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EC number: 265-352-1 | CAS number: 65060-02-8
- 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
Based on the results of the read across study, the acute LD50 of the test substance in male/female rats for the test substance is considered to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- July 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- KL2 due to RA
- Justification for type of information:
- Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Crédo, 69210 L'arbresle, France
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 178 +/- 7 g for males, 159 +/- 8 g for females
- Fasting period before study: 1 day
- Housing: housed in groups by sex
- Diet (e.g. ad libitum): "Rats et Souris entretien référence A04C" (U.A.R., 9160 Villemoisson-sur-Orge, Fance)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2°C
- Humidity (%): 30 to 70%
- Air changes (per hr): 12/h
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light - Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Males:
- 600 mg/kg (10 mL/kg)
Females:
- 200 mg/kg (10 ml/kg)
- 500 mg/kg (10 ml/kg)
- 750 mg/kg (15 ml/kg)
- 1,000 mg/kg (20 ml/kg) - No. of animals per sex per dose:
- 5 animals
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 d for females and 21 d for males
- Frequency of observations and weighing: Animals observed for clinical signs and mortality at frequent intervals on Day 1 and twice daily thereafter; body weight measured on Day 1, 8, 15 and 22.
- Necropsy of survivors performed: yes, animals were sacrificed by CO2.
- Other examinations performed: clinical signs, body weight - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 600 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: equivalent to 570 mg a.i./kg bw
- Mortality:
- Females: No mortality observed at 200 mg/kg. 20, 80 and 100% mortality observed at 500, 750 and 1,000 mg/kg bw, respectively.
Males: 20% mortality observed at 600 mg/kg bw. - Clinical signs:
- other: Females: - 200 and 500 mg/kg: hypoactivity on 4/5 animals on the day of administration. - 750 mg/kg: sedation, hypoactivity, lateral decubitus, dyspnoea, piloerection - 1,000 mg/kg: sedation, hypoactivity, piloerection, contaminated uro-vaginal area Mal
- Interpretation of results:
- other: Acute Tox. 4 based on CLP criteria
- Conclusions:
- Based on the results of the read across study, the acute LD50 of the test substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw).
- Executive summary:
A study was conducted to determine the acute oral toxicity of the read across substance, C12-14 ADMAES (> 95% active), in Sprague-Dawley rats according to OECD 401 Guideline. Groups of five Sprague-Dawley rats (5/dose) received a single oral (gavage) dose of 600 mg/kg bw of the read across substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 or 21 day observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg in females and 600 mg/kg in males. Under the study conditions, the acute oral median lethal dose (LD50) of the read across substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw) (Molinier, 1995). Based on the results of the read across study, similar LD50 value is expected for the test substance.
Reference
For details, kindly refer to the attached background material section of the IUCLID.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 570 mg/kg bw
- Quality of whole database:
- A reliable good quality study.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- other:
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as corrosive to the skin
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
A study was conducted to determine the acute oral toxicity of the read across substance, C12-14 ADMAES (> 95% active), in Sprague-Dawley rats according to OECD 401 Guideline. Groups of five Sprague-Dawley rats (5/dose) received a single oral (gavage) dose of 600 mg/kg bw of the read across substance. Parameters evaluated included survival, clinical observations, body weight and necropsy findings in all animals after a 14 or 21 day observation period in females and males, respectively. Mortality was observed at 500, 750 and 1,000 mg/kg in females and 600 mg/kg in males. Under the study conditions, the acute oral median lethal dose (LD50) of the read across substance in male/female rats was found to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw) (Molinier, 1995). Based on the results of the read across study, similar LD50 value is expected for the test substance.
Inhalation:
In accordance with Annex VII, Section 8.5, Column 2, additional acute toxicity study for inhalation route does not need to be conducted because the substance is classified as corrosive to the skin. Further, the substance is a solid (flakes) with a low vapour pressure at room temperature. Due to its physical state and physical chemical properties it is unlikely that this substance will form inhalable dust, mist or fumes during normal processing and use conditions. In case inhalable forms of the substance are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humansfollowing inhalation exposurecan be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.
Dermal:
In accordance with Annex VII, Section 8.5, Column 2, additional acute toxicity study for dermal route does not need to be conducted because the substance is classified as corrosive to the skin.
Justification for classification or non-classification
Based on the results of the read across studies, the test substance,C16 TMA-MS, is considered to be classified as 'Acute Tox.4, H302: harmful if swallowed' for oral route and 'Acute Tox.3, H311: toxic in contact with skin' for dermal route, according to the EU CLP criteria (Regulation EC 1272/2008). In addition, for the inhalation route, although C16 TMA MS is classified to be corrosive (see section 5.3) and this drives its mechanism of action of toxicity, its inherent low vapour pressure prohibits the occurrence of respiratory irritation or corrosion by vapour. Therefore, it does not warrant an additional labelling as: EUH071 — ‘Corrosive to the respiratory tract’ according to EU CLP criteria (Regulation EC 1272/2008).
Further, the available data does not show indication that classification for STOT-SE cat 1 or 2 is indicated. For STOT-SE Cat 3: C16 TMA MS or QAS substances are not narcotic.
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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