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Diss Factsheets
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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
Eye irritation
Administrative data
- Endpoint:
- eye 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.
- 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 / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- None
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL or 0.1 g of the undiluted test substance was instilled into one eye of each rabbit. The other eye served as control.
- Concentration (if solution): 100% (undiluted) - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 24, 48, 72 h and 7 and 14 d.
- Number of animals or in vitro replicates:
- Six
- Details on study design:
- 0.1 mL or 0.1 g of the undiluted test substance was instilled into the one eye of each animal, and the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48 and 72 h and 7 and 14 d after instillation. Any residue of the test substance and accumulated discharge are flushed from the eye each time they are scored.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: 24 h
- Score:
- 11.33
- Reversibility:
- not specified
- Remarks on result:
- other: irritating according to CLP (self classified)
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- other: 48 h
- Score:
- 7.67
- Reversibility:
- not specified
- Remarks on result:
- other: irritating according to CLP (self classified)
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- other: 72 h
- Score:
- 5.67
- Reversibility:
- not specified
- Remarks on result:
- other: irritating according to CLP (self classified)
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- other: 7 d
- Score:
- 3.33
- Reversibility:
- not specified
- Remarks on result:
- other: irritating according to CLP (self classified)
- Irritation parameter:
- maximum mean total score (MMTS)
- Remarks:
- :Undiluted test substance
- Basis:
- mean
- Time point:
- other: 14 d
- Score:
- 2.33
- Reversibility:
- not specified
- Remarks on result:
- other: irritating according to CLP (self classified); except for conjuctival redness, which was the most prominent response and was present in 3/6 animals, the remaining eye irritation response (i.e., chemosis and discharge) were reduced to almost 0 by Day 14.
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- Category II
- Remarks:
- Migrated information (reversible effects on eye) Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the undiluted test substance can be assessed to be a irritating to the eyes. According to CLP criteria (EC 1272/2008) the test substance can be considered to be a category II- eye irritant (with reversible effects on the eye).
- Executive summary:
The ocular irritation potential of the test substance, amides, C18 -unsatd., N,N-bis(hydroxyethyl) was investigated using New Zealand white rabbits in accordance with Title 21, Code of Federal Regulations, 191.11.
A volume of 0.1 mL or 0.1 g the test substance was instilled into one eye of each of six New Zealand white rabbits; the other eye served as control. The eyes were evaluated for damage to cornea, iris and bulbar and palpebral conjunctivae at 24, 48, 72 h and 7 and 14 d.
Irritation response in the conjuctiva was observed in terms of redness, chemosis and discharge. The mean conjcutival redness score was 2 in 4/6 animals. Further, mean irritation score of 11.33, 7.67, 5.67, 3.33 and 2.33 was observed after 24, 48 and 72 h and 7 and 14 days of observation. Except for conjuctival redness, which was the most prominent response and was present in 3/6 animals, the remaining eye irritation response (i.e., chemosis and discharge) were reduced to almost 0 by Day 14.
Under the test conditions, the undiluted test substance canbe assessed to be a irritating to the eyes. According to CLP criteria (EC 1272/2008), the test substance can be considered to be a category II- eye irritant (with reversible effects on the eye).
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.
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