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EC number: 943-172-0 | CAS number: -
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From September 9, 2015 to October 1, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
Test material
- Reference substance name:
- Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt
- EC Number:
- 943-172-0
- IUPAC Name:
- Reaction mass of C18 (unsatd.) fatty acid amides/esters of diethanolamine, C16-18 (even-numbered) fatty amine ethoxylates, castor oil ethoxylates and sulfosuccinates of C18 (unsatd.) fatty acid diethanolamide, sodium salt
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- Paste
- Details on test material:
- - Name of test material (as cited in study report): Vegetable or animal oil, hydrogenated, reaction products with diethanolamine, maleic anhydride and sodium sulphite
- Lot No.: CH 192435/01
- Purity: Not applicable (UVCB)
- Organic Carbon: 30.2%
- Hydrotox No.: 15/5241
- Origin: DACC
- Stability: Stable within the durability and with appropriate storage conditions
- Solubility in water: ~1 g/L
- Appearance: Light beige liquid/paste
- Storage conditions: Ambient temperature, dark, dry
- Expiration date: July 15, 2015
- Safety directions: H315, H319. Use protective clothing: gloves and protection goggles.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Animal supply and acclimatisation
- Supplier: Harlan Italy s.r.l., San Pietro al Natisone (UD), Italy
- Age and body weight at study initiation: 6-7 weeks old; 150-174 g
- Date of arrival: September 03, 2015
- Weight range at arrival: from 160 to 168 g
- Acclimatisation period: At least 5 d
Animal husbandry
- Animals per cage: 3 during the study; up to 5 during acclimatisation
- Housing: Polisulphone solid bottomed cages measuring 59.5x38x20 cm with nesting material provided into suitable bedding bags
- Diet: 4 RF 18 (Mucedola S.r.l., Via G. Galilei, 4, 20019, Settimo Milanese (MI) Italy)
- Diet supply: ad libitum throughout the study except for the dosing procedure
Environmental conditions
- Water: ad libitum
- Air changes: Approximately 15 to 20 air changes per h
- Temperature: 22±2°C
- Humidity: 55±15%
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on oral exposure:
- Fasting procedure: Food was removed from the cages overnight prior to dosing (Day 1) and was made available approximately 4 h after dosing.
Dosing method: The formulated test substance was administered, by gavage, at a dose volume of 10 mL/kg using a plastic feeding tube attached to a graded syringe
Dose preparation: The test substance was suspended in vehicle i.e. 0.5% aqueous solution of carboxymethylcellulose in concentration of 200 mg/mL. - Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- not specified
- Details on study design:
- - Dosing: First group of 3 female animals was dosed at a level of 2,000 mg/kg bw. No mortality was observed. A second group of 3 female animals was then dosed at the same dose level. No further doses were investigated since the objective of the study had been achieved.
- Duration of observation period following administration: 14 d.
- Frequency of observations: Mortality and morbidity-All animals were checked twice daily.
- Body weight: All animals were weighed at allocation to the study (Day 1), on the day of dosing (Day 1) and on Days 2, 8 and 15. Body weight change calculated for Days 2, 8 and 15 of the dosing phase was relevant to Day 1 of the phase.
- Termination: Animals were sacrificed on Day 15 by carbon dioxide narcosis
- Necropsy: Necropsy was carried out on all animals (gross necropsy examination for both external and internal abnormalities, with particular attention to the gastro-intestinal tract).
- Clinical signs observation: Approximately 0.5, 2 and 4 h after dosing and daily thereafter for 14 d.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No clinical signs were observed in any of the treated animals.
- Gross pathology:
- No abnormalities were observed at necropsy examination performed on all animals at the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP criteria not met
- Conclusions:
- The LD50 of the test substance was determined to be ≥2,000 mg/kg bw.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in rats according to OECD Guideline 423, EU Method B.1 and EPA OPPTS 870.1100, in compliance with GLP. In this study, groups of females were administered the test substance by gavage in a stepwise manner. Treated animals were then observed for mortality, clinical signs and body weight changes for 14 d and were then culled and subjected to gross pathological examination. In the first step, the test substance was administered to a group of 3 females at 2,000 mg/kg bw. A second group of 3 females was then dosed at the same level. No mortality and no signs of toxicity were observed. No abnormalities were recorded at necropsy. Based on the findings of the study, the oral LD50 of the test substance was determined to be >2,000 mg/kg bw (Caruso R, 2015).
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