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EC number: 241-516-8 | CAS number: 17517-01-0
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 4th 2002 to February 7th 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- The test protocol followed the recommended procedure of the application for quasi-drugs in Japan.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Q and A for application for quasi-drugs and cosmetics by Ministry of health, labour and welfare in Japan (Q14)
- Version / remarks:
- The test protocol followed the recommended procedure of the application for quasi-drugs in Japan.
- GLP compliance:
- no
Test material
- Reference substance name:
- N,N-dimethyl-3-(octadecyloxy)propylamine
- EC Number:
- 241-516-8
- EC Name:
- N,N-dimethyl-3-(octadecyloxy)propylamine
- Cas Number:
- 17517-01-0
- Molecular formula:
- C23H49NO
- IUPAC Name:
- dimethyl[3-(octadecyloxy)propyl]amine
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- C18H38O
- IUPAC Name:
- octadecan-1-ol
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Details on test animals or test system and environmental conditions:
- -Experimental animals
1) Species, strain, sex
Guinea pigs, Hartley strain, white, females
2) Breeder and Breeding style
Japan SLC, Inc. (3371-8, Koto-cho, Nishi-ku, Hamamatsu, Shizuoka), Clean, Closed colony
3) Study groups and the number of animals
Animals were used in groups of 5 for the study.
4) Age in weeks and body weights
Animals were obtained at 5 weeks of age, acclimatized to laboratory conditions for 6 days and quarantined during these days. Only well-grown animals in good physical condition were subjected to the study. The mean body weight was 407 g at the start of the study.
-Animal rearing management
1) Rearing environment
Animals were kept under the following conditions; room temperature: 23±2°C, relative humidity: 50±10%, ventilation frequency: 17 times/hour, lighting time: 12 hours (6:00 to 18:00)/day.
2) Rearing equipment and housing
Upon receipt, animals were housed 5 per cage in aluminum cages (W350XD400×H230 mm: Natsume Seisakusyo Co., Ltd.) placed on an automatic flush rack (Natsume Seisakusyo Co., Ltd.).
3) Feed and Drinking water
Animals were given free access to solid feed (RC4: Oriental Yeast Co., Ltd.) and municipal tap water filtered through a 5-μm cartridge filter.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped and shaved
- Vehicle:
- other: Ethanol
- Controls:
- yes, concurrent vehicle
- yes, concurrent negative control
- Amount / concentration applied:
- -Amount
The fabric of which was impregnated with 0.1 mL of each solution was applied.
-Concentration
5% and 1% (as active ingredient) - Duration of treatment / exposure:
- 24-hour occlusive patch
- Observation period:
- 3, 24, 48 h after the 24-hour occlusive patch removal
- Number of animals:
- 5 animals/treatment
- Details on study design:
- -Study methods
1) Application methods
The application site was the left and right flank, and clipped and shaved. A tape for a patch test (small size: Torii Pharmaceutical Co., Ltd.), the fabric of which was impregnated with 0.1 mL of the test solution, was applied by a 24-hour occlusive patch test method. In addition, for securing dressings, the tape for a patch test was secured with adhesive sponge tape (Microfoam: 3M company) and elastic adhesive bandage (Silkytex, Alcare Co., Ltd). The application sites were varied among the animals so that the reaction might be averaged among the application sites.
2)
Skin reactions were judged using the Draize scoring criteria.
0: No erythema
1: Very slight erythema (barely perceptible)
2: Well-defined erythema
3: Moderate to severe erythema
4: Severe erythema (beet redness) to slight eschar formation (injuries in depth)
0: No edema
1: Very slight edema (barely perceptible)
2: Slight edema (edges of area well defined by definite raising)
3: Moderate edema (raised approximately 1 mm)
4: Severe edema (raised more than 1 mm and extending beyond the area of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3.8
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: 5% solution
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3.4
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: 5 % solution
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2.8
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: 1% solution
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.8
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: 1% solution
- Irritant / corrosive response data:
- -Findings
1) 5% solution of N,N-dimethyl octadecyloxy propylamine (Lot. EA-3) (vehicle: ethanol)
Well-defined erythema was observed, accompanied with only mild edema in 4 of 5 animals from 3 hours after removal. The lesion progressed to eschar formation and mild edema 24 hours after removal and then, further progressed to eschar formation and severe edema 48 hours after removal. As for the rest of one animal, well-defined erythema was observed from 3 hours after removal. The lesion progressed to moderate to severe erythema, accompanied with only mild edema 24 hours after removal and persisted until 48 hours after removal.
2) 1% solution of N,N-dimethyl octadecyloxy propylamine (Lot. EA-3)(vehicle: ethanol)
Only mild erythema was observed in all of the animals from 3 hours after removal. The lesion progressed to moderate to severe erythema, accompanied with only mild edema in 2 of 5 animals 24 hours after removal and further progressed to eschar formation and mild edema 48 hours after removal. In addition, the lesion progressed to well-defined erythema in 3 animals 24 hours after removal and persisted until 48 hours after removal.
3) Ethanol (vehicle control)
No irritation reactions were observed at any time point.
4) Distilled water (negative control)
No irritation reactions were observed at any time point. - Other effects:
- During the study period, no abnormalities in clinical signs were noted.
Applicant's summary and conclusion
- Interpretation of results:
- other: The study cannot be used for classification directly because the diluted test solution was used. However the irritation/corrosive potential of test substance was evaluated based on this study for classification.
- Conclusions:
- 5% solution of N,N-dimethyl octadecyloxy propylamine (Lot. EA-3) (vehicle: ethanol):
Well-defined erythema was observed, accompanied with only mild edema in 4 of 5 animals from 3 hours after removal. The lesion progressed to eschar formation and mild edema 24 hours after removal and then, further progressed to eschar formation and severe edema 48 hours after removal. As for the rest of one animal, well-defined erythema was observed from 3 hours after removal. The lesion progressed to moderate to severe erythema, accompanied with only mild edema 24 hours after removal and persisted until 48 hours after removal. - Executive summary:
The primary skin irritation of N,N-dimethyl octadecyloxy propylamine (Lot. EA-3) were evaluated in guinea pigs. Animals were used in groups of 5 for the study. The application site was the left and right flanks of animals. The lint fabric of a tape for a patch test was impregnated with 0.1 mL of the test solution, and a 24 -hour occlusive-patch test was performed.
As a result, no abnormalities in clinical signs were noted. The mean scores of skin reactions are shown as follows.
(Based of the avarage score of 5 animals. Highest score: 4)
Test solution
Concentration* (%)
Vehicle
Time after removal 3 hr (erythema /edema)
24 hr (erythema /edema)
48 hr (erythema /edema)
N,N-dimethyl octadecyloxy propylamine
(Lot.EA-3)5
Ethanol
2 / 0.8
3.8 / 1.8
3.8 / 3.4
N,N-dimethyl octadecyloxy propylamine
(Lot.EA-3)1
Ethanol
1 / 0
2.4 / 0.4
2.8 / 0.8
Ethanol (vehicle control)
-
-
0 / 0
0 / 0
0 / 0
Distilled water (negative control)
-
-
0 / 0
0 / 0
0 / 0
*Concentrations as “N,N-dimethyl octadecyloxy propylamine”
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