NOAEL Studies
Cosmetic Ingredient
Laureth-50 NOAEL Studies
INCI: LAURETH-50
CAS: 9002-92-0
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
CIR Safety Assessment 22 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| CIR Safety Assessment | NOAEL | =0 | ppm | rat | oral | - | developmental toxicity | 64; 145; 33, p.11 |
| CIR Safety Assessment | NOAEL | =0.1 | % | rat | oral | 2 years | oral toxicity | 0; 5; 1, p.56 |
| CIR Safety Assessment | NOAEL | =0.375 | % | rat | oral | 21 days | repeated dose toxicity | 21; 6; 0, p.55 |
| CIR Safety Assessment | NOAEL | >0.5 | % | rat | oral | - | developmental toxicity | 0; 05; 1, p.67 |
| CIR Safety Assessment | NOAEL | =1 | % | rat | oral | 90-day | repeated dose toxicity | 90; 20; 0, p.56 |
| CIR Safety Assessment | NOAEL | =1.6 | g/kg | rat | oral | 14 days | oral toxicity | 0, 0; 75, 1; 6, 3, p.56 |
| CIR Safety Assessment | NOAEL | =7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | 0; 03; 1, p.55 |
| CIR Safety Assessment | NOAEL | =25 | % | rat | - | - | reproductive toxicity | 5; 10; 25, p.64 |
| CIR Safety Assessment | NOAEL | >50 | mg/kg | rat | oral | - | developmental toxicity | 9; 19; 25, p.67 |
| CIR Safety Assessment | NOAEL | =190 | mg/kg | rat | oral | 2 years | oral toxicity | 50; 0; 1, p.56 |
| CIR Safety Assessment | NOAEL | >250 | mg/ kg | rat | oral | - | developmental toxicity | 250; 50; 10, p.67 |
| CIR Safety Assessment | NOAEL | =300 | ppm | rat | oral | 90 days | repeated dose toxicity | 300; 10; 000, p.55 |
| CIR Safety Assessment | NOAEL | =300 | mg/kg | - | - | - | NOAEL study | 300; (3; 333, p.68 |
| CIR Safety Assessment | NOAEL | =400 | mg/kg | rat | oral | 13 weeks | oral toxicity | 10; 2; (0, p.56 |
| CIR Safety Assessment | NOAEL | =500 | mg/kg | rat | oral | - | developmental toxicity | 2; 250; 3, p.68 |
| CIR Safety Assessment | NOAEL | =1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | 2; (0; 02, p.56 |
| CIR Safety Assessment | NOAEL | <1200 | mg/kg bw | rat | dermal | 14-day | NOAEL study | 12; 5; 1, p.57 |
| CIR Safety Assessment | NOAEL | =1250 | mg/kg | rat | - | - | developmental toxicity | 3; 625, p.67 |
| CIR Safety Assessment | NOAEL | =1500 | mg/kg | rat | oral | - | developmental toxicity | 2; 250; 3, p.68 |
| CIR Safety Assessment | NOAEL | =1650 | mg/kg bw | rat | - | - | developmental toxicity | 20; 4; 1, p.68 |
| CIR Safety Assessment | NOAEL | =4000 | mg/kg | rabbit | dermal | 12-day | NOAEL study | 0; 3; 6, p.57 |
| CIR Safety Assessment | NOAEL | =5000 | ppm | rat | oral | - | developmental toxicity | 50; 64; 145, p.11 |
FDA 9 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| FDA | NOAEL | =1 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA | NOAEL | =2 | mg/kg bw/day | rabbit (Himalayan; male/female) | intravenous | GD 6-20 | developmental toxicity teratogenicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - DevelopmentalToxicityTeratogenicity - Examination of the influence on the pregnant rabbit and the fetus by intravenous administration_8926/94 - b747d769-caa5-4710-917c-b0a7168e8d76/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA | NOAEL | <=3 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA | NOAEL | =4 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: other: |
| FDA | NOEL | <=9 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 13 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Thirteen week intravenous toxicity study of ASK in rats_93208 - ecb3ee72-a144-4f20-b22b-4eea21e625e3/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: ophthalmological examination: no abnormal phenotype detected |
| FDA | NOEL | <=10 | mg/kg bw/day | rat (Crj: CD(SD); male/female) | intravenous | 9 weeks | reproductive toxicity | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - ToxicityReproduction - Fertility and early embryogenesis study in rats_3 - 635088d5-3b74-44ca-ac59-db9cf0055187/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: mortality: no abnormal phenotype detected |
| FDA | NOEL | <=12 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 4 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Subacute toxicity test of ASK – 010 intravenous doses intermittently for 4 weeks and recovery test by discontinuation of doses for 4 weeks in dogs_(b)(4)-87-DVSA- 035 - acb8bf05-cec2-47d0-8e08-354f12b6e979/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA | NOEL | <=14 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 7 days | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - 7-day subchronic toxicity study of polidocanol by intravenous administration to Sprague- Dawley rats (Comparison of polidocanol from three different manufacturers)_11128/1/98 - c3a8681f-f873-46bf-9779-a216475f993b/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: urinalysis: no abnormal phenotype detected |
| FDA | NOEL | <=16 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 5 weeks | repeated dose toxicity other | 652075c3-23dd-4b58-b6b0-8a16302f8993_dossier.i6z - RepeatedDoseToxicityOther - Repeated dose study (4 weeks) in beagle dogs after i.v. injection of polidocanol_(b)(4)-66.357-1 - 548d7cc9-30df-4515-9eca-ffff56744678/7ebfb452-97f0-4abd-9eca-7b7a068fa4f4 - basis: body weight and weight gain: no abnormal phenotype detected |
NTP ICE eye irritation 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE eye irritation | Draize rabbit irritation score | 0 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=778; Record_ID=eye_irritation_131; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=Draize rabbit irritation score; Response=0; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP ICE eye irritation | EPA Classification | 3 | unitless | Rabbit | Ocular | - | In Vivo; Draize Eye Irritation/Corrosion Test | sheet=Data; excel_row=780; Record_ID=eye_irritation_131; Data_Type=In Vivo; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Draize Eye Irritation/Corrosion Test; Endpoint=EPA Classification; Response=3; Response_Unit=Unitless; Species=Rabbit; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP ICE eye irritation | Intensity | 0.01 | %/sec | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=782; Record_ID=eye_irritation_1240; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Vitrigel; Endpoint=Intensity; Response=0.01; Response_Unit=%/sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP ICE eye irritation | Lag time | >180 | s | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=781; Record_ID=eye_irritation_1240; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Vitrigel; Endpoint=Lag time; Response_Modifier=>; Response=180; Response_Unit=sec; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
| NTP ICE eye irritation | Plateau level | 0 | % | - | Ocular | - | In Vitro; Vitrigel | sheet=Data; excel_row=776; Record_ID=eye_irritation_1240; Data_Type=In Vitro; Mixture=Chemical; DTXSID=DTXSID2025218; Assay=Vitrigel; Endpoint=Plateau level; Response=0; Response_Unit=%; PMID=26472347.0; Reference=Yamaguchi et al. 2016; URL=10.1002/jat.3254; URL_CompTox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID2025218; URL_CEBS=https://doi.org/10.22427/NTP-DATA-DTXSID2025218 |
ECHA 13 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | LEL | >=1 | mg/kg bw/day | Dog | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca8781031; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=edema|enlarged axillary lymph nodes|enlarged lymph nodes|fibrosis|hemorrhage|hypertrophic|icterus|increased salivation|injection site inflammation|perivascular space|sclerosis; TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852647_15852650_15852651_15852653:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_90460bd7595d59a8fd7f1d38a9e92d9a |
| ECHA | LEL | >=3 | mg/kg bw/day | Dog | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca8781031; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=decreased hemoglobin concentration|vomiting; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852648_15852652:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_0cac9b8fa82764b902364ceec9214f89 |
| ECHA | LEL | >=6 | mg/kg bw/day | Dog | injection | short-term; 4 weeks | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209de4b096bca878210e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=increased salivation|injection site hemorrhage|injection site inflammation; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853656_15853658_15853659_15853660_15853662_15853663:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_a770e72a4a71ac12639c36774abdce59 |
| ECHA | LEL | =9 | mg/kg bw/day | Rat | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620e4e4b096bca878324d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=abnormal skin appearance|abnormal spleen morphology|decreased circulating phospholipid level|decreased circulating total protein level|extramedullary hematopoiesis|fibrosis|hyperplastic|increased mean corpuscular hemoglobin|increased mean corpuscular volume|reticulocytosis|tail necrosis|tail vein|thrombosis|white blood cell count increased (lab result); TOXICOLOGICAL_EFFECT_CATEGORY=nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854528_15854529_15854530_15854532_15854536:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6c4eceb487df46aa8d3d53dd4ea1da1f |
| ECHA | LEL | =12 | mg/kg bw/day | Dog | injection | short-term; 4 weeks | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209de4b096bca878210e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=atrophy of prostate|decreased lymphocyte cell number|decreased prostate gland weight|increased urine protein level|urine bilirubin increased|urine occult blood|white blood cell count increased (lab result); TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853657_15853664:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_7bd75246e08b9d7532c40fb8eb1cfb22 |
| ECHA | LEL | =14 | mg/kg bw/day | Rat | injection | short-term; 7 days | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620c0e4b096bca87828b7; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=abnormal skin appearance|decreased hematocrit|decreased hemoglobin concentration|decreased red blood cell count|fatty|fibrotic|granulomatous inflammation|hemorrhage|hepatocellular vacuolation|increased circulating alanine transaminase level|increased circulating alkaline phosphatase level|increased circulating aspartate transaminase level|increased circulating bilirubin level|increased liver weight|inflammation|tail swellings|white blood cell count increased (lab result); TOXICOLOGICAL_EFFECT_CATEGORY=gross pathology|hematology|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853969_15853970:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_6e9f91713b6921b078adb9f4149c8533 |
| ECHA | LOAEL | =300 | mg/kg bw/day | Rat | oral | subchronic; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=behavior: functional findings; TOXICOLOGICAL_EFFECT_CATEGORY=neurobehavior; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834757_15849016:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4e21ab53aa519098fca51503c8dd0696 |
| ECHA | LOAEL | =700 | mg/kg bw/day | Rat | oral | subchronic (developmental); 71 days | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=clinical signs; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834756_15848645:F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_f812e38d830b1888e10fb9eda60dd506 |
| ECHA | NOAEL | =1 | mg/kg bw/day | Rat | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620e4e4b096bca878324d; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854528_15854529_15854530_15854532_15854536:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_45dca679c50021fb3ad8ca35043d6192 |
| ECHA | NOAEL | <=3 | mg/kg bw/day | Dog | injection | short-term; 4 weeks | short-term | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6209de4b096bca878210e; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15853656_15853658_15853659_15853660_15853662_15853663:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_4639760a6da81943f50da35ae755dc2c |
| ECHA | NOAEL | =100 | mg/kg bw/day | Rat | oral | subchronic; 28 days | short-term | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=behaviour (functional findings)|organ weights and organ / body weight ratios|serum/plasma hormone analyses|body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|neurobehavior|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834757_15849016:M:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, and this record was expert reviewed; QC_STATUS=pass; SOURCE_HASH=ToxValhc_23e2dcaa24521fcd6c8de8b2cc8292d4 |
| ECHA | NOAEL | =300 | mg/kg bw/day | Rat | oral | subchronic (developmental); 71 days | reproduction developmental | QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eaf51e4b0a7c65d1cd6ee; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/en/registration-dossier/-/registered-dossier/10916?documentUUID=37f09d4e-7c98-40c0-b77a-07775c8f32c9; YEAR=2021; ORIGINAL_YEAR=2021; TOXICOLOGICAL_EFFECT=behaviour (functional findings)|organ weights and organ / body weight ratios|body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|neurobehavior|nonneoplastic histopathology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Oral_15834756_15848645: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_c92d6c62e8a8633e6c57c701d6886c3a |
| ECHA | NOEL | <=9 | mg/kg bw/day | Dog | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca8781031; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=7ebfb452-97f0-4abd-9eca-7b7a068fa4f4; TOXICOLOGICAL_EFFECT=no abnormal phenotype detected; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852647_15852650_15852651_15852653:M/F:--; QC_CATEGORY=Programmatically extracted from structured data source; Source overall passed QC, but this record was not manually checked; QC_STATUS=not determined; SOURCE_HASH=ToxValhc_ef370b4c6e8771a63d0cb6a9513e9912 |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =4.93 | 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:15634213:-:--; 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_cafcd2090903470c91ba676b489747c7 |
Regulatory source 23 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| Regulatory source | - | 300 | mg/kg | - | - | - | - | p.68 |
| Regulatory source | - | <1200 | mg/kg bw | rat | dermal | 14-day | - | p.57 |
| Regulatory source | - | 4000 | mg/kg | rabbit | dermal | 12-day | - | p.57 |
| Regulatory source | developmental toxicity | 0 | ppm | rat | oral | - | developmental toxicity | p.11 |
| Regulatory source | developmental toxicity | >0.5 | % | rat | oral | - | developmental toxicity | p.67 |
| Regulatory source | developmental toxicity | >50 | mg/kg | rat | oral | - | developmental toxicity | p.67 |
| Regulatory source | developmental toxicity | 50 | mg/kg | rat | oral | 60 days | developmental toxicity | p.67 |
| Regulatory source | developmental toxicity | >250 | mg/ kg | rat | oral | - | developmental toxicity | p.67 |
| Regulatory source | developmental toxicity | 500 | mg/kg | rat | oral | - | developmental toxicity | p.68 |
| Regulatory source | developmental toxicity | 1250 | mg/kg | rat | - | - | developmental toxicity | p.67 |
| Regulatory source | developmental toxicity | 1500 | mg/kg | rat | oral | - | developmental toxicity | p.68 |
| Regulatory source | developmental toxicity | 1650 | mg/kg bw | rat | - | - | developmental toxicity | p.68 |
| Regulatory source | developmental toxicity | 5000 | ppm | rat | oral | - | developmental toxicity | p.11 |
| Regulatory source | oral toxicity | 0.1 | % | rat | oral | 2 years | oral toxicity | p.56 |
| Regulatory source | oral toxicity | 1.6 | g/kg | rat | oral | 14 days | oral toxicity | p.56 |
| Regulatory source | oral toxicity | 190 | mg/kg | rat | oral | 2 years | oral toxicity | p.56 |
| Regulatory source | oral toxicity | 400 | mg/kg | rat | oral | 13 weeks | oral toxicity | p.56 |
| Regulatory source | oral toxicity | 1200 | mg/kg | rat | oral | 13 weeks | oral toxicity | p.56 |
| Regulatory source | repeated dose toxicity | 0.375 | % | rat | oral | 21 days | repeated dose toxicity | p.55 |
| Regulatory source | repeated dose toxicity | 1 | % | rat | oral | 90-day | repeated dose toxicity | p.56 |
| Regulatory source | repeated dose toxicity | 7 | mg/kg | rat | oral | 90 days | repeated dose toxicity | p.55 |
| Regulatory source | repeated dose toxicity | 300 | ppm | rat | oral | 90 days | repeated dose toxicity | p.55 |
| Regulatory source | reproductive toxicity | 25 | % | rat | - | - | reproductive toxicity | p.64 |
openFDA substances 16 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 002FR4N8OV | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 0AWH8BFG9A | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 6HQ855798J | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | 6SU0SC83AH | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | APG12V4K45 | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | BD7AST04GA | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | ELB3Y6474W | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | KZF7XN8153 | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | MGU0HEW21Q | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | N72LMW566G | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | OAH19558U1 | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | QU7U88D04I | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | RPD53041LR | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | W9D845551A | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | WG3R46N0SV | UNII | - | - | - | polymer | - |
| openFDA substances | FDA UNII substance identifier | Z95S6G8201 | UNII | - | - | - | polymer | - |