NOAEL Studies
Active Ingredient
Thiamine HCl NOAEL Studies
INCI: THIAMINE HCL
CAS: 67-03-8
Raw No Observed Adverse Effect Level endpoint records grouped by source. This page does not render calculated Margin of Safety values.
COSMOS DB 3 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| COSMOS DB | NOAEL | 7.5 | mg/kg bw/day | rat | oral | 125 day | Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 50 | mg/kg bw/day | rat | oral | 28 day | Short Term Toxicity | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
| COSMOS DB | NOAEL | 300 | mg/kg bw/day | rat | oral | NA | Multigeneration Reproductive | US FDA CFSAN PAFA; US FDA CFSAN PAFA Study |
EFSA 2 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| EFSA | NOAEL | =36 | mg/kg bw/day | Rat | oral: feed | 90 days | subchronic | EFSA AFC - 2008 - OutputID 2289 - Flavouring Group Evaluation 76, (FGE.76): Consideration of sulphur-containing heterocyclic compounds evaluated by JECFA (59th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29, miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21. Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food - doi:10.2903/j.efsa.2008.875 |
| EFSA | NOAEL | =36 | mg/kg bw/day | Rat | oral | subchronic; 90 days | subchronic | LONG_REF=EFSA AFC (2008). Flavouring Group Evaluation 76, (FGE.76): Consideration of sulphur-containing heterocyclic compounds evaluated by JECFA (59th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29, miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21. Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food. doi:10.2903/j.efsa.2008.875.; TITLE=Flavouring Group Evaluation 76, (FGE.76): Consideration of sulphur-containing heterocyclic compounds evaluated by JECFA (59th meeting) structurally related to thiazoles, thiophene, thiazoline and thienyl derivatives from chemical group 29, miscellaneous substances from chemical group 30 evaluated by EFSA in FGE.21. Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food; AUTHOR=EFSA AFC; DOI=doi:10.2903/j.efsa.2008.875; STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/65201d30e4b0f0a60ddd1165; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://zenodo.org/record/5076033#.Y9fEoXbMI2z; YEAR=2008; ORIGINAL_YEAR=2008; STUDY_GROUP=EFSA_dup_-_15614140_15614141:-:--; 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_a810aa18ed90389994fd1716585145c8 |
WHO/JECFA 20 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| WHO/JECFA | NOEL | =0.29 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=4564d414ea1e0df1; raw_unit=mg/kg bw per day; context=The NOEL was 0.29 mg/kg bw per day (Morgareidge & Oser, 1970). (viii) 2,4-Dimethyl-5-acetylthiazole (No. |
| WHO/JECFA | NOEL | =0.29 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=4564d414ea1e0df1; raw_unit=mg/kg bw per day; context=The NOEL was 0.29 mg/kg bw per day (Morgareidge & Oser, 1970). (viii) 2,4-Dimethyl-5-acetylthiazole (No. |
| WHO/JECFA | NOEL | =0.92 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=8ebc062ef988a28a; raw_unit=mg/kg bw per day; context=0.07 N/R B5 Yes The NOEL of 0.92 mg/kg bw per day for the related flavouring agent No. |
| WHO/JECFA | NOEL | =0.92 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=8ebc062ef988a28a; raw_unit=mg/kg bw per day; context=0.07 N/R B5 Yes The NOEL of 0.92 mg/kg bw per day for the related flavouring agent No. |
| WHO/JECFA | NOEL | =1.2 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=5e5096156ca2f3c0; raw_unit=mg/kg bw per day; context=4 N/R B5 Yes The NOEL of 1.2 mg/kg bw per day for the related flavouring agent No. |
| WHO/JECFA | NOEL | =1.2 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=5e5096156ca2f3c0; raw_unit=mg/kg bw per day; context=4 N/R B5 Yes The NOEL of 1.2 mg/kg bw per day for the related flavouring agent No. |
| WHO/JECFA | NOEL | =5.1 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=897daa0b9cdce116; raw_unit=mg/kg bw per day; context=0.2 N/R B5 Yes The NOEL of 5.1 mg/kg bw per day is > 20 000 times the estimated intake of benzothiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =5.1 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=897daa0b9cdce116; raw_unit=mg/kg bw per day; context=0.2 N/R B5 Yes The NOEL of 5.1 mg/kg bw per day is > 20 000 times the estimated intake of benzothiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =8.6 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=bb32d202bae29ded; raw_unit=mg/kg bw per day; context=0.01 N/R B5 Yes The NOEL of 8.6 mg/kg bw per day is > 40 million times the estimated intake of 2-methyl-5-methoxythiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =8.6 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=bb32d202bae29ded; raw_unit=mg/kg bw per day; context=0.01 N/R B5 Yes The NOEL of 8.6 mg/kg bw per day is > 40 million times the estimated intake of 2-methyl-5-methoxythiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =11 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=937c58417a9de48b; raw_unit=mg/kg bw per day; context=0.05 N/R B5 Yes The NOEL of 11 mg/kg bw per day is > 5 million times the estimated intake of a mixture of 2-isobutyl-4,6-dimethyl- and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine when used as a flavouring agent. |
| WHO/JECFA | NOEL | =11 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=937c58417a9de48b; raw_unit=mg/kg bw per day; context=0.05 N/R B5 Yes The NOEL of 11 mg/kg bw per day is > 5 million times the estimated intake of a mixture of 2-isobutyl-4,6-dimethyl- and 4-isobutyl-2,6-dimethyldihydro-1,3,5-dithiazine when used as a flavouring agent. |
| WHO/JECFA | NOEL | =24 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=002ae2b21e882083; raw_unit=mg/kg bw per day; context=2 N/R B5 Yes The NOEL of 24 mg/kg bw per day is > 10 million times the estimated intake of 2,4-dimethyl-5-acetylthiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =24 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=002ae2b21e882083; raw_unit=mg/kg bw per day; context=2 N/R B5 Yes The NOEL of 24 mg/kg bw per day is > 10 million times the estimated intake of 2,4-dimethyl-5-acetylthiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =36 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=ec1ec19e0517b8ca; raw_unit=mg/kg bw per day; context=The NOEL of 36 mg/kg bw per day is > 500 times the estimated intake of thiamine hydrochloride when used as a flavouring agent. |
| WHO/JECFA | NOEL | =36 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=ec1ec19e0517b8ca; raw_unit=mg/kg bw per day; context=The NOEL of 36 mg/kg bw per day is > 500 times the estimated intake of thiamine hydrochloride when used as a flavouring agent. |
| WHO/JECFA | NOEL | =50 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=37be0563e6b5ed3d; raw_unit=mg/kg bw per day; context=10 N/R B5 Yes The NOEL of 50 mg/kg bw per day is > 200 000 times the estimated intake of 2-acetylthiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =50 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=37be0563e6b5ed3d; raw_unit=mg/kg bw per day; context=10 N/R B5 Yes The NOEL of 50 mg/kg bw per day is > 200 000 times the estimated intake of 2-acetylthiazole when used as a flavouring agent. |
| WHO/JECFA | NOEL | =290 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=869959bf658973b6; raw_unit=mg/kg bw per day; context=0.01 N/R B5 Yes The NOEL of 290 mg/kg bw per day for the related flavouring agent No. |
| WHO/JECFA | NOEL | =290 | mg/kg bw/day | - | - | - | Toxicology study | document_id=jecfa_jecmono_v50je12; title=Sulfur-Containing Heterocyclic Compounds (JECFA Food Additives Series 50); path=mirror/documents/jecfa/jecmono/v50je12.htm; row_hash=869959bf658973b6; raw_unit=mg/kg bw per day; context=0.01 N/R B5 Yes The NOEL of 290 mg/kg bw per day for the related flavouring agent No. |
NTP ICE acute oral 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| NTP ICE acute oral | LD50 | =3710 | mg/kg bw | Rat | oral | acute | Rat Acute Oral Toxicity | NLM ChemIDplus TEST (undated); record_id=acute_oral_9210; row=1351; data_type=In Vivo; mixture=Chemical; chemical_name=Thiamine hydrochloride; preferred_name=Thiamine hydrochloride; dtxsid=DTXSID0040622; url=https://chem.nlm.nih.gov/chemidplus/; url_comptox=https://comptox.epa.gov/dashboard/chemical/details/DTXSID0040622; source_file=acute_oral.xlsx |
ECHA 5 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ECHA | LEL | =7870 | mg/kg bw/day | Rat | oral | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/26096/7/3/2?documentUUID=75987c2e-d2af-4ce5-b537-f7b6b2bb8190; YEAR=1948; ORIGINAL_YEAR=1948; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15808795_15808796: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_0a286be5cf3758a90594104ce5ed53e1 |
| ECHA | LEL | =9136 | mg/kg bw/day | Mouse | oral | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/26096/7/3/2?documentUUID=75987c2e-d2af-4ce5-b537-f7b6b2bb8190; YEAR=1948; ORIGINAL_YEAR=1948; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15800389_15800390: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_38d1c34192265e2da233a3236c7a15c1 |
| ECHA | LEL | =19400 | mg/kg bw/day | Rat | oral | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/26096/7/3/2?documentUUID=75987c2e-d2af-4ce5-b537-f7b6b2bb8190; YEAR=1948; ORIGINAL_YEAR=1948; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15808795_15808796: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_eb6e3d0e0458926c9987bcdeacddbce7 |
| ECHA | LEL | =19670 | mg/kg bw/day | Mouse | oral | - | acute | QUALITY=2 (reliable with restrictions); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/6605975fe4b063812d6fa6ed; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/26096/7/3/2?documentUUID=75987c2e-d2af-4ce5-b537-f7b6b2bb8190; YEAR=1948; ORIGINAL_YEAR=1948; STUDY_GROUP=ECHA IUCLID_dup_Acute Toxicity Oral_15800389_15800390: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_864d39d1b4ba543ccdc05027b6b13351 |
| ECHA | NOAEL | >=1000 | mg/kg bw/day | Rat | oral | - | reproduction developmental | GUIDELINE=other:; QUALITY=1 (reliable without restriction); STORED_SOURCE_RECORD=https://clowder.edap-cluster.com/files/669eac4ae4b0a7c65d1be5e6; RECORD_SOURCE_LEVEL=Extraction document; SOURCE_URL=https://echa.europa.eu/; SUBSOURCE_URL=https://echa.europa.eu/registration-dossier/-/registered-dossier/26096/7/9/3?documentUUID=75987c2e-d2af-4ce5-b537-f7b6b2bb8190; YEAR=1948; ORIGINAL_YEAR=1948; STUDY_GROUP=ECHA IUCLID:15825045: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_bd8510c11b9a5682ad4e9cc4cb35d0c1 |
ToxValDB GESTIS DNEL 1 endpoint
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| ToxValDB GESTIS DNEL | DNEL systemic | =11 | 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:15635225:-:--; 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_0b43dea3775ccd5f324db96d040e6957 |
openFDA substances 4 endpoints
| Source | Endpoint Type | Value | Unit | Species | Route | Duration | Study Type | Reference |
|---|---|---|---|---|---|---|---|---|
| openFDA substances | FDA UNII substance identifier | M572600E5P | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H17N4OS.Cl.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"M572600E5P"} |
| openFDA substances | FDA UNII substance identifier | M572600E5P | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H17N4OS.Cl.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"M572600E5P"} |
| openFDA substances | FDA UNII substance identifier | M572600E5P | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H17N4OS.Cl.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"M572600E5P"} |
| openFDA substances | FDA UNII substance identifier | M572600E5P | UNII | - | - | - | chemical | {"approval_status":null,"molecular_formula":"C12H17N4OS.Cl.ClH","source_table":"substance_identifiers_fda","substance_class":"chemical","unii_code":"M572600E5P"} |