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EC number: 203-661-5 | CAS number: 109-28-4
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in accordance with OECD guideline 402 and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- N-[3-(dimethylamino)propyl]oleamide
- EC Number:
- 203-661-5
- EC Name:
- N-[3-(dimethylamino)propyl]oleamide
- Cas Number:
- 109-28-4
- Molecular formula:
- C23H46N2O
- IUPAC Name:
- (9Z)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- Test material form:
- other: liquid
- Details on test material:
- Batch: R 401/57
Purity: 78.2%
Color: reddish
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Supplier: RCC Ltd Laboratory Animal Services
Age at beginning of study: 8-9 weeks (males), 12-13 weeks (females)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Application area: ca. 40 cm²
Application volume: 2.24 ml/kg body weight - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: at least 14 days
- Determination of body weight: shortly before test substance administration, weekly thereafter and on the last day of observation
- Necropsy with gross-pathology examination performed on the last day of the observation period
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- None occured.
- Clinical signs:
- Most of the animals showed transiently impaired general state, dyspnoea and piloerection (maximum incidence on day 1).
Local effects at the application site: erythema (grade 1-3), edema (grade 2), eschar formation (crust), squamation, squamation beyond the area of exposure, necrotic areas at the skin, brown discoloration of application site and skin obduration of application site. - Body weight:
- Mean body weights of the animals were slightly decreased during the first post-exposure observation week but increased during the second week.
- Gross pathology:
- With exception of the changes in the skin no macroscopic pathologic abnormalities were detected in the animals examined on the last day of observation.
Any other information on results incl. tables
Nature and duration of local clinical signs (females) | |||||
Dose (mg/kg bw): | 2000 | ||||
Sex: | female | ||||
Administration | 1 | ||||
Number of animals: | 5 | ||||
Animal number: | 100 | 101 | 102 | 103 | 104 |
Erythema, grade 2: | - | - | - | d12 -d14 | d12 -d14 |
Erythema, grade 3: | d1 | d1 | d1 | d1 | d1 |
Edema grade 2: | - | - | - | d12-d14 | d12 -d14 |
Application site, brown discolored: | d1-d14 | d1-d14 | d1-d8 | d1-d8 | d1-d12 |
Application site, skin obduration: | d1-d14 | d1-d14 | d1-d8 | d1-d8 | d1-d12 |
Necrotic areas at the skin: | d1-d14 | d1-d14 | d1-d8 | d1-d8 | d1-d12 |
Eschar formation (crust): | d5-d14 | d4-d14 | d4-d14 | d4-d14 | d4-d14 |
Moderate erythema, with wet areas: | d8-d14 | d8-d14 | d8-d14 | d8d12-d14 | d8-d12 |
Squamation: | - | - | - | d11-d13 | d14 |
Squamation beyond area of exposure: | - | - | d6-d8 | d6-d8 | - |
Nature and duration of local clinical signs (males) | |||||
Dose (mg/kg bw): | 2000 | ||||
Sex: | male | ||||
Administration | 1 | ||||
Number of animals: | 5 | ||||
Animal number: | 105 | 106 | 107 | 108 | 109 |
Erythema, grade 1: | d12-d14 | - | - | d14 | - |
Erythema, grade 2: | - | - | - | d11 -d13 | d13 -d14 |
Erythema, grade 3: | d1 | d1 | d1; d7 | d1 | d1 |
Edema grade 2: | d12-d14 | - | - | d11-d14 | d12 -d14 |
Application site, brown discolored: | d1-d11 | d1-d14 | d5-d6 | d5-d8 | d5-d12 |
Application site, skin obduration: | d1-d11 | d1-d14 | d1-d8 | d1-d8 | d1-d12 |
Necrotic areas at the skin: | d1-d11 | d1-d14 | d1-d6 | d1-d8 | d1-d12 |
Eschar formation: | d4-d13 | d1-d14 | d1-d14 | d4-d8 | d4-d14 |
Moderate erythema, with wet areas: | - | - | d8-d14 | - | - |
Squamation: | d14 | - | - | d11-d14 | d4 |
Squamation beyond area of exposure: | - | d6-d7 | - | - | - |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study the LD50 of 3-Dimethylaminopropyl-ölsäureamide after dermal application was found to be >2000 mg/kg body weight in rats. No classification according to Regulation (EC) No 1272/2008 (CLP) is required.
- Executive summary:
The test substance 3-Dimethyl-aminopropyl-ölsäureamide was tested for acute dermal toxicity in the rat according to OECD guideline 402. A single dose of 2000 mg/kg body weight was applied to the clipped skin of five male and five female rats and
covered by a semi-occlusive dressing for 24 hours. The animals were observed for 14 days after application of the test substance. No mortality occurred. Most of the animals showed transiently impaired general state, dyspnoea and piloerection on study day 1. The following skin effects were observed at the application site: erythema (grade 1-3), edema (grade 2), eschar formation (crust), squamation, squamation beyond the area of exposure, necrotic areas at the skin, brown discoloration of application site and skin obduration of application site. Mean body weights of the female and male animals were slightly decreased during the first
post-exposure observation week but increased during the second week. Upon necropsy of the animals after 14 days, no pathological abnormalities were detected. Under the conditions of this study, the LD50 of 3-Dimethylaminopropyl-ölsäureamide after dermal application was found to be greater than 2000 mg/kg body weight. Thus, no classification according to Regulation (EC) No 1272/2008 (CLP) is required.
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