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EC number: 269-915-2 | CAS number: 68390-97-6 This substance is identified by SDA Substance Name: C16-C18 alkyl dimethyl amine and SDA Reporting Number: 19-040-00.
- 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
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- From 15 JAN 1973 to 01 JUN 1975
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication/study report which meets basic scientific principles, pre-GLP.
- Reason / purpose for cross-reference:
- reference to same study
- Objective of study:
- absorption
- excretion
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Excretion study in humans after dermal application of test substance.
- GLP compliance:
- no
- Remarks:
- Pre-GLP
- Radiolabelling:
- yes
- Remarks:
- C14
- Species:
- human
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- - Fasting period before study: 12 hours
- Housing: t he subjects employed were volunteers who remained at the test facility throughout the course of the study - Route of administration:
- dermal
- Vehicle:
- water
- Details on exposure:
- TEST SITE
- Area of exposure: forearm, 4 x 15 cm clipped skin
- non-occlusive plastic shield
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 8 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration and frequency of treatment / exposure:
- - Single dose
- Remarks:
- Doses / Concentrations:
- The dose was 10 mg (100 µCi 14C) per subject - No. of animals per sex per dose / concentration:
- - Two human volunteers
- Control animals:
- no
- Positive control reference chemical:
- No
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, feces, CO2
- Time and frequency of sampling:
urine: 0-6 h, 6-24 h, every 24 h until 144 h
feces: individually
CO2: for 15 minutes at 0, 1,2,3,4,5,6,8,12,24,26,48 and 72 h after dosing
After 8 h of exposure the skin was cleaned and the percentage of radioactivity retained in the stratum corneum was assayed by repeated (10x) stripping the skin - Preliminary studies:
- no preliminary study
- Type:
- excretion
- Results:
- 0.01 and 0.23 % of the administered radioactivity was found in the excretion products. See below for details.
- Type:
- absorption
- Results:
- A small percentage of cutaneously applied [1-14C-dodecyl]-test substance was absorbed by humans. See below for details
- Details on absorption:
- A small percentage of cutaneously applied [1-14C-dodecyl]-test substance was absorbed by humans as indicated by the appearance of 0.01 and 0.23% of the administered radioactivity in the excretion products of the two human subjects. The percent absorption in the two human subjects was determined to be < 0.2% based on assumption of maximum non-detectable amounts in all urine collections falling in the non-detectable range. More than 92% of the applied dose could be recovered from the site by swabbing with moist gauze eight hours after dose application. The tape strippings of the application site showed that the stratum corneum contained less than two-tenths of one percent of the applied dose.
All blood samples taken contained less than 3.0E-5 percent of the dose per gram - Details on excretion:
- A small percentage of cutaneously applied [1-14C-dodecyl]-test substance was absorbed by humans as indicated by the appearance of 0.01% and 0.23% of the administered radioactivity in the excretion products of the two human subjects. More than 92 % could be recovered from the application site 8 h after application
- Metabolites identified:
- not specified
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Only a small percentage of cutaneously applied [1-14C-dodecyl]-test substance was absorbed by humans as indicated by the appearance of 0.01 and 0.23% of the administered radioactivity in the excretion products of the two human subjects. The percent absorption in the two human subjects was determined to be 0.2% based on assumption of maximum non-detectable amounts in all urine collections falling in the non-detectable range. More than 92% of the applied dose could be recovered from the site by swabbing with moist gauze eight hours after dose application. The tape strippings of the application site showed that the stratum corneum contained less than two-tenths of one percent of the applied dose. - Executive summary:
The absorption and excretion pattern of [1-14C-dodecyl]-dimethyl amine oxide administered dermally to two human subjects was examined. The subjects employed were volunteers who remained at the test facility throughout the course of the study. Each subject was given a complete physical examination before and after the study. The physical examination included clinical chemistries, ophthalmoscopic eye examination, EKG, hematology and blood pressure. Recommended procedures for informed consent and experimental review were followed. Before dosing, subjects were food fasted for twelve hours. Zero time blood samples were taken immediately before dosing .
An area 15 cm x 4 cm was marked off on the outer surface of the subjects’ forearms which had been clipped free of hair and inspected for breaks. One-half mL of an aqueous solution containing 10 mg of [1-14C-dodecyl]-dimethyl amine oxide (100 µCi14C) was applied evenly over the site with a plastic syringe. The site was allowed to dry by evaporation and was covered with a non-occlusive, plastic shield. After eight hours, the DMAO remaining at the application site was removed by repeatedly (10 x) swabbing the skin with water moistened gauze pads. The portion of the radioactive dose retained in the stratum corneum was assayed by repeatedly (10 x) stripping a 7.2 squared centimeter area within the area of application with tape. Normal handling and exposure of the application site was permitted after these procedures. Urine was collected in polyethylene bottles over the intervals 0-6 hours and 6-24 hours, and subsequently over 24-hour intervals through 144 hours. During the collection period, samples were stored at 0° C; upon completion of a collection interval, the urine samples were frozen on dry ice. Feces samples were collected individually as available in plastic bags and were stored frozen. Expired CO2was collected in a modified Hanks apparatus. The air flow rate through the collection box was 12 L/min. Carbon dioxide collections on the orally dosed subjects were performed at 0, 1, 2, 3, 4, 5, 6, 8, 12, 24, 36, 48 and 72 hours after dosing. The collection period was 15 minutes. Total expired radioactivity was computed from these samples of expired gases.
A small percentage of cutaneously applied [1-14C-dodecyl]-dimethyl amine oxide was absorbed by humans as indicated by the appearance of 0.01 and 0.23% of the administered radioactivity in the excretion products of the two human subjects. The percent absorption in the two human subjects was determined to be 0.2% based on assumption of maximum non-detectable amounts in all urine collections falling in the non-detectable range. More than 92% of the applied dose could be recovered from the site by swabbing with moist gauze eight hours after dose application. The tape strippings of the application site showed that the stratum corneum contained less than two-tenths of one percent of the applied dose. OECD (2006) assumed that <1% was absorbed through the skin of humans.
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only short abstract available
- Objective of study:
- metabolism
- Principles of method if other than guideline:
- Metabolism study in rats after oral application of test substance.
- GLP compliance:
- not specified
- Radiolabelling:
- yes
- Remarks:
- C14
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 180 - 230 g (range for animals treated with either DDA (this study) or DDAO)
- Fasting period before study: overnight
- Housing: stainless stell cages
- Individual metabolism cages: yes - Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Duration and frequency of treatment / exposure:
- single exposure
- Remarks:
- Doses / Concentrations:
135 mg/kg - No. of animals per sex per dose / concentration:
- one animal
- Control animals:
- no
- Positive control reference chemical:
- No
- Details on dosing and sampling:
- Metabolite studies:
- Urine was sampled from 0-24 h. Samples were used for identificatin of metabolites - Preliminary studies:
- no preliminary study
- Type:
- metabolism
- Results:
- metabolite profile was the same as that of the 0-24 h urine from rats dosed with 14C-DDAO (100 mg/kg)
- Metabolites identified:
- yes
- Details on metabolites:
- The metabolite profile was the same as that of the 0-24 h urine from rats dosed with 14C-DDAO (100 mg/kg). One metabolie that was identifies is N,N-dimethyl-4-aminobutyric acid. No further information available.
- Conclusions:
- No bioaccumulation potential based on study results.
Under the conditions of the test the metabolite profile was the same as that of the 0-24 h urine from rats dosed with 14C-DDAO (100 mg/kg). - Executive summary:
One rat was exposed to 135 mg/kg 14C-DDA orally by gavage. The metabolite profile was the same as that of the 0-24 h urine from rats dosed with 14C-DDAO (100 mg/kg).
Referenceopen allclose all
Description of key information
See detailed explanations below in section "additional information".
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 100
Additional information
All available toxicokinetic data are based on oral or dermal exposure. No studies after inhalation exposure are available.
Only one study is available for the toxicokinetic behaviour (absorption – distribution – metabolism – excretion) of members of the DMA category:
Turan et al. (1981), primarily investigating C12-DMAO, also performed a study with C12-DMA, which, however, was only briefly described in the publication (RL4). They applied 135 mg radioactively labeled C12-DMA/kg bw orally to one rat. From this animal, they analyzed the metabolite profile in 0-24 h urine. By comparing the metabolite profile data from C12-DMA with those of C12-DMAO (100 mg/kg bw, orally applied as well), the authors concluded that the metabolic fate of DMAs and DMAOs after oral uptake is comparable. Since DMA is metabolized in the body to DMAO, it can plausibly be assumed that DMAOs can be used in a read across approach to cover this endpoint.
In a reliable study (similar to OECD guideline 417) with radiolabelled C12-DMAO, different exposure pathways (oral and dermal) were used. The tested species were humans (oral and dermal), rats (oral and dermal), rabbits and mice (only dermal application) (Procter & Gamble, 1975).
In this study, absorption, distribution and excretion of DMAOs were investigated. In humans, dermal absorption of DMAO was determined to be 0.2% based on the assumption of maximum non-detectable amounts in all urine collections falling in the non-detectable range. More than 92% of the applied dose could be recovered from the site by swabbing with moist gauze eight hours after dose application, indicating that dermal absorption was maximally 8%.
Regarding the distribution of DMAOs in the body, small amounts of DMAO were found in liver, kidney, blood and testes in mice, rabbits and rats.
According to Turan et al. (1981), the metabolite structures suggest that DMAO metabolism involves different pathways. These pathways are proposed to be omega- and beta-oxidation of the aliphatic chain, amine oxide reduction as well as aliphatic mid-chain hydroxylation. One metabolite product was identified as N-dimethyl-4-aminobutyric acid N-oxide.
These authors also investigated the excretion of radioactively labeled C12-DMAO in humans, rabbits and rats after oral application. In all three species, most of the radioactivity was recovered in the urine within 72 h (rats: 66% and 54%, rabbits: 59%) or 144 h (humans: 57% and 44%). About 20-30% of the DMAO was sufficiently degraded to yield CO2.
Turan et al. (1981) also reported data after dermal application of DMAO. In mice, DMAOs were dermally absorbed, excretion was mainly via urine. The same was observed in rabbits and rats. All three species were able to degrade the alkyl chain, with rabbits and humans being more efficient than the rat. The rat excreted a much greater portion of urinary radioactivity as long chain compounds. Under the conditions employed, the rabbit shows more similarities to the metabolism of DMAO by man than does the rat. No evidence was found to indicate that unmetabolized DMAO was excreted in the urine.
After oral application of a single dose of DMAO, the substance was rapidly and extensively absorbed and excreted in humans. Between 37 and 50% of the administered radioactivity appeared in the urine within 24 h after dose administration, 18 and 22% of the dosed radioactivity were found in expired carbon dioxide during the 24 h interval and 2.7 and 2.5 % were recovered in feces. In rats, 73.9 and 67.4% of the radioactivity were excreted within 24 h, mainly as expired CO2.
It can be concluded that DMAOs as well as DMAs are, upon absorption, extensively metabolized and eliminated in a fast way, mainly in urine and CO2. Dermal absorption of DMAO is maximally 8%. Data on absorption after oral application is limited; therefore, the standard absorption of 100% is assumed. No bioaccumulation of DMAO or DMA is assumed.
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