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EC number: 911-428-0 | CAS number: -
- 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
- Category name:
- Montan waxes and related waxes
Justifications and discussions
- Category definition:
- All category members substances are derived from naturally occurring montan waxes by chemical modification. They are of high structural similarity with only very minor differences in their physico-chemical properties (high molecular weight, melting point, flammability, solubility, octanol-water partition coefficient) as well as in their toxicological and ecotoxicological behavior.
- Category rationale:
- REPORTING FORMAT FOR THE CATEGORY APPROACH
1. CATEGORY HYPOTHESIS
The category covers the multi-constituent substances identified in Table 1 of the attached category document.
The original category was established for the 2010 registration deadline of these substances under REACH (> 1000 tonnes/a, November 2010), and comprised three category members, i.e. montan waxes, types S, E and OP. This category was extended to a total of 10 related montan waxes for the 2013 REACH registration (100 to 1000 tonnes/a) deadline by the Lead registrant (i.e. included also Montan waxes, type CAV 102,O, WE4, WM31, WE40, KPS, and NaV101). This category is now extended further to include the Montan wax, type LG, which is registered for the 2018 REACH registration deadline (10 to 100 tonnes/a).
All these substances are derived from naturally occurring montan waxes by chemical modification.
The category hypothesis is that all members are of high structural similarity with only very minor differences in their physico-chemical properties (high molecular weight, melting point, flammability, solubility, octanol-water partition coefficient) as well as in their toxicological and ecotoxicological behavior.
All members of the category share a very similar chemical structure with long, mainly even-numbered alkanoic acids of a similar chain length profile (alkanoic units), the corresponding esters with alkyl alcohols of the same chain length distribution, ethanediol, butanediol or glycerol and the corresponding calcium salts. Slight variations in composition and the distribution of chain lengths between members of the category are not expected to have a substantial impact on their physico-chemical, toxicological and ecotoxicological properties. The montan wax, type WM31 deviates insofar as tallow acids (saturated long chain fatty acids with chain length of C12-C22, which are derived from hydrogenated animal fat) supplement the montan wax basis derived from fossil plants. However the composition and the properties of these animal fatty acids are very similar to the fossil plant fatty acids.
All members have comparable physico-chemical properties (e.g. melting point, density, low solubility in water, partition coefficient octanol-water) and exhibit low toxicity in mammals and environmental organisms. Some minor differences are observed in ready biodegradability experiments.
Thus, the available toxicological and ecotoxicological data can be used for all other members of this category.
For repeated-dose toxicological endpoints the category is supplemented with the following substances, showing very similar chemical structures, but are originating from other sources (non-fossil plants):
- D-003 (origin: sugar cane wax): predominantly even-numbered long chain fatty acids (mainly C24-C36 with a maximum of C28-C32)
- Carnauba wax (origin: leaves of tropic palms): esters of even-numbered long chain fatty acids and alcohols (mainly C14-C34 acids with a maximum of C20-C30, mainly C20-C36 alcohols with a maximum of C30-C34), free aliphatic long chain fatty acids and alcohols, esters of ω-hydroxy-carboxylic acids with mainly C20-C36 alcohols with a maximum of C30-C34, esters of p-hydroxy- and p-methoxycinnamic acid
- Policosanol (origin: sugar cane wax): mostly even numbered long chain fatty alcohols (C24-C34), mainly octacosanol (C28)
These substances have been shown a similar composition in comparison to the corresponding refined montan wax derivatives, whereas Carnauba wax contains some additional constituents, derived from cinnamic acid (Lange and Wildgruber, 2006; Matthies, 2001).
2. CATEGORY JUSTIFICATION
The members of the category are structurally similar, consisting of mostly even-numbered very long saturated alkyl chains with various functional groups.
The seven montan waxes substances are solids at room temperature. They have similar (low) melting points and densities. Their solubility in water is low and the partition coefficients octanol-water are ≤ 2.0, see data matrix below.
Based on the available data, the category members show no toxicity after single oral exposures, no irritating effects to skin or eye, no skin sensitizing effects, repeated dose toxicity, no mutagenic properties and no biologically significant effects to aquatic, terrestrial and sediment organisms as well as bacteria. The category members are of limited biodegradability (see PBT/vPvB assessment).
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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