Is Isotretinoin Regulatory safe in cosmetics?
Isotretinoin Regulatory has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted.
Good
Active Ingredient
Isotretinoin Regulatory
Also known as: (13Z)-Retinoic acid, 13-cis-Vitamin A acid, 13-cis-beta-Retinoic acid, 13-cis-retinoic acid, Retinoic acid, 13-cis- (+13 more)
INCI: ISOTRETINOIN
Isotretinoin Regulatory (CAS 4759-48-2) is a cosmetic active ingredient functioning as Insufficient data. EU Regulation 1223/2009 status: permitted, max 45%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
View industrial chemical safety profile for CAS 4759-48-2 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Isotretinoin Regulatory is classified GHS Danger (H315, H319, H335, H360, H400, H410) in the chemicals database but is allowed in EU cosmetics at max 45%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Insufficient data
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohexen-1-yl)nona-2,4,6,8-tetraenoic acid
InChIKey
SHGAZHPCJJPHSC-XFYACQKRSA-N
Regulatory Status
EU EU Status
permitted
EU Max Conc.
45%
US US Status
permitted
US Notes
No specific restrictions
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Isotretinoin Regulatory.
Calculate MoS for your specific formulation with the MoS Calculator.
EPA ToxValDB — Toxicity Values
3 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | =3389 mg/kg | Mouse | oral | - | ChemIDplus |
| LD50 | =1960 mg/kg | Rabbit | oral | - | ChemIDplus |
| LD50 | >4000 mg/kg | Rat | oral | - | ChemIDplus |
Expanded Jurisdictional Detail
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
Additional Jurisdictional Restrictions (1)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| GCC | banned | - | All cosmetics |
Additional Ingredient Properties
1 property record from structured ingredient metadata.
pregnancy_detail
{"pregnancy_safe": "no", "breastfeeding_safe": "no", "trimester_restriction": "all", "risk_category": "FDA-X", "reason": "Known teratogen; severe birth defects", "alternative_ingredient": "Azelaic Acid", "source": "FDA; ACOG"}
Function Categories & List Membership
Regulatory List Membership (1)
California Proposition 65 (OEHHA)
Expert Verdict
Expert safety assessment and concern-level summary for Isotretinoin Regulatory.
Regulatory Flags
prop65
Known Synonyms
(13Z)-Retinoic acid
13-cis-Vitamin A acid
13-cis-beta-Retinoic acid
13-cis-retinoic acid
Retinoic acid, 13-cis-
Roaccutane
Accutane
4-09-00-02388
BRN 1885770
EINECS 225-296-0
Isotretinoinum
Isotane
UNII-EH28UP18IF
Isosuprea Lidose
(13-cis)-Retinoate
(13-cis)-Retinoic acid
(2Z,4E,6E,8E)-3,7-dimethyl-9-(2,6,6-trimethylcyclohex-1-en-1-yl)nona-2,4,6,8-tetraenoic acid
(7E,9E,11E,13Z)-retinoic acid
Regulatory Lists
pharmaceutical
OEHHA Proposition 65 (3/2019)
Canada; pharmaceutical
OEHHA Proposition 65 (1/2023)
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
ISOTRETINOIN
ChEMBL ID
CHEMBL547
Max Phase
4
Adverse Event Associations
1412
Frequently Asked Questions
Is Isotretinoin Regulatory allowed in the EU?
Isotretinoin Regulatory EU regulatory status: permitted. Maximum allowed concentration: 45%. This is based on EU Regulation 1223/2009 and its amendments.
What does Isotretinoin Regulatory do in cosmetics?
Isotretinoin Regulatory functions as: Insufficient data. It is classified as a Active Ingredient in our database. CAS number: 4759-48-2.
Is Isotretinoin Regulatory used outside cosmetics?
Isotretinoin Regulatory also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Isotretinoin Regulatory have different safety status in cosmetics vs industrial chemicals?
Isotretinoin Regulatory is classified GHS Danger (H315, H319, H335, H360, H400, H410) in the chemicals database but is allowed in EU cosmetics at max 45%.
Compliance Tools
Check Isotretinoin Regulatory compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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