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Diss Factsheets
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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Remarks:
- Individual scores are not provided
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1979
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: J. Officiel de la Republique Francaise (1971). Methodes officielles d’analyse des cosmetiques et produits de beaute. Annexe II: Methode officielle pour la determination de i’irritation oculaire. Arrete du 16 Avril 1973. Journal Officiel 21 April. p. 3953.
- Version / remarks:
- 1973
- Qualifier:
- according to guideline
- Guideline:
- other: Association Francaise de Normalisation (1982). Evaluation de lrritation et/au de la Corrosion Cutanie chez le Lapin. NF T03-263
- Version / remarks:
- 1982
- Principles of method if other than guideline:
- The study compared the results of three different in vivo test methods for the investigation of skin irritation in rabbits: (i) the OECD method (used for this endpoint study record), (ii) a method published by French authorities for the testing of cosmetics and toiletries and (iii) a method proposed by AFNOR (Association Francaise de Normalisation).
- 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
- Specific details on test material used for the study:
- Beige Powder
Purity: no data
Storage: no data
Expiration: no data
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Roucher SA, Couhé.
- Age at study initiation: no data
- Weight at study initiation: 2.5 kg.
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: no data
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 g of moistended test material
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours and after 7 days and 14 days
- Number of animals:
- 6 animals for each protocol (OECD, Cosmetics, AFNOR)
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm x cm
- % coverage: 100
- Type of wrap if used: gauze pad (semiocclusive) or occlusive dressing
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: 4 h
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) 1, 24, 48, and 72 hours and after 7 days and 14 days
SCORING SYSTEM:
- Method of calculation:cf. Draize, Woodard & Calvery (1948)
Criteria used for interpretation based on Primary Dermal Irritation Index (PDII) according to AFNOR scale:
PDII below 0.5.................non irritant
0.5-3................................slightly irritant
3-5...................................moderately irritant
5-8...................................severely irritant
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.13
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Remarks:
- Individual scores for each animal are not provided
- Irritant / corrosive response data:
- Non irritant based on OECD protocol
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material is not irritant to the skin of rabbits in this semi-occlusive istudy when tested according to the OECD protocol.
- Executive summary:
In a non-GLP primary dermal irritation study (Guillot and al, 1982) performed similarly to the OECD No. 404, six male New Zealand White rabbits were dermally exposed to 0.5 g of undiluted Metformin HCl to the dorsal surface of the trunk (skin was clipped before application) for 4 hours under an semiocclusive conditions. Skin reactions were assessed 1, 24, 48 and 72 hours after patch removal using the Draize scale. The irritancy of the test item was then defined on the basis of the the primary cutaneous index (PCI, comparable to the Primary Dermal Irritation Index PDII) using the scale appropriate for AFNOR.
The PCI/PDII is 0.13 (OECD protocol, maximum possible score = 8), the test substance was therefore considered as non-irritant to the skin.
Under the conditions of this test, no classification for skin irritation is required according to the criteria of the CLP Regulation (EC) N°1272/2008 and the Directive 67/548/EEC.
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