NOAEL Studies
Surfactant
Cocamidopropyl Betaine NOAEL Studies
INCI: COCAMIDOPROPYL BETAINE
CAS: 61789-40-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =250 | mg/kg | rat | dermal | subchronic | repeated dose toxicity | {"citation":"1; 6; 3","dose":"Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group.","effect":"t-related deaths or effects were observed during the course of the study for either sex. Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group. Microscopic evaluations found nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg per d group, and in 2 male and 2 female rats in the 500 mg/kg per d group. This effect was not observed in the 250 mg/kg per d dose group. No other treatment-related effects were observed. The study concluded that the NOEL for this subchronic study of CAPB in rats was 250 mg/kg per d. Dermal Irritation Animal. The available data on skin irritation studies are sum- marized in Table 6.37-43 These studies demonstrated that, while a full-strength CAPB solution, 30% active, was a mild irritant, a 50% dilution was nonirritating. Human Cocamidopropyl betaine. In a study of cumulative irritation, 0.3 mL of 2 soap formulations were applied to skin sites on the backs of 10 panelists using occlusive patches.37 Each formula- tion contained 1.9% active CAPB. Daily 23 hour patches were applied for...","page":14,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_002"} |
| CIR Safety Assessment | NOAEL | =250 | mg/kg | rat | dermal | subchronic | repeated dose toxicity | {"citation":"1; 6; 3","dose":"Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group.","effect":"t-related deaths or effects were observed during the course of the study for either sex. Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group. Microscopic evaluations found nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg per d group, and in 2 male and 2 female rats in the 500 mg/kg per d group. This effect was not observed in the 250 mg/kg per d dose group. No other treatment-related effects were observed. The study concluded that the NOEL for this subchronic study of CAPB in rats was 250 mg/kg per d. Dermal Irritation Animal. The available data on skin irritation studies are sum- marized in Table 6.37-43 These studies demonstrated that, while a full-strength CAPB solution, 30% active, was a mild irritant, a 50% dilution was nonirritating. Human Cocamidopropyl betaine. In a study of cumulative irritation, 0.3 mL of 2 soap formulations were applied to skin sites on the backs of 10 panelists using occlusive patches.37 Each formula- tion contained 1.9% active CAPB. Daily 23 hour patches were applied for...","page":14,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_002"} |
| CIR Safety Assessment | NOAEL | =250 | mg/kg | rat | dermal | subchronic | repeated dose toxicity | {"citation":"1; 6; 3","dose":"Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group.","effect":"t-related deaths or effects were observed during the course of the study for either sex. Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group. Microscopic evaluations found nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg per d group, and in 2 male and 2 female rats in the 500 mg/kg per d group. This effect was not observed in the 250 mg/kg per d dose group. No other treatment-related effects were observed. The study concluded that the NOEL for this subchronic study of CAPB in rats was 250 mg/kg per d. Dermal Irritation Animal. The available data on skin irritation studies are sum- marized in Table 6.37-43 These studies demonstrated that, while a full-strength CAPB solution, 30% active, was a mild irritant, a 50% dilution was nonirritating. Human Cocamidopropyl betaine. In a study of cumulative irritation, 0.3 mL of 2 soap formulations were applied to skin sites on the backs of 10 panelists using occlusive patches.37 Each formula- tion contained 1.9% active CAPB. Daily 23 hour patches were applied for...","page":14,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_002"} |
| CIR Safety Assessment | NOAEL | =250 | mg/kg | rat | dermal | subchronic | repeated dose toxicity | {"citation":"1; 6; 3","dose":"Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group.","effect":"t-related deaths or effects were observed during the course of the study for either sex. Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group. Microscopic evaluations found nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg per d group, and in 2 male and 2 female rats in the 500 mg/kg per d group. This effect was not observed in the 250 mg/kg per d dose group. No other treatment-related effects were observed. The study concluded that the NOEL for this subchronic study of CAPB in rats was 250 mg/kg per d. Dermal Irritation Animal. The available data on skin irritation studies are sum- marized in Table 6.37-43 These studies demonstrated that, while a full-strength CAPB solution, 30% active, was a mild irritant, a 50% dilution was nonirritating. Human Cocamidopropyl betaine. In a study of cumulative irritation, 0.3 mL of 2 soap formulations were applied to skin sites on the backs of 10 panelists using occlusive patches.37 Each formula- tion contained 1.9% active CAPB. Daily 23 hour patches were applied for...","page":14,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_002"} |
| CIR Safety Assessment | NOAEL | =500 | mg/kg | rat | - | - | NOAEL study | {"citation":"500","dose":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations.","effect":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations. Effects were greater in the females than the males. These effects were considered to be the result of the irritating properties of CAPB and not of systemic toxicity, especially since the 1000 mg/kg recovery animals had complete and regular regeneration of the nonglandular mucosa. No other treatment-related effects were observed in the organs. The study concluded that the NOEL was 500 mg/kg per d and the LOEL was 1000 mg/kg per d for exposure to CAPB in this rat study. Burnett et al 89S","page":13,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_001"} |
| CIR Safety Assessment | NOAEL | =500 | mg/kg | rat | - | - | NOAEL study | {"citation":"500","dose":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations.","effect":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations. Effects were greater in the females than the males. These effects were considered to be the result of the irritating properties of CAPB and not of systemic toxicity, especially since the 1000 mg/kg recovery animals had complete and regular regeneration of the nonglandular mucosa. No other treatment-related effects were observed in the organs. The study concluded that the NOEL was 500 mg/kg per d and the LOEL was 1000 mg/kg per d for exposure to CAPB in this rat study. Burnett et al 89S","page":13,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_001"} |
| CIR Safety Assessment | NOAEL | =500 | mg/kg | rat | - | - | NOAEL study | {"citation":"500","dose":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations.","effect":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations. Effects were greater in the females than the males. These effects were considered to be the result of the irritating properties of CAPB and not of systemic toxicity, especially since the 1000 mg/kg recovery animals had complete and regular regeneration of the nonglandular mucosa. No other treatment-related effects were observed in the organs. The study concluded that the NOEL was 500 mg/kg per d and the LOEL was 1000 mg/kg per d for exposure to CAPB in this rat study. Burnett et al 89S","page":13,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_001"} |
| CIR Safety Assessment | NOAEL | =500 | mg/kg | rat | - | - | NOAEL study | {"citation":"500","dose":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations.","effect":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations. Effects were greater in the females than the males. These effects were considered to be the result of the irritating properties of CAPB and not of systemic toxicity, especially since the 1000 mg/kg recovery animals had complete and regular regeneration of the nonglandular mucosa. No other treatment-related effects were observed in the organs. The study concluded that the NOEL was 500 mg/kg per d and the LOEL was 1000 mg/kg per d for exposure to CAPB in this rat study. Burnett et al 89S","page":13,"pdf":"PRS518.pdf","row_type":"noael_study","study_id":"PRS518_noael_001"} |
NTP ICE skin sensitization 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE skin sensitization | CD86, EC120 | range1.449 | ug/mL | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; mMUSST | sheet=Data_invitro; excel_row=7771; Record_ID=skin_sensitization_invitro_1869; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=mMUSST; Endpoint=CD86, EC120; Response_Modifier=range; Reported_Response=4.23 to 8.47; Reported_Response_Unit=uM; Conversion_Factor_Value=342.5; Conversion_Factor_Source=PubChem; Converted_Response=1.449 to 2.901; Converted_Response_Unit=ug/mL; Response=1.449 - 2.901; Response_Unit=ug/mL; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072 |
| NTP ICE skin sensitization | Depletion Cys | 3.9 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=251; Record_ID=skin_sensitization_invitro_70; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=DPRA; Endpoint=Depletion Cys; Reported_Response=3.9; Reported_Response_Unit=%; Response=3.9; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072 |
| NTP ICE skin sensitization | Depletion Lys | 0 | % | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; DPRA | sheet=Data_invitro; excel_row=224; Record_ID=skin_sensitization_invitro_70; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=DPRA; Endpoint=Depletion Lys; Reported_Response=0; Reported_Response_Unit=%; Response=0; Response_Unit=%; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072 |
| NTP ICE skin sensitization | EC1.5 | range31.1 | uM | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; LuSens | sheet=Data_invitro; excel_row=8024; Record_ID=skin_sensitization_invitro_1814; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=LuSens; Endpoint=EC1.5; Response_Modifier=range; Reported_Response=31.10 to 62.20; Reported_Response_Unit=uM; Response=31.10 - 62.20; Response_Unit=uM; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072 |
| NTP ICE skin sensitization | EC3 | >35 | % | Mouse | Dermal | - | In Vivo; Urbisch_SkinSensitization2020; LLNA | sheet=Data_invivo; excel_row=12781; Record_ID=skin_sensitization_invivo_2793; Data_Type=In Vivo; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=LLNA; Endpoint=EC3; Response_Modifier=>; Response=35; Response_Unit=%; Species=Mouse; Route=Dermal; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072 |
| NTP ICE skin sensitization | Imax | <1.16 | ratio | - | Dermal | - | In Vitro; Urbisch_SkinSensitization2020; LuSens | sheet=Data_invitro; excel_row=7548; Record_ID=skin_sensitization_invitro_1814; Data_Type=In Vitro; Internal_Data_Source=Urbisch_SkinSensitization2020; Mixture=Chemical; DTXSID=DTXSID6028072; Assay=LuSens; Endpoint=Imax; Response_Modifier=<; Reported_Response_Modifier=<; Reported_Response=1.1599999999999999; Reported_Response_Unit=Unitless; Response=1.16; Response_Unit=Ratio; Reference=Urbisch et al. 2015; 25541156; 10.1016/j.yrtph.2014.12.008; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID6028072 |
ECHA 6 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | NOAEL | =95 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1b5e4b0a7c65d22fd88; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/9/3?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: gross pathology|maternal: mortality|maternal: organ weights and organ / body weight ratios|maternal: pre and post implantation loss|maternal: total litter losses by resorption; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival|organ weight|reproduction; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822442_15825350:F:-maternal; 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_8f0a3b1e462234a85d6f5ffcf175385b |
| ECHA | NOAEL | =250 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | QUALITY=4 (not assignable); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7cac6e4b0a7c65d2235f0; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/6/2?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=body weight and weight gain|organ weights and organ / body weight ratios|urinalysis|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality|ophthalmological examination; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology|organ weight|urinalysis; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15847174_15847253_15848622:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_921c9963d7e8cf3fd8badddab5c85b55 |
| ECHA | NOAEL | =286 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac7be4b0a7c65d1bf4ca; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23579/7/9/3?documentUUID=5c6d1924-6cb5-40be-ae9f-50b1b7e4e74d; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID:15825230:M/F:-fetal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_14018bc0900684e406f5a2f52ade8708 |
| ECHA | NOAEL | =500 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf22e4b0a7c65d1cc962; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/23579/7/6/2?documentUUID=5c6d1924-6cb5-40be-ae9f-50b1b7e4e74d; YEAR=2017; ORIGINAL_YEAR=2017; TOXICOLOGICAL_EFFECT=gross pathology; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15849724_15849725:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_0533e2ec34fef219a26c5c4a29563bf5 |
| ECHA | NOAEL | >950 | mg/kg bw/day | Rat | oral | - | developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d1b5e4b0a7c65d22fd88; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/9/3?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=fetus: reduction in number of live offspring|fetus: fetal/pup body weight changes|fetus: external malformations|fetus: skeletal malformations|fetus: visceral malformations; TOXICOLOGICAL_EFFECT_CATEGORY=development; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15821123_15825351:-:-fetal; 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_bcd8042cac46134a490d4a026869c69b |
| ECHA | NOAEL | =1000 | mg/kg bw/day | Rat | oral | - | reproduction developmental | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7d24ce4b0a7c65d232864; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/15928/7/9/3?documentUUID=316af4ce-fbb8-4f1a-b826-8916103a82a2; YEAR=1967; ORIGINAL_YEAR=1967; TOXICOLOGICAL_EFFECT=maternal: body weight and weight gain|maternal: clinical signs|maternal: food consumption and compound intake|maternal: gross pathology|maternal: histopathology: non-neoplastic|maternal: mortality|maternal: organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical signs|food and/or water consumption|gross pathology|mortality/survival|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Developmental Toxicity Teratogenicity_15822442_15825350:F:-maternal; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_c9fc9313502fd681f501fcfa578834b0 |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =8.22 | 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:15634317:-:--; 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_4976fbc683507de8e0ab875efdc838b2 |
ToxValDB HPVIS 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB HPVIS | LOAEL | =300 | mg/kg bw/day | Rat | oral | short-term; 7 days | short-term | LONG_REF=Bailey, D. E. 1988. Dose Range-finding Toxicity Study in Rats. Report number 444-223. Hazleton Laboratories America, Inc., Vienna, VA, U. S.; TITLE=Dose Range-finding Toxicity Study in Rats. Report number 444-223; AUTHOR=Bailey, D. E; QUALITY=1; EXTERNAL_SOURCE_ID=60981; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1988; ORIGINAL_YEAR=1988; STUDY_GROUP=HPVIS:15639692:-:--; 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_bf6dae4f8e6733b16d4f725b7270c270 |
| ToxValDB HPVIS | LOAEL | =1000 | mg/kg bw/day | Rat | oral | short-term; 28 days | short-term | LONG_REF=Potokar, M., W. Sterzel and W. Pittermann. 1991. Dehyton K, 28-Tage-Test mit Wiederholter Oraler Verabreichung an Ratten. Report number TED 910119. Henkel KGaA, Duesseldorf, Germany.; TITLE=Dehyton K, 28-Tage-Test mit Wiederholter Oraler Verabreichung an Ratten. Report number TED 910119; AUTHOR=Potokar, M., W. Sterzel and W. Pittermann; QUALITY=1; EXTERNAL_SOURCE_ID=61792; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; TOXICOLOGICAL_EFFECT_CATEGORY=-|multiple; STUDY_GROUP=HPVIS_dup_HPVIS Mammalian Repeat Dose_15639647_15639799:-:--; 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_8c89b4a30bd653b75df1b7428e232fc2 |
| ToxValDB HPVIS | NOAEL | =250 | mg/kg bw/day | Rat | oral | chronic; 92 days | chronic | LONG_REF=Zuehlke, U. 1991. 90 Day Oral (Gavage) Subchronic Toxicity Study in the Rat. Report number 954-348-155. Hazleton Laboratories Deutschland GmbH, Muenster, Germany; TITLE=90 Day Oral (Gavage) Subchronic Toxicity Study in the Rat. Report number 954-348-155; AUTHOR=Zuehlke, U; QUALITY=1; EXTERNAL_SOURCE_ID=63098; EXTERNAL_SOURCE_ID_DESC=HPVIS ID; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/63861d6de4b04f6bb1480596; RECORD_SOURCE_LEVEL=Extraction document; YEAR=1991; ORIGINAL_YEAR=1991; STUDY_GROUP=HPVIS:15639977:-:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_7dcabec514364f25c68e52278b6df645 |
Regulatory source 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 500 | mg/kg | rat | - | - | - | SOURCE_SUBDIR=PRS518; REPORT_TITLE=Final Report of the Cosmetic Ingredient; OPINION_NUMBER=PRS518; COMMITTEE=CIR Expert Panel; REPORT_DATE=2 The 2011; VALUE_TEXT=500; DOSE=n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations.; EFFECT=n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations. Effects were greater in the females than the males. These effects were considered to be the result of the irritating properties of CAPB and not of systemic toxicity, especially since the 1000 mg/kg recovery animals had complete and regular regeneration of the nonglandular mucosa. No other treatment-related effects were observed in the organs. The study concluded that the NOEL was 500 mg/kg per d and the LOEL was 1000 mg/kg per d for exposure to CAPB in this rat study. Burnett et al 89S; CITATION=500; CITATION_NUMBERS=[500]; REFERENCE=500; DETAILS_JSON={"cas_number":"61789-40-0","citation":"500","dose":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations.","duration":"","effect":"n of the rats in the 1000 mg/kg dose group found acanthosis of the gastric mucosa, inflammatory edema of the submucosa, and multiple ulcerations. Effects were greater in the females than the males. These effects were considered to be the result of the irritating properties of CAPB and not of systemic toxicity, especially since the 1000 mg/kg recovery animals had complete and regular regeneration of the nonglandular mucosa. No other treatment-related effects were observed in the organs. The study concluded that the NOEL was 500 mg/kg per d and the LOEL was 1000 mg/kg per d for exposure to CAPB in this rat study. Burnett et al 89S","endpoint":"","ingredient":"the Cosmetic Ingredient","loael_value":"","noael_unit":"mg/kg","noael_value":"500","page":13,"route":"","species":"rat","study_id":"PRS518_noael_001"} |
| Regulatory source | repeated dose toxicity | 250 | mg/kg | rat | dermal | subchronic | repeated dose toxicity | SOURCE_SUBDIR=PRS518; REPORT_TITLE=Final Report of the Cosmetic Ingredient; OPINION_NUMBER=PRS518; COMMITTEE=CIR Expert Panel; REPORT_DATE=2 The 2011; VALUE_TEXT=250; DOSE=Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group.; EFFECT=t-related deaths or effects were observed during the course of the study for either sex. Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group. Microscopic evaluations found nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg per d group, and in 2 male and 2 female rats in the 500 mg/kg per d group. This effect was not observed in the 250 mg/kg per d dose group. No other treatment-related effects were observed. The study concluded that the NOEL for this subchronic study of CAPB in rats was 250 mg/kg per d. Dermal Irritation Animal. The available data on skin irritation studies are sum- marized in Table 6.37-43 These studies demonstrated that, while a full-strength CAPB solution, 30% active, was a mild irritant, a 50% dilution was nonirritating. Human Cocamidopropyl betaine. In a study of cumulative irritation, 0.3 mL of 2 soap formulations were applied to skin sites on the backs of 10 panelists using occlusive patches.37 Each formula- tion contained 1.9% active CAPB. Daily 23 hour patches were applied for...; CITATION=1; 6; 3; CITATION_NUMBERS=[1,6,3]; REFERENCE=1; 6; 3; DETAILS_JSON={"cas_number":"61789-40-0","citation":"1; 6; 3","dose":"Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group.","duration":"subchronic","effect":"t-related deaths or effects were observed during the course of the study for either sex. Necropsy revealed stomach ulcers at the fundic and cardiac regions in 1 male and 1 female in the high-dose group. Microscopic evaluations found nonglandular gastritis in 6 male and 3 female rats in the 1000 mg/kg per d group, and in 2 male and 2 female rats in the 500 mg/kg per d group. This effect was not observed in the 250 mg/kg per d dose group. No other treatment-related effects were observed. The study concluded that the NOEL for this subchronic study of CAPB in rats was 250 mg/kg per d. Dermal Irritation Animal. The available data on skin irritation studies are sum- marized in Table 6.37-43 These studies demonstrated that, while a full-strength CAPB solution, 30% active, was a mild irritant, a 50% dilution was nonirritating. Human Cocamidopropyl betaine. In a study of cumulative irritation, 0.3 mL of 2 soap formulations were applied to skin sites on the backs of 10 panelists using occlusive patches.37 Each formula- tion contained 1.9% active CAPB. Daily 23 hour patches were applied for...","endpoint":"repeated dose toxicity","ingredient":"the Cosmetic Ingredient","loael_value":"","noael_unit":"mg/kg","noael_value":"250","page":14,"route":"dermal","species":"rat","study_id":"PRS518_noael_002"} |
| Regulatory source | repeated dose toxicity | 500 | mg/kg | rat | oral | 28-day | repeated dose toxicity | SOURCE_SUBDIR=PRS518; REPORT_TITLE=Final Report of the Cosmetic Ingredient; OPINION_NUMBER=PRS518; COMMITTEE=CIR Expert Panel; REPORT_DATE=2 The 2011; VALUE_TEXT=500; 1000; DOSE=In another 28-day oral toxicity study, rats received 0, 250, 500, or 1000 mg/kg of an unknown concentration of CAPB.; EFFECT=controls. In another 28-day oral toxicity study, rats received 0, 250, 500, or 1000 mg/kg of an unknown concentration of CAPB. In the 1000 mg/kg dose group, compound-related edema of the mucosa of the nonglandular stomach was observed at macro- scopic examination and acanthosis of the mucosa, inflamma- tory edema of the submucosa, and multiple ulcerations were observed during microscopic examination. These effects were thought to be the result of the irritating properties of CAPB and not of systemic toxicity. The NOEL and LOEL for this study were 500 and 1000 mg/kg per d, respectively. A subchronic oral toxicity study of an unknown concentration of CAPB rats that received 0, 250, 500, or 1000 mg/kg per d CAPB concluded that the NOEL was 250 mg/kg per d. Gastritis Table 9. Quantitative Risk Assessment of Amidoamine (AA) in Cosmetic Products Containing CAPBa,b,118 Product Category % Max Concentration of Use (active) % Activity f Raw Material Product Exposurec (mg/cm2) CAPB Exposure (mg/cm2) AA CEL (mg/cm2) SAF AA AEL AA AEL/CEL Baby shampoo 4 30 200 26.67 0.13 100 1.80 13.50 Other b...; CITATION=28; 0, 250, 500; 500; CITATION_NUMBERS=[28,250,500]; REFERENCE=28; 0, 250, 500; 500; DETAILS_JSON={"cas_number":"61789-40-0","citation":"28; 0, 250, 500; 500","dose":"In another 28-day oral toxicity study, rats received 0, 250, 500, or 1000 mg/kg of an unknown concentration of CAPB.","duration":"28-day","effect":"controls. In another 28-day oral toxicity study, rats received 0, 250, 500, or 1000 mg/kg of an unknown concentration of CAPB. In the 1000 mg/kg dose group, compound-related edema of the mucosa of the nonglandular stomach was observed at macro- scopic examination and acanthosis of the mucosa, inflamma- tory edema of the submucosa, and multiple ulcerations were observed during microscopic examination. These effects were thought to be the result of the irritating properties of CAPB and not of systemic toxicity. The NOEL and LOEL for this study were 500 and 1000 mg/kg per d, respectively. A subchronic oral toxicity study of an unknown concentration of CAPB rats that received 0, 250, 500, or 1000 mg/kg per d CAPB concluded that the NOEL was 250 mg/kg per d. Gastritis Table 9. Quantitative Risk Assessment of Amidoamine (AA) in Cosmetic Products Containing CAPBa,b,118 Product Category % Max Concentration of Use (active) % Activity f Raw Material Product Exposurec (mg/cm2) CAPB Exposure (mg/cm2) AA CEL (mg/cm2) SAF AA AEL AA AEL/CEL Baby shampoo 4 30 200 26.67 0.13 100 1.80 13.50 Other b...","endpoint":"repeated dose toxicity","ingredient":"the Cosmetic Ingredient","loael_value":"","noael_unit":"mg/kg","noael_value":"500; 1000","page":28,"route":"oral","species":"rat","study_id":"PRS518_noael_003"} |
openFDA substances 8 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 5OCF3O11KX | UNII | - | - | - | mixture | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"5OCF3O11KX"} |
| openFDA substances | FDA UNII substance identifier | 5OCF3O11KX | UNII | - | - | - | mixture | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"5OCF3O11KX"} |
| openFDA substances | FDA UNII substance identifier | 5OCF3O11KX | UNII | - | - | - | mixture | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"5OCF3O11KX"} |
| openFDA substances | FDA UNII substance identifier | 5OCF3O11KX | UNII | - | - | - | mixture | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"mixture","unii_code":"5OCF3O11KX"} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |
| openFDA substances | FDA UNII substance identifier | concept | identifier | - | - | - | concept | {"approval_status":null,"molecular_formula":null,"source_table":"substance_identifiers_fda","substance_class":"concept","unii_code":null} |