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Diss Factsheets
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EC number: 203-268-9 | CAS number: 105-08-8
- 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:
8.1. Assessment of PBT/vPvB Properties - Comparison with the Criteria of Annex XIII
The criteria set out under REACH for determining whether a substance is PBT/vPvB are as follows:
Criterion
PBT criteria
vPvB criteria
P
Half-life (T½) > 60 d in marine water or
Half-life (T½) > 40 d in fresh or estuarine water or
Half-life (T½) > 180 d in marine sediment or Half-life (T½) > 120 d in fresh or estuarine water; sediment or
Half-life (T½) in soil > 120 d
Half-life (T½) > 60 d in marine fresh or estuarine water or
Half-life (T½) > 180 d in marine, fresh or estuarine water; sediment
Half-life (T½) > 180 d in soil
B
BCF > 2000 L/kg in fresh or marine aquatic species
BCF > 5000 L/kg
T
Chronic NOEC < 0.01 mg/l for marine or freshwater organisms, or
Substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2 or 3) or
There is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.
Not applicable
Note: (a) BCF is bioconcentration factor, NOEC is no-observed effect concentration and CMR is a substance classified as carcinogenic, mutagenic or toxic for reproduction
(b) For marine environmental risk assessment, half-life data in freshwater sediment can be overruled by data obtained under marine conditions
(c) Substances are classified when they fulfill the criteria for all three inherent properties for P, B and T. However, there is certain flexibility, for instance in cases where one criterion is marginally not fulfilled but the others are exceeded considerably.
8.1.1. Persistence Assessment
In a study conducted according to OECD Guideline 301A, CHDM was readily biodegradable with 99.2% of it gone by day 3. A second study was conducted according to OECD Guideline 302B and also showed 98% degradation by study day 19. Therefore, CHDM would not be rated as persistent according to REACH Annex XIII regulation and would not be rated as a P or vP substance (half-life in fresh-water of greater than 60 days).
8.1.2. Bioaccumulation Assessment
A study measuring bioconcentration was not available for CHDM. Log Kow estimates of 0.36 to 1.47 suggest a low potential for bioaccumulation. In addition, the environmental program (EPIWIN v3.0) was run and estimated a log BCF of 0.65 (BCF = 4.45 L/kg wet-wt), and a log BAF of 0.505 (BAF of 3.2 L/kg wet-wt). Both of these values support a low potential to bioaccumulate and are well below the REACH Annex XIII criteria for B or vB.
8.1.3. Toxicity Assessment
All three trophic levels were represented in studies: primary producers represented by algae, plant eating animals represented by daphnids and freshwater snails and predators represented by fish and planarians. A chronic study in fish or daphnids was not available for CHDM. In fathead minnows (Pimphales promelas), the 96-hour LC50 was > 125.3 mg/L and in daphnia, the 96-hour LC50 was > 100 mg/L. The 72-hour algae EC50 was > 122.9 mg/L. CHDM is not classified as mutagenic (category 1 or 2) or toxic for reproduction (category 1, 2 or 3). A chronic toxicity/carcinogenicity study was not identified for CHDM, but a lack of evidence from histopathology in a 90-day study for any organ abnormalities and negative genotoxicity studies suggest that CHDM would not be considered a carcinogen.
There is no evidence to suggest that CHDM would be classified as T/R48 or XN/R48 for chronic toxicity.
CHDM was, however, corrosive to the eye and would be classified as H318. Effects were observed in the eye after direct administration but were cleared in all cases by study day 14.
8.1.4. Summary and overall Conclusions on PBT or vPvB Properties
Overall, CHDM does not meet the criteria for being rated as a PBT or vPvB substance. CHDM appears to be readily biodegradable and does not have the potential to bioaccumulate. Aquatic toxicity is minimal and it is not rated as a mutagen or toxic for reproduction. Studies available do not support CHDM as having adverse chronic toxicity or being a carcinogen. CHDM is considered, however, to be corrosive to the eye and is classified as H318
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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