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EC number: 214-230-6 | CAS number: 1115-70-4
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2019
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- - Principle of test: Human Application/Efficacy Test, Randomized controlled study to investigate topically applied metformin in the treatment of melasma.
- Short description of test conditions: 20 volunteers are treated daily with a 30% metformin lotion for 8 weeks (open application at the face)
- Parameters analysed / observed: Adverse effects (erythema, edema) - GLP compliance:
- no
Test material
- Reference substance name:
- Metformin hydrochloride
- EC Number:
- 214-230-6
- EC Name:
- Metformin hydrochloride
- Cas Number:
- 1115-70-4
- Molecular formula:
- C4H11N5.ClH
- IUPAC Name:
- N,N-dimethylimidodicarbonimidic diamide hydrochloride
- Test material form:
- solid: bulk
- Remarks:
- migrated information: powder
Constituent 1
Method
- Type of population:
- other: patients with Melasma (pigmentary disorder of the facial skin)
- Ethical approval:
- confirmed, but no further information available
- Subjects:
- - Number of subjects exposed:
- Sex: female (N = 16) male(N 0 4)
- Age: 23 - 84 years
Pregnant and lactating women; patients on oral contraceptives, phenytoin, with renal dysfunction, who were allergic to the medications under trial; and acne vulgaris and rosacea patients were excluded from the study. - Clinical history:
- Patients with melasma of more than 18 years of age, who were not on any medications for melasma since at least 2 weeks for topical therapy, 1 month for systemic steroids, 3 months for cosmetic procedures such as laser, dermabrasion, or peels, were included.
- Controls:
- Another group of 20 patients was treated with TCC (hydroquinone + steroid + tretinoin). No negative control.
- Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST USED: open application test (epicutaneous test)
ADMINISTRATION
- Type of application: open
- Vehicle / solvent: Ethanol/propylene glycol (70:30, w:w)
- Concentrations: 30%
- Volume applied: not provided (thin film)
- Testing/scoring schedule: not specified
- Removal of test substance: no
EXAMINATIONS
- Grading/Scoring system: adverse effects
- Statistical analysis: No
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No adverse effects observed
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 20
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 0
RESULT: Based on the results of this study, there is no indication of an allergic potential of Metformin
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, there is no indication of a sensitizing potential of Metformin.
- Executive summary:
Aims: The aim of this study was to evaluate the safety and efficacy of topical metformin in the treatment of melasma, a pegmentary disorder of the facial skin, and to compare its efficacy with TCC (hydroquinone 2% + tretinoin 0.025% + fluocinolone acetonide 0.01%).
Methods: This was a randomized controlled study conducted on 40 patients with melasma aged more than 18 years. Patients in group 1 (n = 20) were treated with 30% metformin lotion, whereas group 2 patients (n = 20) were treated with TCC for 8 weeks. Pigmentation was assessed using Melasma Area and Severity Index (MASI) at baseline and after 8 weeks. Outcome measures included global improvement scale (grades 1‐4) and patient satisfaction. Safety was assessed according to adverse events and patch testing.
Results: All 40 patients completed the study. Out of 20 patients in group 1, 11 showed grade 1 improvement (1% to <25%) and grade 2 (25%‐50%) and grade 3 (>50%‐75%) improvements were seen in one patient each. In group 2, grades 1, 2, 3, and 4 improvements were seen in 14, 2, 1, and 1 patients, respectively. However, the difference was not statistically significant.
Adverse events were noted in three patients in group 2 and none in group 1, i.e. no adverse effects were observed in the group of patients treated with a 30% Metformin formulation.
Conclusion: Topical metformin is a novel, safe, and almost as effective modality as TCC to treat melasma. Based on the results of this study, there is no indication of a sensitizing potential of Metformin.
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