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EC number: 269-125-8 | CAS number: 68187-80-4
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted on the structural analogue amides, C18(unsatd.), N,N-bis(hydroxyethyl) in accordance with Title 21, Code of Federal Regulations, 191.11.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Title 21, Code of Federal Regulations, 191.11.
- Principles of method if other than guideline:
- None
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)oleamide
- EC Number:
- 202-281-7
- EC Name:
- N,N-bis(2-hydroxyethyl)oleamide
- Cas Number:
- 93-83-4
- Molecular formula:
- C22H43NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)octadec-9-enamide
- Reference substance name:
- Amides, C18(unsatd.), N,N-bis(hydroxyethyl)
- IUPAC Name:
- Amides, C18(unsatd.), N,N-bis(hydroxyethyl)
- Details on test material:
- - Name of test material (as cited in study report): Varamide A-7
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow, ad libitum
- Water (e.g. ad libitum): ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: one abraded aread and one intact area
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL (0.5 g) of the 100% concentration of the test substance.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: Backs and flanks of the animals were clipped hair free
- Test substance application: 0.5 mL (0.5 g) of the undiluted test substance was applied in an occlusive patch to the abraded and intact areas of the skin, covered with gauze patch by adhesive-tape.
Duration: 24 h
Scoring criteria: According to Draize classification.
Observations: at 24 and 72 h.
Results and discussion
In vivo
Results
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 5.5
- Max. score:
- 8
- Reversibility:
- no data
- Remarks on result:
- other: irritating to the skin (mean of erythema and edema scores at 24 and 72 h).
- Other effects:
- None
Any other information on results incl. tables
Results for the primary skin irritation of the abraded and intact skin at 24 and 72 hrs:
Animal number |
24 h |
72 h |
||
Abraded |
Intact |
Abraded |
Intact |
|
1 |
3-2 |
3-2 |
3-3 |
3-3 |
2 |
3-2 |
3-2 |
3-3 |
3-3 |
3 |
3-2 |
3-2 |
3-3 |
3-3 |
4 |
3-2 |
3-2 |
3-3 |
3-3 |
5 |
3-2 |
3-2 |
3-3 |
3-3 |
6 |
3-2 |
3-2 |
3-3 |
3-3 |
Scoring was done similar to the Draize system of classification.
Observations: Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on abraded and intact rabbit skin.
The mean primary skin irritation index obtained = 5.50 (mean of erythema and edema scores at 24 and 72 h).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant)
- Remarks:
- Migrated information irritating to the skin Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the test substance had an irritant effect on the skin and was classified as a irritating according to the definitions given in the U.S. Federal Hazardous Substances Act. The Draize system of classification, which is separate from the Federal Register test, would regard the test substance as a severe irritant to the skin. Further, according to CLP criteria (EC 1272/2008) , the test substance may be considered to be Category 2 skin irritant as the mean scores of erythema and edema were >2.3 after 72 h.
- Executive summary:
A study was conducted to assess the skin irritation potential of test substance, amides, C18 -unsatd., N,N-bis(hydroxyethyl) to the rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11.
Six animals were treated with undiluted 0.5 mL (0.5 g) of the test substance. The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for a duration of 24 h. The degree of erythema and edema were recorded according to Draize scoring system after 24 and 72 h.
Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on the abraded and intact rabbit skin. The meanprimary skin irritation index (PII) was 5.5.
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