NOAEL Studies
Cosmetic Ingredient
Thioglycolic Acid NOAEL Studies
INCI: THIOGLYCOLIC ACID
CAS: 68-11-1
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
NTP_ICE_acute_inhalation 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_acute_inhalation | LC50 | 0.21 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=4625; Record_ID=acute_inhalation_977; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=0.21; Response_Unit=mg/L; Reference=ChemIDplus; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_acute_inhalation | LC50 | 1.094 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=4624; Record_ID=acute_inhalation_1070; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=1.094; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/2175/7/3/3/?documentUUID=29f6fa98-8d79-4e5f-90c4-abd63dedb2a1; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_acute_inhalation | LC50 | 1.388 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=4622; Record_ID=acute_inhalation_1075; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=1.388; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/2175/7/3/3/?documentUUID=29f6fa98-8d79-4e5f-90c4-abd63dedb2a1; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_acute_inhalation | LC50 | 1.981 | mg/L | - | Inhalation | Duration=4 hr | In Vivo; AcuteInhalNICEATM; Rat Acute Inhalation Toxicity | sheet=Data; excel_row=4623; Record_ID=acute_inhalation_1072; Data_Type=In Vivo; Internal_Data_Source=AcuteInhalNICEATM; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Rat Acute Inhalation Toxicity; Endpoint=LC50; Response=1.981; Response_Unit=mg/L; Reference=REACH; URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/2175/7/3/3/?documentUUID=29f6fa98-8d79-4e5f-90c4-abd63dedb2a1; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
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=15474; RecordID=ARPathway2016_1477; DatasetName=ARPathway2016; DTXSID=DTXSID8026141; Assay=AR Pathway Model, Antagonist; Endpoint=Model Score; Response=0; Response_Unit=Unitless; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
NTP_ICE_skin_irritation 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_irritation | Breakthrough Time | 11.62 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=5178; Record_ID=skin_irritation_invitro_116; Data_Type=In Vitro; Concentration=97; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Corrositex; Endpoint=Breakthrough Time; Response=11.62; Response_Unit=min; Reference=Gordon et al. 1994; Not available; Not available; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_skin_irritation | Breakthrough Time | 35.6 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=5171; Record_ID=skin_irritation_invitro_119; Data_Type=In Vitro; Concentration=15.1; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Corrositex; Endpoint=Breakthrough Time; Response=35.6; Response_Unit=min; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_skin_irritation | Breakthrough Time | 37.7 | min | - | Dermal | - | In Vitro; Corrositex | sheet=Data_invitro; excel_row=5173; Record_ID=skin_irritation_invitro_118; Data_Type=In Vitro; Concentration=15.1; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Corrositex; Endpoint=Breakthrough Time; Response=37.7; Response_Unit=min; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_skin_irritation | TER | 1.2 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=5176; Record_ID=skin_irritation_invitro_2565; Data_Type=In Vitro; Concentration=15.1; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=TER Corrosion; Endpoint=TER; Response=1.2; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_skin_irritation | TER | 1.6 | kiloohms | - | Dermal | - | In Vitro; TER Corrosion | sheet=Data_invitro; excel_row=5179; Record_ID=skin_irritation_invitro_2566; Data_Type=In Vitro; Concentration=15.1; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=TER Corrosion; Endpoint=TER; Response=1.6; Response_Unit=kiloohms; Reference=Botham et al. 1995; Not available; 10.1177/026119299502300207; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
NTP_ICE_skin_sensitization 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP_ICE_skin_sensitization | Incidence of positive responses | 0 | % | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=9508; Record_ID=skin_sensitization_invivo_2108; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.25; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Human Repeat Insult Patch Test; Endpoint=Incidence of positive responses; Response=0; Response_Unit=%; Species=Human; Route=Dermal; Reference=Voss 1958; 13598934; 10.1038/jid.1958.120; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_skin_sensitization | Induction dose per skin area | 1476 | ug/cm2 | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=9506; Record_ID=skin_sensitization_invivo_2108; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.25; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Human Repeat Insult Patch Test; Endpoint=Induction dose per skin area; Response=1476; Response_Unit=ug/cm2; Species=Human; Route=Dermal; Reference=Voss 1958; 13598934; 10.1038/jid.1958.120; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
| NTP_ICE_skin_sensitization | Relative reliability score | 4 | unitless | Human | Dermal | - | In Vivo; HPPT2020WIP; Human Repeat Insult Patch Test | sheet=Data_invivo; excel_row=9512; Record_ID=skin_sensitization_invivo_2108; Data_Type=In Vivo; Internal_Data_Source=HPPT2020WIP; Concentration=1.25; Concentration_Units=%; Mixture=Chemical; DTXSID=DTXSID8026141; Assay=Human Repeat Insult Patch Test; Endpoint=Relative reliability score; Response=4; Response_Unit=Unitless; Species=Human; Route=Dermal; Reference=Voss 1958; 13598934; 10.1038/jid.1958.120; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID8026141; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID8026141 |
SCCS_vision_codex 56 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| SCCS_vision_codex | NOAEL | =0.044 | mg/kg bw | rat | dermal | 13 weeks | dermal absorption | {"dose":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface...","effect":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_016"} |
| SCCS_vision_codex | NOAEL | =0.044 | mg/kg bw | rat | dermal | 13 weeks | dermal absorption | {"dose":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface...","effect":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_016"} |
| SCCS_vision_codex | NOAEL | =0.044 | mg/kg bw | rat | dermal | 13 weeks | dermal absorption | {"dose":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface...","effect":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_016"} |
| SCCS_vision_codex | NOAEL | =0.044 | mg/kg bw | rat | dermal | 13 weeks | dermal absorption | {"dose":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface...","effect":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_016"} |
| SCCS_vision_codex | NOAEL | =1.66 | mg/kg bw | rat | dermal | 5 year | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":"likely related to the use over a 5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse eff","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.66 | mg/kg bw | rat | dermal | 5 year | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":"likely related to the use over a 5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse eff","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.66 | mg/kg bw | rat | dermal | 5 year | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":"likely related to the use over a 5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse eff","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_012"} |
| SCCS_vision_codex | NOAEL | =1.66 | mg/kg bw | rat | dermal | 5 year | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":"likely related to the use over a 5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse eff","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_012"} |
| SCCS_vision_codex | NOAEL | =7 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinati","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_003"} |
| SCCS_vision_codex | NOAEL | =7 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinati","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_003"} |
| SCCS_vision_codex | NOAEL | =7 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinati","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_003"} |
| SCCS_vision_codex | NOAEL | =7 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinati","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_003"} |
| SCCS_vision_codex | NOAEL | =11 | % | rat | dermal | 13 weeks | NOAEL study | {"dose":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicit...","effect":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst ca","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_015"} |
| SCCS_vision_codex | NOAEL | =11 | % | rat | dermal | 13 weeks | NOAEL study | {"dose":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicit...","effect":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst ca","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_015"} |
| SCCS_vision_codex | NOAEL | =11 | % | rat | dermal | 13 weeks | NOAEL study | {"dose":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicit...","effect":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst ca","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_015"} |
| SCCS_vision_codex | NOAEL | =11 | % | rat | dermal | 13 weeks | NOAEL study | {"dose":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicit...","effect":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst ca","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_015"} |
| SCCS_vision_codex | NOAEL | =11.25 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_005"} |
| SCCS_vision_codex | NOAEL | =11.25 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_005"} |
| SCCS_vision_codex | NOAEL | =11.25 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_005"} |
| SCCS_vision_codex | NOAEL | =11.25 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_005"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild de","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_002"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild de","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_002"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild de","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_002"} |
| SCCS_vision_codex | NOAEL | =20 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | {"dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","effect":"Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild de","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_002"} |
| SCCS_vision_codex | NOAEL | =45 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | {"dose":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice.","effect":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The Lowest-Observed- Effect-Levels (LOELs) at the application site were 11.25 and 45 mg/kg bw/d in rats and mice, respectively, based on skin irritation, there was no No-Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_001"} |
| SCCS_vision_codex | NOAEL | =45 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | {"dose":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice.","effect":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The Lowest-Observed- Effect-Levels (LOELs) at the application site were 11.25 and 45 mg/kg bw/d in rats and mice, respectively, based on skin irritation, there was no No-Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_001"} |
| SCCS_vision_codex | NOAEL | =45 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | {"dose":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice.","effect":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The Lowest-Observed- Effect-Levels (LOELs) at the application site were 11.25 and 45 mg/kg bw/d in rats and mice, respectively, based on skin irritation, there was no No-Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_001"} |
| SCCS_vision_codex | NOAEL | =45 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | {"dose":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice.","effect":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The Lowest-Observed- Effect-Levels (LOELs) at the application site were 11.25 and 45 mg/kg bw/d in rats and mice, respectively, based on skin irritation, there was no No-Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_001"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive to","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_010"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive to","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_010"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive to","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_010"} |
| SCCS_vision_codex | NOAEL | =65 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive to","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_010"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | {"dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","effect":"rmation is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weigh","page":29,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_008"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | {"dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","effect":"rmation is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weigh","page":29,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_008"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | {"dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","effect":"rmation is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weigh","page":29,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_008"} |
| SCCS_vision_codex | NOAEL | =80 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | {"dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","effect":"rmation is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weigh","page":29,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_008"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with maternal lethality. 3.3.9. Toxicokinetics","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with maternal lethality. 3.3.9. Toxicokinetics","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with maternal lethality. 3.3.9. Toxicokinetics","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_011"} |
| SCCS_vision_codex | NOAEL | =100 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | {"dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with maternal lethality. 3.3.9. Toxicokinetics","page":30,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_011"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | dermal | 13 weeks | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":") event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjus","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_014"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | dermal | 13 weeks | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":") event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjus","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_014"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | dermal | 13 weeks | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":") event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjus","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_014"} |
| SCCS_vision_codex | NOAEL | =129 | mg/kg bw/d | rat | dermal | 13 weeks | NOAEL study | {"dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","effect":") event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjus","page":32,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_014"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"te was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"te was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"te was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_004"} |
| SCCS_vision_codex | NOAEL | =180 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | {"dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","effect":"te was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","page":23,"pdf":"sccs_o_141.pdf","row_type":"noael_study","study_id":"sccs_o_141_noael_004"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | oral | 28 days | repeated dose toxicity | {"dose":"roups with an increase of 50-55% in the high-dose group.","effect":"roups with an increase of 50-55% in the high-dose group. SCCS considers increased cholesterol and increased relative liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3","page":24,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_005"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | oral | 28 days | repeated dose toxicity | {"dose":"roups with an increase of 50-55% in the high-dose group.","effect":"roups with an increase of 50-55% in the high-dose group. SCCS considers increased cholesterol and increased relative liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3","page":24,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_005"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | oral | 28 days | repeated dose toxicity | {"dose":"roups with an increase of 50-55% in the high-dose group.","effect":"roups with an increase of 50-55% in the high-dose group. SCCS considers increased cholesterol and increased relative liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3","page":24,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_005"} |
| SCCS_vision_codex | NOAEL | =300 | mg/kg bw/day | - | oral | 28 days | repeated dose toxicity | {"dose":"roups with an increase of 50-55% in the high-dose group.","effect":"roups with an increase of 50-55% in the high-dose group. SCCS considers increased cholesterol and increased relative liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3","page":24,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_005"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | - | subacute | repeated dose toxicity | {"dose":"The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","effect":"males. These changes did not regress in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","page":23,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | - | subacute | repeated dose toxicity | {"dose":"The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","effect":"males. These changes did not regress in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","page":23,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | - | subacute | repeated dose toxicity | {"dose":"The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","effect":"males. These changes did not regress in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","page":23,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_001"} |
| SCCS_vision_codex | NOAEL | =1000 | mg/kg bw/day | rat | - | subacute | repeated dose toxicity | {"dose":"The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","effect":"males. These changes did not regress in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","page":23,"pdf":"sccs_o_167.pdf","row_type":"noael_study","study_id":"sccs_o_167_noael_001"} |
ToxValDB_GESTIS_DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_GESTIS_DNEL | DNEL systemic | =1.58 | mg/m3 | Human | inhalation | - | Toxicity Value | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6543dd69e4b045b9ff7cd87e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://www.dguv.de/ifa/gestis/gestis-dnel-liste/index-2.jsp; STUDY_GROUP=GESTIS DNEL:15635236:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_e8e55d559c8f9e21814982bc8446d96f |
UnifiedCodex:SCCS_SHADOW:beta.noael_studies 28 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =1.66 | mg/kg bw | rat | dermal | 5 year | - | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 1.66; DOSE=Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...; EFFECT=likely related to the use over a 5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse eff; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","duration":"5 year","effect":"likely related to the use over a 5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse eff","endpoint":"","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 1.66","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_012"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 11 | % | rat | dermal | 13 weeks | - | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=11; DOSE=c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicit...; EFFECT=c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst ca; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicit...","duration":"13 weeks","effect":"c acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst ca","endpoint":"","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"%","noael_value":"11","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_015"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =129 | mg/kg bw/d | rat | dermal | 13 weeks | - | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 129; DOSE=Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...; EFFECT=) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjus; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","duration":"13 weeks","effect":") event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjus","endpoint":"","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 129","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_014"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | =180 | mg/kg bw/d | rat | dermal | 5 year | - | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 180; DOSE=Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...; EFFECT=5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect le; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60...","duration":"5 year","effect":"5 year and a 18 month period was about one (1.2 and 0.94 respectively) event per one million units sold. 3.3.12. Special investigations 3.3.13.1 Safety evaluation (including calculation of the MoS) Thioglycolic acid CALCULATION OF THE MARGIN OF SAFETY – depilatories 5% Product applied to the skin area surface 2000 cm2 * = 2000 mg Amount of thioglycolic acid applied (5% of 1960 mg) = 100 mg Typical body weight of human = 60 kg External exposure dose 100/60 = 1.66 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect le","endpoint":"","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 180","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_013"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg bw/day | rat | - | 28 days | - | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=1000; DOSE=gue-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.; EFFECT=gue-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"gue-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","duration":"28 days","effect":"gue-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","endpoint":"","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":23,"route":"","species":"rat","study_id":"sccs_o_167_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | - | 1000 | mg/kg bw/day | rat | - | 28-day | - | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=1000; DOSE=As the rat specific alpha-2- microglobulin nephropathy has no concurrent impairment in humans, the NOAEL of 1000 mg/kg bw/day will be used a default value for the human health risk assessment.; EFFECT=SCCS/1541/14 Opinion on vetiveryl acetate ___________________________________________________________________________________________ 24 microglobulin nephropathy, which is known as a species specific disturbance of the male rat and thus, not indicative of a hazard to human health. As the rat specific alpha-2- microglobulin nephropathy has no concurrent impairment in humans, the NOAEL of 1000 mg/kg bw/day will be used a default value for the human health risk assessment. (Reference: 84) SCCS comment Kidney weights were increased in all treated male groups and were accompanied by histopathological changes including hyaline droplets. According to the study report authors, the alpha-2-microglobulin nature of the findings was confirmed by Mallory’s Heidenhain staining. The SCCS considers that the exact mechanism by which the test substance used in this 28-day study causes kidney damage in male ra; CITATION=Reference: 84) SCCS comment Kidney weights were increased in all treated male groups and were accompanied by histopathological changes including hyaline droplets; CITATION_NUMBERS=[84]; REFERENCE=Reference: 84) SCCS comment Kidney weights were increased in all treated male groups and were accompanied by histopathological changes including hyaline droplets; DETAILS_JSON={"cas_number":"68-11-1","citation":"Reference: 84) SCCS comment Kidney weights were increased in all treated male groups and were accompanied by histopathological changes including hyaline droplets","dose":"As the rat specific alpha-2- microglobulin nephropathy has no concurrent impairment in humans, the NOAEL of 1000 mg/kg bw/day will be used a default value for the human health risk assessment.","duration":"28-day","effect":"SCCS/1541/14 Opinion on vetiveryl acetate ___________________________________________________________________________________________ 24 microglobulin nephropathy, which is known as a species specific disturbance of the male rat and thus, not indicative of a hazard to human health. As the rat specific alpha-2- microglobulin nephropathy has no concurrent impairment in humans, the NOAEL of 1000 mg/kg bw/day will be used a default value for the human health risk assessment. (Reference: 84) SCCS comment Kidney weights were increased in all treated male groups and were accompanied by histopathological changes including hyaline droplets. According to the study report authors, the alpha-2-microglobulin nature of the findings was confirmed by Mallory’s Heidenhain staining. The SCCS considers that the exact mechanism by which the test substance used in this 28-day study causes kidney damage in male ra","endpoint":"","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":24,"route":"","species":"rat","study_id":"sccs_o_167_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =0.044 | mg/kg bw | rat | dermal | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 0.044; DOSE=ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface...; EFFECT=ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface...","duration":"13 weeks","effect":"ed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily","endpoint":"dermal absorption","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw","noael_value":"= 0.044","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_016"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =129 | mg/kg bw/d | rat | dermal | 5 days | dermal absorption | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 129; DOSE=5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of...; EFFECT=5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily use, the SCCS considers a MoS of 78 as acceptable under the conditions of r; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of...","duration":"5 days","effect":"5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily use, the SCCS considers a MoS of 78 as acceptable under the conditions of r","endpoint":"dermal absorption","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 129","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_018"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =129 | mg/kg bw/d | rat | dermal | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 129; DOSE=eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days t...; EFFECT=eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily use, the SCCS considers a MoS of 78 as acceptable under the conditions of reasonably foreseeable use. 3.3.14. Discussion; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days t...","duration":"13 weeks","effect":"eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily use, the SCCS considers a MoS of 78 as acceptable under the conditions of reasonably foreseeable use. 3.3.14. Discussion","endpoint":"dermal absorption","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 129","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_019"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | dermal absorption | =180 | mg/kg bw/d | rat | dermal | 13 weeks | dermal absorption | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT== 180; DOSE=80 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thi...; EFFECT=80 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily use,; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"80 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thi...","duration":"13 weeks","effect":"80 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment/week = 129 mg/kg bw/d * Lower legs, axillae and bikini lines (US EPA 1997, Cowan 2008) Margin of Safety Adjusted NOAEL/SED = 78 CALCULATION OF THE MARGIN OF SAFETY – eyelashes up to 11% Product applied to the skin area surface 24 cm2 (*) = 24 mg Amount of thioglycolic acid applied (11% of 24 mg) = 2.64 mg Typical body weight of human = 60 kg External exposure dose 2.64/60 = 0.044 mg/kg bw No observed adverse effect level NOAEL = 180 mg/kg bw/d (dermal 13 weeks toxicity study, rat) Adjusted NOAEL for 5 days treatment /week = 129 mg/kg bw/d (*) Approximative surface area of the eyelids and therefore indicative of the worst case exposure scenario Margin of Safety Adjusted NOAEL/SED = 2932 SCCS comment In the absence of reliable data on dermal absorption of thioglycolic acid in the use concentration of depilatory preparations, MoS calculation was based on a dermal toxicity study. Since the depilatories are not intended for daily use,","endpoint":"dermal absorption","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"= 180","page":32,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_017"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 7 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=7; DOSE=The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.; EFFECT=site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinati; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","duration":"7 days","effect":"site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinati","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"7","page":23,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_003"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 11.25 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=11.25; DOSE=SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.; LOAEL_VALUE=11.25 mg/kg bw/d; EFFECT=the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","duration":"90 days","effect":"the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"11.25 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"11.25","page":23,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 11.25 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=11.25; DOSE=The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations.; LOAEL_VALUE=11.25 mg/kg bw/d; EFFECT=ycolate may also be used in products for permanent waves. However, current safety evaluation does not deal with the esters of glycolic acid. General toxicity The acute toxicity has been evaluated in several studies by oral, dermal and inhalation routes (see 3.3.1). The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations. In the repeated dose dermal toxicity study of NTP in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. Thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with significant maternal toxicity. Irritation / sensitisation Thioglycolic acid and ammonium thioglycolate are skin irritants; at high concentrations they can be corrosive. Thioglycolic acid, ammonium, and sodium thioglycolate are ocular irritants. However under professional use the; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations.","duration":"5 days","effect":"ycolate may also be used in products for permanent waves. However, current safety evaluation does not deal with the esters of glycolic acid. General toxicity The acute toxicity has been evaluated in several studies by oral, dermal and inhalation routes (see 3.3.1). The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations. In the repeated dose dermal toxicity study of NTP in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. Thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with significant maternal toxicity. Irritation / sensitisation Thioglycolic acid and ammonium thioglycolate are skin irritants; at high concentrations they can be corrosive. Thioglycolic acid, ammonium, and sodium thioglycolate are ocular irritants. However under professional use the","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"11.25 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"11.25","page":33,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_021"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/d | rat | oral | 7 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=20; DOSE=The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.; EFFECT=Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild de; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.","duration":"7 days","effect":"Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20 mg/kg bw/d and the NOEL at 7 mg/kg bw/d. (Taken from Burnett 2009) The dermal toxicity of cold wave solutions (pH 9.0-9.5) containing 7.0% ammonium thioglycolate was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild de","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":23,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 20 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=20; DOSE=Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...; EFFECT=tion toxicity study is available in the ECHA registration dossier database, however this information is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","duration":"developmental","effect":"tion toxicity study is available in the ECHA registration dossier database, however this information is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":29,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 45 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=45; DOSE=tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice.; EFFECT=tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The Lowest-Observed- Effect-Levels (LOELs) at the application site were 11.25 and 45 mg/kg bw/d in rats and mice, respectively, based on skin irritation, there was no No-Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice.","duration":"5 days","effect":"tered via dermal route, 5 days per week, for 13 weeks at dose levels of 0, 11.25, 22.5, 45, 90, or 180 mg/kg bw /d to Fischer 344 rats and 0, 22.5, 45, 90, 180, or 360 mg/kg bw/d to B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The Lowest-Observed- Effect-Levels (LOELs) at the application site were 11.25 and 45 mg/kg bw/d in rats and mice, respectively, based on skin irritation, there was no No-Observed-Effect-Level (NOEL) at the application site. The NOAELs for systemic toxicity can be estimated to be higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. In an oral repeated dose toxicity study compliant with the OECD guideline # 408, sodium thioglycolate was administered by gavage, 7 days per week, for 13 weeks, to Sprague- Dawley rats at dose levels of 0, 7, 20 and 60 mg/kg bw/d. The main effects, fully reversible, seem to be related to the inhibition of the β-oxidation of fatty acids. The NOAEL was established at 20","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"45","page":23,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 80 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=80; DOSE=Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...; EFFECT=rmation is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weigh; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","duration":"developmental","effect":"rmation is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weigh","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":29,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_008"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 80 | mg/kg bw/d | rat | dermal | developmental | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=80; DOSE=Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...; EFFECT=s not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weights, as well as oestrous cycles, were observed up to dose levels of 180 and 360 mg/kg bw/d, respectively. (This study is also described; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","duration":"developmental","effect":"s not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d which cannot definitively be attributed to maternal condition). In the 13-week dermal subchronic toxicity study in rats and mice with sodium thioglycolate, no treatment-related effects on sperm density and motility, caudal epididymal sperm, spermatid head counts in the testes and testis weights, as well as oestrous cycles, were observed up to dose levels of 180 and 360 mg/kg bw/d, respectively. (This study is also described","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"80","page":29,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_009"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 180 | mg/kg bw/d | rat | dermal | 90 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=180; DOSE=SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.; LOAEL_VALUE=11.25 mg/kg bw/d; EFFECT=te was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d.","duration":"90 days","effect":"te was evaluated using albino rabbits. Four cold wave solutions were applied to the skin via injunction at doses of 0.5,1.0, 2.0, and 4.0 mL/kg, respectively, for 90 days. Eleven of 18 rabbits given 4.0 mL/kg doses and 2 of 17 rabbits given 2.0 mL/kg doses died. No deaths occurred in groups doses with 1.0 mL/kg (15 rabbits). A mild dermatitis was observed at microscopic examinations of sections of skin from approximately 50 animals. SCCS comment In the NTP repeated dose dermal toxicity study in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. 3.3.5.3. Chronic (> 12 months) toxicity","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"11.25 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"180","page":23,"route":"dermal","species":"rat","study_id":"sccs_o_141_noael_004"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 180 | mg/kg bw/d | rat | oral | 5 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=180; DOSE=The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations.; LOAEL_VALUE=11.25 mg/kg bw/d; EFFECT=ble scientific literature. Esters of thioglycolic acid including glyceryl thioglycolate may also be used in products for permanent waves. However, current safety evaluation does not deal with the esters of glycolic acid. General toxicity The acute toxicity has been evaluated in several studies by oral, dermal and inhalation routes (see 3.3.1). The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations. In the repeated dose dermal toxicity study of NTP in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. Thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with significant maternal toxicity. Irritation / sensitisation Thioglycolic acid and ammonium thioglycolate are skin irritants; at high concentrations they can be corrosive. Thioglycolic acid, ammonium, a; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations.","duration":"5 days","effect":"ble scientific literature. Esters of thioglycolic acid including glyceryl thioglycolate may also be used in products for permanent waves. However, current safety evaluation does not deal with the esters of glycolic acid. General toxicity The acute toxicity has been evaluated in several studies by oral, dermal and inhalation routes (see 3.3.1). The repeated dose toxicity of sodium thioglycolate was evaluated by dermal and oral administrations. In the repeated dose dermal toxicity study of NTP in rats, the systemic NOAEL was 180 mg/kg bw/d and the local LOAEL was 11.25 mg/kg bw/d. The systemic NOAEL (corrected for 5 days treatment per week: 180 x 5 / 7 = 129 mg/kg bw/d) was used to calculate the MoS. Thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with significant maternal toxicity. Irritation / sensitisation Thioglycolic acid and ammonium thioglycolate are skin irritants; at high concentrations they can be corrosive. Thioglycolic acid, ammonium, a","endpoint":"repeated dose toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"11.25 mg/kg bw/d","noael_unit":"mg/kg bw/d","noael_value":"180","page":33,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_020"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 300 | mg/kg bw/day | - | oral | 28 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=300; DOSE=roups with an increase of 50-55% in the high-dose group.; EFFECT=roups with an increase of 50-55% in the high-dose group. SCCS considers increased cholesterol and increased relative liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"roups with an increase of 50-55% in the high-dose group.","duration":"28 days","effect":"roups with an increase of 50-55% in the high-dose group. SCCS considers increased cholesterol and increased relative liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3","endpoint":"repeated dose toxicity","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":24,"route":"oral","species":"","study_id":"sccs_o_167_noael_005"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 300 | mg/kg bw/day | - | oral | 28 days | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=300; DOSE=ive liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days).; EFFECT=ive liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3.3.6 Mutagenicity / Genotoxicity Vetiveryl acetate was tested for mutagenicity/genotoxicity in several studies i; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"ive liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days).","duration":"28 days","effect":"ive liver weights of a magnitude above 50% at the highest dose level as adverse effects, although only in the absence of any associated microscopic changes in liver, as histopathological changes in the liver cannot be expected to be observed in this study because of the short study duration (28 days). Based on the findings in this 28-day study, the mid-dose level of 300 mg/kg bw/day is considered as the NOAEL for the test substance used in this study. However, for vetiveryl acetate, based on the submitted study, a NOAEL for repeated dose toxicity cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported (see 3.1.4) and as the composition of the test substance used in the submitted 28-day study is unknown to the SCCS. 3.3.5.2 Sub-chronic (90 days) toxicity (oral) No data submitted. 3.3.5.3 Chronic (> 12 months) toxicity No data submitted. 3.3.6 Mutagenicity / Genotoxicity Vetiveryl acetate was tested for mutagenicity/genotoxicity in several studies i","endpoint":"repeated dose toxicity","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":24,"route":"oral","species":"","study_id":"sccs_o_167_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 300 | mg/kg bw/day | rat | oral | 28-day | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=300; DOSE=General toxicity The test substances used in the acute toxicity studies are of low acute toxicity with LD50 values after oral administration above 2000 mg/kg bw and above 5000 mg/kg bw following dermal application.; EFFECT=ication of constituents of a typical vetiveryl acetate (including the concentration range of the constituents) is required. In the absence of knowledge of the composition of the test substance used in the submitted studies, the relevance of test results is questionable. General toxicity The test substances used in the acute toxicity studies are of low acute toxicity with LD50 values after oral administration above 2000 mg/kg bw and above 5000 mg/kg bw following dermal application. In the 28-day study in rats, a NOAEL of 300 mg/kg bw/day is considered for the test substance used, based on increased cholesterol and increased relative liver weights (magnitude above 50%) at the highest dose level (1000 mg/kg bw/day). A 90-day study was not submitted. Based on the submitted studies, the acute and repeated dose toxicity of vetiveryl acetate cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported and as the composition of the test substances used in the submit; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"General toxicity The test substances used in the acute toxicity studies are of low acute toxicity with LD50 values after oral administration above 2000 mg/kg bw and above 5000 mg/kg bw following dermal application.","duration":"28-day","effect":"ication of constituents of a typical vetiveryl acetate (including the concentration range of the constituents) is required. In the absence of knowledge of the composition of the test substance used in the submitted studies, the relevance of test results is questionable. General toxicity The test substances used in the acute toxicity studies are of low acute toxicity with LD50 values after oral administration above 2000 mg/kg bw and above 5000 mg/kg bw following dermal application. In the 28-day study in rats, a NOAEL of 300 mg/kg bw/day is considered for the test substance used, based on increased cholesterol and increased relative liver weights (magnitude above 50%) at the highest dose level (1000 mg/kg bw/day). A 90-day study was not submitted. Based on the submitted studies, the acute and repeated dose toxicity of vetiveryl acetate cannot be evaluated as only partial and insufficient information on the composition of vetiveryl acetate on the market is reported and as the composition of the test substances used in the submit","endpoint":"repeated dose toxicity","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"300","page":43,"route":"oral","species":"rat","study_id":"sccs_o_167_noael_007"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1000 | mg/kg bw/day | rat | - | subacute | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=1000; DOSE=The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.; EFFECT=males. These changes did not regress in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","duration":"subacute","effect":"males. These changes did not regress in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","endpoint":"repeated dose toxicity","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":23,"route":"","species":"rat","study_id":"sccs_o_167_noael_001"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | repeated dose toxicity | 1000 | mg/kg bw/day | rat | - | subacute | repeated dose toxicity | SOURCE_SUBDIR=sccs_o_167; REPORT_TITLE=OPINION ON vetiveryl acetate (fragrance ingredient); OPINION_NUMBER=SCCS/1541/14; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=16 December 2014; VALUE_TEXT=1000; DOSE=The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.; EFFECT=ss in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females.","duration":"subacute","effect":"ss in the recovery males, which also showed mononuclear cell foci and interstitial fibrosis in the kidneys. Conclusion: The subacute administration of vetiveryl acetate to male and female Sprague-Dawley rats on 7 consecutive days per week for 28 days at dose levels of 0, 125, 300 and 1000 mg/kg bw/day led to no toxicologically relevant effects in females. Only adaptive and/or effects on slightly disturbed organ function, predominantly the liver, were noted in females. Thus, the 'No Observed Adverse Effect Level' (NOAEL) for female rats can be considered to be 1000 mg/kg bw/day. The kidney effects detected in males from all treatment groups were considered to represent an adverse effect and therefore, a NOAEL for male rats was not established. However, the kidney effects can be considered as signs of the alpha-2-","endpoint":"repeated dose toxicity","ingredient":"codes .................................... 9","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"1000","page":23,"route":"","species":"rat","study_id":"sccs_o_167_noael_002"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 20 | mg/kg bw/d | - | - | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=20; DOSE=Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...; EFFECT=n to possible carcinogenic effects of thioglycolic acid and its salts. 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity (Taken from ECHA website) A two-generation reproduction toxicity study is available in the ECHA registration dossier database, however this information is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 an...","duration":"developmental","effect":"n to possible carcinogenic effects of thioglycolic acid and its salts. 3.3.8. Reproductive toxicity 3.3.8.1. Two generation reproduction toxicity (Taken from ECHA website) A two-generation reproduction toxicity study is available in the ECHA registration dossier database, however this information is subject to copyright laws. Only a detailed summary of this study is published on the ECHA website and the complete report was not made available to the SCCS. The results of this study support the conclusion on the NOAEL identified in the teratogenicity study. 3.3.8.2. Teratogenicity (Taken from OECD 2009) In a reproduction/developmental toxicity screening test performed following the OECD guideline # 421, the NOAEL for parental toxicity was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d), the NOEL for reproductive performance (mating, fertility and delivery) was 20 mg/kg bw/d (based on deaths at 40 and 80 mg/kg bw/d) and the NOEL for toxic effects on progeny was 40 mg/kg bw/d (based on the dead litter at 80 mg/kg bw/d","endpoint":"reproductive toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/d","noael_value":"20","page":29,"route":"","species":"","study_id":"sccs_o_141_noael_006"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 65 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=65; DOSE=SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive to; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive to","endpoint":"reproductive toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"65","page":30,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_010"} |
| UnifiedCodex:SCCS_SHADOW:beta.noael_studies | reproductive toxicity | 100 | mg/kg bw/day | rat | oral | developmental | reproductive toxicity | SOURCE_SUBDIR=sccs_o_141; REPORT_TITLE=OPINION ON Thioglycolic acid and its salts (TGA); OPINION_NUMBER=SCCS/1520/13; COMMITTEE=Scientific Committee on Consumer Safety (SCCS); REPORT_DATE=11 November 2013; VALUE_TEXT=100; DOSE=SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.; EFFECT=SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with maternal lethality. 3.3.9. Toxicokinetics; CITATION_NUMBERS=[]; DETAILS_JSON={"cas_number":"68-11-1","citation":"","dose":"SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits.","duration":"developmental","effect":"SCCS-rejected applicant NOAEL: SCCS/1520/13 Opinion on thioglycolic acid and its salts (TGA) 30 the NOAEL was 65 mg/kg bw/day (the highest dose tested) in rabbits. The developmental toxicity NOAEL was 100 mg/kg bw/day for rats and 65 mg/kg bw/day for rabbits. When ammonium thioglycolate was administered by gavage, the NOAELs for maternal and embryo-foetal toxicity were 15 and 75 mg/kg bw/d, respectively. No teratogenic effects were observed in all studies (study reports from 1998, summary available on the ECHA website. Overall, thioglycolic acid and its salts are not considered to be developmental or reproductive toxicants, except at dose levels associated with maternal lethality. 3.3.9. Toxicokinetics","endpoint":"reproductive toxicity","ingredient":"s. Hair dye products containing these substances must be","loael_value":"","noael_unit":"mg/kg bw/day","noael_value":"100","page":30,"route":"oral","species":"rat","study_id":"sccs_o_141_noael_011"} |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 7857H94KHM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H4O2S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"7857H94KHM"} |
| openFDA substances | FDA UNII substance identifier | 7857H94KHM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H4O2S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"7857H94KHM"} |
| openFDA substances | FDA UNII substance identifier | 7857H94KHM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H4O2S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"7857H94KHM"} |
| openFDA substances | FDA UNII substance identifier | 7857H94KHM | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C2H4O2S","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"7857H94KHM"} |