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EC number: 948-061-0 | 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:
- 14-28 November 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- purity of test item, environmental conditions not reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- purity of test item, environmental conditions not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides
- EC Number:
- 948-061-0
- Molecular formula:
- C18 H40 NO+ Cl- ; C20 H44 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H46 NO+ Cl- ; C22 H48 NO+ Cl-
- IUPAC Name:
- Quaternary ammonium compounds, C14-18 (even numbered) and C18 unsaturated-alkyl-hydroxyethyl-dimethyl, chlorides
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Chimex / M 303- Physical state: Yellowish limpid liquid- Date received: October 9, 1995- Purity test date: July 27, 1995STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: Stored at room temperature, away from the light
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- OFA
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: IFFA-CREDO (69210 - L'ARBRESLE, FRANCE).- Age at study initiation: 6 weeks- Weight at study initiation: 190-206 g (males); 162-178 g (females)- Fasting period before study: Animals have been fasted prior to test substance administration by withholding food overnight.- Housing: 5 animals by sex in polypropylene cages (310 x 465 x 190)- Diet: Complete pelleted rat maintenance diet UAR A04-10 (91360 - EPINAY SUR ORGE, FRANCE), ad libitum- Acclimation period: 5 days IN-LIFE DATES: 14-28 November 1995
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled water
- Details on oral exposure:
- VEHICLE - Concentration in vehicle: 400 mg/L MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw DOSAGE PREPARATION Test substance was diluted in distilled water and the preparation was kept under magnet stirring during the treatments.
- Doses:
- 2000 mg/kg bw
- 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: The animals were observed daily for 14 days after the treatment. A clinical observation was carried out at least once a day in order to evaluate the general appearance, the behaviour and vegetative functions of the animals. An individual clinical observation was realized one hour after treatment. The continuous observations during the five following hours were renewed each following day. Body weight was taken just prior to the test substance administration (Day 1) and on Days 3, 7 and 14 after the treatment. - Necropsy of survivors performed: Yes; all the animals dead during the test were autopsied. On Day 14, the rats were sacrificed after lethal barbituric anaesthesia, then autopsied. All abnormalities were recorded. No tissues are saved
- Statistics:
- None
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Mortality was observed in 40 % females and no mortality was observed in males.
- Clinical signs:
- - One hour after treatment slight piloerection was noticed in all animals, lasting for the 5 following hours.- 24 hours after treatment all animals show toxic signs: important piloerection, diarrhea, hollow flanks, noisy breathing, porphyrin around the eyes. The next morning (Day 3) one female animal was found dead, another lost weight, this latter was found dead 24 hours later. On Day 4 all other surviving animals were appeared to be normal, until the end of the study.
- Body weight:
- The individual growth weight of all surviving animals (males and females) was normal and regular. All animals showed expected gains in body weight over the 14 day study period.
- Gross pathology:
- The post mortem examination of 2 female animals died during the test revealed lesions at stomach level (very distended wall, presence of coagulated blood).No macroscopic abnormalities were noted at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions of this study, the LD50 of test substance is higher than 2000 mg/kg bw and not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 401 and in compliance with GLP, Sprague-Dawley OFA rats (5/sex/dose) were administered a single oral (gavage) dose of test substance at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.
Mortality was observed in 40 % females and no mortality was observed in males. Toxic signs were observed in all animals between the 6th and 24th hours after treatment: piloerection, diarrhea, noisy breathing and hollow flank. All animals showed expected gains in body weight over the 14 day study period. No macroscopic abnormalities were noted at necropsy. Some stomach lesions (distension and haemorrhage) were noticed in animals died during the study.
Rat Oral LD50 (combined) > 2000 mg/kg bw
Under the experimental conditions of this study, the LD50 of test substance is higher than 2000 mg/kg bw and not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
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