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EC number: 219-648-2 | CAS number: 2491-06-7
- 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
Endpoint summary
Administrative data
Description of key information
LD50 was considered to be 5400 mg/kg bw (95% confidential limit 4500 - 6400 mg/kg) for males and females,5800 mg/kg (95% confidential limit = 5100 – 6600 mg/kg) for males and 3900 mg/kg (95% confidential limit = 3000 - 5000 mg/kg) forfemales, when Crl:CD® BR male and female rats were treated with N,N-dimethylglycinium chloride orally by gavage.
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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication
- Qualifier:
- according to guideline
- Guideline:
- other: as below
- Principles of method if other than guideline:
- Acute oral toxicity of N,N-dimethylglycinium chloride (2491-06-7) in rat.
- GLP compliance:
- not specified
- Test type:
- other: not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): N,N-dimethylglycinium Hydrochloride
- Molecular formula (if other than submission substance): C4H10ClNO2
- Molecular weight (if other than submission substance): 139.581 g/mol
- Substance type: Organic - Species:
- rat
- Strain:
- other: Crl:CD® BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: No data
- Age at study initiation: young adult albino rats were taken for the study.
- Weight at study initiation: No data
- Fasting period before study: 17 to 20 hours
- Housing:
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): ad libitum
- Acclimation period: No data - Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- distilled
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3000 and 5000 mg/kg for female and 5000 and 6500 mg/kg for male
- Amount of vehicle (if gavage): 20.00 ml/Kg
- Justification for choice of vehicle: distilled water
- Lot/batch no. (if required):not specified
- Purity:not specified
MAXIMUM DOSE VOLUME APPLIED:not specified
DOSAGE PREPARATION (if unusual): Test material was mixed in distilled water, pH then adjusted to 7.4 using a NaOH solution and administered at a dose volume of 20.00 ml/Kg for each animal.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose:not specified - Doses:
- Females – 3000, 5000, 7000 mg/kg
Male – 5000, 6000 and 7000 mg/kg - No. of animals per sex per dose:
- Total = 30
5 female -3000 mg/kg
5 female - 5000 mg/kg
5 female - 7000 mg/kg
5 male - 5000 mg/kg
5 male - 6000 mg/kg
5 male - 7000 mg/kg - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: The animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. Surviving animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality.
Weighing: All animals were weighed just before test material administration and again at Day 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: The animals were observed for clinical signs, body weight and gross pathology were examination. - Statistics:
- A Computer Program for Estimating LD50 and its Confidence Limits Using a Modified Behrens-Reed-Muench Cumulant Method
- Preliminary study:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 4 500 - 6 400
- Remarks on result:
- other: 50 5 mortality observed
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 5 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 5 100 - 6 600
- Remarks on result:
- other: 50 % mortality observed
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 3 900 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 3 000 - 5 000
- Remarks on result:
- other: 50 % mortality observed
- Mortality:
- When treated with 7000 mg/kg bw, all male and female died within 2.5 to 4 hours.
When treated with 6000 mg/kg bw, 3 male died.
When treated with 5000 mg/kg bw, all female rats were died.
When treated with 3000 and 5000 mg/kg bw, no mortality were observed in male and female rats. - Clinical signs:
- other: Hypoactivity, ataxia, diarrhea, brown-stained abdomen, red-stained face, dyspnea, circling movements, prostration and absence of pain reflex in rats were observed in treated rats.
- Gross pathology:
- Test substance centred around the gastrointestinal tract were observed in dead animals and no gross lesions were observed in the animals which surviving to the termination of the experimental phase.
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- LD50 was considered to be 5400 mg/kg bw (95% confidential limit 4500 - 6400 mg/kg) for males and females, 5800 mg/kg (95% confidential limit = 5100 – 6600 mg/kg) for males and 3900 mg/kg (95% confidential limit = 3000 - 5000 mg/kg) for females, when Crl:CD® BR male and female rats were treated with N,N-dimethylglycinium chloride orally by gavage.
- Executive summary:
In a acute oral toxicity study, groups of five female and five male young adult albino Crl:CD® BR rats were treated with N,N-dimethylglycinium chloride at the concentration of 3000, 5000, 7000 mg/kg in Females and 5000, 6000 and 7000 mg/kg in Males.Each dose of test material was mixed in distilled water, pH then adjusted to 7.4 using a NaOH solution and administered at a dose volume of 20 ml/kg for each animal by gavage route.Animals were fasted17 to 20 hours prior to dosing. Water wasfully available at all times.The animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. Surviving animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality. All animals were weighed just before test material administration and again at Day 7 and 14. All animals, whether dying during the study or euthanatized at study termination, were subjected to a gross necropsy examination and all abnormalities were reported. All male and female died within 2.5 to 4 hours at 7000 mg/kg bw, 3 male died at 6000 mg/kg bw, all female rats were died at 5000 mg/kg bw and no mortality were observed in male and female rats at 3000 and 5000 mg/kg bw. Hypoactivity, ataxia, diarrhea, brown-stained abdomen, red-stained face, dyspnea, circling movements, prostration and absence of pain reflex in rats were observed in treated rats. Weight gain was observed in animals which survive to the end of the observation period.Test substance centred around the gastrointestinal tract were observed in dead animals and no gross lesions were observed in the animals which surviving to the termination of the experimental phase. Therefore,LD50 was considered to be 5400 mg/kg bw (95% confidential limit 4500 - 6400 mg/kg) for males and females,5800 mg/kg (95% confidential limit = 5100 – 6600 mg/kg) for males and 3900 mg/kg (95% confidential limit = 3000 - 5000 mg/kg) forfemales, when Crl:CD® BR male and female rats were treated with N,N-dimethylglycinium chloride orally by gavage.
Reference
Table – Acute oral toxicity in rats
DOSE AS DMG FREEBASE G/KG |
1DOSE AS DMG FREEBASE G/KG |
NUMBER DOSED |
CUMULATIVE MORTALITY |
|||||||||
HOUR |
DAY |
|||||||||||
1 |
2.5 |
4 |
1 |
2 |
3 |
4 |
5 |
6 |
7-14 |
|||
3 |
2.3 |
5F |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
3.8 |
5M |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5 |
3.8 |
5F |
0 |
0 |
0 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
6 |
4.6 |
5M |
0 |
0 |
0 |
2 |
3 |
3 |
3 |
3 |
3 |
3 |
7 |
5.3 |
5M |
0 |
1 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
7 |
5.3 |
5F |
0 |
3 |
4 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
1 - Dose reflects content as DMG freebase equivalent calculated at 75.9% of the hydrochloride level.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 400 mg/kg bw
- Quality of whole database:
- Data is Klimisch 2 and from peer- reviewed journal
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 oral toxicity:
In different studies,2-(dimethylamino)acetic acid hydrochloridehas been investigated for acute oral toxicity to a greater or lesser extent. Often are the studies based on in vivo experiments and estimated data in rodents, i.e. most commonly in rats for2-(dimethylamino)acetic acid hydrochloridealong with the study available on structurally similar read across substanceN,N-dimethylglycine (CAS no 1118-68-9)The predicted data using the OECD QSAR toolbox has also been compared with the experimental studies.
In a experimental study conducted by Kendallet al(International Journal of Toxicology, Volume: 1 issue: 3s, page 198, 1992), groups of five female and five male young adult albino Crl:CD® BR rats were treated with N,N-dimethylglycinium chloride at the concentration of 3000, 5000, 7000 mg/kg in Females and 5000, 6000 and 7000 mg/kg in Males.Each dose of test material was mixed in distilled water, pH then adjusted to 7.4 using a NaOH solution and administered at a dose volume of 20 ml/kg for each animal by gavage route.Animals were fasted17 to 20 hours prior to dosing. Water wasfully available at all times.The animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. Surviving animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality. All animals were weighed just before test material administration and again at Day 7 and 14. All animals, whether dying during the study or euthanatized at study termination, were subjected to a gross necropsy examination and all abnormalities were reported. All male and female died within 2.5 to 4 hours at 7000 mg/kg bw, 3 male died at 6000 mg/kg bw, all female rats were died at 5000 mg/kg bw and no mortality were observed in male and female rats at 3000 and 5000 mg/kg bw. Hypoactivity, ataxia, diarrhea, brown-stained abdomen, red-stained face, dyspnea, circling movements, prostration and absence of pain reflex in rats were observed in treated rats. Weight gain was observed in animals which survive to the end of the observation period.Test substance centred around the gastrointestinal tract were observed in dead animals and no gross lesions were observed in the animals which surviving to the termination of the experimental phase. Therefore,LD50 was considered to be 5400 mg/kg bw (95% confidential limit 4500 - 6400 mg/kg) for males and females,5800 mg/kg (95% confidential limit = 5100 – 6600 mg/kg) for males and 3900 mg/kg (95% confidential limit = 3000 - 5000 mg/kg) forfemales, when Crl:CD® BR male and female rats were treated with N,N-dimethylglycinium chloride orally by gavage.
In another prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for2-(dimethylamino) acetic acid hydrochloride. The LD50 was estimated to be 2676 mg/kg bw when rats were orally exposed with2-(dimethylamino) acetic acid hydrochloride.
Further suppurated by experimental study conducted by Kendall et al(International Journal of Toxicology, Volume: 1 issue: 3s, page(s): 199-199, 1982) on structurally similar read across substance N,N-dimethylglycine (CAS 1118-68-9),five female and five male young adult albino Crl:CD® BR rats were treated with N,N-dimethylglycine the in concentration of 3000 and 5000 mg/kg in Females and 5000 and 6500 mg/kg in Males orally by gavage.Each dose of test material was mixed in distilled water, pH then adjusted to 7.4 using a NaOH solution and administered at a dose volume of 20 ml/kg for each animal by gavage route.Animals were fasted17 to 20 hours prior to dosing. Water wasfully available at all times.The animals were observed for clinical signs and mortality at 1, 2.5 and 4 hours after test material administration. Animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality. All animals were weighed just before test material administration and again at Day 7 and 14. All animals were euthanatized at study termination and were subjected to a gross necropsy examination with all abnormalities being recorded.No deaths were observed in treated male and female rats. Hypoactivity, ataxia, diarrhea, brown-stained abdomen, red-stained face and brown-stained urogential area were observed in treated rats. Weight gain was observed in animals.Multiple opaque areas over the entire spleen were observed in one 3000 mg/kg bw treated female rat. No gross lesions were observed in other treated rats. Therefore, LD50 was considered to be > 6500 mg/kg bw for Males and > 5000 mg/kg bw for Females, when Crl:CD® BR male and female rats were treated with N,N-dimethylglycine orally by gavage.
This is suppurated by experimental study summarized by Hoornet al(Mutation Research, 222 (1989) 343-350) on structurally similar read across substance N,N-dimethylglycine (CAS 1118-68-9), rats were treated with N,N-dimethylglycine at the concentration of 7000 mg/kg bw. No mortality was observed in treated rats at 7000 gm/kg bw. Therefore, The LD50 was considered to be >7000 mg/kg bw, when rats were treated with N,N-dimethylglycine orally.
Again this is supported by experimental study given by U.S. National Library of Medicine (ChemIDplus, A TOXNET DATABASE, Lite Browse Advanced, 2017) on structurally similar read across substance N-Nitrososarcosine (CAS no: 13256-22-9),rats were treated with N-Nitrososarcosine at the concentration of 5000 mg/kg bw. No mortality was observedin treated rats.Therefore, LD50 was considered to be >5000 mg/kg bw, when rats were treated with N-Nitrososarcosine (CAS no: 13256-22-9) orally.
Thus, based on the above studies and predictions on2-(dimethylamino)acetic acid hydrochlorideand its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,2-(dimethylamino)acetic acid hydrochloridecan be classified as category V of acute oral toxicity.
Justification for classification or non-classification
Based on the above studies and predictions on2-(dimethylamino)acetic acid hydrochlorideand its read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,2-(dimethylamino)acetic acid hydrochloridecan be classified as category V of acute oral toxicity.
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