Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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

Endpoint summary
Administrative data
Description of key information
Key values for acute aquatic toxicity
Fish: 96h-LC50 > water solubility limit
Daphnids: 48h-EC50 > water solubility limit
Algae: 72h-EC50 > water solubility limit
Key value for chronic aquatic toxicity
Fish: Data waiving according to column 2 of REACH Annex IX
Daphnids: 21d-NOEC > water solubility limit
Algae: 72h-NOEC > water solubility limit
Key value for toxicity to microorganisms
3h-EC50 (activated sludge microorganisms, respiration) >= 1000 mg/L
3h-EC10 (activated sludge microorganisms, respiration) >= 1000 mg/L
Additional information
Please refer to CSR for further details on study summaries of different members of the Montan waxes category as well as Read-across justification in section 13 'assessment reports'.
Acute aquatic toxicity
Four reliable 96-hour acute toxicity studies (RL 1) on fish with Montan waxes types NaV 101, WE 4, CaV 102 and type E were performed according to OECD 203, compliant to GLP and meeting the validity criteria of the OECD 203 (1992) guideline. No toxicity was found with any of these substances at nominal concentrations well above the solubility limit (100 mg/L to 10 g/L upper nominal test item concentrations, depending on the study). Therefore, the LC50 for freshwater fish is > water solubility limit.
In five reliable studies (RL 1) with Montan waxes types NaV 101, WE 4, CaV 102, type E and type LG no biologically relevant toxicity to Daphnia magna was observed using water accommodated fractions with nominal loading rates up to the limit concentration of 100 mg/L recommended by the OECD 202 guideline. Therefore, the EC50 for aquatic invertebrates is > water solubility limit.
Montan waxes, types LG, KPS, WM 31, O, NaV 101, S, E, and OP were tested in reliable (RL1) OECD 201 tests with the unicellular freshwater green alga Desmodesmus subspicatus or Pseudokirchneriella subcapitata. All studies were performed compliant to GLP and meeting the validity criteria of the OECD guideline. No inhibition of growth was observed with any of the Montan waxes types tested at nominal concentrations well above their solubility limits. Therefore, Montan waxes category members are concluded to be acutely non-toxic to aquatic plants / alga. The EC50 for freshwater algae is > water solubility limit.
In conclusion, no acute hazard for the aquatic environment is anticipated.
Chronic aquatic toxicity
Note, chronic data is included because of the low water solubility of the submission substance.
Montan waxes, type S and WE40 were tested in reliable (category 1) OECD 211 tests (Daphnia magna Reproduction Test). The studies were performed compliant to GLP meeting the validity criteria of the OECD-guideline. No toxicity was observed in regard to any of relevant endpoints investigated at a nominal concentration well above the solubility limit (100 mg/L).The EC50 or NOEC for freshwater invertebrates is > water solubility limit.
Montan waxes, types LG, KPS, WM 31, O, NaV 101, S, E, and OP were tested in reliable (reliability category 1) OECD 201 tests with the unicellular freshwater green alga Desmodesmus subspicatusor or Pseudokirchneriella subcapitata. All studies were performed compliant to GLP and meeting the validity criteria of the OECD guideline. No inhibition of growth was observed with any of the Montan waxes types tested at nominal concentrations well above their solubility limits. Therefore, Montan waxes category members are concluded to be chronically non-toxic to aquatic plants / alga. Therefore, EC10/LC10 or NOEC for freshwater algae > water solubility limit.
In conclusion, no chronic hazard for aquatic organisms is anticipated.
Toxicity to microorganisms
In five reliable studies (two RL 1, three RL 2) with different members of the Montan waxes category, no signs of toxicity were observed at the nominal limit concentrations of 1000 mg/L (types WE 40 and NAV 101) and 10,000 mg/L (types W, E and OP). The tests were performed according to OECD 209 tests (Activated Sludge Respiration Inhibition) and compliant to GLP meeting the validity criteria of the OECD-guideline. Therefore, EC10/LC10 or NOEC for aquatic micro-organisms is ≥ 1000 mg/L.
No hazard for STP microorganisms is anticipated well above the water solubility of the submission substance.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
