What is the NOAEL for 13-cis Retinoic acid?
13-cis Retinoic acid has 9 NOAEL studies in the database. The lowest reported value is developmental listing type. Source: California Proposition 65.
NOAEL Data
Prop 65
Cosmetic Ingredient
13-cis Retinoic acid
Also known as: Isotretinoin, (13Z)-Retinoic acid, 13-cis-Vitamin A acid, 13-cis-beta-Retinoic acid, 13-cis-retinoic acid (+14 more)
CAS 4759-48-2
13-cis Retinoic acid (CAS 4759-48-2) is a chemical substance; key hazard signal: developmental. Key regulatory status: California Proposition 65, 4 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, CA Prop 65.
Cross-Vertical Regulatory Divergence
13-cis Retinoic acid is classified GHS Danger (H315, H319, H335, H360, H400, H410) in the chemicals database but is allowed in EU cosmetics at max 45%.
SOURCE
Cross-vertical comparison
Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
SOURCE
noael studies public
NOAEL studies
9
SOURCE
chemical inventory jurisdictions
Regulatory lists
4
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
25 fields
Name
13-cis Retinoic acid
CAS Number
4759-48-2
DTXSID
DTXSID4023177
Molecular Formula
C20H28O2
InChI Key
SHGAZHPCJJPHSC-XFYACQKRSA-N
Monoisotopic Mass
300.20893
Synonyms
Isotretinoin(13Z)-Retinoic acid13-cis-Vitamin A acid13-cis-beta-Retinoic acid13-cis-retinoic acidRetinoic acid, 13-cis-RoaccutaneAccutane4-09-00-02388BRN 1885770EINECS 225-296-0Isotretinoinum
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 | - |
Regulatory Lists
Inventory, screening, and regulatory list matches from public chemical databases.
SOURCE
EPA CPDat
4 records
| List | Keyword | Source |
|---|---|---|
| pharmaceutical | US International Trade Commission | CPCat |
| 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 9 of 9 studies
| Value | Unit | Endpoint | Route | Species | Source |
|---|---|---|---|---|---|
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| SQEdevelopmental | listing type | California Proposition 65 listing | - | - | California Proposition 65 |
| EH28UP18IF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| EH28UP18IF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| EH28UP18IF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| EH28UP18IF | UNII | FDA UNII substance identifier | - | - | openFDA substances |
| >4000 | mg/kg bw | LD50 | oral | Rat | NTP_ICE_acute_oral |
Showing 9 of 9 studies
Cosmetic Safety Profile
Same-CAS cosmetic ingredient record for cross-vertical context.
SOURCE
CosIng / Ingredients DB
EU Status
permitted
Max
45%
Category
active
Pharmaceutical Data
Same-CAS pharmaceutical records from drug and bioactivity sources.
SOURCE
EMBL-EBI ChEMBL
ISOTRETINOIN
ChEMBL Phase
4
Adverse Events
1412
Bioactivity
19
Frequently Asked Questions
What regulatory lists include 13-cis Retinoic acid?
13-cis Retinoic acid appears on 4 regulatory/inventory lists including pharmaceutical, OEHHA Proposition 65 (3/2019), Canada; pharmaceutical, and 1 more. Source: EPA CPDat.
Is 13-cis Retinoic acid on the California Proposition 65 list?
Yes, 13-cis Retinoic acid is listed under California Proposition 65 for developmental. Source: California OEHHA Proposition 65.
Is 13-cis Retinoic acid used in cosmetics?
Yes, 13-cis Retinoic acid is also indexed as a cosmetic ingredient under the name Isotretinoin Regulatory. 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 13-cis Retinoic acid come from?
Safety data is sourced from EPA ToxValDB, EPA CPDat, EPA DSSTox, California Proposition 65, CosIng / Ingredients DB, ChEMBL / DailyMed. All data traces to primary regulatory sources and is updated from official government databases.
Does 13-cis Retinoic acid have different safety status in cosmetics vs industrial chemicals?
13-cis Retinoic acid is classified GHS Danger (H315, H319, H335, H360, H400, H410) in the chemicals database but is allowed in EU cosmetics at max 45%.
Is 13-cis Retinoic acid used outside industrial chemicals?
13-cis Retinoic acid also appears in cosmetics, pharmaceutical databases.