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Diss Factsheets
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EC number: 946-512-6 | 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
Endpoint summary
Administrative data
Description of key information
Read-across data on acute oral toxicity of tetradonium bromide (C14 TMAB) in rats indicate LD50 value of 390 mg/kg bw.
Read-across data for acute dermal toxicity on cetrimonium chloride (C16 TMAC) in rabbits. A dermal LD50 value of 4.3 ml/kg bw was found for cetrimonium chloride (corresponding to 2150 mg/kg bw ).
Read-across data for acute inhalation toxicity on cetrimonium
bromide (C16 TMAC) includes a 30 minutes inhalation study with mice. The
study indicates pulmonary irritation as dose-related reduced tidal
volume and increase in respiratory frequency was found with a LOEC of
1.8 mg cetrimonium bromide/m3 and a NOEC of 0.57 mg cetrimonium
bromide/m3. Initial signs of pulmonary inflammation were found at 19 mg
cetrimonium bromide/m3 based on an increase in macrophages in BAL.
See attached read-across justification in section 13.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 390 mg/kg bw
- Quality of whole database:
- Klimisch Score 1, as all reported parameters are closely comparable to guideline.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- discriminating conc.
- Value:
- 1.8 mg/m³
- Quality of whole database:
- Klimisch score 2
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 150 mg/kg bw
- Quality of whole database:
- Klimisch score 2
Additional information
Justification for selection of acute toxicity – oral endpoint
Read-aross to data on tetradonium bromide. The study is an oral
acute toxicity study with rats similar to OECD 401 but with an initial
range finding study for a more exact establishment of LD50.
Justification for selection of acute toxicity – inhalation endpoint
Read across to available study concerning inhalation of cetrimonium
bromide. Non-guideline study determining pulmonary irritation and
inflammation in mice after 30 minutes of exposure. The observed effects
considered relevant for classification for respiratory (pulmonary)
irritation, STOT SE3; H335.
Justification for selection of acute toxicity – dermal endpoint
Read across to available dermal acute toxicity study on cetrimonium
chloride. No evidence for classifcation for acute dermal toxicity
applies according to the CLP critera.
Justification for classification or non-classification
Read-across to C12 -14 TMAB is made from data on C14 TMAB, C16 TMAC and C16 TMAB (see read-across justification attached in section 13).
Data on acute oral toxicity of tetradonium bromide, indicate that tetradonium bromide should be classified as Acute tox 4; H302 for acute oral toxicity.
A dermal LD50 value of 4.3 ml/kg bw was found for cetrimonium chloride (corresponding to 2150 mg/kg bw ), which is above the CLP classification criteria.
Read-across from data on acute inhalation toxicity on cetrimonium bromide indicates that tetradonium bromide should be classified as STOT SE3; H335. A 30 minutes inhalation study with mice indicates pulmonary irritation as dose-related reduced tidal volume and increase in respiratory frequency was found with a LOEC of 1.8 mg cetrimonium bromide/m3 and a NOEC of 0.57 mg cetrimonium bromide/m3. Initial signs of pulmonary inflammation were found at 19 mg cetrimonium bromide/m3 based on an increase in macrophages in BAL.
However, no mortality were noted at rather low dose levels used (up to 19 mg/m3), thus, data are not sufficient and conclusive regarding assessment of acute toxicity by inhalation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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