Registration Dossier
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EC number: 274-581-6 | CAS number: 70356-09-1
- 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

PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Persistence:
Stability: Study on hydrolysis waived due to the extremely poor water solubility of the test item of 0.027 mg/L.
Biodegradation: Both a study on anaerobic biodegradability and a study on (aerobic) inherent biodegradability revealed that the substance is not biodegradable.
In further biodegradation simulation tests, it was shown that the BMDBM is degrading in the water phase with a half-life of up to 12 days. Based on these results, the substance does not meet criteria for persistence in fresh water. Whereas, the half-life of BMDBM in the sediment phase can take up to more than 150 days. Based on these results, BMDBM meets the criteria for persistence in fresh water sediment.
The major observed degradation products in both simulation studies were 4-Methoxybenzoic acid (CAS 100-09-4) and 4-Tert-butyl benzoic acid (CAS 98-73-7). 4-Methoxybenzoic acid is readily biodegradable and not a PBT/vPvB substance.4-Tert-butyl benzoic acid is not readily biodegradable, but can be considered primarily inherently biodegradable, as biodegradation up to 46 % could be observed on an OECD 301F study. The substance has been assessed to fulfill the criteria for P and T, but not for B, therefore, it is not classified as a PBT/vPvB substance.
Bioaccumulation:
It can be concluded that the substance does not meet criteria for B / vB substance. The bioaccumulation study in fish was performed via dietary exposure route. The result obtained shows that the biomagnification factor is far below 1 and the half-life for elimination of BMDBM during depuration phase is 3.8 days. Following the ECHA Endpoint specific guidance R.7c, the BCF value of 1807 L/kg was calculated on the basis of the experimental data obtained in the bioaccumulation study. The BCF value is below the cut-off value of 2000 for B/vB. These results indicate that risk for bioaccumulation and biomagnification in fish is low.
Toxicity:
The substance has no CMR or STOT RE toxicity classification. Acute aquatic toxicity studies as well as a long-term aquatic study according to OECD 211 study conducted up to the level of maximum water solubility revealed no detrimental effects. Based on these results, the assignment is "not T".
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