Registration Dossier
Registration Dossier
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EC number: 214-230-6 | CAS number: 1115-70-4
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation, other
- Remarks:
- Human Application/Efficacy Test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- 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
- 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
- Remarks:
- This clinical trial in humans was published in a peer-reviewed Journal. Clinical trials in humans are generally not performed under GLP regulation.
- Type of study:
- other: Human Application/Efficacy Test
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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source: Systopic laboratories pvt. ltd
- Lot/batch number of test material: not provided
- Expiration date of the lot/batch: not provided
In vivo test system
Test animals
- Species:
- other: Human
- Sex:
- male/female
- Details on test animals and environmental conditions:
- 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.
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.
Results and discussion
In vivo (non-LLNA)
Results
- Key result
- Reading:
- other: Every 2 weeks for 8 weeks
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No adverse effects
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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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