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Diss Factsheets
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EC number: 423-300-7 | CAS number: 128554-52-9
- 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: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- 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: see 'Remark'
- Remarks:
- Study data over 12 years old provided by ECHA, on a previously notified substance considered comparable and suitable for read-across use for the substance being registered (see attachments for justification of read-across). Study conducted in accordance with generally accepted scientific principles, possibly with incomplete or methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 423-300-7
- EC Name:
- -
- Cas Number:
- 128554-52-9
- Molecular formula:
- Molecular formula varies for each reaction product. See section 1.2 for the molecular formula for each identified reaction product.
- IUPAC Name:
- 12-hydroxy-N-({3-[(12-hydroxyoctadecanamido)methyl]phenyl}methyl)octadecanamide
- Reference substance name:
- AMIDE#71
- IUPAC Name:
- AMIDE#71
- Test material form:
- other: solid
- Details on test material:
- Identification: AMIDE#71
Mass median aerodynamic diameter (for liq.+ solid aerosol): 2.8 µm
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- Mass median aerodynamic diameter of test substance: 2.8 µm
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- 5.08 mg/L air
- No. of animals per sex per dose:
- 5 males and 5 females at 5.08 mg/L
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
Observations were made for mortality, signs of toxicity, and effects on organs at necropsy.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5.08 mg/L air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality at 5.08 mg/L air.
Male: 5.08 mg/L; Number of animals: 5; Number of deaths: 0
Female: 5.08 mg/L; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: Clinical signs during exposure consisted of a slightly decreased breathing rate in all animals that developed in severity from slight in the first hour to moderate during the remainder of the exposure period. In a
- Gross pathology:
- Effects on organs: Abnormalities at necropsy were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.
- Other findings:
- None.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.
- Executive summary:
The test substance was assessed for acute inhalation toxicity according to OECD 403.
No mortality occurred at 5.08 mg/L air. Dose-related signs of toxicity included a slightly decreased breathing rate in all animals that developed in severity, from slight in the first hour, to moderate during the remainder of the exposure period. In addition, slightly laboured breathing was noted in two male rats in the last two hours of exposure. Clinical signs shortly after exposure included a decreased breathing rate and sluggishness. The sluggishness continued during the first day and some rats were observed to have grunting respiration. In the remainder of the 14-day observation period no exposure-related observations were seen. At necropsy, abnormalities were limited to the lungs and consisted of a few white spots on two lobes in 3 males and on one lobe in 1 female and discolouration of the lungs in two other females.
The acute inhalation LC50 of the test material in the rats (male and female) was determined to be greater than 5.08 mg/L air.
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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