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EC number: 295-835-2 | CAS number: 92129-33-4
- 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:
- 9.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
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:
- 14 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
Quaternary ammonium compound, di-C16 -18 -alkyldimethyl, chlorides are dialkyldimethylammonium chlorides and belong to the group of the quaternary ammonium compounds for which a common toxicological profile can be expected based on structure-activity relationships. On that background, read-across to structural closely related dialkyldimethylammonium chlorids is scientifically justified and is included in the assessment where appropriate.
For the delineation of DNELs the following exposure patterns are considered:
On account of the physico-chemical properties (ionic substance, vapour pressure) of quaternary ammonium compound, di-C16 -18 -alkyldimethyl, chloride, inhalative exposure to vapours is assumed to be negligible but exposure to dusts at the workplace during the handling of the powdery substance must be taken into consideration. Taking into account the corrosive effect of the paste-like preparation (ie the primary product), it is expected that repeated daily dermal contact is avoided. However, dermal exposure is to be considered when the powdered substance or diluted preparations are handled.
Based hereupon, the following critical DNELs with regard to quaternary ammonium compound, di-C16 -18 -alkyldimethyl, chloride have been identified:
· DNEL long-term,dermal, systemic
· DNEL long-term, inhalation, systemic
Long-term exposure - systemic toxicity
2 .1- Dermal DNEL
Identified key study for DNEL derivation is the 28-day oral toxicity study in rats (Hoechst, 1990) which results in a NOAEL of 100 mg/kg body weight per day. Route to route extrapolation must therefore be applied.
Step 1) Relevant dose-descriptor:
* NOAELoral,systemicrat = 100 mg/kg bw/d
Step 2)Modification of starting point:
* Absorption by dermal route in experimental animals and human
Experimental in vivo study in rabbits and in vitro data on human skin have revealed that the dermal absorption was very low. An increase of the concentration in the skin following dermal application was also not observed. These experimental findings are supported by the physico-chemical
properties of the substance being poorly soluble in water and having a molecular weight of about 580 g/mol, usually only substance with lower molecular weight are absorbed. Therefore, the default factor of 10% skin absorption is used and no correction factor for differences in absorption between animals and human is applied
Correcteddermal, systemicNOAEL = 1000 mg/kg bw/d
Step 3) Assessment factors:
* Interspecies : 4 (Allometric scaling from rat to human)
* Intraspecies : 3 Analysis of various data sets have revealed that for workers a factor of 3 is sufficient for covering any intraspecies variability (ECETOC, 2010)
* Exposure duration: 6 (extrapolation from a subacute exposure to a chronic exposure)
* Dose response : 1 (the starting point for DNEL calculation is a NOAEL)
* Quality of database: 1 (there is no reason to assume a special concern)
DNEL Value based on theCorrecteddermal, systemicNOAEL = 1000 mg/kg bw/d:
= 1000 /(4 x 3 x 6 x 1 x 1) = 14 mg/kg bw/ day
2.2 - Inhalation DNEL
Identified key study for DNEL derivation is the 28-day oral toxicity study in rats (Hoechst 1990) which results in a NOAEL of 100 mg/kg body weight per day. Route to route extrapolation must therefore be applied.
Step 1) Relevant dose-descriptor:
* NOAELoral,systemicrat = 100 mg/kg bw/d
Step 2)Modification of starting point:
* Correction for differences in absorption between oral and inhalation routes
Due to the low vapour pressure , the potential for generating vapour and thus the risk of inhaling the substance is minimal. In the event that aerosols or particulates are inhaled, the pulmonary physiology and clearance dynamics would largely favour the oral absorption rather than the inhalation. Therefore, based on the physico-chemical properties of fatty nitriles and their derivatives, the default factor of 2 in case of oral to inhalation extrapolation seems unjustified and is reduced to 1. This approach is in line with the conclusions of the EU RAR on DODMAC (final report 2002).
* Correction for respiratory volume between rat and human : 1/ 0.38 m3 /kg bw
* Correction for activity driven differences of respiratory volumes in workers compared to workers in rest: 6.7 m3/10 m3
Correctedinhalation, systemicNOAEL = 100 x 1.76 = 176 mg/m3
Step 3) Assessment factors:
* Interspecies: 1 No correction is made for differences in body size, because extrapolation is based on toxicological equivalence of a concentration of a chemical in the air of experimental animals and humans. Animals and humans breathe at a rate depending on their caloric requirements and this was already taken into account into step 2.The default factor for "remaining differences" is not considered scientifically justified. Analysis of various data sets have revealed that for workers a factor of 3 may be appropriate and that potential residual interspecies differences is largely accounted for already in the assessment factor for intraspecies variability (ECETOC 2010).
* Intraspecies : 3 (ECETOC 2010, see the above mentioned justification)
* Exposure duration: 6 (extrapolation from a subacute exposure to a chronic exposure)
* Dose response : 1 (the starting point for DNEL calculation is a NOAEL)
* Quality of database: 1 (there is no reason to assume a special concern)
DNEL Valuebased on theCorrectedinhalation, systemicNOAEL = 176 mg/m3
= 176 /(3 x 6 x 1x 1) = 9.8 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- exposure based waiving
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- exposure based waiving
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
For the delineation of DNELs the following exposure patterns are considered:
Oral DNEL (general population via the environment):
Identified key study for DNEL derivation is a 28-day oral toxicity study in rats (Hoechst, 1990) which results in a NOAEL of 100 mg/kg body weight per day. Route to route extrapolation must therefore be not applied.
Step 1) Relevant dose-descriptor: * NOAELoral,systemicrat = 100 mg/kg bw/d
Step 2) Modification of starting point:
No correction necessary. DNEL is based on an oral toxicity study.
Correctedoral, systemicNOAEL = 100 mg/kg bw/d
Step 3) Assessment factors:
* Interspecies : 4(Allometric scaling from rat to human)
* Intraspecies : 5 Analysis of various data sets have revealed that for general population a factor of 5 is sufficient for covering any intraspecies variability (ECETOC, 2010)
* Exposure duration: 6 (extrapolation from a subacute exposure to a chronic exposure)
* Dose response : 1 (the starting point for DNEL calculation is a NOAEL)
* Quality of database: 1 (there is no reason to assume a special concern)
DNEL Value based on the Correctedoral systemicNOAEL = 100 mg/kg bw/d:
= 100 /(4 x 5 x 6 x 1 x 1) = 0.833 mg/kg bw/ day
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