Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-615-4 | CAS number: 108-78-1
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Version / remarks:
- 1992
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- 1984
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese, 1985
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
- Reference substance name:
- Melamine
- EC Number:
- 203-615-4
- EC Name:
- Melamine
- Cas Number:
- 108-78-1
- Molecular formula:
- C3H6N6
- IUPAC Name:
- 1,3,5-triazine-2,4,6-triamine
- Details on test material:
- - Name of test material (as cited in study report): melamine- Physical state: white powder- Analytical purity: >99.8 %- Lot/batch No.: 94-A-834- Expiration date of the lot/batch: 1 January 1996- Stability under test conditions: stable. Stable for at least 24 h in water.- Storage condition of test material: room temperature, dry and in the dark.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Broekman Institute, Someren
- Age at study initiation: ca. 7-9 weeks
- Weight at start of treatment: 1224 - 1924 g
- Housing: Individually in label led cages with perforated floors (Scanbur Denmark) and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands) approx. 100 g per day. Certificates of analysis were examined and retained in the NOTOX archives.
- Hay (BMI, Helmond, The Netherlands) was provided once a week.
- Water (e.g. ad libitum): Free access to tap-water diluted with decalcified water.
Certificates of analysis were examined and retained in the NOTOX archives.
- Acclimation period: Acclimatisation period was at least 5 days before start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
Air-conditioned room with approximately 15 air changes per hour and the environment controlled with optimal conditions considered as being a temperature of 21°C and a relative humidity of 50 %. Fluctuations from these optimal conditions were noted, but were considered not to have affected study integrity. Lighting was 12 hours artificial fluorescent light and 12 hours dark per day.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 g
VEHICLE
- The powdery test substance was moistened with distilled water, immediately before application, to ensure close contact to the animal's skin. - Duration of treatment / exposure:
- 4 h
- Observation period:
- ca. 1, 24, 48 and 72 h after removal of the dressings and test substance.
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: 2 x 3 cm
- Type of wrap if used: Scotchpak-non-woven patch Micropore tape holding the test substance, which was wrapped around the abdomen and secured with Coban elastic bandage.
REMOVAL OF TEST SUBSTANCE
- With moistened tissue
- Time after start of exposure: 4 h
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: no irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Irritation parameter:
- erythema score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- edema score
- Basis:
- animal: 1 to 6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- IRRITATION
No skin irritation was caused by MELAMINE after 4 hours of exposure in any of the six animals.
CORROSION
There was no evidence of a corrosive effect on the skin. - Other effects:
- COLOURATION
No staining of the treated skin by the test substance was observed.
TOXICITY SYMPTOMS / MORTALITY
No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: EU and EPA pesticide
- Conclusions:
- Dermal application of melamine resulted in no irritation when applied to the intact rabbit skin.
- Executive summary:
A skin irritation study with rabbits according to EU-, OECD- and EPA-methods was performed.
Exposure to melamine resulted in no skin irritation in the treated skin-areas of the 6 rabbits. No signs of systemic intoxication were observed during the study period. Dermal application of melamine resulted in a primary irritation index of 0 (non irritating), when applied to the intact rabbit skin.
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.