Registration Dossier
Registration Dossier
Diss Factsheets
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: 800-353-8 | CAS number: 1379524-06-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was compliant with the relevant guidelines and was conducted in accordance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- The temperature and relative humidity recorded in the animal room were sometimes outside of the target ranges. This minor deviation was not considered to have compromised the validity or integrity of the study.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- see above
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- (9E)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- EC Number:
- 800-353-8
- Cas Number:
- 1379524-06-7
- Molecular formula:
- C23H46N2O
- IUPAC Name:
- (9E)-N-[3-(dimethylamino)propyl]octadec-9-enamide
- Details on test material:
- Test article name : Emulsamine AT-O
Chemical name : alkylamidoamine
Batch number: 6514
Purity: > 95 %
Origin: Feuchy plant
Expiration date of the lot/batch: july 2003
Physical state: dark brown liquid
Storage condition of test material: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CEGAV, Saint Mars d'Egrenne, France
- one male animal
- Age at study initiation: 2 to 4 months old
- Weight at study initiation: 3.2 kg
- Housing: polystyrene cage (48.2 cmx 58cmx 36.5cm)
- Diet : free access to 110 pelleted diet (UAR, Villemoisson, Epinay sur Orge, France)
- Water : drinking water filtered by a FG millipore membrane (0.22 micron), ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-3
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/ hour of filterd, non-recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: The day before the treatment, both flanks of the animal were clipped using electric clippers and the skin of the animal was examined in order to ensure that the animal has healthy intact skin at the beginning of the study.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 ml of the test substance were placed on a dry gauze pad.
- Duration of treatment / exposure:
- 3-minute and 4-hour applications
- Observation period:
- 1h and 24 h
The animal was killed on day 2 for ethical reasons. - Number of animals:
- 1
- Details on study design:
- TEST SITE
- Area of exposure: right and left flank of the animal
REMOVAL OF TEST SUBSTANCE
After removal of the dressing, any residual test item was wipped off by means of moistened cotton pad.
SCORING SYSTEM:
Irritation evaluated according to the grading scale originally proposed by Draize and adopted by OECD test guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- other: lesion
- Basis:
- animal #1
- Time point:
- other: 1 h
- Remarks on result:
- other: brown coloration of the skin
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Remarks on result:
- other: Necrosis
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: 24 h
- Remarks on result:
- other: Scoring masqued by necrosis
- Irritant / corrosive response data:
- After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing (day 2). The animal was then killed for ethical reasons.
Any other information on results incl. tables
Since the test item showed corrosive properties on the first animal, the study was considered complete and the test item was not evaluated on other animals.
Applicant's summary and conclusion
- Interpretation of results:
- corrosive
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under our experimental conditions, the test substance is corrosive when applied topically to rabbits.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test substance should be classified as corrosive and assigned the symbol C, the indication of danger “Corrosive” and the risk phrase R35: “Causes severe burns”. In accordance with CLP Regulation 1272/2008, the test substance should be classified as Category 1 B corrosive substance with the signalword Danger and the hazard statement "H314: Causes severe skin burns and eye damage" associated with it. - Executive summary:
The potential of the test substance to induce skin irritation was evaluated in rabbits according to OECD (No. 404, 17th July 1992) and EC (96/69/EEC, B.4, 31 July 1992) guidelines. The study was conducted in compliance with the principles of Good Laboratory Practice Regulations. In the first instance, the test substance was applied for a period of 3 minutes and 4 hours to a single male New Zealand White rabbit. As the test substance showed corrosive properties on this first animal, the study was considered complete and the test item was not evaluated on other animals. A single dose of 0.5ml of the undiluted test substance was applied to the closely-clipped skin of one flank. The test substance was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reaction were observed approximately 1 hour and 24 hours after removal of the dressing. After a 3-minute or a 4-hour exposure, necrosis was noted at the application site 24 hours after removal of the dressing (day 2) The animal was then killed for ethical reasons. Under our experimental conditions, the test substance is corrosive when applied topically to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test substance should be classified as corrosive and assigned the symbol C, the indication of danger “Corrosive” and the risk phrase R35: “Causes severe burns”. In accordance with CLP Regulation 1272/2008, the test substance should be classified as Category 1 B corrosive substance with the signalword Danger and the hazard statement "H314: Causes severe skin burns and eye damage" associated with it.
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.

EU Privacy Disclaimer
This website uses cookies to ensure you get the best experience on our websites.