Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Exposure related observations in humans: other data

Administrative data

exposure-related observations in humans: other data
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only abstract available

Data source

Reference Type:
Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports.
Graupe, K. et al.
Bibliographic source:
Cutis. 57(1 Suppl):20-35.

Materials and methods

Type of study / information:
Azelaic acid cream (20 percent) was assessed as a new topical treatment for acne.
Endpoint addressed:
skin irritation / corrosion

Test material

Constituent 1
Chemical structure
Reference substance name:
Azelaic acid
EC Number:
EC Name:
Azelaic acid
Cas Number:
Molecular formula:
azelaic acid

Results and discussion

Azelaic acid cream (20 percent) is a new topical treatment for acne with an additional therapeutic potential in rosacea and hyperpigmentation disorders. Azelaic acid (AzA; HOOC-(CH2)7-COOH) is a naturally occurring compound that interferes with acne pathogenesis by virtue of its antikeratinizing, antibacterial, and anti-inflammatory properties. Vehicle-controlled studies have verified that AzA exercises a significant and clinically relevant effect on both non-inflammatory and inflammatory acne lesions. Comparisons with clinically proven therapies have shown that 20 percent AzA cream is an effective monotherapy in mild to moderate forms of acne, with an overall efficacy comparable to that of tretinoin (0.05 percent), benzoyl peroxide (5 percent), and topical erythromycin (2 percent). In the treatment of moderate to severe acne, 20 percent AzA cream may be favorably combined with minocycline (90 percent good and excellent results), and may contribute towards reducing recurrences following discontinuation of systemic therapy (maintenance therapy with AzA cream). Particular advantages of AzA therapy include its favorable safety and side effect profile. It is non-teratogenic, is not associated with systemic adverse events or photodynamic reactions, exhibits excellent local tolerability, and does not induce resistance in Propionibacterium acnes.

Applicant's summary and conclusion

Azelaic acid (20%) was found to have excellent local (dermal) tolerability.