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Diss Factsheets
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EC number: 249-044-4 | CAS number: 28472-97-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Exposure related observations in humans: other data
Administrative data
- Endpoint:
- 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
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available
Data source
Reference
- Reference Type:
- publication
- Title:
- Efficacy and safety of topical azelaic acid (20 percent cream): an overview of results from European clinical trials and experimental reports.
- Author:
- Graupe, K. et al.
- Year:
- 1 996
- 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
- Reference substance name:
- Azelaic acid
- EC Number:
- 204-669-1
- EC Name:
- Azelaic acid
- Cas Number:
- 123-99-9
- Molecular formula:
- C9H16O4
- IUPAC Name:
- azelaic acid
Constituent 1
Results and discussion
- Results:
- 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
- Conclusions:
- Azelaic acid (20%) was found to have excellent local (dermal) tolerability.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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