Registration Dossier
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: 238-405-1 | CAS number: 14433-76-2
- 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:
- 166.67 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 6
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.81 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 8.4
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Only long term exposure values for worker and general population were calculated, because no concrete values (like NOAEL, LOAEL etc) are available from acute or irritation studies. The study design of the test conducted assessing the acute and local toxicity of N,N-dimethyldecanamiddoes not allow in general the derivation of local or acute DNEL, as most of the test were, for example, conducted as limit tests due to animal welfare. In some cases the result of an acute test allows to derive local or acute thresholds. If this is the case the values were entered otherwise this justification is to apply.
For long term effects a valid repeated dose animal studies is available to derive DNEL values.
In a 90-day gavage study (Bayer 2000, J. Ruf) beagle dogs were treated once daily with mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide.
To the applicant a NOEL at 40 mg/kg bw/d (0.4%) reported in this study is based on local effects caused by oral application of the test substance at irritating concentrations (≥2%). At 200 mg/kg bw/d clinical chemistry revealed only slightly increased liver findings (weight increase, N-DEM and CYP-450 increase) but this should not be regarded as adverse effects but as increased metabolic activity of the organ (adaptive response). Therefore the NOAEL is established at 200 mg/kg bw/d.
The 90-day dog study is considered the most appropriate study for a DNEL derivation as dogs were found to be the most sensitive species based on clinical findings at 500 mg/kg bw/d.
Therefore the following values were used to derive DNELs: Dog subchronic (13 weeks; gavage; mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d
As local dermal or inhalation effects can not be evaluated from local oral effects the DNEL values for local effects were not derived.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.29 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 14
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Only long term exposure values for worker and general population were calculated, because no concrete values (like NOAEL, LOAEL etc) are available from acute or irritation studies. The study design of the test conducted assessing the acute and local toxicity of N,N-dimethyldecanamid does not allow in general the derivation of local or acute DNEL, as most of the test were, for example, conducted as limit tests due to animal welfare. In some cases the result of an acute test allows to derive local or acute thresholds. If this is the case the values were entered otherwise this justification is to apply.
For long term effects a valid repeated dose animal studies is available to derive DNEL values.
In a 90-day gavage study (Bayer 2000, J. Ruf) beagle dogs were treated once daily with mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide.
To the applicant a NOEL at 40 mg/kg bw/d (0.4%) reported in this study is based on local effects caused by oral application of the test substance at irritating concentrations (≥2%). At 200 mg/kg bw/d clinical chemistry revealed only slightly increased liver findings (weight increase, N-DEM and CYP-450 increase) but this should not be regarded as adverse effects but as increased metabolic activity of the organ (adaptive response). Therefore the NOAEL is established at 200 mg/kg bw/d.
The 90-day dog study is considered the most appropriate study for a DNEL derivation as dogs were found to be the most sensitive species based on clinical findings at 500 mg/kg bw/d.
Therefore the following values were used to derive DNELs: Dog subchronic (13 weeks; gavage; mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d
As local dermal or inhalation effects can not be evaluated from local oral effects the DNEL values for local effects were not derived.
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.

Route: .live1