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EC number: 214-291-9 | CAS number: 1119-97-7
- 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:
- 1977
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Read-across to tetradonium bromide from data on cetrimonium chloride (with data reliability value of 2).
Data source
Reference
- Reference Type:
- other: Assessment report for American Chemistry Council, Fatty Nitrogen Derivatives Panel, Cationics Task Group
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
- Principles of method if other than guideline:
- No guideline stated
- GLP compliance:
- not specified
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Cetrimonium chloride
- EC Number:
- 203-928-6
- EC Name:
- Cetrimonium chloride
- Cas Number:
- 112-02-7
- Molecular formula:
- C19H42N.Cl
- IUPAC Name:
- N,N,N-trimethylhexadecan-1-aminium chloride
- Details on test material:
- The SCCS opinion document and the assessment report for American Chemistry Council, Fatty Nitrogen Derivatives Panel, Cationics Task Group refer to a study with cetrimonium chloride.
- Name of test material (as cited in study report): cetrimonium chloride
- Molecular formula (if other than submission substance): C19H42N.Cl
- Molecular weight (if other than submission substance): 320.0
Constituent 1
- Specific details on test material used for the study:
- 1-Hexadecanaminium, N,N,N-trimethyl-, chloride (CAS RN 112-02-7; Ammonium, hexadecyltrimethyl-, chloride)
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Three males and three females weighed between 2.25 and 2.90 kg at study initiation. Prior to dosing, the fur was clipped from the test site (approximately 25% of the total body surface). The skin at the application site of one male and two female rabbits was abraded. The skin of the remaining rabbits was not abraded. The undiluted test substance was applied once dermally to the prepared site at the dose level of 4.3 ml/kg. The test substance was spread over the clipped area with a glass stirring rod. The entire test site was covered with two layers of 8-ply gauze, occluded with rubber dental dam and secured with porous tape. The rabbits were restrained in Newmann harnesses and returned to their cages for 24 hours.
- Duration of exposure:
- 24 hours
- Doses:
- 4.3 ml/kg
- No. of animals per sex per dose:
- 3
- Details on study design:
- After the 24-hour exposure period, the harnesses were removed, the occlusive wraps were removed and any remaining test substance was wiped off with a wet disposable towel. Test sites were graded for signs of irritation. Each rabbit was examined thoroughly for signs of systemic toxicity, changes in behavior, mortality and dermal irritation for 14 consecutive days following the day of dosing. After the 14-day observation period, the surviving animals were weighed, killed and necropsied to observe any internal gross effects. A gross necropsy was performed on each animal that died.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 4.3 mL/kg bw
- Based on:
- test mat.
- Mortality:
- One female rabbit died on day 5, one male died on Day 8 and one male died on day 13.
- Clinical signs:
- other: Signs of skin irritation noted at the end of the 24-hour exposure period included slight to severe erythema, moderate or severe edema and whitening of the skin of the exposure area. The erythema remained relatively unchanged throughout the study while the
- Gross pathology:
- At the end of the 24-hour exposure period, all animals exhibited normal behavior and appearance. On day 3, all rabbits exhibited depressed reflexes, body cold to touch, eating and defecating very little or none at all, a clear fluid around the nose and mouth, chin and front limbs. One male and one female rabbit held their heads in a downward and tilted position and the nictitating membranes and eyelid were reddened. These signs persisted throughout the major portion of the study or until death occurred.
Necropsy findings in the animals that died included brown, liquid, fecal material around the anal area, back legs and in colon, lungs adhered to chest wall, lungs white and filled with white granular pockets, gall bladder enlarged and brownish or clear fluid around nose, mouth, chin and front limbs. No visible lesions were noted during the necropsies of the surviving animals at termination.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The only dosage tested (4.3 ml/kg bw) caused death in 50% of the animals, and therefore 4.3 ml/kg bw (comparable to 2150 mg/kg bw with a density of 0.5 g/ml)is considered the LD50-value of cetrimonium chloride. Thus no classifcation for acute dermal toxicity applies according to the CLP critera.
- Executive summary:
The study reported in the SCCS opinion document and in the assessment report for American Chemistry Council, Fatty Nitrogen Derivatives Panel, Cationics Task Group describes an acute dermal toxicity test with cetrimonium chloride in 6 New Zealand white albino rabbits. The application site (approximately 25% of the total body surface) was clipped and for three animals the skin was abraded. The test substance was applied once dermally to the prepared site at the dose level of 4.3 ml/kg. The entire test site was occluded. After 24 hours of exposure, a 14 -day observation period followed. The only dosage tested (4.3 ml/kg bw) caused death in 50% of the animals, and therefore 4.3 ml/kg bw (comparable to 2150 mg/kg bw with a density of 0.5 g/ml) is considered the LD50-value of cetrimonium chloride. Thus no classifcation for acute dermal toxicity applies according to the CLP critera.
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