Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-769-4 | CAS number: 71-91-0
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25-03-1986 to 08-04-1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Principles of method if other than guideline:
- Acute oral toxicity study of the given test chemical in rats.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Tetrylammonium bromide
- EC Number:
- 200-769-4
- EC Name:
- Tetrylammonium bromide
- Cas Number:
- 71-91-0
- Molecular formula:
- C8H20N.Br
- IUPAC Name:
- N,N,N-triethylethanaminium bromide
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material: Tetraethylammonium bromide (4E-ammBr)
- IUPAC name: N,N,N-triethylethanaminium bromide (TEAB)
- Molecular formula: C8H20NBr
- Molecular weight: 210.6 g/mole
- Substance type: Organic
- Purity : 100.1-100.2 % based on Br-
- Appearance: Crystalline powder
- Storage: At ambient temperature in the dark
- Batch No. : HH 85-83A
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa-Credo, Rrussels, Belgium
- Age at study initiation: 8 weeks, 6 days
- Weight at study initiation: Male: 360-402 g, Female: 205-251 g
- Fasting period before study: Animals were fasted overnight before dosing till 3-4 hours after administration of test substance.
- Housing: Animals were housed in Macrolon cage
- Diet (e.g. ad libitum): Standard laboratory animal diet (RMH-B, pellet diameter 10 mm)
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22 °C
- Humidity (%):30-75 %
- Photoperiod (hrs dark / hrs light): Artificial light sequence was 12 hrs dark, 12 hrs light
IN-LIFE DATES: From: 25-03-1986 to 08-04-1986
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Milli-RO
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1800, 2400 and 3200 mg/kg body weight
- Amount of vehicle (if gavage): 10 ml/kg body weight
- Justification for choice of vehicle: Milli-RO water
DOSAGE PREPARATION (if unusual): test substance was formulated in Milli-RO water at 1800, 2400 and 3200 mg/kg body weight. - Doses:
- 1800, 2400 and 3200 mg/kg body weight
- No. of animals per sex per dose:
- Total: 30
1800 mg/kg bw: 5 male, 5 female
2400 mg/kg bw: 5 male, 5 female
3200 mg/kg bw: 5 male, 5 female - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical sign observed daily and body weight on day 0,7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: survival,clinical signs, body weight, gross pathology and histopathology were examined. - Statistics:
- LD50 was calculated with U-distribution and maximum likelihood (Finney).
Results and discussion
- Preliminary study:
- Dose range finding investigation: In order to establish an appropriate dose range, eleven groups of Sprague-Dawley rats, each comprising 1 male and 1 female, were dosed with a single oral dose of the test substance at 75, 100, 130, 180, 240, 320, 420, 750, 1300, 2400 and 4200 mg/kg bw, respectively. Both animals of the 4200 mg/kg bw and the male of the 2400 mg/kg bw group were found dead within a few minutes after dosing. Surviving animals revealed no signs of evident systemic toxicity during the 7 days observation period. Macroscopic examination at autopsy of all animals revealed no gross abnormalities.
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 500 - 3 400
- Remarks on result:
- other: 50 % mortality observed
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 300 - 3 100
- Remarks on result:
- other: 50 % mortality observed
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 2 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 2 200 - 16 500
- Remarks on result:
- other: 50 % mortality observed
- Mortality:
- When treated with 3200 mg/kg bw, 5 male and 3 female died.
When treated with 2400 mg/kg bw, 1 male and 2 female died.
When treated with 1800 mg/kg bw, No mortality were observed in treated male and female rats. - Clinical signs:
- other: Lethargy, tremors, convulsions, coma, laboured breathing and diarrhoea sign of toxicity were observed.Other findings were observed unbalanced gait and bloody nose or eye encrustation. In surviving animals, these signs were reversible since generally as of
- Gross pathology:
- Hyperemia, petechiae or erosion of stomach frequently followed by bloody gastrointestinal content were observed in dead animals. Other gross internal findings were renal hyperemia, motteled kidney, aqueous gastrointestinal content (possibly test substance) and autolysis.At the end of study in surviving animals no test substance related gross abnormalities were observed
- Other findings:
- not specified
Any other information on results incl. tables
Table 1: Day of death and Number of Mortalities after oral administration of TEAB in the rats
Day of Death |
Mortalities (Male/ Female) |
||
|
Dosage mg/kg |
||
|
1800 |
2400 |
3200 |
0 |
0/0 |
1/1 |
5/3 |
1 |
0/0 |
0/1 |
0/0 |
Sum |
|
|
|
Male / Female |
0/0 |
1/2 |
5/3 |
Sexes combined |
0 |
3 |
8 |
Note: the dose groups comprised 5 male and 5 female rats. Indicated are the number of animals (Male / Female) found dead during the 14 day observation period.
Table 2: Daily incidence of Cage side observation for male and female rats after a single oral dose of TEAB: 1800 mg/kg bw
|
Day of observation |
||||||||||||||||||
observation |
Sex |
0a) |
0b) |
0c) |
0d) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
No abnormalities |
M |
2/5 |
3/5 |
3/5 |
4/5 |
2/5 |
4/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
|
5/5 |
5/5 |
5/5 |
|
F |
2/5 |
2/5 |
1/5 |
|
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
5/5 |
Lethargy |
M |
3/5 |
2/5 |
2/5 |
1/5 |
1/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
3/5 |
3/5 |
4/5 |
5/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tremors |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
2/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bloody nose/eye encrustation |
M |
|
|
|
|
2/5 |
1/5 |
|
|
|
|
|
|
|
|
2/5 |
|
|
|
|
F |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diarrhoea |
M |
|
|
|
|
1/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 3: Daily incidence of Cage side observation for male and female rats after a single oral dose of TEAB: 2400 mg/kg bw
|
Day of observation |
||||||||||||||||||
observation |
Sex |
0a) |
0b) |
0c) |
0d) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
No abnormalities |
M |
|
|
|
|
2/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
4/4 |
|
F |
|
|
1/5 |
|
2/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
3/3 |
Lethargy |
M |
4/4 |
4/4 |
4/4 |
4/4 |
1/4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
5/5 |
5/5 |
4/5 |
5/5 |
1/3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Tremors |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
3/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laboured breathing |
M |
|
1/4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unbalanced gait |
M |
|
|
|
1/5 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bloody nose/eye encrustation |
M |
|
|
|
|
1/4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Table 4: Daily incidence of Cage side observation for male and female rats after a single oral dose of TEAB: 3200 mg/kg bw
|
Day of observation |
||||||||||||||||||
observation |
Sex |
0a) |
0b) |
0c) |
0d) |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
No abnormalities |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
1/4 |
|
|
|
1/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
2/2 |
Lethargy |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
1/4 |
2/2 |
2/2 |
2/2 |
1/2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Tremors |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
|
|
2/2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convulsions |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
1/4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comatous |
M |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F |
|
1/4 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
a) Approx. 1/4 - 1 1/4 hours postdosing
b) Approx. 1 3/4- 2 3/4 hours postdosing
c) Approx. 3 1/4 – 4 1/4 hours postdosing
d) Approx. 4 1/2 – 5 1/2 hours hours postdosing
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- The acute oral LD50 value was considered to be 2800 mg/kg bw, with 95% confidence limit of 2500-3400 mg/kg bw for both male and female rats, 2500 mg/kg bw, with 95% confidence limit of 2300-3100 mg/kg bw for male rats and 2800 mg/kg bw, with 95% confidence limit of 1650- 2200 mg/kg bw for female rats, when groups of 5 male and 5 female Sprague-Dawley rats were treated with the given test chemical orally by gavage in Milli-RO water.
- Executive summary:
In a acute oral toxicity study, groups of 5 male and 5 female Sprague-Dawley rats were treated with the given test chemical at the dose concentrations of 1800, 2400 and 3200 mg/kg body weight as per OECD 401.
The given test substance was formulated in Milli-RO water and administered as 10 ml/kg body weight via oral gavage route.
In order to establish an appropriate dose range, eleven groups of Sprague-Dawley rats, each comprising 1 male and 1 female, were dosed with a single oral dose of the test substance at 75, 100, 130, 180, 240, 320, 420, 750, 1300, 2400 and 4200 mg/kg bw, respectively. Both animals of the 4200 mg/kg bw and the male of the 2400 mg/kg bw group were found dead within a few minutes after dosing. Surviving animals revealed no signs of evident systemic toxicity during the 7 days observation period. Macroscopic examination at autopsy of all animals revealed no gross abnormalities.
Based on the toxicity observed in the dose range finding investigation three groups of animals, each comprising 5 males and 5 females, were dosed with a single oral dose of the test substance at 1800, 2400 and 3200 mg/kg body weight, respectively.
Animals were observed for mortality and clinical signs daily and body weight on day 0,7 and 14 day. Necropsy of survivors performed. Gross pathology and histopathology were examined. LD50 was calculated with U-distribution and maximum likelihood (Finney).
Mortality was observed as, when treated with 3200 mg/kg bw, 5 male and 3 female died; when treated with 2400 mg/kg bw, 1 male and 2 female died; when treated with 1800 mg/kg bw, no mortality were observed in male and female rats.
Lethargy, tremors, convulsions, coma, laboured breathing and diarrhoea sign of toxicity were observed. Other findings were observed unbalanced gait and bloody nose or eye encrustation.
In surviving animals, these signs were reversible since generally as of day 3 no more abnormalities were observed during the 14 day observation period. No effect on body weight gain was observed in treated male and female rats. Hyperemia, petechiae or erosion of stomach frequently followed by bloody gastrointestinal content were observed in dead animals. Other gross internal findings were renal hyperemia, motteled kidney, aqueous gastrointestinal content (possibly test substance) and autolysis.At the end of study in surviving animals no test substance related gross abnormalities were observed
Under the condition of the study, the acute oral LD50 value was considered to be 2800 mg/kg bw, with 95% confidence limit of 2500-3400 mg/kg bw for both male and female rats, 2500 mg/kg bw, with 95% confidence limit of 2300-3100 mg/kg bw for male rats and 2800 mg/kg bw, with 95% confidence limit of 1650- 2200 mg/kg bw for female rats, when groups of 5 male and 5 female Sprague-Dawley rats were treated with the given test chemical orally by gavage in Milli-RO water.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
