What is the NOAEL for Topiramate?
Topiramate has 49 NOAEL studies in the database. The lowest reported value is developmental listing type. Source: California Proposition 65.
NOAEL Data
Prop 65
Cosmetic Ingredient
Topiramate
Also known as: 2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamate, BRN 5988957, RWJ-17021-000, Topiramato, Topiramatum (+11 more)
CAS 97240-79-4
Topiramate (CAS 97240-79-4) is a chemical substance; key hazard signal: developmental. Key regulatory status: California Proposition 65, 6 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, CA Prop 65.
Cross-Vertical Regulatory Divergence
Topiramate is classified GHS Danger (H351, H360, H371, H372, H315, H319, H335, H361) in the chemicals database but is allowed in EU cosmetics.
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code
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noael studies public
NOAEL studies
49
SOURCE
chemical inventory jurisdictions
Regulatory lists
6
SOURCE
eu clp annex vi
GHS signal
Not classified
Chemical Identity
CAS, identifiers, formula, and alternate names for the matched substance record.
SOURCE
DSSTox identifiers
22 fields
Name
Topiramate
CAS Number
97240-79-4
DTXSID
DTXSID8023688
Molecular Formula
C12H21NO8S
InChI Key
KJADKKWYZYXHBB-XBWDGYHZSA-N
Monoisotopic Mass
339.098788
Synonyms
2,3:4,5-Bis-O-(1-methylethylidene)-beta-D-fructopyranose sulfamateBRN 5988957RWJ-17021-000TopiramatoTopiramatumUNII-0H73WJJ391TopiragenTrokendi XR2,3:4,5-di-O-isopropylidene-beta-D-fructopyranose sulfamateMcN-4853RWJ-17021TPM
California Proposition 65
California OEHHA listing status and toxicity category.
SOURCE
California OEHHA Proposition 65 List
1 records
| Chemical | Toxicity Type | Cancer | Developmental | Listed |
|---|---|---|---|---|
| - | developmental | No | Yes | - |
Functional Uses
Industrial and product-use categories associated with this substance.
SOURCE
EPA CPDat
1 records
Softener and conditioner
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
6 records
| List | Keyword | Source |
|---|---|---|
| Canada; consumer_product; Substances in Products - Canada (4/2014) | Government of Canada | CPCat |
| pharmaceutical | US International Trade Commission | CPCat |
| pharmaceutical | FDA | United States Food and Drug Administration (FDA) |
| OEHHA Proposition 65 (3/2019) | STATE OF CALIFORNIA ENVIRONMENTAL PROTECTION AGENCY | OEHHA Proposition 65 List |
| Canada; pharmaceutical | DrugBank | DrugBank |
| OEHHA Proposition 65 (1/2023) | California Office of Environmental Health Hazard Assessment | OEHHA Proposition 65 List |
NOAEL Studies
Toxicology endpoints rendered from public NOAEL study rows.
SOURCE
NOAEL studies
Showing 49 of 49 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| FRdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| FRdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| FRdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| FRdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| 0H73WJJ391 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0H73WJJ391 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0H73WJJ391 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0H73WJJ391 | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| 0.72 | fraction | Fu | - | Human | NTP_ICE_adme_parameters |
| >=10 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| >=20 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB_ECHA_IUCLID |
| >=40 | mg/kg bw/day | LEL | oral | Dog | ToxValDB_ECHA_IUCLID |
| >=45 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| >=55 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| >=75 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB_ECHA_IUCLID |
| >=90 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =100 | mg/kg bw/day | LEL | oral | Dog | ToxValDB_ECHA_IUCLID |
| >=120 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| =150 | mg/kg bw/day | LEL | oral | Dog | ToxValDB_ECHA_IUCLID |
| =300 | mg/kg bw/day | LEL | oral | Mouse | ToxValDB_ECHA_IUCLID |
| =750 | mg/kg bw/day | LEL | oral | Rat | ToxValDB_ECHA_IUCLID |
| <=100 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=100 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=100 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=100 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=120 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=120 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=120 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=120 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=150 | mg/kg bw/day | NOEL | oral: capsule | dog (1173; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=150 | mg/kg bw/day | NOEL | oral: capsule | dog (1173; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=150 | mg/kg bw/day | NOEL | oral: capsule | dog (1173; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=150 | mg/kg bw/day | NOEL | oral: capsule | dog (1173; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=300 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=300 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=300 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=300 | mg/kg bw/day | NOEL | oral: feed | rat (Wistar; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=400 | mg/kg bw/day | NOEL | oral: gavage | rat (Crj: CD(SD); male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=400 | mg/kg bw/day | NOEL | oral: gavage | rat (Crj: CD(SD); male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=400 | mg/kg bw/day | NOEL | oral: gavage | rat (Crj: CD(SD); male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=400 | mg/kg bw/day | NOEL | oral: gavage | rat (Crj: CD(SD); male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=500 | mg/kg bw/day | NOEL | oral: gavage | mouse (CD-1; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=500 | mg/kg bw/day | NOEL | oral: gavage | mouse (CD-1; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=500 | mg/kg bw/day | NOEL | oral: gavage | mouse (CD-1; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=500 | mg/kg bw/day | NOEL | oral: gavage | mouse (CD-1; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=750 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=750 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=750 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
| <=750 | mg/kg bw/day | NOEL | oral: gavage | rat (Sprague-Dawley; male/female) | FDA_Toxicity_2b56829b-1a1d-4ed8-8c10-0d596258c60f_dossier.i6z |
Showing 49 of 49 studies
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
permitted
Max
-
Category
Skin Conditioning
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
TOPIRAMATE
ChEMBL Phase
4
Adverse Events
7885
Bioactivity
44
Cannabis Data
Same-CAS cannabis compliance and lab records where available.
SOURCE
Cannabis regulatory / lab data
efsa substances
1 cannabis record found in efsa substances.
View full cannabis profile →Frequently Asked Questions
What regulatory lists include Topiramate?
Topiramate appears on 5 regulatory/inventory lists including Canada; consumer_product; Substances in Products - Canada (4/2014), pharmaceutical, OEHHA Proposition 65 (3/2019), and 2 more. Source: EPA CPDat.
Is Topiramate on the California Proposition 65 list?
Yes, Topiramate is listed under California Proposition 65 for developmental. Source: California OEHHA Proposition 65.
Is Topiramate used in cosmetics?
Yes, Topiramate is also indexed as a cosmetic ingredient under the name Topiramate. View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.
Where does the safety data for Topiramate come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, California Proposition 65, CosIng / Ingredients DB, ChEMBL / DailyMed, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.
Does Topiramate have different safety status in cosmetics vs industrial chemicals?
Topiramate is classified GHS Danger (H351, H360, H371, H372, H315, H319, H335, H361) in the chemicals database but is allowed in EU cosmetics.
Is Topiramate used outside industrial chemicals?
Topiramate also appears in cosmetics, pharmaceutical, cannabis databases.