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Diss Factsheets
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EC number: 210-478-4 | CAS number: 616-38-6
- 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
Endpoint summary
Administrative data
Description of key information
90-day oral toxicity study in rats, No Effect Level = 500 mg/kg/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
Additional information
A repeated dose toxicity study was conducted by Istituto Di Recherche Biomediche "Antoine Marxer" RBM S.p.a., Italy, on behalf of Enichem Synthesis S.p.a., Italy, to assess the repeated dose toxicity by the oral route of administration of the test substance DMC. The study was conducted according to OECD test guideline 408, and in compliance with GLP.
The test material was administered by oral gavage to groups of rats (15 males and 15 females per group) for 13 weeks; at the end of the dosing period, 10 rats/sex/dose level were sacrificed for pathology examination, while 5 rats/sex/dose level were retained without treatment for a 4 -week recovery period. Dose groups were 0 (vehicle control), 1, 5, 50, and 500 mg/kg/day.
No deaths related to the test substance were seen, nor were any clinical signs during the dosing or recovery periods, and no compound-related changes were seen in post-mortem examinations.
In conclusion, on the basis of the overall results obtained in this study, oral administration of the test article DMC daily for 13 consecutive weeks to rats was well tolerated up to and including the highest dosage of 500 mg/kg/day and therefore this dose level is considered the NEL both in male and female rats.
Justification for classification or non-classification
According to Directive 67/548/EEC, classification as "R48 Danger of serious damage to health by prolonged exposure" applies when an effect is seen in rats by oral administration at up to 50 mg/kg bodyweight/day during a 90 -day study. In the test, no effects were seen up to 500 mg/kg/day, and so classification is not required on the basis of this result.
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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