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EC number: 939-017-1 | CAS number: 1469982-94-2
- 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
- Study period:
- 2013-02-07 to 2013-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted by GLP Guidelines according to OECD 402 protocol with no deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Undiluted Isostearamide DEA was applied to the closely clipped, intact skin of New Zealand white male and female rabbits (5 each) at a dose level 2000 mg/kg. The treated areas were covered with two layers of porous gauze dressing and a plastic sheet, which was secured in place with non-irritating surgical tape. The animals were observed for clinical signs for a period of 14 days (or until death). Necropsy of all animals was performed.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Isostearamide DEA
- IUPAC Name:
- Isostearamide DEA
- Test material form:
- other: Yellow liquid
- Details on test material:
- Batch Number OE11208
Purity: 100% - UVCB
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbitry
- Age at study initiation: at least 12 weeks
- Weight at study initiation: 2.4 - 3.0 kg
- Fasting period before study: None
- Housing: Individually caged in stainless steel cages
- Diet (e.g. ad libitum): Purina Rabbit Chow, ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 63 - 73 oF
- Humidity (%): 30 - 70%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Twenty-four hours prior to application of the test material, the dorsal and ventral areas of the trunks of the animals were shaved with electric clippers. Undiluted Isostearamide DEA to the intact skin of New Zealand white male and female rabbits at a dose of 2000 mg/kg. The treated areas were covered with two layers of porous gauze dressing and a plastic sheet, which was secured in place with non-irritating surgical tape. The animals were then returned to their individual cages.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations were performed once daily, the weight change was recorded at 7 and 14 days after dosing
- Necropsy of survivors performed: yes
- Other examinations performed: none - Statistics:
- Satistical analysis was not performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed.
- Clinical signs:
- other: Erythema, edema, and desquamation were seen in some animals up to day 12. By day 12, all animals appeared normal and healthy.
- Gross pathology:
- No findings were seen at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- The Acute Skin Absorption Minimal Lethal Dose for male and female rabbits was found to be > 2000 mg/kg.
- Executive summary:
Undiluted Isostearamide DEA was applied to the intact skin of New Zealand white male and female rabbits at a dose of 2000 mg/kg. The treated areas were covered with two layers of porous gauze dressing and a plastic sheet, which was secured in place with non-irritating surgical tape. Observations were made for toxic signs and the viscera of the test animals were examined macroscopically.
The only clinical signs included erythema, edema, and desquamation up to day 12 after dosing. All animals appeared normal and healthy from days 12 - 14. No mortality was seen, and there were no unusual findings at necropsy. The LD50 of Isostearamide DEA is > 2000 mg/kg.
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