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EC number: 242-332-0 | CAS number: 18448-65-2
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Inadequate study details and results
- Justification for type of information:
- Read-across data is presented from quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808-53-2, EC Number 276-038-9. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Consumer Product Safety Commission 16 CFR 1500
- Deviations:
- yes
- Remarks:
- Only 5 animals per group
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Didecyldimethylammonium chloride
- EC Number:
- 230-525-2
- EC Name:
- Didecyldimethylammonium chloride
- Cas Number:
- 7173-51-5
- Molecular formula:
- C22H48N.Cl
- IUPAC Name:
- Didecyldimethylammonium chloride
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- The product tested was a gold liquid which was stored in an airtight container at room temperature from receipt throughout the study period.
(Similar to C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) 75% a.i. with only water, no IPA [isopropanol])
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Five male SpragueDawley derived albino rats from Hilltop Lab Animals, Inc., weight ranging from 200 to 265 grams.
Food was witheld from the rats for approximately 18 hours prior to dosing. Following dosing, food consisting of PURINA LABORATORY CHOW and water were available ad libitum. The rats were housed in groups in stainless steel wire mesh cages suspended above the droppings. The animals were housed under a 12-hour light/12-hour dark cycle. The rats were acclimated to the laboratory at least seven days prior to dosing and were individually identified by numbered ear tags and tail marks with permanent ink.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The test sample was administered by esophageal intubation to five groups, each composed of five male Sprague-Dawley derived albino rats from Hilltop Lab Animals, Inc., weight ranging from 200 to 265 grams. Four groups were treated on April 1, 1981, and the fifth group was treated on April 8, 1981. The sample was administered undiluted at dosage levels of 0.464, 1.00, 2.15, 4.64, and 10.0 grams per kilogram of body weight using an average density value of 1.036 g/ml for administration on a sample volume basis.
- Doses:
- 0.464, 1.00, 2.15, 4.64, and 10.0 grams per kilogram of body weight
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
- Details on study design:
- All animals were observed closely for gross signs of systemic toxicity and mortality at one and one-half to two hours, three and three-quarter to four and one-quarter hours, and give and one-half to six hours post administration during the day of dosing, and at least once daily thereafter for a total of 14 days. Gross necropsies were performed on the animals that died. At the end of the 14-day observation period the surviving rats were weighed, sacrificed by C02 inhalation and gross necropsies were performed. Statittical analysis of the mortality data was by the moving average method.
- Statistics:
- moving average method
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 710 mg/kg bw
- 95% CL:
- > 1.26 - < 2.33
- Clinical signs:
- other: The results of the observations for gross signs of systemic toxicity noted throughout the study at the various dosage levels showed central nervous system depression, piloerection, and diarrhea were found in all animals and persisted up to four days in su
- Gross pathology:
- Gross necropsies performed at the termination of the study revealed no gross pathological alterations or lesions in any of the surviving animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on these results, the product tested (75 % C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2) and 25% water) is classfied as harmful by oral ingestion as that term is defined in the Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.
Based on the concentration of the product, the same classification is valid for the active ingredient C12-18-alkylbis(hydroxyethyl)methyl, chloride (CAS no 71808-53-2). - Executive summary:
The acute oral toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study conducted according to the Consumer Product Safety Commission 16 CFR 1500.
This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across.
The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).
Under the conditions of the study the LD50 was determined to be 1710 mg/kg bw and, as a consequence, the substance is classified as a Category 4, harmful if swallowed according to the GHS criterial ( Regulation [EC] No 1272/2008 of the European Parliament and of the Council of 16 December 2008).
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