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EC number: 269-665-4 | CAS number: 68308-74-7
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No studies using inhalation exposure are available. The inhalation DNEL is therefore derived by extrapolation from the NOAEL of 50 mg/kg bw/d from the repeated dose oral toxicity studies. Following correction for breathing rate (/0.38), activity level (*0.67) and the extent of oral absorption (50%, assumed) and inhalation absorption (100%, assumed), an inhalation NOAEC of 44 mg/m3 is derived.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute studies to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required (differences already accounted for)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
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:
- 0.2 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No studies using repeated dermal exposure are available. The dermal DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d Further correction is not required as the extent of oral and dermal absorption is assumed to be equivalent (worst case assumption)
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute studies to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat study)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 61 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- Use of a LOAEL (EC3 value)
- AF for differences in duration of exposure:
- 1
- Justification:
- Not relevant for skin sensitisation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not relevant for local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 61 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- Use of a LOAEL (EC3 value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not relevant for skin sensitisation
- AF for other interspecies differences:
- 2.5
- Justification:
- Not relevant for local effects
- AF for intraspecies differences:
- 5
- Justification:
- Default value (workers)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Available data relevant to DNEL derivation come from the skin sensitisation study (for local dermal effects) and from the OECD 422 reproductive/developmental toxicity screening study (for systemic effects).
Local dermal DNEL: starting point
An EC3 of 9.13% was calculated in a skin sensitisation study (Local Lymph Node Assay).
Systemic DNELs: starting point
NOAELs of 50 mg/kg bw/d (systemic toxicity, males), 300 mg/kg bw/d (systemic toxicity, females), 50 mg/kg bw/d (reproductive toxicity) and 1000 mg/kg bw/d (developmental toxicity) are derived for the OECD 422 study. An overall oral NOAEL of 50 mg/kg bw/d is therefore used as the starting point.
Inhalation DNEL values
Systemic DNELs
No studies involving inhalation exposure are available. The long-term systemic inhalation DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d. Following correction for breathing rate (/0.38), activity level (*0.67) and the extent of oral absorption (50%, assumed) and inhalation absorption (100%, assumed), a corrected inhalation NOAEC of 44 mg/m3 was derived. Individual Assessment Factors of 1 (for dose-response relationship), 6 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties) result in an overall Assessment Factor of 75. Applying the overall Assessment Factor to the modified starting point results in a long-term systemic inhalation DNEL of 0.6 mg/m3.
A short-term systemic inhalation DNEL is not derived in the absence of any identified hazard, based on low vapour and consequently low likelihood of exposure.
Local DNELs
Local inhalation DNELs are not derived in the absence of any identified hazard. No classification of Amides, tall-oil fatty, N,N-di-Methyl (DMATO) was appropriate for acute oral, dermal or inhalation toxicity.
Dermal DNEL values
Systemic DNELs
No studies using repeated dermal exposure are available. The long-term systemic dermal DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d.
Further correction is not required as the extent of oral and dermal absorption is assumed to be equivalent, as a worst case. Individual Assessment Factors of 1 (for dose-response relationship), 6 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties) result in an overall Assessment Factor of 300. Applying the overall Assessment Factor to the starting point results in a long-term systemic DNEL of 0.2 mg/kg bw/d.
A short-term systemic dermal DNEL is not derived in the absence of any identified hazard. No classification was necessary for dermal toxicity.
Local DNELs
The substance is identified as a potential skin sensitiser in a mouse LLNA (EC3 = 9.13%; 2282.5 µg/cm2). Individual Assessment Factors of 3 (for dose-response relationship; the EC3 is considered equivalent to the LOAEL), 1 (for exposure duration, not relevant for sensitisation), 1 (for allometric scaling, not relevant for local effects), 2.5 (for other interspecies differences), 5 (for intraspecies differences: workers) and 1 (for database quality) result in an overall Assessment Factor of 37.5. Applying the overall Assessment Factor to the LOAEL results in a local dermal DNEL for sensitisation of 61 µg/cm2.
Identification of respiratory sensitisers is important due to the health concerns associated occupational asthma but there are no accepted regulatory models currently capable of assessing the potential for induction of respiratory sensitisation/allergy. Various models are available for assessing the potential for induction of allergic contact dermatitis (ACD), for example the Local Lymph Node Assay, but Dearman and Kimber have reported that only a small number of compounds that give positive LLNA responses are actually respiratory sensitisers. There are important mechanistic differences in the aetiology of ACD and respiratory allergy. Respiratory allergic responses are classified as Type I hypersensitivity mediated by IgE whereas ACD is a Type IV hypersensitivity mediated by T cells. ACD involves T helper cells of one subpopulation, involving interleukin-2, interferon-gamma and tumour necrosis factor beta (TNF-ß); respiratory allergy is associated with the Th2 T helper cells of a second subpopulation associated with production of Interleukins 4, 10 and 13; these cytokines tend to favour humoral immune function and stimulation of B cells to produce IgE. The activities of inflammatory mediators and Th2 cytokines may result in respiratory allergy including effects in mast cells and eosinophils. Dearman and Kimber 1999 and Arts and Kuper 2007 have investigated the use of LLNA models to assess the respiratory allergenicity of compounds using mice in a sensitised state following dermal or respiratory contact. Both allergic states involve proliferative responses but the resultant T-cell populations and effective pathways are different for contact and respiratory sensitisers. Only a small number of potentially contact sensitising substances have respiratory allergic effects, typically low molecular weight substances capable of forming haptens. In the absence of validated IgE or pulmonary response assays to determine respiratory sensitising potential, the identification of a respiratory allergen is largely dependent on human evidence and direct correlation between contact and respiratory sensitising substances can be drawn from the results of the LLNA test in isolation.
Given that DMATO shows no evidence of inflammatory or irritant responses, it cannot be concluded that any respiratory allergic hazard is indicated by the positive contact sensitising response in the LLNA study summary.
Toxicology and Applied Pharmacology 226 (2008) 1 -13. D R Boverhof et al.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No studies using inhalation exposure are available. The inhalation DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d. Following correction for breathing rate (/1.15) and the extent of oral absorption (50%, assumed) and inhalation absorption (100%, assumed), a corrected inhalation NOAEC of 22 mg/m3 is derived.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute studies to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required (differences already accounted for)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
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:
- 0.1 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No studies of repeated toxicity using dermal exposure are available. The dermal DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d. Further correction is not required as the extent of oral and dermal absorption is assumed to be equivalent (worst case assumption)
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute studies to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat study)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 µg/cm²
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- Use of a LOAEL (EC3 value)
- AF for differences in duration of exposure:
- 1
- Justification:
- Not relevant for skin sensitisation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not relevant for local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- other: LOAEL
- AF for dose response relationship:
- 3
- Justification:
- Use of a LOAEL (EC3 value)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not relevant for local effects
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The oral DNEL is derived from the oral NOAEL of 50 mg/kg bw/d. Further correction is not required.
- AF for dose response relationship:
- 1
- Justification:
- Default value
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from sub-acute studies to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default value (rat study)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value
- AF for intraspecies differences:
- 10
- Justification:
- Default value
- AF for the quality of the whole database:
- 1
- Justification:
- Default value
- AF for remaining uncertainties:
- 1
- Justification:
- Default value
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
Available data relevant to DNEL derivation come from the skin sensitisation study (for local dermal effects) and from the OECD 422 reproductive/developmental toxicity screening study (for systemic effects).
Local dermal DNEL: starting point
An EC3 of 9.13% was calculated in a skin sensitisation study (Local Lymph Node Assay).
Systemic DNELs: starting point
NOAELs of 50 mg/kg bw/d (systemic toxicity, males), 300 mg/kg bw/d (systemic toxicity, females), 50 mg/kg bw/d (reproductive toxicity) and 1000 mg/kg bw/d (developmental toxicity) are derived for the OECD 422 study. An overall oral NOAEL of 50 mg/kg bw/d is therefore used as the starting points.
Inhalation DNEL values
Systemic DNELs
No studies involving inhalation exposure are available. The long-term systemic inhalation DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d. Following correction for breathing rate (1/1.15) and the extent of oral absorption (50%, assumed) and inhalation absorption (100%, assumed), a corrected inhalation NOAEC of 22 mg/m3was derived. Individual Assessment Factors of 1 (for dose-response relationship), 6 (for duration of exposure), 1 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties) result in an overall Assessment Factor of 150. Applying the overall Assessment Factor to the modified starting point results in a long-term systemic inhalation DNEL of 0.15 mg/m3.
A short-term systemic inhalation DNEL is not derived in the absence of any identified hazard.
Local DNELs
Local inhalation DNELs are not derived in the absence of any identified hazard. No classification of Amides, tall-oil fatty, N,N-di-Methyl (DMATO) was appropriate for acute oral, dermal or inhalation toxicity.
Dermal DNEL values
Systemic DNELs
No studies using repeated dermal exposure are available. The long-term systemic dermal DNEL is therefore derived by extrapolation from the oral NOAEL of 50 mg/kg bw/d.
Further correction is not required as the extent of oral and dermal absorption is assumed to be equivalent (worst case assumption). Individual Assessment Factors of 1 (for dose-response relationship), 6 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 5 (for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties) result in an overall Assessment Factor of 600. Applying the overall Assessment Factor to the starting point results in a long-term systemic DNEL of 0.1 mg/kg bw/d.
A short-term systemic dermal DNEL is not derived in the absence of any identified hazard. No classification was necessary for dermal toxicity.
Local DNELs
The substance is identified as a potential skin sensitiser in a mouse LLNA (EC3 = 9.13%; 2282.5 µg/cm2). Individual Assessment Factors of 3 (for dose-response relationship; the EC3 is considered equivalent to the LOAEL), 1 (for exposure duration, not relevant for sensitisation), 1 (for allometric scaling, not relevant for local effects), 2.5 (for other interspecies differences), 5 (for intraspecies differences: workers) and 2 (for database quality) result in an overall Assessment Factor of 37.5. Applying the overall Assessment Factor to the LOAEL results in a local dermal DNEL for sensitisation of 61 µg/cm2.
Oral DNEL values
Systemic DNELs
The long-term systemic oral DNEL is derived from the overall NOAEL of 50 mg/kg bw/d. Further correction is not required. Individual Assessment Factors of 1 (for dose-response relationship), 6 (for duration of exposure), 4 (for allometric scaling), 2.5 (for other interspecies differences), 10 (for intraspecies differences, 1 (for database quality) and 1 (for remaining uncertainties) result in an overall Assessment Factor of 600. Applying the overall Assessment Factor to the starting point, results in a long-term systemic oral DNEL of 0.1 mg/kg bw/day.
A short-term systemic oral DNEL is not derived in the absence of any identified hazard.
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.