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: 914-471-3 | 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

Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no data for dermal pathway available, same absorption rate assumed
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- subchronic and chronic studies available, no difference observed
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance
- AF for other interspecies differences:
- 1
- Justification:
- no LOAEL identified, "real" NOAEL expected to be much higher, NOAEL very conservative
- AF for intraspecies differences:
- 5
- Justification:
- ECHA Guidiance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidiance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidiance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Workers
Acute Exposure
DNELs for acute exposure - systemic effects are not derived, because no relevant acute toxicity was observed (LD50 oral >2000 mg/kg bw; LD50 dermal >2000 mg/kg bw) and no hazards leading to classification and labeling were identified.
DNELs for acute exposure - local effects are not derived, because the members of this category have not to be classified as irritating to skin or eyes and are considered unlikely to become bioavailable in the skin. Furthermore, exposure of humans via inhalation is considered unlikely taking into account the vapour pressure of the substance and the physical form of the substances.
Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs existing.
Long-term exposure
DNEL long-term dermal exposure - systemic effects:
Several repeated-dose studies with oral exposure exist, which show no toxicity of the test materials. The key study for Montan wax, type S (OECD 422 with extended treatment, Sisti and Oberto, 2010) reveals a NOAEL of 1000 mg/kg bw/day after subchronic exposure duration. This NOAEL is supported by several other, less reliable studies on other members of the Montan waxes group.
Repeated dose studies with Montan waxes:
- Type S: NOAEL 1000 mg/kg bw/day, rat, subchronic (Sisti and Oberto, 2010)
- Type WE4: NOAEL 3916-4090 mg/kg bw/day, rat, subchronic (Jung and Hoffmann, 1980)
- Type KPS: NOAEL 2000-2500 mg/kg bw/day, rat, chronic (Scholz et al., 1969)
- Type KPS: NOAEL 1250 mg/kg bw/day, dog, subchronic (Scholz and Brunk, 1967)
and reliable supporting studies with structurally related substances:
- D-003: NOAEL 1500 mg/kg bw/day, rat, 2 years (Gamez et al., 2007)
- Policosanol: NOAEL 500 mg/kg bw/day, rat, 2 years (Aleman et al., 1994)
The NOAEL for oral exposure of 1000 mg/kg bw/day is regarded as starting point for the derivation of DNELs.
The substances are not likely to be systemically available after dermal exposure. As worst case consideration a DNEL "long-term dermal exposure - systemic effects" can be derived by route-to-route extrapolation of the data after long-term oral exposure. The key study for Montan wax, type S (OECD 422 with extended treatment, Sisti and Oberto, 2010) reveals a NOAEL of 1000 mg/kg bw/day (highest dose tested, no toxicity observed). This NOAEL is supported by several other, less reliable studies on other members of the Montan waxes group and reliable supporting studies with structurally related substances (see below). Assuming, that dermal absorption is not higher than oral absorption the NOAEL for oral exposure of 1000 mg/kg bw/day is regarded as starting point for the derivation of the DNEL "long-term dermal exposure - systemic effects".An allometric scaling factor of 4 is applied to account for constitutionally species differences and a factor 1 for remaining interspecies differences, because no effects were observed at the highest concentration tested in any of the studies, i. e. only NOAELs were derived and the LOAELs after repeated exposure remains unidentified. Due to the very low acute toxicity it is expected that the true NOAEL is much higher than the NOAEL identified in the studies with repeated exposure. Application of the default factor of 2.5 for remaining uncertainties beyond allometric scaling would probably result in an overly conservative DNEL value. The comparison of subchronic with chronic studies does not indicate an increase of toxicity with increasing exposure duration, so a factor 1 is used for time extrapolation. In the absence of any substance specific data a default factor of 5 is used for intraspecies extrapolation. This results in an overall assessment factor of 20 (4 x 5). Based on these data a DNEL long-term dermal exposure - systemic effects of 50 mg/kg bw/day is derived for the members of this category. This procedure is very conservative because no systemic uptake from dermal exposure is expected.
DNEL long-term inhalation exposure - systemic effects:
There are no studies with long term inhalation exposure to the members of the Montan waxes category available.
Exposure of humans via inhalation is considered unlikely taking into account the vapour pressure of the substance
and the physical form of the substances. Therefore, no DNEL "long-term inhalation exposure - systemic effects" is derived.
DNELs for long-term exposure - local effects are not derived, because the members of this category have not to be classified as irritating to skin or eyes. Furthermore, exposure of humans via inhalation is considered unlikely taking into account the vapour pressure and the physical form of the substances.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no data for dermal pathway available, same absorption rate assumed
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- subchronic and chronic studies available, no difference observed
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance
- AF for other interspecies differences:
- 1
- Justification:
- no LOAEL identified, "real" NOAEL expected to be much higher, NOAEL very conservative
- AF for intraspecies differences:
- 10
- Justification:
- ECHA Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- ECHA Guidance
- AF for differences in duration of exposure:
- 1
- Justification:
- subchronic and chronic studies available, no difference observed
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA Guidance
- AF for other interspecies differences:
- 1
- Justification:
- no LOAEL identified, "real" NOAEL expected to be much higher, NOAEL very conservative
- AF for intraspecies differences:
- 10
- Justification:
- ECHA Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA Guidance
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
General population
Acute exposure
DNELs for acute exposure - systemic effects are not derived, because no relevant acute toxicity was observed (LD50 oral >2000 mg/kg bw; LD50 dermal >2000 mg/kg bw) and no hazards leading to classification and labeling were identified.
DNELs for acute exposure - local effects are not derived, because the members of this category have not to be classified as irritating to skin or eyes and are considered unlikely to become bioavailable in the skin. Furthermore,exposure of humans via inhalation is considered unlikely taking into account the vapour pressure of the substance and the physical form of the substances.
Finally, there is no established accepted methodology for the derivation of acute toxicity DNELs existing.
Long-term exposure
DNEL long-term inhalation exposure - systemic effects:
There are no studies with long term inhalation exposure to the members of the Montan waxes category available.
Exposure of humans via inhalation is considered unlikely taking into account the vapour pressure and the physical form of the substances.
It is considered unlikely that the substances will become systemically available after inhalation exposure. Therefore, no DNEL "long-term inhalation exposure - systemic effects" is derived.DNEL long-term oral exposure - systemic effects:
Several repeated-dose studies with oral exposure exist, which show no toxicity of the test materials. The key study for Montan wax, type S (OECD 422 with extended treatment, Sisti and Oberto, 2010) reveals a NOAEL of 1000 mg/kg bw/day after subchronic exposure duration. This NOAEL is supported by several other, less reliable studies on other members of the Montan waxes group.
Repeated dose studies with Montan waxes:
- Type S: NOAEL 1000 mg/kg bw/day, rat, subchronic (Sisti and Oberto, 2010)
- Type WE4: NOAEL 3916-4090 mg/kg bw/day, rat, subchronic (Jung and Hoffmann, 1980)
- Type KPS: NOAEL 2000-2500 mg/kg bw/day, rat, chronic (Scholz et al., 1969)
- Type KPS: NOAEL 1250 mg/kg bw/day, dog, subchronic (Scholz and Brunk, 1967)
and reliable supporting studies with structurally related substances:
- D-003: NOAEL 1500 mg/kg bw/day, rat, 2 years (Gamez et al., 2007)
- Policosanol: NOAEL 500 mg/kg bw/day, rat, 2 years (Aleman et al., 1994)
The NOAEL for oral exposure of 1000 mg/kg bw/day is regarded as starting point for the derivation of the DNEL. An allometric scaling factor of 4 is applied to account for constitutionally species differences and a factor 1 for remaining interspecies differences, because no effects were observed at the highest concentration tested in any of the studies, i. e. only NOAELs were derived and the LOAELs after repeated exposure remains unidentified. Due to the very low acute toxicity it is expected that the true NOAEL is much higher than the NOAEL identified in the studies with repeated exposure. Application of the default factor of 2.5 for remaining uncertainties beyond allometric scaling would probably result in an overly conservative DNEL value. The comparison of subchronic chronic studies does not indicate an increase of toxicity with increasing exposure duration, so a factor 1 is used for time extrapolation. In the absence of any substance specific data a default factor of 10 is used for intraspecies extrapolation. This results in an overall assessment factor of 40 (4 x 10). Based on these data a DNEL long-term oral exposure ¿ systemic effects of 25 mg/kg bw/day is derived for the members of this category. This procedure is very conservative because no LOAEL could be identified.
DNEL long-term dermal exposure - systemic effects:
No data on toxicity of the members of this category after long-term dermal exposure are available. The substances are not likely to be systemically available after dermal exposure. As worst case consideration a DNEL "long-term dermal exposure - systemic effects" can be derived by route-to-route extrapolation of the data after long-term oral exposure. The key study for Montan wax, typeS (OECD 422 with extended treatment, Sisti and Oberto, 2010)reveals a NOAEL of 1000 mg/kg bw/day after subchronic exposure duration. This NOAEL is supported by several other, less reliable studies on other members of the Montan waxes group and reliable supporting studies with structurally related substances (see below). Assuming, that dermal absorption is not higher than oral absorption the NOAEL for oral exposure of 1000 mg/kg bw/day is regarded as starting point for the derivation of the DNEL "long-term dermal exposure - systemic effects". In analogy to oral exposure, an overall assessment factor of 40 (4 x 10) is used. Based on these data a DNEL long-term dermal exposure ¿ systemic effects of 25 mg/kg bw/day is derived for the members of this category. This procedure is very conservative because no systemic uptake from dermal exposure is expected.
DNELs for long-term exposure - local effects are not derived, because the members of this category do not show irritating effects and have not to be classified as irritating to skin or eyes. Furthermore,
exposure of humans via inhalation is considered unlikely taking into account the vapour pressure and the physical form of the substances.
DNELs for long-term exposure - local effects:
DNELs for long-term exposure - local effects (dermal and inhalative) are not derived, because the members of this category have not to be classified as irritating to skin or eyes and are considered unlikely to become bioavailable in the skin. Furthermore, exposure of humans via inhalation is considered unlikely taking into account the vapour pressureand the physical form of the substances.
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.
