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EC number: 209-810-0 | CAS number: 593-81-7
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
- Acute oral toxicity: rats (HC/CFY (Remote Sprague-Dawley), TMA HCl as 58 % solution, single oral dose of 2000 mg/kg bw, gavage; LD50 > 2000 mg/kg bw (Key study 1,1984).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable well-documented study report, which meets basic scientific principles.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Trimethylamine hydrochloride was administered to HC/CFY rats by gavage at a single dose of 2000 mg/kg bw.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: HC/CFY (Remote Sprague-Dawley)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: not specified
- Age at study initiation: approximately four to six weeks of age
- Weight at study initiation: 86 to 111 g
- Fasting period before study: no. Access to food was only prevented overnight prior to and approximately 4 hours after dosing.
- Housing: housed in groups by sex in metal cages with wire mesh floors.
- Diet (e.g. ad libitum): ad libitum (a standard laboratory rodent diet (Laboratory Diet No. 1 Spratt's Rodent Breeding Diet (LAD1) Expanded obtained from Spratt's Specialist Services Division, new Malden, Surrey, England).
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 -23
- Humidity (%): 38 (mean)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: the substance was administered as supplied by the sponsor at a volume not exceeding 1.9 mL/kg (S.G.1.038).
- Doses:
- 2.0 g/kg bw (single oral dose).
- No. of animals per sex per dose:
- 5 males and 5 females in total.
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days. Animals were observed soon after dosing, then at frequent intervals for the remainder of Day 1. On subsequent days the animals were observed at least twice. Clinical signs were recorded at each observation.
- Frequency of observations and weighing: daily observations; individual bodyweights of rats were recorded on days 1 (day of dosing), 8 and 15 and at death.
- Necropsy of survivors performed: yes. Surviving animals were killed on day 15 by cervical dislocation. All animals were subjected to a macroskopic post mortem examination (opening the abdominal and thoracic cavities). The macroskopic appearance of abnormal organs was recorded.
- Other examinations performed: approximate time of death of individual rats; nature, severity, approximate time of onset and duration of each toxic sign. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 000 mg/kg bw
- Mortality:
- 3 rats dies following treatment at 2.0 g/kg bw within 3 and 20 hours of dosing.
- Clinical signs:
- - Pilo-erection, lethargy, decreased resypiratory rate and pallor pf the extremities.
The signs were accompanied by:
- abnormal body carriage (hunched posture),
- abnormal gait (waddling) and
- ptosis
amongst treated rats,
as well as
- body tremor and
- ataxia in the rats that subsequently died. - Body weight:
- Slight bodyweight losses were recorded for male rats that died.
Bodyweight gains of survinving rats were normal on Day 8 and 15. - Gross pathology:
- Autopsy revealed haemorrhage of the lungs and pallor of liver in the two male rats, with pallor of the spleen in one and pallor of the kidneys in the other one.
One male rats showed thickening of the glandular region of the stomach and intestine. The female rats was cannibalised so a meaningsful autopsy could not be undertaken.
Terminal autospy findings of surviving rats was normal. - Interpretation of results:
- other:
- Remarks:
- EU-GHS criteria not met
- Conclusions:
- Deaths occurred amongst rats treated at 2.0 g/kg bodyweight with trimethylamine hydrochloride salt, 58 % soultion. The acute median lethal dose (LD 50) is expected to be in the region of 2.0 g/kg body weight.
- Executive summary:
The acute oral toxicity of trimethylamine hydrochloride was investigated in HC/CFY rats by standard acute method (OECD 401, Huntingdon Research Centre plc., 1984). At a single oral dose of 2 g/kg bw 3 out of 10 rats died. The clinical signs were pilo-erection, lethargy, decreased respiratory rate and pallor of the extremities. The signs were accompanied by abnormal body carriage (hunched posture), abnormal gait (waddling) and ptosis or body tremor and ataxia in the rats that subsequently died. Slight bodyweight losses were recorded for male rats that died. Bodyweight gains of survinving rats were normal on Day 8 and 15. Autopsy revealed haemorrhage of the lungs and pallor of liver in the two male rats, with pallor of the spleen in one and pallor of the kidneys in the other one. One male rats showed thickening of the glandular region of the stomach and intestine. The female rats was cannibalised so a meaningsful autopsy could not be undertaken. Terminal autospy findings of surviving rats was normal.
In conclusion, an approximate lethal dosis is around 2 g/kg bw or 2000 mg/kg bw.
Based on the LD50 around 2 g/kg bw, classification is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- The study is well documented and has Klimisch score of 2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Acute toxicity: oral
The acute oral toxicity of Trimethylamine hydrochloride was investigated in HC/CFY rats by standard acute method (Key study, acc. to OECD 401). At a single oral dose of 2 g/kg bw (which corresponds to 2000 mg/kg bw) 3 out of 10 rats died. The clinical signs were pilo-erection, lethargy, decreased respiratory rate and pallor of the extremities. The signs were accompanied by abnormal body carriage (hunched posture), abnormal gait (waddling) and ptosis or body tremor and ataxia in the rats that subsequently died. Slight bodyweight losses were recorded for male rats that died. Bodyweight gains of survinving rats were normal on Day 8 and 15. Autopsy revealed haemorrhage of the lungs and pallor of liver in the two male rats, with pallor of the spleen in one and pallor of the kidneys in the other one. One male rats showed thickening of the glandular region of the stomach and intestine. The female rats was cannibalised so a meaningsful autopsy could not be undertaken. Terminal autospy findings of surviving rats was normal.
In conclusion, an approximate lethal dosis is around 2 g/kg bw or 2000 mg/kg bw.
Based on the LD50 around 2 g/kg bw, classification is not warranted according to the criteria of EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Trimethylamine and Trimethylammonium chloride belong to the group of tertiary aliphatic amines with a sp³-hybridized nitrogen with three methyl groups (common structure / functional group). The solvation of both Trimethylamine and Trimethylammonium chloride in water results in solutions of the Trimethylammonium cation (common "breakdown product"). Both respective counterions are naturally and ubiquitous occurring ions and are also to a certain extent required for the maintenance of various body functions. Besides the influence on the pH value of an aqueous solution (OH-), they do not bear a relevant intrinsic property, allowing one in general to focus on the Trimethylammonium cation. Genetic toxicity of the respective counterion is not applicable (Cl-, OH-), so primarily the trimethylammonium cation has to be evaluated. The Trimethylammonium cation is believed to act and to be metabolised by the same mechanisms by microorganisms and by other classes of living organisms and not to bind to biomolecules or DNA. Trimethylamine has been shown not to be acutely toxic via the dermal route of exposure.
Therefore both substances are expected to follow the same pattern of genetic toxicity. For the detailed procedure of the read-across principle and justifications, please refer to the analogue approach justification depicted below and the separate Read-Across Statement (Chemservice S.A., 2015).
Justification for classification or non-classification
Trimethylamine hydrochloride had LD50 value greater than 2000 mg/kg bw for acute oral toxicity. Trimethylamine as the read across substance had LD50 value greater than 5000 mg/kg bw for acute dermalral toxicity. Therefore, Trimethylamine hydrochloride does not meet the criteria for classification and labelling for oral, dermal or inhalatory toxicity in accordance with European Regulation (EC) No. 1272/2008.
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