NOAEL Studies
Cosmetic Ingredient
Tafluprost NOAEL Studies
INCI: ETHYL TAFLUPROSTAMIDE (COSMETIC INCI); INN: TAFLUPROST
CAS: 209860-87-7
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z 32 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOAEL | =0.0003 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | from gestation day (GD) 6 until lactation day (LD) 20 | reproductive toxicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - ToxicityReproduction - A study for effects of AFP-168 on pre- and post-natal development including maternal function, in rats via intravenous administration._MRL TT #04-5574 - c31e8a77-44ca-42a0-adb1-20933cfe1a04/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other: |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOAEL | =0.0003 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | from gestation day (GD) 6 until lactation day (LD) 20 | reproductive toxicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - ToxicityReproduction - A study for effects of AFP-168 on pre- and post-natal development including maternal function, in rats via intravenous administration._MRL TT #04-5574 - c31e8a77-44ca-42a0-adb1-20933cfe1a04/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other: |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOAEL | =0.0003 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | from gestation day (GD) 6 until lactation day (LD) 20 | reproductive toxicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - ToxicityReproduction - A study for effects of AFP-168 on pre- and post-natal development including maternal function, in rats via intravenous administration._MRL TT #04-5574 - c31e8a77-44ca-42a0-adb1-20933cfe1a04/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other: |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOAEL | =0.0003 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | from gestation day (GD) 6 until lactation day (LD) 20 | reproductive toxicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - ToxicityReproduction - A study for effects of AFP-168 on pre- and post-natal development including maternal function, in rats via intravenous administration._MRL TT #04-5574 - c31e8a77-44ca-42a0-adb1-20933cfe1a04/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other: |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.03 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | subcutaneous | 13 weeks | carcinogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - Carcinogenicity - 13 week subcutaneous administration range-finding study in the rat_MRL TT #03-5574 - ac5aa987-01b1-45b3-a976-ba769884165b/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: haematology |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.1 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 26 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 26 week intravenous administration toxicity study in rats_1241/031; MRL TT #01-5526 - 3e9eb702-b23f-44f9-b792-d40120ebce0e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.0003 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Days (GD) 6 to 17 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit_MRLTT #01-5528 - 7a30a9ac-be30-4c35-9ae6-f7f7d21d0307/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: clinical signs: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.01 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 39 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 39-week intravenous administration toxicity study in the dog_1241/030; MRL TT #01-5530. - f9608f33-805e-46b0-ba54-375ae58a7300/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: food consumption and compound intake: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.00001 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Day (GD) 7 to GD 19 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit - second study_MRL TT #02-5551 - 12b5a60b-56d2-41b0-80e4-8ce385dac24e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: number of abortions: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=1.35 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 13 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 13-week ocular toxicity study in the cynomolgus monkey_MRL TT #11-7800 - 6ea357e6-5399-4652-b1f1-88c4182ff7f4/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=15 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 52 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 52-week ocular toxicity study in the cynomolgus monkey_M RLTT# 01-5531 - fcae1d73-b9a8-475a-be11-b7ff4d16139a/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.03 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | subcutaneous | 13 weeks | carcinogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - Carcinogenicity - 13 week subcutaneous administration range-finding study in the rat_MRL TT #03-5574 - ac5aa987-01b1-45b3-a976-ba769884165b/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: haematology |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.1 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 26 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 26 week intravenous administration toxicity study in rats_1241/031; MRL TT #01-5526 - 3e9eb702-b23f-44f9-b792-d40120ebce0e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.0003 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Days (GD) 6 to 17 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit_MRLTT #01-5528 - 7a30a9ac-be30-4c35-9ae6-f7f7d21d0307/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: clinical signs: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.01 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 39 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 39-week intravenous administration toxicity study in the dog_1241/030; MRL TT #01-5530. - f9608f33-805e-46b0-ba54-375ae58a7300/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: food consumption and compound intake: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.00001 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Day (GD) 7 to GD 19 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit - second study_MRL TT #02-5551 - 12b5a60b-56d2-41b0-80e4-8ce385dac24e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: number of abortions: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=1.35 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 13 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 13-week ocular toxicity study in the cynomolgus monkey_MRL TT #11-7800 - 6ea357e6-5399-4652-b1f1-88c4182ff7f4/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=15 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 52 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 52-week ocular toxicity study in the cynomolgus monkey_M RLTT# 01-5531 - fcae1d73-b9a8-475a-be11-b7ff4d16139a/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.03 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | subcutaneous | 13 weeks | carcinogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - Carcinogenicity - 13 week subcutaneous administration range-finding study in the rat_MRL TT #03-5574 - ac5aa987-01b1-45b3-a976-ba769884165b/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: haematology |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.1 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 26 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 26 week intravenous administration toxicity study in rats_1241/031; MRL TT #01-5526 - 3e9eb702-b23f-44f9-b792-d40120ebce0e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.0003 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Days (GD) 6 to 17 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit_MRLTT #01-5528 - 7a30a9ac-be30-4c35-9ae6-f7f7d21d0307/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: clinical signs: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.01 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 39 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 39-week intravenous administration toxicity study in the dog_1241/030; MRL TT #01-5530. - f9608f33-805e-46b0-ba54-375ae58a7300/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: food consumption and compound intake: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.00001 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Day (GD) 7 to GD 19 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit - second study_MRL TT #02-5551 - 12b5a60b-56d2-41b0-80e4-8ce385dac24e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: number of abortions: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=1.35 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 13 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 13-week ocular toxicity study in the cynomolgus monkey_MRL TT #11-7800 - 6ea357e6-5399-4652-b1f1-88c4182ff7f4/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=15 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 52 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 52-week ocular toxicity study in the cynomolgus monkey_M RLTT# 01-5531 - fcae1d73-b9a8-475a-be11-b7ff4d16139a/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.03 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | subcutaneous | 13 weeks | carcinogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - Carcinogenicity - 13 week subcutaneous administration range-finding study in the rat_MRL TT #03-5574 - ac5aa987-01b1-45b3-a976-ba769884165b/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: haematology |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.1 | mg/kg bw/day | rat (Sprague-Dawley; male/female) | intravenous | 26 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 26 week intravenous administration toxicity study in rats_1241/031; MRL TT #01-5526 - 3e9eb702-b23f-44f9-b792-d40120ebce0e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: body weight and weight gain: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.0003 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Days (GD) 6 to 17 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit_MRLTT #01-5528 - 7a30a9ac-be30-4c35-9ae6-f7f7d21d0307/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: clinical signs: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.01 | mg/kg bw/day | dog (Beagle; male/female) | intravenous | 39 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 39-week intravenous administration toxicity study in the dog_1241/030; MRL TT #01-5530. - f9608f33-805e-46b0-ba54-375ae58a7300/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: food consumption and compound intake: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=0.00001 | mg/kg bw/day | rabbit (New Zealand White; male/female) | intravenous | Gestation Day (GD) 7 to GD 19 | developmental toxicity teratogenicity | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - DevelopmentalToxicityTeratogenicity - Intravenous study of embryo-foetal development in the rabbit - second study_MRL TT #02-5551 - 12b5a60b-56d2-41b0-80e4-8ce385dac24e/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: number of abortions: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=1.35 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 13 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 13-week ocular toxicity study in the cynomolgus monkey_MRL TT #11-7800 - 6ea357e6-5399-4652-b1f1-88c4182ff7f4/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
| FDA_Toxicity_a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z | NOEL | <=15 | ug/eye/time | monkey (Macaca fascicularis; male/female) | other: | 52 weeks | repeated dose toxicity other | a881b3e3-f356-4118-b7ee-630b793fd47c_dossier.i6z - RepeatedDoseToxicityOther - 52-week ocular toxicity study in the cynomolgus monkey_M RLTT# 01-5531 - fcae1d73-b9a8-475a-be11-b7ff4d16139a/4c39441b-5a42-41cf-a60f-8d2184906fd0 - basis: other:: no abnormal phenotype detected |
ToxValDB_ECHA_IUCLID 12 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB_ECHA_IUCLID | LEL | =0.03 | mg/kg bw/day | Rat | injection | chronic; 24 months | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c841e4b0a7c65d2178b1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=body weight and weight gain|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818045_15818047_15818049_15818051: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_04859eb227de174747729f742cc9eb60 |
| ToxValDB_ECHA_IUCLID | LEL | >=0.003 | mg/kg bw/day | Rat | injection | chronic; 24 months | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c841e4b0a7c65d2178b1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=food consumption and compound intake|histopathology: non-neoplastic; TOXICOLOGICAL_EFFECT_CATEGORY=food and/or water consumption|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818046_15818048_15818050: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_8d60c9782624bbf96378e10c5fefcdf0 |
| ToxValDB_ECHA_IUCLID | LEL | >=0.009 | mg/kg bw/day | Rat | injection | chronic; 24 months | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c841e4b0a7c65d2178b1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=organ weight and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=organ weight; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818046_15818048_15818050: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_4cacc1de1e1f62717e13ea0417f9b94e |
| ToxValDB_ECHA_IUCLID | LEL | >=0.01 | mg/kg bw/day | Rat | injection | chronic; 26 weeks | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c62027e4b096bca8780422; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=bone marrow shows myelofibrosis|decreased erythrocyte cell number|decreased hemoglobin concentration|fibrosis|hyperostosis; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852018_15852019_15852020_15852023: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_d72c62945de27c0d9715bbed16d0b7c3 |
| ToxValDB_ECHA_IUCLID | LEL | >=0.45 | ug/eye/time | Monkey | oral | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca878103f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=abnormal intraocular pressure; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852663_15852664_15852665_15852666: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_3206c247eec715d1ecb4ee226ae8eb8b |
| ToxValDB_ECHA_IUCLID | LEL | >=0.001 | mg/kg bw/day | Dog | injection | chronic; 39 weeks | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620f6e4b096bca8783645; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=abnormal feces composition|vomiting; TOXICOLOGICAL_EFFECT_CATEGORY=clinical signs; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854754_15854757_15854758_15854761: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_5df3321563e87b78aca6fc43c59e0513 |
| ToxValDB_ECHA_IUCLID | LEL | >=0.15 | ug/eye/time | Monkey | oral | chronic; 52 weeks | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620f6e4b096bca8783695; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=abnormal intraocular pressure|eye inflammation; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854817_15854818_15854819: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_601124c89626ff3a261e912161c79d96 |
| ToxValDB_ECHA_IUCLID | NOEL | <=0.1 | mg/kg bw/day | Mouse | injection | chronic; 78 weeks | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c836e4b0a7c65d2174d1; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical signs|food consumption and compound intake|gross pathology|haematology|histopathology: neoplastic|histopathology: non-neoplastic|mortality; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|cancer|clinical signs|food and/or water consumption|gross pathology|hematology|mortality/survival|nonneoplastic histopathology; STUDY_GROUP=ECHA IUCLID:15818078: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_470576e974d5b6d03b8102b47160fb5a |
| ToxValDB_ECHA_IUCLID | NOEL | <=0.03 | mg/kg bw/day | Rat | injection | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/66a7c819e4b0a7c65d216992; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=body weight and weight gain|clinical biochemistry|clinical signs|food consumption and compound intake|gross pathology|haematology|organ weights and organ / body weight ratios; TOXICOLOGICAL_EFFECT_CATEGORY=body weight|clinical chemistry|clinical signs|food and/or water consumption|gross pathology|hematology|organ weight; STUDY_GROUP=ECHA IUCLID_dup_Carcinogenicity_15818535_15818537: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_715f90b3176a1c6d0d7c5bf990b105d5 |
| ToxValDB_ECHA_IUCLID | NOEL | <=1.35 | ug/eye/time | Monkey | oral | subchronic; 13 weeks | subchronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c6205ae4b096bca878103f; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=no abnormal phenotype detected; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15852663_15852664_15852665_15852666: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_33ec92c52ab1cafbbc9be10f485c60f2 |
| ToxValDB_ECHA_IUCLID | NOEL | <=0.01 | mg/kg bw/day | Dog | injection | chronic; 39 weeks | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620f6e4b096bca8783645; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=no abnormal phenotype detected; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854754_15854757_15854758_15854761: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_0881966f6946f14d3bf8d5b05faf966e |
| ToxValDB_ECHA_IUCLID | NOEL | <=15 | ug/eye/time | Monkey | oral | chronic; 52 weeks | chronic | STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/67c620f6e4b096bca8783695; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://iuclid6.echa.europa.eu/us-fda-toxicity-data?documentUUID=4c39441b-5a42-41cf-a60f-8d2184906fd0; TOXICOLOGICAL_EFFECT=no abnormal phenotype detected; STUDY_GROUP=ECHA IUCLID_dup_Repeated Dose Toxicity Other_15854817_15854818_15854819: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_558018b3203a231f5b1b3a2f961863aa |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | 1O6WQ6T7G3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C25H34F2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1O6WQ6T7G3"} |
| openFDA substances | FDA UNII substance identifier | 1O6WQ6T7G3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C25H34F2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1O6WQ6T7G3"} |
| openFDA substances | FDA UNII substance identifier | 1O6WQ6T7G3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C25H34F2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1O6WQ6T7G3"} |
| openFDA substances | FDA UNII substance identifier | 1O6WQ6T7G3 | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C25H34F2O5","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"1O6WQ6T7G3"} |