No adequate data is given to support safe use at a maximum authorised concentration of 0.0015 % in rinse-off cosmetic products. However, the weight of evidences over several decades of consumer exposure to cosmetic products indicates","page":35,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_035"} |
| SCCS_vision_codex | NOAEL | =11.1 | % | rat | oral | - | reproductive toxicity | {"dose":"Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","effect":"Unlabeled table on page 30: Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_036"} |
| SCCS_vision_codex | NOAEL | =10.2 | % | rat | oral | - | NOAEL study | {"dose":"Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_039"} |
| SCCS_vision_codex | NOAEL | =2.6 | mg/kg/day | rat | oral | 90-day | repeated dose toxicity | {"citation":"Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic","dose":"Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid].","effect":"skin. There were no other differences in general behaviour or appearance. There were no treatment-related changes in haematological, biochemical, urinary parameters nor any pathology. Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid]. The No Observed Effect Level (NOEL) in this study was estimated to be greater than or equal to the highest dose tested (29.1 mg a.i. /kg/day). Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; 10/sex/dose reproduction) Test substance: Kathon 886 NAR (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0,","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | oral | 90 days | repeated dose toxicity | {"dose":"99.9 area% (HPLC) Vehicle: water Dose levels:","effect":"l- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0, 25, 75 or 225 ppm a.i. Route: drinking water Exposure: 90 days (subchronic), approximately 5 months (15 weeks up 21 postnatal day 21, reproduction) GLP: in compliance Study period 1981 Kathon 886 NAR, with magnesium salts, is given as 15.1% a.i. but there is no indication of the CMI/MI ratio. Dose levels were selected based on a range-finding study that indicated a no-observed- effect-level (NOEL) of 200 ppm a.i. after two weeks of CMI/MI administration in the drinking water. Rats were exposed to CMI/MI via their drinking water at concentrations of 25, 75 or 225 ppm a.i. for three months [equivalent to an average intake of 2.38, 6.28 and 16.3 mg/kg/day in males and 4.06, 10.8, and 24.7 mg/kg/day in females]. Two additional groups of rats (25/sex/group) were given tap water or tap water containing the inorganic ions present in the CMI/MI solution, at a concentration equal to that in the high dose group (225","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_002"} |
| SCCS_vision_codex | NOAEL | =75 | ppm | - | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"ted changes were seen. Reproductive organs at all doses were comparable to the controls. Reproductive Results Reproductive capability was similar in all groups. Litter size and survival at birth was also similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_003"} |
| SCCS_vision_codex | NOAEL | =225 | ppm | rat | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"lso similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and female","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_004"} |
| SCCS_vision_codex | NOAEL | =104 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","effect":"and atonia as well as eschar formation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","page":24,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.34 | - | - | - | Chronic | repeated dose toxicity | {"citation":"Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data","dose":"At the mid-dose, the only effect observed was a very slight incidence of rhinitis.","effect":"f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3","page":26,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_009"} |
| SCCS_vision_codex | NOAEL | =30 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","dose":"id and high dose groups.","effect":"id and high dose groups. Gastric irritation was the primary effect observed. No adverse effects on the histopathology of any other tissues/organs were observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_010"} |
| SCCS_vision_codex | NOAEL | =300 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth","dose":"Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.","effect":"ere observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepare","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_011"} |
| SCCS_vision_codex | NOAEL | =3.7 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"sia, hyperkeratosis, eschar, dermal inflammation, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazo","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_013"} |
| SCCS_vision_codex | NOAEL | =13.9 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"e histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N°","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_015"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | Developmental | reproductive toxicity | {"dose":"The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i.","effect":"r doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_024"} |
| SCCS_vision_codex | NOAEL | =19.6 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":"mg/kg/day in the P1 animals;","effect":"mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_026"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":">15 mg a.i./kg bw/day during organogenesis (highest dose tested).","effect":">15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_030"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | oral | Developmental | reproductive toxicity | {"citation":"(Ref 80)","dose":"2 mg/kg bw Developmental NOEL:","effect":"t Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P1 two generation reproductive toxicity study,(Ref 80), based on significantly reduced water intake","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_031"} |
| SCCS_vision_codex | NOAEL | =0.00038 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ith an aerosol of the test substance at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_032"} |
| SCCS_vision_codex | NOAEL | =2.8 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ce at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_033"} |
| SCCS_vision_codex | NOAEL | =100 | % | human | dermal | - | reproductive toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":": 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_034"} |
| SCCS_vision_codex | NOAEL | =0.0015 | % | - | - | subchronic | repeated dose toxicity | {"effect":", 10% magnesium chloride and 62% water. This seems to be a change in the manufacturing process, but there is no indication as to when this change was made. The CMI/MI formulations described in the dossier show variations in the CMI/MI ratio and several physicochemical parameters. Toxicity The value of the acute, subchronic and reproductive toxicity studies is limited as the test formulations are not properly characterised and there are other data gaps. For the calculation of the Margin of Safety, the parental P1 NOAEL of 2.8 mg a.i./kg bw/day from the Kathon MW two generation reproductive toxicity study was used. Skin/eye irritation and sensitisation P56, (5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1) is corrosive or irritating at high concentrations. No adequate data is given to support safe use at a maximum authorised concentration of 0.0015 % in rinse-off cosmetic products. However, the weight of evidences over several decades of consumer exposure to cosmetic products indicates","page":35,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_035"} |
| SCCS_vision_codex | NOAEL | =11.1 | % | rat | oral | - | reproductive toxicity | {"dose":"Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","effect":"Unlabeled table on page 30: Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_036"} |
| SCCS_vision_codex | NOAEL | =10.2 | % | rat | oral | - | NOAEL study | {"dose":"Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_039"} |
| SCCS_vision_codex | NOAEL | =2.6 | mg/kg/day | rat | oral | 90-day | repeated dose toxicity | {"citation":"Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic","dose":"Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid].","effect":"skin. There were no other differences in general behaviour or appearance. There were no treatment-related changes in haematological, biochemical, urinary parameters nor any pathology. Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid]. The No Observed Effect Level (NOEL) in this study was estimated to be greater than or equal to the highest dose tested (29.1 mg a.i. /kg/day). Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; 10/sex/dose reproduction) Test substance: Kathon 886 NAR (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0,","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | oral | 90 days | repeated dose toxicity | {"dose":"99.9 area% (HPLC) Vehicle: water Dose levels:","effect":"l- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0, 25, 75 or 225 ppm a.i. Route: drinking water Exposure: 90 days (subchronic), approximately 5 months (15 weeks up 21 postnatal day 21, reproduction) GLP: in compliance Study period 1981 Kathon 886 NAR, with magnesium salts, is given as 15.1% a.i. but there is no indication of the CMI/MI ratio. Dose levels were selected based on a range-finding study that indicated a no-observed- effect-level (NOEL) of 200 ppm a.i. after two weeks of CMI/MI administration in the drinking water. Rats were exposed to CMI/MI via their drinking water at concentrations of 25, 75 or 225 ppm a.i. for three months [equivalent to an average intake of 2.38, 6.28 and 16.3 mg/kg/day in males and 4.06, 10.8, and 24.7 mg/kg/day in females]. Two additional groups of rats (25/sex/group) were given tap water or tap water containing the inorganic ions present in the CMI/MI solution, at a concentration equal to that in the high dose group (225","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_002"} |
| SCCS_vision_codex | NOAEL | =75 | ppm | - | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"ted changes were seen. Reproductive organs at all doses were comparable to the controls. Reproductive Results Reproductive capability was similar in all groups. Litter size and survival at birth was also similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_003"} |
| SCCS_vision_codex | NOAEL | =225 | ppm | rat | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"lso similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and female","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_004"} |
| SCCS_vision_codex | NOAEL | =104 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","effect":"and atonia as well as eschar formation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","page":24,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.34 | - | - | - | Chronic | repeated dose toxicity | {"citation":"Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data","dose":"At the mid-dose, the only effect observed was a very slight incidence of rhinitis.","effect":"f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3","page":26,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_009"} |
| SCCS_vision_codex | NOAEL | =30 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","dose":"id and high dose groups.","effect":"id and high dose groups. Gastric irritation was the primary effect observed. No adverse effects on the histopathology of any other tissues/organs were observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_010"} |
| SCCS_vision_codex | NOAEL | =300 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth","dose":"Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.","effect":"ere observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepare","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_011"} |
| SCCS_vision_codex | NOAEL | =3.7 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"sia, hyperkeratosis, eschar, dermal inflammation, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazo","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_013"} |
| SCCS_vision_codex | NOAEL | =13.9 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"e histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N°","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_015"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | Developmental | reproductive toxicity | {"dose":"The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i.","effect":"r doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_024"} |
| SCCS_vision_codex | NOAEL | =19.6 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":"mg/kg/day in the P1 animals;","effect":"mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_026"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":">15 mg a.i./kg bw/day during organogenesis (highest dose tested).","effect":">15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_030"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | oral | Developmental | reproductive toxicity | {"citation":"(Ref 80)","dose":"2 mg/kg bw Developmental NOEL:","effect":"t Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P1 two generation reproductive toxicity study,(Ref 80), based on significantly reduced water intake","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_031"} |
| SCCS_vision_codex | NOAEL | =0.00038 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ith an aerosol of the test substance at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_032"} |
| SCCS_vision_codex | NOAEL | =2.8 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ce at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_033"} |
| SCCS_vision_codex | NOAEL | =100 | % | human | dermal | - | reproductive toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":": 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_034"} |
| SCCS_vision_codex | NOAEL | =0.0015 | % | - | - | subchronic | repeated dose toxicity | {"effect":", 10% magnesium chloride and 62% water. This seems to be a change in the manufacturing process, but there is no indication as to when this change was made. The CMI/MI formulations described in the dossier show variations in the CMI/MI ratio and several physicochemical parameters. Toxicity The value of the acute, subchronic and reproductive toxicity studies is limited as the test formulations are not properly characterised and there are other data gaps. For the calculation of the Margin of Safety, the parental P1 NOAEL of 2.8 mg a.i./kg bw/day from the Kathon MW two generation reproductive toxicity study was used. Skin/eye irritation and sensitisation P56, (5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1) is corrosive or irritating at high concentrations. No adequate data is given to support safe use at a maximum authorised concentration of 0.0015 % in rinse-off cosmetic products. However, the weight of evidences over several decades of consumer exposure to cosmetic products indicates","page":35,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_035"} |
| SCCS_vision_codex | NOAEL | =11.1 | % | rat | oral | - | reproductive toxicity | {"dose":"Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","effect":"Unlabeled table on page 30: Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_036"} |
| SCCS_vision_codex | NOAEL | =10.2 | % | rat | oral | - | NOAEL study | {"dose":"Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_039"} |
| SCCS_vision_codex | NOAEL | =2.6 | mg/kg/day | rat | oral | 90-day | repeated dose toxicity | {"citation":"Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic","dose":"Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid].","effect":"skin. There were no other differences in general behaviour or appearance. There were no treatment-related changes in haematological, biochemical, urinary parameters nor any pathology. Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid]. The No Observed Effect Level (NOEL) in this study was estimated to be greater than or equal to the highest dose tested (29.1 mg a.i. /kg/day). Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; 10/sex/dose reproduction) Test substance: Kathon 886 NAR (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0,","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_001"} |
| SCCS_vision_codex | NOAEL | =200 | ppm | rat | oral | 90 days | repeated dose toxicity | {"dose":"99.9 area% (HPLC) Vehicle: water Dose levels:","effect":"l- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0, 25, 75 or 225 ppm a.i. Route: drinking water Exposure: 90 days (subchronic), approximately 5 months (15 weeks up 21 postnatal day 21, reproduction) GLP: in compliance Study period 1981 Kathon 886 NAR, with magnesium salts, is given as 15.1% a.i. but there is no indication of the CMI/MI ratio. Dose levels were selected based on a range-finding study that indicated a no-observed- effect-level (NOEL) of 200 ppm a.i. after two weeks of CMI/MI administration in the drinking water. Rats were exposed to CMI/MI via their drinking water at concentrations of 25, 75 or 225 ppm a.i. for three months [equivalent to an average intake of 2.38, 6.28 and 16.3 mg/kg/day in males and 4.06, 10.8, and 24.7 mg/kg/day in females]. Two additional groups of rats (25/sex/group) were given tap water or tap water containing the inorganic ions present in the CMI/MI solution, at a concentration equal to that in the high dose group (225","page":21,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_002"} |
| SCCS_vision_codex | NOAEL | =75 | ppm | - | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"ted changes were seen. Reproductive organs at all doses were comparable to the controls. Reproductive Results Reproductive capability was similar in all groups. Litter size and survival at birth was also similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_003"} |
| SCCS_vision_codex | NOAEL | =225 | ppm | rat | - | - | reproductive toxicity | {"dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","effect":"lso similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and female","page":22,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_004"} |
| SCCS_vision_codex | NOAEL | =104 | mg/kg/day | rat | - | - | NOAEL study | {"dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","effect":"and atonia as well as eschar formation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","page":24,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_006"} |
| SCCS_vision_codex | NOAEL | =0.34 | - | - | - | Chronic | repeated dose toxicity | {"citation":"Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data","dose":"At the mid-dose, the only effect observed was a very slight incidence of rhinitis.","effect":"f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3","page":26,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_009"} |
| SCCS_vision_codex | NOAEL | =30 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","dose":"id and high dose groups.","effect":"id and high dose groups. Gastric irritation was the primary effect observed. No adverse effects on the histopathology of any other tissues/organs were observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_010"} |
| SCCS_vision_codex | NOAEL | =300 | ppm | rat | oral | 24 months | carcinogenicity | {"citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth","dose":"Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.","effect":"ere observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepare","page":29,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_011"} |
| SCCS_vision_codex | NOAEL | =3.7 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"sia, hyperkeratosis, eschar, dermal inflammation, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazo","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_013"} |
| SCCS_vision_codex | NOAEL | =13.9 | % | rat | oral | - | reproductive toxicity | {"citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","effect":"e histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N°","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_015"} |
| SCCS_vision_codex | NOAEL | =4 | % | rat | oral | Developmental | reproductive toxicity | {"dose":"The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i.","effect":"r doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_024"} |
| SCCS_vision_codex | NOAEL | =19.6 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":"mg/kg/day in the P1 animals;","effect":"mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_026"} |
| SCCS_vision_codex | NOAEL | =2 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | {"dose":">15 mg a.i./kg bw/day during organogenesis (highest dose tested).","effect":">15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_030"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg/day | - | oral | Developmental | reproductive toxicity | {"citation":"(Ref 80)","dose":"2 mg/kg bw Developmental NOEL:","effect":"t Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P1 two generation reproductive toxicity study,(Ref 80), based on significantly reduced water intake","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_031"} |
| SCCS_vision_codex | NOAEL | =0.00038 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ith an aerosol of the test substance at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_032"} |
| SCCS_vision_codex | NOAEL | =2.8 | mg/kg bw | human | dermal | - | reproductive toxicity | {"citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":"ce at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_033"} |
| SCCS_vision_codex | NOAEL | =100 | % | human | dermal | - | reproductive toxicity | {"dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","effect":": 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","page":34,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_034"} |
| SCCS_vision_codex | NOAEL | =0.0015 | % | - | - | subchronic | repeated dose toxicity | {"effect":", 10% magnesium chloride and 62% water. This seems to be a change in the manufacturing process, but there is no indication as to when this change was made. The CMI/MI formulations described in the dossier show variations in the CMI/MI ratio and several physicochemical parameters. Toxicity The value of the acute, subchronic and reproductive toxicity studies is limited as the test formulations are not properly characterised and there are other data gaps. For the calculation of the Margin of Safety, the parental P1 NOAEL of 2.8 mg a.i./kg bw/day from the Kathon MW two generation reproductive toxicity study was used. Skin/eye irritation and sensitisation P56, (5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1) is corrosive or irritating at high concentrations. No adequate data is given to support safe use at a maximum authorised concentration of 0.0015 % in rinse-off cosmetic products. However, the weight of evidences over several decades of consumer exposure to cosmetic products indicates","page":35,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_035"} |
| SCCS_vision_codex | NOAEL | =11.1 | % | rat | oral | - | reproductive toxicity | {"dose":"Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","effect":"Unlabeled table on page 30: Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","page":30,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_036"} |
| SCCS_vision_codex | NOAEL | =10.2 | % | rat | oral | - | NOAEL study | {"dose":"Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76","page":31,"pdf":"sccs_o_009.pdf","row_type":"noael_study","study_id":"sccs_o_009_noael_039"} |
ToxRefDB_ToxRefDB_v3_pod.csv 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxRefDB_ToxRefDB_v3_pod.csv | LEL | =8 | mg/kg bw/day | rabbit (new zealand white; New Zealand White) | oral | 7 GD to 19 GD | DEV | study_id=825; toxval_study_source_id=studyid825_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight|in life observation-clinical signs-defecation|in life observation-food consumption-food consumption|in life observation-body weight-body weight gain|pathology gross-stomach-thickened|pathology gross-stomach-necrosis|pathology gross-stomach-discolored|in life observation-clinical signs-no feces|in life observation-mortality-mortality|in life observation-clinical signs-defecation (diarrhea); dose_level=3; study_year=1992; study_citation=Thomas, T.; Solomom, H.; O'Hara, G. (1992) Kathon Biocide: Oral (Gavage) Developmental Toxicity Study In Rabbits. Lab Project Number: 91P-074. Unpublished Study Prepared By Rohm And Haas Toxicology Dept. 206 P.; dsstox_substance_id=DTXSID9034286; 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 | =9.8 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 0 day to 24 month | CHR | study_id=829; toxval_study_source_id=studyid829_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-stomach-hyperkeratosis|pathology gross-stomach-prominent limiting ridge|pathology gross-stomach-foci|pathology microscopic-stomach-hyperplasia|urinalysis-specific gravity/osmolality-specific gravity/osmolality|pathology microscopic-stomach-necrosis|pathology gross-stomach-thickened|in life observation-body weight-body weight|in life observation-body weight-body weight gain|pathology microscopic-kidney-mineralization|pathology microscopic-adrenal gland-vacuolization; dose_level=2; study_year=1994; study_citation=Quinn, D.; O'Hara, G.; Brown, W. (1994) Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149. Unpublished Study Prepared By Rohm And Haas Company Toxicology Department. 5150 P.; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =6.6 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 0 day to 24 month | CHR | study_id=829; toxval_study_source_id=studyid829_Adult_F0_M_systemic; toxval_effect_list=urinalysis-specific gravity/osmolality-specific gravity/osmolality|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-hyperkeratosis|pathology gross-stomach-foci|pathology gross-stomach-prominent limiting ridge|pathology gross-stomach-thickened|pathology microscopic-parathyroid gland-hyperplasia|pathology microscopic-stomach-inflammation|pathology microscopic-stomach-necrosis|pathology microscopic-stomach-edema|pathology microscopic-kidney-hydronephrosis|in life observation-body weight-body weight|in life observation-body weight-body weight gain|pathology microscopic-liver-proliferation|pathology microscopic-stomach-ulcer; dose_level=2; study_year=1994; study_citation=Quinn, D.; O'Hara, G.; Brown, W. (1994) Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149. Unpublished Study Prepared By Rohm And Haas Company Toxicology Department. 5150 P.; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =0.75 | mg/kg bw/day | rat (sprague dawley; CD(SD)BR) | dermal | 0 week to 13 week | SUB | study_id=6188; toxval_study_source_id=studyid6188_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-erythema|in life observation-clinical signs-desquamation|in life observation-clinical signs-scabbing|in life observation-clinical signs-[other]|pathology microscopic-skin-edema|pathology microscopic-skin-acanthosis|in life observation-clinical signs-skin ulceration|pathology microscopic-skin-infiltration cellular|pathology microscopic-skin-parakeratosis; dose_level=1; study_year=1994; study_citation=Zuhlke, U. 1994. Acticide 14: 90-day dermal subchronic study in the rat. Hazleton Deutschland, Project ID 1154-002. MRID 43462005.; dsstox_substance_id=DTXSID9034286; admin_method=Topical; 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 | =3.75 | mg/kg bw/day | rat (sprague dawley; CD(SD)BR) | dermal | 0 week to 13 week | SUB | study_id=6188; toxval_study_source_id=studyid6188_Adult_F0_M_systemic; toxval_effect_list=in life observation-clinical signs-erythema|in life observation-clinical signs-desquamation|in life observation-clinical signs-[other]|pathology microscopic-skin-acanthosis|in life observation-clinical signs-scabbing|pathology microscopic-skin-focal cellular change|pathology microscopic-skin-infiltration cellular|pathology microscopic-skin-parakeratosis|pathology microscopic-skin-edema; dose_level=2; study_year=1994; study_citation=Zuhlke, U. 1994. Acticide 14: 90-day dermal subchronic study in the rat. Hazleton Deutschland, Project ID 1154-002. MRID 43462005.; dsstox_substance_id=DTXSID9034286; admin_method=Topical; 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 | =70 | mg/kg bw/day | rat (sprague dawley; sprague dawley) | oral | 6 GD to 15 GD | DEV | study_id=6189; toxval_study_source_id=studyid6189_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-labored respiration|in life observation-body weight-body weight gain|in life observation-body weight-body weight|in life observation-food consumption-food consumption; dose_level=2; study_year=1994; study_citation=Fuchs, A. (1994) Acticide 14 oral (gavage) teratogenicity study in the rat. Project ID 1154-003. Report No. 1178-1154-003.Unpublished.; dsstox_substance_id=DTXSID9034286; 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 | >139 | mg/kg bw/day | rat (sprague dawley; sprague dawley) | oral | 6 GD to 15 GD | DEV | study_id=6189; toxval_study_source_id=studyid6189_Fetal_Fetal_MF_NA; dose_level=3; study_year=1994; study_citation=Fuchs, A. (1994) Acticide 14 oral (gavage) teratogenicity study in the rat. Project ID 1154-003. Report No. 1178-1154-003.Unpublished.; dsstox_substance_id=DTXSID9034286; 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 | =4.4 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F0_F_systemic; toxval_effect_list=in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperkeratosis|in life observation-food consumption-food consumption|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-erosion|pathology microscopic-stomach-edema|pathology microscopic-stomach-inflammation|in life observation-body weight-body weight gain; dose_level=1; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =2.8 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F0_M_systemic; toxval_effect_list=in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-hyperkeratosis|pathology microscopic-stomach-edema|pathology microscopic-stomach-inflammation|pathology microscopic-stomach-erosion|in life observation-body weight-body weight gain; dose_level=1; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =5.5 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F1_F_systemic; toxval_effect_list=in life observation-water consumption-water consumption|pathology microscopic-stomach-erosion|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-hyperkeratosis; dose_level=1; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =4.3 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F1_M_systemic; toxval_effect_list=in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperkeratosis|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-erosion|pathology microscopic-stomach-edema|pathology microscopic-stomach-inflammation; dose_level=1; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | >39.1 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Juvenile_F1_F_NA; dose_level=3; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =11.8 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-stomach-hyperkeratosis|in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-erosion; dose_level=2; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =8.5 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F0_M_systemic; toxval_effect_list=in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-hyperkeratosis; dose_level=2; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =16 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F1_F_systemic; toxval_effect_list=pathology microscopic-stomach-erosion|in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperplasia|pathology microscopic-stomach-hyperkeratosis; dose_level=2; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =13.4 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 10 weeks (premating) to 2 generation | MGR | study_id=6190; toxval_study_source_id=studyid6190_Adult_F1_M_systemic; toxval_effect_list=pathology microscopic-stomach-hyperkeratosis|in life observation-water consumption-water consumption|pathology microscopic-stomach-hyperplasia; dose_level=2; study_year=1998; study_citation=Robison, P., L.P. Craig, and T.L. Danberry. (1998) Kathon 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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 | =2 | mg/kg bw/day | rabbit (new zealand white; New Zealand White) | oral | 7 GD to 19 GD | DEV | study_id=825; toxval_study_source_id=studyid825_Adult_F0_F_systemic; toxval_effect_list=pathology gross-stomach-thickened|pathology gross-stomach-discolored|in life observation-body weight-body weight gain|pathology gross-stomach-necrosis|in life observation-food consumption-food consumption|in life observation-clinical signs-no feces|in life observation-mortality-mortality|in life observation-body weight-body weight|in life observation-clinical signs-defecation|in life observation-clinical signs-defecation (diarrhea); dose_level=2; study_year=1992; study_citation=Thomas, T.; Solomom, H.; O'Hara, G. (1992) Kathon Biocide: Oral (Gavage) Developmental Toxicity Study In Rabbits. Lab Project Number: 91P-074. Unpublished Study Prepared By Rohm And Haas Toxicology Dept. 206 P.; dsstox_substance_id=DTXSID9034286; 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 | =3.1 | mg/kg bw/day | rat (sprague dawley; Sprague Dawley (CD)) | oral | 0 day to 24 month | CHR | study_id=829; toxval_study_source_id=studyid829_Adult_F0_F_systemic; toxval_effect_list=pathology microscopic-stomach-hyperkeratosis|pathology microscopic-adrenal gland-vacuolization|pathology gross-stomach-prominent limiting ridge|pathology gross-stomach-foci|pathology microscopic-stomach-hyperplasia|in life observation-body weight-body weight gain|urinalysis-specific gravity/osmolality-specific gravity/osmolality|pathology microscopic-kidney-mineralization|in life observation-body weight-body weight|pathology microscopic-stomach-necrosis|pathology gross-stomach-thickened; dose_level=1; study_year=1994; study_citation=Quinn, D.; O'Hara, G.; Brown, W. (1994) Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149. Unpublished Study Prepared By Rohm And Haas Company Toxicology Department. 5150 P.; dsstox_substance_id=DTXSID9034286; admin_method=Water; 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; CD(SD)BR) | dermal | 0 week to 13 week | SUB | study_id=6188; toxval_study_source_id=studyid6188_Adult_F0_F_systemic; toxval_effect_list=in life observation-clinical signs-scabbing|in life observation-clinical signs-desquamation|pathology microscopic-skin-infiltration cellular|in life observation-clinical signs-skin ulceration|pathology microscopic-skin-parakeratosis|pathology microscopic-skin-acanthosis|pathology microscopic-skin-edema|in life observation-clinical signs-erythema|in life observation-clinical signs-[other]; dose_level=0; study_year=1994; study_citation=Zuhlke, U. 1994. Acticide 14: 90-day dermal subchronic study in the rat. Hazleton Deutschland, Project ID 1154-002. MRID 43462005.; dsstox_substance_id=DTXSID9034286; admin_method=Topical; 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 | =28 | mg/kg bw/day | rat (sprague dawley; sprague dawley) | oral | 6 GD to 15 GD | DEV | study_id=6189; toxval_study_source_id=studyid6189_Adult_F0_F_systemic; toxval_effect_list=in life observation-body weight-body weight gain|in life observation-clinical signs-labored respiration|in life observation-body weight-body weight|in life observation-food consumption-food consumption; dose_level=1; study_year=1994; study_citation=Fuchs, A. (1994) Acticide 14 oral (gavage) teratogenicity study in the rat. Project ID 1154-003. Report No. 1178-1154-003.Unpublished.; dsstox_substance_id=DTXSID9034286; admin_method=Gavage/Intubation; cas_source=toxval_ToxRefDB.xlsx:DTXSID; blob_url=https://clowder.edap-cluster.com/files/688cbadae4b02565bc3f8c07/blob; blob_sha256=69dd2da06ffc6a98a1bed684c347d8b2f31e6d35d607d4f2f83ebb6845a708d5 |
ToxValDB_ECOTOX 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECOTOX | LOEL | =30 | % | Mouse | dermal | short-term; 16 days | short-term | LONG_REF=Contact Dermatitis15(1): 17-23 Maisey,J., and K. Miller Assessment of the Ability of Mice Fed on Vitamin A Supplemented Diet to Respond to a Variety of Potential Contact Sensitizers 1986; TITLE=Assessment of the Ability of Mice Fed on Vitamin A Supplemented Diet to Respond to a Variety of Potential Contact Sensitizers; AUTHOR=Maisey,J., and K. Miller; DOI=10.1111/j.1600-0536.1986.tb01255.x; QUALITY=Control type: Carrier or solvent control; EXTERNAL_SOURCE_ID=81179; 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=1986; ORIGINAL_YEAR=1986; TOXICOLOGICAL_EFFECT=Immunological: Thickness; TOXICOLOGICAL_EFFECT_CATEGORY=other; STUDY_GROUP=ECOTOX:15604352:F:--; QC_CATEGORY=Data source QC'd by data provider prior to ECOTOX import; QC_STATUS=not determined; SOURCE_HASH=e30b9008a62e6e99cd09bd52aaf17025 |
ToxValDB_ToxRefDB 19 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ToxRefDB | LEL | =8 | mg/kg bw/day | Rabbit | oral | short-term (developmental); 13 days | reproduction developmental | LONG_REF=Thomas, T.; Solomom, H.; O\'Hara, G. (1992) Kathon Biocide: Oral (Gavage) Developmental Toxicity Study In Rabbits. Lab Project Number: 91P-074. Unpublished Study Prepared By Rohm And Haas Toxicology Dept. 206 P.; TITLE=Kathon Biocide: Oral (Gavage) Developmental Toxicity Study In Rabbits; AUTHOR=Thomas, T.; Solomom, H.; O\'Hara, G; EXTERNAL_SOURCE_ID=825; 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=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: in life observation-clinical signs-defecation|systemic: in life observation-food consumption-food consumption|systemic: in life observation-body weight-body weight gain|systemic: in life observation-clinical signs-defecation (diarrhea)|systemic: pathology gross-stomach-necrosis|systemic: in life observation-clinical signs-no feces|systemic: in life observation-mortality-mortality|systemic: pathology gross-stomach-thickened|systemic: pathology gross-stomach-discolored; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival; STUDY_GROUP=ToxRefDB_dup_-_15682937_15682938_15682939_15682940:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4b07034644dd398dfb8bfe89eff3a506 |
| ToxValDB_ToxRefDB | LEL | =9.8 | mg/kg bw/day | Rat | oral | chronic; 24 months | chronic | LONG_REF=Quinn, D.; O\'Hara, G.; Brown, W. (1994) Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149. Unpublished Study Prepared By Rohm And Haas Company Toxicology Department. 5150 P.; TITLE=Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149; AUTHOR=Quinn, D.; O\'Hara, G.; Brown, W; EXTERNAL_SOURCE_ID=829; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-necrosis|systemic: pathology gross-stomach-foci|systemic: pathology gross-stomach-thickened|systemic: urinalysis-specific gravity/osmolality-specific gravity/osmolality|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology gross-stomach-prominent limiting ridge|systemic: pathology microscopic-stomach-hyperplasia|systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-kidney-mineralization|systemic: pathology microscopic-adrenal gland-vacuolization; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|gross pathology|nonneoplastic histopathology|urinalysis; STUDY_GROUP=ToxRefDB_dup_-_15682945_15682946_15682947_15682948:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_135acd0aea3162e109fa95a486cf164f |
| ToxValDB_ToxRefDB | LEL | =6.6 | mg/kg bw/day | Rat | oral | chronic; 24 months | chronic | LONG_REF=Quinn, D.; O\'Hara, G.; Brown, W. (1994) Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149. Unpublished Study Prepared By Rohm And Haas Company Toxicology Department. 5150 P.; TITLE=Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149; AUTHOR=Quinn, D.; O\'Hara, G.; Brown, W; EXTERNAL_SOURCE_ID=829; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: urinalysis-specific gravity/osmolality-specific gravity/osmolality|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology gross-stomach-foci|systemic: pathology gross-stomach-prominent limiting ridge|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology gross-stomach-thickened|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-stomach-ulcer|systemic: pathology microscopic-stomach-edema|systemic: pathology microscopic-kidney-hydronephrosis|systemic: in life observation-body weight-body weight|systemic: pathology microscopic-parathyroid gland-hyperplasia|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-stomach-necrosis|systemic: pathology microscopic-liver-proliferation; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|gross pathology|nonneoplastic histopathology|urinalysis; STUDY_GROUP=ToxRefDB_dup_-_15682949_15682950_15682951_15682952:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2edc5a8ca9a1c11dc93d7bae814d3ece |
| ToxValDB_ToxRefDB | LEL | =0.75 | mg/kg bw/day | Rat | dermal | subchronic; 13 weeks | subchronic | LONG_REF=Zuhlke, U. 1994. Acticide 14: 90-day dermal subchronic study in the rat. Hazleton Deutschland, Project ID 1154-002. MRID 43462005.; TITLE=Acticide 14: 90-day dermal subchronic study in the rat; AUTHOR=Zuhlke, U; EXTERNAL_SOURCE_ID=6188; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-desquamation|systemic: in life observation-clinical signs-erythema|systemic: in life observation-clinical signs-scabbing|systemic: in life observation-clinical signs-[other]|systemic: in life observation-clinical signs-skin ulceration|systemic: pathology microscopic-skin-infiltration cellular|systemic: pathology microscopic-skin-edema|systemic: pathology microscopic-skin-acanthosis|systemic: pathology microscopic-skin-parakeratosis; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ToxRefDB_dup_-_15711200_15711201:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_395e34c905afc652efc9fd4791434ffd |
| ToxValDB_ToxRefDB | LEL | =3.75 | mg/kg bw/day | Rat | dermal | subchronic; 13 weeks | subchronic | LONG_REF=Zuhlke, U. 1994. Acticide 14: 90-day dermal subchronic study in the rat. Hazleton Deutschland, Project ID 1154-002. MRID 43462005.; TITLE=Acticide 14: 90-day dermal subchronic study in the rat; AUTHOR=Zuhlke, U; EXTERNAL_SOURCE_ID=6188; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-erythema|systemic: in life observation-clinical signs-desquamation|systemic: in life observation-clinical signs-[other]|systemic: pathology microscopic-skin-infiltration cellular|systemic: pathology microscopic-skin-parakeratosis|systemic: pathology microscopic-skin-acanthosis|systemic: in life observation-clinical signs-scabbing|systemic: pathology microscopic-skin-focal cellular change|systemic: pathology microscopic-skin-edema; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ToxRefDB_dup_-_15711202_15711203:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2c75b835bf393e4b4db271cf425ee1f8 |
| ToxValDB_ToxRefDB | LEL | =70 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | reproduction developmental | LONG_REF=Fuchs, A. (1994) Acticide 14 oral (gavage) teratogenicity study in the rat. Project ID 1154-003. Report No. 1178-1154-003.Unpublished.; TITLE=Acticide 14 oral (gavage) teratogenicity study in the rat; AUTHOR=Fuchs, A; EXTERNAL_SOURCE_ID=6189; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-labored respiration|systemic: in life observation-body weight-body weight gain|systemic: in life observation-body weight-body weight|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15711204_15711205_15711206_15711207:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_44df3d458740c1e5ed27b6f3343e7bdd |
| ToxValDB_ToxRefDB | LEL | >139 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | developmental | LONG_REF=Fuchs, A. (1994) Acticide 14 oral (gavage) teratogenicity study in the rat. Project ID 1154-003. Report No. 1178-1154-003.Unpublished.; TITLE=Acticide 14 oral (gavage) teratogenicity study in the rat; AUTHOR=Fuchs, A; EXTERNAL_SOURCE_ID=6189; 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=1994; ORIGINAL_YEAR=1994; STUDY_GROUP=ToxRefDB_dup_-_15711208_15711209_15711210_15711211:M/F:fetusfetal; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_2b44bbb69d5a0a97455659d87505c3e1 |
| ToxValDB_ToxRefDB | LEL | =4.4 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-erosion|systemic: in life observation-food consumption-food consumption|systemic: pathology microscopic-stomach-edema|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-stomach-inflammation; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711212_15711213_15711214:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_14f31c870e094efd2b8dc2054f3a91b3 |
| ToxValDB_ToxRefDB | LEL | =2.8 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-edema|systemic: in life observation-body weight-body weight gain|systemic: pathology microscopic-stomach-inflammation|systemic: pathology microscopic-stomach-erosion; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711215_15711216_15711217:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_28ad1cbea24882e68218528c022a3d17 |
| ToxValDB_ToxRefDB | LEL | =5.5 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-stomach-erosion; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711218_15711219_15711220:F:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_46629be4eff15d2c380ab28d5acbc787 |
| ToxValDB_ToxRefDB | LEL | =4.3 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-edema|systemic: pathology microscopic-stomach-erosion|systemic: pathology microscopic-stomach-inflammation; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711221_15711222_15711223:M:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8ba13537ab3620b79aa091d3a74c646b |
| ToxValDB_ToxRefDB | LEL | >39.1 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; STUDY_GROUP=ToxRefDB_dup_-_15711224_15711225_15711226_15711227:F:F1juvenile; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0fb2e3b55add605098b019c85818a446 |
| ToxValDB_ToxRefDB | LOAEL | =11.8 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-stomach-hyperplasia|systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-erosion; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711212_15711213_15711214:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_8f248681fdc25756ca1b32510d2fb305 |
| ToxValDB_ToxRefDB | LOAEL | =8.5 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-hyperkeratosis|systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711215_15711216_15711217:M:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_d95c2eb7e29ba5959c9264ea57e7307b |
| ToxValDB_ToxRefDB | LOAEL | =16 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-stomach-erosion; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711218_15711219_15711220:F:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7c253edb2aa725b68fddc5f559484907 |
| ToxValDB_ToxRefDB | LOAEL | =13.4 | mg/kg bw/day | Rat | oral | chronic (developmental) | reproduction developmental | LONG_REF=Robison, P., L.P. Craig, and T.L. Danberry. (1998) KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats. Rohm and Haas Company, Toxicology Department, Spring House, PA. Report No. 96R-189. August 7, 1998. MRID 44656101; TITLE=KathonAR 886F Biocide: Two-Generation Reproductive Toxicity Study in Rats; AUTHOR=Robison, P., L.P. Craig, and T.L. Danberry; EXTERNAL_SOURCE_ID=6190; 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=1998; ORIGINAL_YEAR=1998; TOXICOLOGICAL_EFFECT=systemic: pathology microscopic-stomach-hyperkeratosis|systemic: in life observation-water consumption-water consumption|systemic: pathology microscopic-stomach-hyperplasia; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ToxRefDB_dup_-_15711221_15711222_15711223:M:F1adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_b6cd6eb11bd5ca35576355758d695bf4 |
| ToxValDB_ToxRefDB | NEL | =2 | mg/kg bw/day | Rabbit | oral | short-term (developmental); 13 days | reproduction developmental | LONG_REF=Thomas, T.; Solomom, H.; O\'Hara, G. (1992) Kathon Biocide: Oral (Gavage) Developmental Toxicity Study In Rabbits. Lab Project Number: 91P-074. Unpublished Study Prepared By Rohm And Haas Toxicology Dept. 206 P.; TITLE=Kathon Biocide: Oral (Gavage) Developmental Toxicity Study In Rabbits; AUTHOR=Thomas, T.; Solomom, H.; O\'Hara, G; EXTERNAL_SOURCE_ID=825; 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=1992; ORIGINAL_YEAR=1992; TOXICOLOGICAL_EFFECT=systemic: pathology gross-stomach-discolored|systemic: in life observation-body weight-body weight gain|systemic: pathology gross-stomach-thickened|systemic: pathology gross-stomach-necrosis|systemic: in life observation-clinical signs-no feces|systemic: in life observation-mortality-mortality|systemic: in life observation-clinical signs-defecation (diarrhea)|systemic: in life observation-body weight-body weight|systemic: in life observation-clinical signs-defecation|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival; STUDY_GROUP=ToxRefDB_dup_-_15682937_15682938_15682939_15682940:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_22f9e69c39eb5fb3071c46dfa7cbd153 |
| ToxValDB_ToxRefDB | NEL | =3.1 | mg/kg bw/day | Rat | oral | chronic; 24 months | chronic | LONG_REF=Quinn, D.; O\'Hara, G.; Brown, W. (1994) Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149. Unpublished Study Prepared By Rohm And Haas Company Toxicology Department. 5150 P.; TITLE=Kathon Biocide: 24-Month Drinking Water Chronic/Oncogenic Study In Rats: Final Report: Lab Project Number: 90P/149: 90R/149; AUTHOR=Quinn, D.; O\'Hara, G.; Brown, W; EXTERNAL_SOURCE_ID=829; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: in life observation-body weight-body weight|systemic: in life observation-body weight-body weight gain|systemic: pathology gross-stomach-foci|systemic: pathology microscopic-stomach-necrosis|systemic: pathology microscopic-stomach-hyperplasia|systemic: pathology microscopic-stomach-hyperkeratosis|systemic: pathology microscopic-adrenal gland-vacuolization|systemic: pathology gross-stomach-prominent limiting ridge|systemic: urinalysis-specific gravity/osmolality-specific gravity/osmolality|systemic: pathology microscopic-kidney-mineralization|systemic: pathology gross-stomach-thickened; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|gross pathology|nonneoplastic histopathology|urinalysis; STUDY_GROUP=ToxRefDB_dup_-_15682945_15682946_15682947_15682948:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_c7423f7fde68a556867ed9099e8aae91 |
| ToxValDB_ToxRefDB | NEL | =28 | mg/kg bw/day | Rat | oral | short-term (developmental); 10 days | reproduction developmental | LONG_REF=Fuchs, A. (1994) Acticide 14 oral (gavage) teratogenicity study in the rat. Project ID 1154-003. Report No. 1178-1154-003.Unpublished.; TITLE=Acticide 14 oral (gavage) teratogenicity study in the rat; AUTHOR=Fuchs, A; EXTERNAL_SOURCE_ID=6189; 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=1994; ORIGINAL_YEAR=1994; TOXICOLOGICAL_EFFECT=systemic: in life observation-clinical signs-labored respiration|systemic: in life observation-body weight-body weight gain|systemic: in life observation-body weight-body weight|systemic: in life observation-food consumption-food consumption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption; STUDY_GROUP=ToxRefDB_dup_-_15711204_15711205_15711206_15711207:F:F0adult; QC_CATEGORY=Data source QC'd by data provider prior to ToxRefDB import; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6405974b44ed8ece28302de3db52017e |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 43 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =104 | mg/kg/day | rat | - | - | - | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 0,104; DOSE=The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.; EFFECT=and atonia as well as eschar formation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","duration":"","effect":"and atonia as well as eschar formation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"= 0,104","page":24,"route":"","species":"rat","study_id":"sccs_o_009_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =104 | mg/kg/day | rat | - | - | - | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 0,104; DOSE=The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.; EFFECT=mation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","duration":"","effect":"mation. These reactions were generally mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"= 0,104","page":24,"route":"","species":"rat","study_id":"sccs_o_009_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =104 | mg/kg/day | rat | - | - | - | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 0,104; DOSE=The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.; EFFECT=mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites.","duration":"","effect":"mild in the males and more pronounced in the females. The only microscopic treatment-related findings were related lesions such as inflammation, parakeratosis and acanthosis at the treated skin sites. Group Control Low Mid High Dose mg/kg/day 0 0.75 3.75 18.75 Mean total score (on scale 1 - 4) Males 0.0 0.0 0.0 0.3 Females 0.0 0.0 0.1 0.4 Eschar formation (%) Males 0 0 0 60 Females 0 2 7 75 Exfoliation (%) Males 0 0 0 0 Females 0 0 0 0 NOAEL: <= 0,104 mg/kg/day (a.i.) NOAEL (male rat): 0.104 mg a.i./kg/day NOAEL (female rat): not observed.","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"= 0,104","page":24,"route":"","species":"rat","study_id":"sccs_o_009_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 10.2 | % | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=10.2; DOSE=Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.; EFFECT=Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.","duration":"","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"10.2","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_039"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =19.6 | mg/kg bw | rat | oral | - | - | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 19.6; DOSE=Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.; EFFECT=Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i.","duration":"","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rat Gavage | NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. | 1994 | 76","endpoint":"","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 19.6","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_042"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 30 | ppm | rat | oral | 24 months | carcinogenicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=30; DOSE=id and high dose groups.; EFFECT=id and high dose groups. Gastric irritation was the primary effect observed. No adverse effects on the histopathology of any other tissues/organs were observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males; CITATION=Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males; CITATION_NUMBERS=[74,1,120]; REFERENCE=Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","dose":"id and high dose groups.","duration":"24 months","effect":"id and high dose groups. Gastric irritation was the primary effect observed. No adverse effects on the histopathology of any other tissues/organs were observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males","endpoint":"carcinogenicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"30","page":29,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 300 | ppm | rat | oral | 24 months | carcinogenicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=300; DOSE=Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.; EFFECT=ere observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepare; CITATION=Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth; CITATION_NUMBERS=[74,1,120,40,5,2,4,3]; REFERENCE=Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth","dose":"Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.","duration":"24 months","effect":"ere observed away from the site of dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepare","endpoint":"carcinogenicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"300","page":29,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_011"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | carcinogenicity | 300 | ppm | rat | oral | 24 months | carcinogenicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=300; DOSE=Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.; EFFECT=dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepared from; CITATION=Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth; CITATION_NUMBERS=[74,1,120,40,5,2,4,3]; REFERENCE=Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Meth","dose":"Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i.","duration":"24 months","effect":"dosing. No systemic effects were observed. Conclusion Kathon™ 886 in the drinking water for 24 months produced no treatment-related effects on the type or incidence of neoplasms in rats at concentrations up to and including 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day). CMI/MI is not considered carcinogenic. The No-Observed-Effect Level (NOEL) in this study was 30 ppm a.i. (2.0 to 3.1 mg a.i./kg/day), based primarily on gastric irritation of the stomach at 100 and 300 ppm a.i.. The No-Observed-Adverse-Effect Level (NOAEL) was 300 ppm a.i. (17.2 to 25.7 mg/a.i./kg/day), since no evidence of systemic toxicity was observed at any dose and there was no adverse effects on the histopathology of any tissues/organs distant from the site of dosing at any dose. Ref.: 74 Dermal Study Guideline: / Species/strain: Mouse, Charles River CD-1 Group size: 120 males (40/dose) Test substance: Kathon™ CG (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 1.5% active ingredient Batch: Lot N° MH31:9E (prepared from","endpoint":"carcinogenicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"300","page":29,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 13.9 | % | rat | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Kathon™ 886 13.9% a.i. | Rat Gavage | Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). | 1980 | 75; EFFECT=Unlabeled table on page 31: Kathon™ 886 13.9% a.i. | Rat Gavage | Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). | 1980 | 75; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Kathon™ 886 13.9% a.i. | Rat Gavage | Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). | 1980 | 75","duration":"Developmental","effect":"Unlabeled table on page 31: Kathon™ 886 13.9% a.i. | Rat Gavage | Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). | 1980 | 75","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_038"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 10.2 | % | rabbit | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=10.2; EFFECT=Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rabbit Gavage | Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day | 2002 | 78; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"","duration":"Developmental","effect":"Unlabeled table on page 31: Acticide 14 10.2%CMI/4% MI | Rabbit Gavage | Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day | 2002 | 78","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"10.2","page":31,"route":"oral","species":"rabbit","study_id":"sccs_o_009_noael_040"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 13.9 | % | rabbit | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=2 mg/kg bw Developmental NOEL:; EFFECT=Unlabeled table on page 31: Kathon MW 13.9% a.i | Rabbit Gavage | NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] | 1991 | 77; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"2 mg/kg bw Developmental NOEL:","duration":"Developmental","effect":"Unlabeled table on page 31: Kathon MW 13.9% a.i | Rabbit Gavage | NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] | 1991 | 77","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":31,"route":"oral","species":"rabbit","study_id":"sccs_o_009_noael_041"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | developmental toxicity | 2 | mg/kg bw | rabbit | oral | Developmental | developmental toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=2; DOSE=2 mg/kg bw Developmental NOEL:; EFFECT=Unlabeled table on page 31: Kathon MW 13.9% a.i | Rabbit Gavage | NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] | 1991 | 77; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"2 mg/kg bw Developmental NOEL:","duration":"Developmental","effect":"Unlabeled table on page 31: Kathon MW 13.9% a.i | Rabbit Gavage | NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] | 1991 | 77","endpoint":"developmental toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2","page":31,"route":"oral","species":"rabbit","study_id":"sccs_o_009_noael_043"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 2.6 | mg/kg/day | rat | oral | 90-day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=2.6 to 3.0; DOSE=Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid].; EFFECT=skin. There were no other differences in general behaviour or appearance. There were no treatment-related changes in haematological, biochemical, urinary parameters nor any pathology. Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid]. The No Observed Effect Level (NOEL) in this study was estimated to be greater than or equal to the highest dose tested (29.1 mg a.i. /kg/day). Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; 10/sex/dose reproduction) Test substance: Kathon 886 NAR (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0,; CITATION=Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; CITATION_NUMBERS=[37,90,250,15]; REFERENCE=Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic","dose":"Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid].","duration":"90-day","effect":"skin. There were no other differences in general behaviour or appearance. There were no treatment-related changes in haematological, biochemical, urinary parameters nor any pathology. Conclusion No systemic toxicity was observed up to and including the highest dose of either CMI/MI (800 ppm, equivalent 29.1 mg a.i./kg/day] or its metabolites, N-methyl malonamic acid and malonic acid tested in combination [13 to 15 mg/kg/day N-methyl malonamic acid/2.6 to 3.0 mg/kg/day malonic acid]. The No Observed Effect Level (NOEL) in this study was estimated to be greater than or equal to the highest dose tested (29.1 mg a.i. /kg/day). Ref.: 37 90-day repeated oral dose and one-generation reproduction toxicity in rodents Guideline: / Species/strain: Rat, COBS CD (SD) BR Group size: 250 (15/sex/dose subchronic; 10/sex/dose reproduction) Test substance: Kathon 886 NAR (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0,","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"2.6 to 3.0","page":21,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 200 | ppm | rat | oral | 90 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=200; DOSE=99.9 area% (HPLC) Vehicle: water Dose levels:; EFFECT=l- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0, 25, 75 or 225 ppm a.i. Route: drinking water Exposure: 90 days (subchronic), approximately 5 months (15 weeks up 21 postnatal day 21, reproduction) GLP: in compliance Study period 1981 Kathon 886 NAR, with magnesium salts, is given as 15.1% a.i. but there is no indication of the CMI/MI ratio. Dose levels were selected based on a range-finding study that indicated a no-observed- effect-level (NOEL) of 200 ppm a.i. after two weeks of CMI/MI administration in the drinking water. Rats were exposed to CMI/MI via their drinking water at concentrations of 25, 75 or 225 ppm a.i. for three months [equivalent to an average intake of 2.38, 6.28 and 16.3 mg/kg/day in males and 4.06, 10.8, and 24.7 mg/kg/day in females]. Two additional groups of rats (25/sex/group) were given tap water or tap water containing the inorganic ions present in the CMI/MI solution, at a concentration equal to that in the high dose group (225; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"99.9 area% (HPLC) Vehicle: water Dose levels:","duration":"90 days","effect":"l- 4-isothiazolin-3-one, 15.5% a.i CMI/MI) Batch: Lot N° SW81-0138 Purity: 99.9 area% (HPLC) Vehicle: water Dose levels: 0, 25, 75 or 225 ppm a.i. Route: drinking water Exposure: 90 days (subchronic), approximately 5 months (15 weeks up 21 postnatal day 21, reproduction) GLP: in compliance Study period 1981 Kathon 886 NAR, with magnesium salts, is given as 15.1% a.i. but there is no indication of the CMI/MI ratio. Dose levels were selected based on a range-finding study that indicated a no-observed- effect-level (NOEL) of 200 ppm a.i. after two weeks of CMI/MI administration in the drinking water. Rats were exposed to CMI/MI via their drinking water at concentrations of 25, 75 or 225 ppm a.i. for three months [equivalent to an average intake of 2.38, 6.28 and 16.3 mg/kg/day in males and 4.06, 10.8, and 24.7 mg/kg/day in females]. Two additional groups of rats (25/sex/group) were given tap water or tap water containing the inorganic ions present in the CMI/MI solution, at a concentration equal to that in the high dose group (225","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"200","page":21,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.34 | - | - | - | Chronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=unclear:f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3; DOSE=At the mid-dose, the only effect observed was a very slight incidence of rhinitis.; EFFECT=f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3; CITATION=Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data; CITATION_NUMBERS=[43,3,1]; REFERENCE=Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data","dose":"At the mid-dose, the only effect observed was a very slight incidence of rhinitis.","duration":"Chronic","effect":"f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"","noael_value":"unclear:f the nasal cavity were noted. Both changes were minor, potentially reversible physiologic responses to an upper respiratory tract irritant. Additional changes included very slight to slight hyperplasia of the squamous epithelium in the nasal turbinates and varying degrees of sinusitis in the paranasal sinuses. These were described as being secondary effects and not direct-treatment related. At the mid-dose, the only effect observed was a very slight incidence of rhinitis. Conclusion The No Observed Effect Level (NOEL) was 0.34 mg/m³, based on minimal irritation of the respiratory tract at 1.15 mg/m³. No adverse effects on the histopathology of any tissues/organs distant from the site of dosing were noted up to and including the highest dose tested (2.64 mg a.i./m³). Ref.: 43 General comment The value of these repeated dose studies is limited as the test formulations are not properly characterised or are not at the 3:1 ratio and there are other data gaps. 3.3.5.3. Chronic (> 12 months) toxicity See 3.3.7. Carcinogenicity 3","page":26,"route":"","species":"","study_id":"sccs_o_009_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 0.0015 | % | - | - | subchronic | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=0.0015; EFFECT=, 10% magnesium chloride and 62% water. This seems to be a change in the manufacturing process, but there is no indication as to when this change was made. The CMI/MI formulations described in the dossier show variations in the CMI/MI ratio and several physicochemical parameters. Toxicity The value of the acute, subchronic and reproductive toxicity studies is limited as the test formulations are not properly characterised and there are other data gaps. For the calculation of the Margin of Safety, the parental P1 NOAEL of 2.8 mg a.i./kg bw/day from the Kathon MW two generation reproductive toxicity study was used. Skin/eye irritation and sensitisation P56, (5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1) is corrosive or irritating at high concentrations. No adequate data is given to support safe use at a maximum authorised concentration of 0.0015 % in rinse-off cosmetic products. However, the weight of evidences over several decades of consumer exposure to cosmetic products indicates; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"","duration":"subchronic","effect":", 10% magnesium chloride and 62% water. This seems to be a change in the manufacturing process, but there is no indication as to when this change was made. The CMI/MI formulations described in the dossier show variations in the CMI/MI ratio and several physicochemical parameters. Toxicity The value of the acute, subchronic and reproductive toxicity studies is limited as the test formulations are not properly characterised and there are other data gaps. For the calculation of the Margin of Safety, the parental P1 NOAEL of 2.8 mg a.i./kg bw/day from the Kathon MW two generation reproductive toxicity study was used. Skin/eye irritation and sensitisation P56, (5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3-one in a ratio of 3:1) is corrosive or irritating at high concentrations. No adequate data is given to support safe use at a maximum authorised concentration of 0.0015 % in rinse-off cosmetic products. However, the weight of evidences over several decades of consumer exposure to cosmetic products indicates","endpoint":"repeated dose toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"0.0015","page":35,"route":"","species":"","study_id":"sccs_o_009_noael_035"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 75 | ppm | - | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=75; DOSE=Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.; EFFECT=ted changes were seen. Reproductive organs at all doses were comparable to the controls. Reproductive Results Reproductive capability was similar in all groups. Litter size and survival at birth was also similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","duration":"","effect":"ted changes were seen. Reproductive organs at all doses were comparable to the controls. Reproductive Results Reproductive capability was similar in all groups. Litter size and survival at birth was also similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"75","page":22,"route":"","species":"","study_id":"sccs_o_009_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 225 | ppm | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=225; DOSE=Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.; EFFECT=lso similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and female; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","duration":"","effect":"lso similar in all groups. One dam at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and female","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"225","page":22,"route":"","species":"rat","study_id":"sccs_o_009_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 225 | ppm | rat | - | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=225; DOSE=Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.; EFFECT=at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, resp; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i.","duration":"","effect":"at the high concentration lost the entire litter by day 4 due to a lactation problem. This is not uncommon and was not considered treatment related. Pups of the other high concentration group dams, except one, survived and thrived to day 21. Conclusion The No Observed Effect Level (NOEL) in this study was 75 ppm a.i. [equivalent to 6.28 and 10.8 mg/kg body weight/day in males and females, respectively], based primarily on irritation of the glandular stomach at the high dose. The No Observed Adverse Effect Level (NOAEL) was 225 ppm a.i. [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, respectively], the highest dose tested, since no adverse effects were observed on the histopathology of any tissues or organs distant from the site of dosing. No adverse effects were observed on reproductive capability of male and female rats and no effects were observed on foetal health or pup survival (to day 21) up to and including the high dose [equivalent to 16.3 and 24.7 mg/kg body weight/day in males and females, resp","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"225","page":22,"route":"","species":"rat","study_id":"sccs_o_009_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 3.7 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=3.7; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=sia, hyperkeratosis, eschar, dermal inflammation, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazo; CITATION=Ref.: 73 3; CITATION_NUMBERS=[73,3]; REFERENCE=Ref.: 73 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":"sia, hyperkeratosis, eschar, dermal inflammation, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazo","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"3.7","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 3.7 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=3.7; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=, and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, C; CITATION=Ref.: 73 3; CITATION_NUMBERS=[73,3]; REFERENCE=Ref.: 73 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":", and increased dermal collagen. No other adverse histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, C","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"3.7","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=e histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N°; CITATION=Ref.: 73 3; CITATION_NUMBERS=[73,3]; REFERENCE=Ref.: 73 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":"e histopathological effects of tissues/organs were seen. There was no evidence of systemic toxicity. Conclusion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N°","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=ion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100,; CITATION=Ref.: 73 3; CITATION_NUMBERS=[73,3]; REFERENCE=Ref.: 73 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":"ion Due to the lack of positive histopathological findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100,","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=gical findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100, or 300 ppm a.i. of CMI/MI Route: oral GLP: Y; CITATION=Ref.: 73 3; CITATION_NUMBERS=[73,3]; REFERENCE=Ref.: 73 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":"gical findings, the test substance was not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100, or 300 ppm a.i. of CMI/MI Route: oral GLP: Y","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=s not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100, or 300 ppm a.i. of CMI/MI Route: oral GLP: Yes Report date 1998; CITATION=Ref.: 73 3; CITATION_NUMBERS=[73,3]; REFERENCE=Ref.: 73 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 73 3","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":"s not considered to be carcinogenic. Ref.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100, or 300 ppm a.i. of CMI/MI Route: oral GLP: Yes Report date 1998","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.; EFFECT=ef.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100, or 300 ppm a.i. of CMI/MI Route: oral GLP: Yes Report date 1998; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i.","duration":"","effect":"ef.: 73 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity Test substance Species Result Study date Ref Kathon 886F 11.1%CMI/3.7 % MI a.i Rat Drinking water Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] 1998 80 Acticide 14 13.9%a.i. Rat Gavage Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day 1998 81 Guideline: OECD 416 Species/strain: Rat, Crl: CD®BR strain Group size: 26 males and 26 females /dose Test substance: Kathon 886F (5-chloro-2-methyl-4-isothiazolin-3-one and 2-Methyl-4- isothiazolin-3-one, CMI/MI), 14.76% active ingredient Batch: Lot N° 0157A001 Purity: / Vehicle: deionized water Positive control: none Dose levels: 0, 0 (salt control), 30, 100, or 300 ppm a.i. of CMI/MI Route: oral GLP: Yes Report date 1998","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 30 | ppm | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=30; DOSE=The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i.; EFFECT=endent. The oestrus cycle in P1 or P2 females at any treatment level was comparable with the controls, as was the sperm motility, morphology, testicular sperm count or caudal epididymal reserves of P1 or P2 males. All other endpoints (gestation index, gestation length, number of pups per litter or treatment-related gross findings in F1 or F2 pups) were similar to those in the controls in either generation. The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i. (2.8-4.4 mg/kg/day in the P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i.","duration":"","effect":"endent. The oestrus cycle in P1 or P2 females at any treatment level was comparable with the controls, as was the sperm motility, morphology, testicular sperm count or caudal epididymal reserves of P1 or P2 males. All other endpoints (gestation index, gestation length, number of pups per litter or treatment-related gross findings in F1 or F2 pups) were similar to those in the controls in either generation. The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i. (2.8-4.4 mg/kg/day in the P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"30","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 30 | ppm | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=30; DOSE=The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i.; EFFECT=P2 females at any treatment level was comparable with the controls, as was the sperm motility, morphology, testicular sperm count or caudal epididymal reserves of P1 or P2 males. All other endpoints (gestation index, gestation length, number of pups per litter or treatment-related gross findings in F1 or F2 pups) were similar to those in the controls in either generation. The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i. (2.8-4.4 mg/kg/day in the P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i.","duration":"","effect":"P2 females at any treatment level was comparable with the controls, as was the sperm motility, morphology, testicular sperm count or caudal epididymal reserves of P1 or P2 males. All other endpoints (gestation index, gestation length, number of pups per litter or treatment-related gross findings in F1 or F2 pups) were similar to those in the controls in either generation. The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i. (2.8-4.4 mg/kg/day in the P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"30","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 300 | ppm | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=300; DOSE=The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i.; EFFECT=gestation length, number of pups per litter or treatment-related gross findings in F1 or F2 pups) were similar to those in the controls in either generation. The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i. (2.8-4.4 mg/kg/day in the P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i.","duration":"Developmental","effect":"gestation length, number of pups per litter or treatment-related gross findings in F1 or F2 pups) were similar to those in the controls in either generation. The study authors considered that rats exposed to CMI/MI in the drinking water through two generations had a No Observed Adverse Effect Level (NOAEL) of 30 ppm a.i. (2.8-4.4 mg/kg/day in the P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"ppm","noael_value":"300","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_022"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses.; EFFECT=e P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg b; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses.","duration":"Developmental","effect":"e P1 animals; 4.3-5.5 mg/kg/day in the P2 animals) for parental animal toxicity, based on the gastric irritation of stomach at higher doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg b","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_023"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 4 | % | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=4; DOSE=The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i.; EFFECT=r doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i.","duration":"Developmental","effect":"r doses. The No Observed Effect Level (NOEL) for reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"4","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_024"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 4 | % | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=4; DOSE=reproductive toxicity was 300 ppm a.i.; EFFECT=reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"reproductive toxicity was 300 ppm a.i.","duration":"Developmental","effect":"reproductive toxicity was 300 ppm a.i. (22.7-28.0 mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation r","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"4","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_025"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | =19.6 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 19.6; DOSE=mg/kg/day in the P1 animals;; EFFECT=mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"mg/kg/day in the P1 animals;","duration":"Developmental","effect":"mg/kg/day in the P1 animals; 35.7-39.1 mg/kg/day in the P2 animals), the highest dose tested. There were no effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 19.6","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_026"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 4 | % | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=4; DOSE=effects on fertility or foetal development at any dose level.; EFFECT=effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"effects on fertility or foetal development at any dose level.","duration":"Developmental","effect":"effects on fertility or foetal development at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"4","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_027"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 4 | % | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=4; DOSE=elopment at any dose level.; EFFECT=elopment at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calcula; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"elopment at any dose level.","duration":"Developmental","effect":"elopment at any dose level. 3.3.8.2. Teratogenicity Test substance Species Result Study date Ref Kathon™ 886 13.9% a.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calcula","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"4","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_028"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; DOSE=Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested).; EFFECT=.i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested).","duration":"Developmental","effect":".i. Rat Gavage Developmental NOEL for CMI/MI was >15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_029"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 2 | mg/kg bw | rat | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=2; DOSE=>15 mg a.i./kg bw/day during organogenesis (highest dose tested).; EFFECT=>15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":">15 mg a.i./kg bw/day during organogenesis (highest dose tested).","duration":"Developmental","effect":">15 mg a.i./kg bw/day during organogenesis (highest dose tested). 1980 75 Acticide 14 10.2%CMI/4% MI Rat Gavage NOAEL maternal toxicity: <= 3.95 . mg/kg bw a.i. NOAEL teratogenenicity : >= 19.6 . mg/kg bw a.i. NOAEL embryotoxicity: >= 19.6 mg/kg bw a.i. 1994 76 Acticide 14 10.2%CMI/4% MI Rabbit Gavage Developmental NOAEL was > 5.49 mg a.i./kg bw/day NOAEL for maternal toxicity and foetal toxicity was 1.41 mg a.i./kg bw/day 2002 78 Kathon MW 13.9% a.i Rabbit Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"2","page":31,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_030"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg/day | - | oral | Developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=20; DOSE=2 mg/kg bw Developmental NOEL:; EFFECT=t Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P1 two generation reproductive toxicity study,(Ref 80), based on significantly reduced water intake; CITATION=(Ref 80); CITATION_NUMBERS=[80]; REFERENCE=(Ref 80); DETAILS_JSON={"cas_number":"26172-55-4","citation":"(Ref 80)","dose":"2 mg/kg bw Developmental NOEL:","duration":"Developmental","effect":"t Gavage NOEL maternal toxicity: 2 mg/kg bw Developmental NOEL: 8 mg a.i./kg bw/day [highest dose based on severe maternal toxicity at 20 mg/kg/day] 1991 77 General comment on reproductive toxicity In the two generation reproductive toxicity and the teratogenicity study, the chemical characterisation of Kathon™ 886 was CMI/MI 3:1 ratio with magnesium salts. The other studies were not considered for the calculation of the MoS due to the inadequate chemical characterisation of the test substances. Therefore, the NOAEL of 2.8 mg a.i./kg bw/day Kathon™ 886 from the parental P1 two generation reproductive toxicity study,(Ref 80), based on significantly reduced water intake","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg/day","noael_value":"20","page":31,"route":"oral","species":"","study_id":"sccs_o_009_noael_031"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | =0.00038 | mg/kg bw | human | dermal | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 0.00038; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...; EFFECT=ith an aerosol of the test substance at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.; CITATION=Ref.: 29 3; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","duration":"","effect":"ith an aerosol of the test substance at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.00038","page":34,"route":"dermal","species":"human","study_id":"sccs_o_009_noael_032"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | =2.8 | mg/kg bw | human | dermal | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT== 2.8; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...; EFFECT=ce at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.; CITATION=Ref.: 29 3; CITATION_NUMBERS=[29,3]; REFERENCE=Ref.: 29 3; DETAILS_JSON={"cas_number":"26172-55-4","citation":"Ref.: 29 3","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","duration":"","effect":"ce at 0.17, 0.35 and 0.72 mg ai/m3 nor CMI/MI did produce respiratory sensitisation. Ref.: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 2.8","page":34,"route":"dermal","species":"human","study_id":"sccs_o_009_noael_033"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 100 | % | human | dermal | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=100; DOSE=Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...; EFFECT=: 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (S...","duration":"","effect":": 29 3.3.13. Safety evaluation (including calculation of the MoS) CALCULATION OF THE MARGIN OF SAFETY Indicative daily exposure rinse-off products (approximate value, including retention factors) = 1.5 g/day Concentration CMI/MI = 0.0015% Daily exposure CMI/MI = 0.0225 mg Dermal absorption = 100% Typical body weight of human = 60 kg Systemic exposure dose (SED) rinse off = 0.00038 mg/kg bw No observed adverse effect level (NOAEL) = 2.8 mg/kg bw (two-generation reproductive study, parental P1) Margin of Safety NOAEL / SED = 7368 A worst case scenario of 100% absorption has been assumed for the calculation of MoS.","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"100","page":34,"route":"dermal","species":"human","study_id":"sccs_o_009_noael_034"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 11.1 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=11.1; DOSE=Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80; EFFECT=Unlabeled table on page 30: Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","duration":"","effect":"Unlabeled table on page 30: Kathon 886F 11.1%CMI/3.7 % MI a.i | Rat Drinking water | Parental P1 NOAEL 2.8 –4.4 mg a.i/kg bw/day P1 Reproductive NOEL 22.7-28.0 mg a.i/kg bw/day P2 Reproductive NOEL 35.7-39.1 mg a.i /kg bw/day [highest dose tested] | 1998 | 80","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"11.1","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_036"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 13.9 | % | rat | oral | - | reproductive toxicity | SOURCE_SUBDIR=sccs_o_009; REPORT_TITLE=OPINION ON the mixture of 5-chloro-2-methylisothiazolin-3(2H)-one and 2-methylisothiazolin-3(2H)-one COLIPA n° P56; OPINION_NUMBER=SCCS/1238/09; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=8 December 2009; VALUE_TEXT=13.9; EFFECT=Unlabeled table on page 30: Acticide 14 13.9%a.i. | Rat Gavage | Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day | 1998 | 81; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"26172-55-4","citation":"","dose":"","duration":"","effect":"Unlabeled table on page 30: Acticide 14 13.9%a.i. | Rat Gavage | Reproductive NOAEL was >/= 10 mg a.i./kg bw/day Parental NOAEL was >/=10 mg a.i./kg bw/day F1 NOAEL was >/= 2.5 mg a.i/kg bw/day F2 NOAEL >/= 2.5 mg a.i./kg bw/day | 1998 | 81","endpoint":"reproductive toxicity","ingredient":"s, toys, textiles,","loael_value":"","noael_unit":"%","noael_value":"13.9","page":30,"route":"oral","species":"rat","study_id":"sccs_o_009_noael_037"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | DEL7T5QRPN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4ClNOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DEL7T5QRPN"} |
| openFDA substances | FDA UNII substance identifier | DEL7T5QRPN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4ClNOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DEL7T5QRPN"} |
| openFDA substances | FDA UNII substance identifier | DEL7T5QRPN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4ClNOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DEL7T5QRPN"} |
| openFDA substances | FDA UNII substance identifier | DEL7T5QRPN | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C4H4ClNOS","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"DEL7T5QRPN"} |