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EC number: 427-370-1 | CAS number: 164288-56-6
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline, GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 427-370-1
- EC Name:
- -
- Cas Number:
- 164288-56-6
- Molecular formula:
- C21H44N3O3Cl
- IUPAC Name:
- {[(2-hydroxyethyl)carbamoyl]methyl}dimethyl(3-octadecanamidopropyl)azanium chloride
- Reference substance name:
- Sodium chloride
- EC Number:
- 231-598-3
- EC Name:
- Sodium chloride
- Cas Number:
- 7647-14-5
- Molecular formula:
- ClNa
- IUPAC Name:
- sodium chloride
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
Constituent 1
impurity 1
impurity 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- AnimaIs and Animal Husbandry
Male and female Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rats supplied by Charles River (UK) Ltd, Margate, Kent, UK were used. At the start of the study the males weighed 202 ta 220g, and the females 208 to 225g, and were eight to twelve weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink marking on the tail and a number written on a cage card.
The animals were housed in groups of up to five by sex in solid-floor polypropylene cages furnished with woodflakes. With the exception of an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Rat and Mouse Expanded Diet No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed throughout the study.
The animal room was maintained at a temperature of 19 ta 21°C and relative humidity of 37 to 67%. The rate of air exchange was approximately
15 changes per hour and the lighting was controlled by a time switch to give 12 hours light and 12 hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- dose level: 500 mg/kg
concentration: 50 mg/mL
dose volume: 10 mL/kg - Doses:
- preliminery study:2000 and 500 mg/kg bw
main study: 500 mg/kg bw - No. of animals per sex per dose:
- Preliminary sighting study: 1 (male)
Preliminary sighting study: 1 (female)
Main study: 5 (male)
Main study: 5 (female)
Results and discussion
- Preliminary study:
- The female treated with 2000 mg/kg was found dead one day after dosing. Clinical signs of toxicity noted in the male treated with 2000 mg/kg were hunched posture, lethargy, pilo-erection, decreased respiratory rate, Iaboured respiration, diarrhoea, dehydration and emaciation. Signs of toxicity noted in animals treated with 500 mg/kg were hunched posture and lethargy.
The male treated with 2000 mg/kg recovered twelve days after dosing and the animals treated with 500 mg/kg recovered six days after dosing.
Based on this information, a dose level of 500 mg/kg bodyweight was selected for the main study.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- discriminating dose
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: Common clinical signs of toxicity noted during the study were hunched posture with incidents of noisy respiration. Animals recovered two to four days after dosing.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The discriminatory dose was identified as 500 mg/kg bodyweight.
The acute oral median lethal dose (LD50 of the test item in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material may be of some concern if swallowed due to the nature of the toxic effects noted, but did not meet the criteria for classification under EU labelling regulations. No symbol or risk phrase are required. - Executive summary:
A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley CD strain rat. The method complied with that described in the OECD Guidelines for Testing of Chemicals No. 420 "Acute Oral Toxicity - Fixed Dose Method" (adopted 1 7 July 1992) and Method B1 bis in Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). The results may be used as a basis for classification and labelling under Annex VI of Council Directive 67/548/EEC (adapted to technical progress by Commission Directive 93/21/EEC) relating to the classification, packaging and labelling of dangerous substances.
Following a preliminary study at dose levels of 2000 and 500 mg/kg, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a solution in distilled water at a dose level of 500 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed and subjected to gross necropsy.
There were no deaths. Clinical signs of toxicity noted during the study were hunched posture and noisy respiration. Animals recovered two to four days after dosing.
All animals showed expected gains in bodyweight during the 14-day study period.
No abnormalities were noted at necropsy.
The discriminatory dose was identified as 500 mg/kg bodyweight.
The acute oral median lethal dose (LD50 of the test material, notified substance (i.e. 100% active matter), in the Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight. The test material may be of some concern if swallowed due to the nature of the toxic effects noted, but did not meet the criteria for classification under EU labelling regulations. No symbol or risk phrase are required.
This result is in compliance with those noted in the supporting study performed the diluted presentation the test item (i.e. LD 0 > 2000 mg/kg in a fixed dose).
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