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Diss Factsheets
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EC number: 222-695-1 | CAS number: 3576-88-3
- 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
Carcinogenicity
Administrative data
Description of key information
Melam is not considered to be carcinogen based on the negative results of mutagenicity studies, the practically non-toxicity in repeated dose toxicity studies and the low exposure.
Key value for chemical safety assessment
Justification for classification or non-classification
Melam is not considered to be carcinogen based on the negative results of mutagenicity studies, the practically non-toxicity in repeated dose toxicity studies and the low exposure.
Additional information
According to REACH, Annex X, "A carcinogenicity study may be proposed by the registrant or may be required by the Agency in accordance with Articles 40 or 41 if:
the substance has a widespread dispersive use or there is evidence of frequent or long-term human exposure, and
the substance is classified as mutagen category 3 or there is evidence from the repeated dose study(ies) that the substance is able to induce hyperplasia and/or preneoplastic lesions.
If the substances is classified as mutagen category 1 or 2, the default presumption would be that a genotoxic mechanism for carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be required."
Melam is not genotoxic in two Ames-tests, in two in vitro chromosome aberration assays and in an in vivo micronucleus test. Melam is therefore not classified as mutagen. No toxicity at all and especially also no systemic toxicity was detected in the repeated dose oral toxicity studies even at the high dose of 1000 mg/kg bw.
The exposure of humans is low: Melam has not a wide dispersive use. Melam is exclusively introduced into plastic material during compounding. It is included by this process into a matrix and is no longer available for inhalation or dermal exposure. Melam is used for electronic components in Personal Computers, Televisions, Laptops etc.
Workers: The exposure of workers will be low, as the conditions during manufacturing will prevent an exposure to dust. The exposure is low, even if one takes worst case conditions: For Melam, as for every solid, there exists a general exposure level to prevent irritation of the respiratory tract, that is 10 mg/m3 for inhalable dust and 3 mg/m3 for respirable particles. Respirable particles that are retained in the respiratory tract, will be dissolved in the aqueous mucous layer and mainly be swallowed. It is assumed that a worker inhales 10 m3 of air during a working day and that the average bodyweight of the worker is 70 kg. At an average concentration of 10 mg melam per m3 the worker inhales 100 mg/day or 1.43 mg/kg bw/day.
Consumers: There is no direct contact by hands touching the components. So the only exposure might be inhalation of vapour, escaping from the electronic components. The vapour pressure of melam is very low and only insignificant exposures are expected from this source.
Conclusion: According to the conditions laid down in REACH, Annex X, there is no requirement to propose a carcinogenicity study.
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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