Registration Dossier
Registration Dossier
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EC number: 214-230-6 | CAS number: 1115-70-4
Endpoint summary
Administrative data
Description of key information
A QSAR calculation demonstrated the absence of potential for sensitisation. This is supported by experience from long term workplace exposure with no reported evidence for skin sensitisation in humans.
In addition data from a Human Application/Efficacy Test using a randomized controlled study protocol to investigate topically applied metformin in the treatment of melasma showed absence of adverse effects (erythema, edema) indicating absence of skin sensitisation potentials in humans.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- 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
- 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
- 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
- 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. - 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
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation, other
- Type of information:
- (Q)SAR
- Adequacy of study:
- supporting study
- Study period:
- 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA Guidance QSAR
- GLP compliance:
- no
- Run / experiment:
- other: 1
- Parameter:
- other:
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The QSAR analysis using a knowlegde based QSAR system shows no indication for skin sensitisation.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the provided information there is no need for classification according to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
