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EC number: 812-038-2 | CAS number: 1192651-80-1
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The aim of this study was to assess the toxicity potential of Tetrabutylammonium bromide after single oral administration in rats.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- Tetrabutylammonium bromide
- EC Number:
- 216-699-2
- EC Name:
- Tetrabutylammonium bromide
- Cas Number:
- 1643-19-2
- Molecular formula:
- C16H36N.Br
- IUPAC Name:
- N,N,N-tributylbutan-1-aminium bromide
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Tetrabutylammonium bromide
- Molecular formula: C16H36N.Br
- Molecular weight: 322.37 g/mol
- Substance type: Organic
- Physical state: White Solid (Crystals)
- Analytical purity: 99.9%
- Lot/batch No.: Lot 1/02
- Storage condition of test material:Stored in cool, dry place. Kept in closed container when not in use.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Bharat Serum and Vaccines Limited, India.
- Age at study initiation: 8- 11 weeks at the time of dosing.
- Health status: Healthy young adult animals were used for the study. Females were nulliparous and non pregnant.
- Weight at study initiation: 197 g - 218 g (Individual body weights were within ± 4% prior to treatment after overnight fasting)
- Fasting period: The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing.
- Housing: The animals were housed individually in polycarbonate cages.
- Bedding: All cages were provided with corn cobs.
- Diet: All animals were provided conventional laboratory rodent diet (Nutrivet Life Sciences, Pune), ad libitum.
- Water: Aqua guard filtered tap water was provided ad libitum via drinking bottles.
- Acclimation period: at least five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4 - 23.1.
- Humidity (%):Minimum: 38.4 - 58.7.
- Air changes (per hr): More than 12 changes per hour.
- Photoperiod (hrs dark / hrs light):12/12
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: distilled water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):up to 10 ml
- Justification for choice of vehicle:N/A
- Lot/batch no. (if required):N/A
- Purity:N/A
MAXIMUM DOSE VOLUME APPLIED:10 ml/kg body weight. - Doses:
- 300 mg/kg bw, 2000 mg/kg bw
- No. of animals per sex per dose:
- 9
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Daily
- Necropsy of survivors performed: yes
At the end of 14 day observation period, all the survived rats were euthanised by overdose of CO2 for external and internal observations.
- Other examinations performed:
Clinical Observation
After test item administration, individual animals were frequently observed at 30 minutes, 1, 2, 3 and 4 hours post dosing on day 0 (day of dosing). Subsequently, all the surviving animals were observed once a day during the 14 day observation period.
Body weight
All surviving rats were weighed on days 0 (prior to dosing), 7 and 14. Animals were weighed immediately after found dead.
other:
Mortality
All surviving animals were observed twice daily (morning and evening) for morbidity and mortality, throughout the acclimatization and study period.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 500 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed in the animals treated with 300 mg/kg dose throughout the 14 days observation period, whereas all three animals treated with 2000 mg/kg dose level were found dead on day 0 post dosing (two rats found dead after 1 hour, one rat found dead after 2 hours).
- Clinical signs:
- At 300 mg/kg, all six animals were observed normal throughout the experiment period. At 2000 mg/kg bw, one animal was observed with mild tremors at 30 minutes, mild to moderate abdominal breathing at 30 minutes and 1 hour and sternal recumbency at 1 hour followed by death. The other two animals dosed at 2000 mg/kg bw were observed with mild tremors, moderate abdominal breathing, sternal recumbency and moderate salivation at 30 minutes followed by death.
- Body weight:
- Body weight gain was observed in the animals treated with 300 mg/kg body weight, during the 14 day observation period, as compared to day 0.
- Gross pathology:
- No external or internal gross pathological changes were seen in all the six animals treated with 300 mg/kg body weight during terminal sacrifice. At 2000 mg/kg, one rat was observed with no abnormalities, whereas the other two animals were observed with wet around mouth.
The rats dosed at 2000 mg/kg bw showed severe red discoloration of all lung lobes and test item was observed in stomach and intestine.
Any other information on results incl. tables
Table 1: Individual Animal Body Weight (g) andBody Weight Changes(%)
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Body Weight (gram) |
Body Weight Change (%) |
||||
Day 0 |
Day 7 |
Day 14 |
Found Dead Animal |
Day 0-7 |
Day 0-14 |
||
1 |
G1/ 300 |
197 |
219 |
227 |
- |
11.17 |
15.23 |
2 |
206 |
238 |
258 |
- |
15.53 |
25.24 |
|
3 |
207 |
230 |
246 |
- |
11.11 |
18.84 |
|
4 |
200 |
205 |
210 |
- |
2.50 |
5.00 |
|
5 |
197 |
218 |
212 |
- |
10.66 |
7.61 |
|
6 |
198 |
220 |
223 |
- |
11.11 |
12.63 |
|
7 |
G2/ 2000 |
218 |
- |
- |
214 |
- |
- |
8 |
215 |
- |
- |
217 |
- |
- |
|
9 |
212 |
- |
- |
211 |
- |
- |
Key:- = Not Applicable
Table 2: Summary of Animal Body Weight (g) and Body Weight Changes (%)
Sex:Female
Group/ Dose (mg/kg) |
Rats Body Weight (g) |
Body Weight Changes (%) |
||||
Day 0 |
Day 7 |
Day 14 |
0-7 |
0-14 |
||
G1/ 300 |
Mean |
200.83 |
221.67 |
229.33 |
10.35 |
14.09 |
SD |
4.54 |
11.29 |
19.08 |
4.25 |
7.42 |
|
n |
6 |
6 |
6 |
6 |
6 |
|
G2/ 2000 |
Mean |
215.00 |
- |
- |
- |
- |
SD |
3.00 |
- |
- |
- |
- |
|
n |
3 |
- |
- |
- |
- |
Keys:- = Not Applicable, SD = Standard Deviation, n = Number of Animals
Table 3: Individual Animal Clinical Signs and Symptoms
Sex:Female
Animal No. |
Group/ Dose (mg/kg) |
Hours (Day 0) |
||||
1/2 |
1 |
2 |
3 |
4 |
||
1 |
G1/ 300 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
|
3 |
1 |
1 |
1 |
1 |
1 |
|
4 |
1 |
1 |
1 |
1 |
1 |
|
5 |
1 |
1 |
1 |
1 |
1 |
|
6 |
1 |
1 |
1 |
1 |
1 |
|
7 |
G2/ 2000 |
166+ 4+ |
155 4++ 2 |
- |
- |
- |
8 |
166+ 4++ 155 145++ 2 |
- |
- |
- |
- |
|
9 |
166+ 4++ 155 145++ 2 |
- |
- |
- |
- |
Animal No. |
Group/ Dose (mg/kg) |
Days post dosing |
|||||||||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||||||||||||||||||
1 |
G1/ 300 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
||||||||||||||||
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
4 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
5 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
6 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
|||||||||||||||||
7 |
G2/ 2000 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||||||||||||||||
8 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
|||||||||||||||||
9 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
Keys:- = Not applicable, 1 = Normal, 2 = Found dead, 4 = Abdominal breathing, 145 = Salivation, 155 = Sternal recumbency, 166 = Tremors, + = Mild, ++ = Moderate
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of an acute oral toxicity study, the acute oral LD50 (cut-off value) of tetrabutylammonium bromide was found to exceed 500 mg/kg body weight. This result is read across to SAM-3, as described in the read across rationale attached in section 13.
- Executive summary:
An acute oral toxicity study was performed with tetrabutylammonium bromide in ratsaccording to OECD guideline 423.
Three female rats were dosed at 300 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 300 mg/kg body weight and no mortality was observed. Three other rats were dosed with 2000 mg/kg weight. All the rats at 2000 mg/kg were found dead on day 0 post dosing. Hence, further dosing was stopped. Body weight gain was observed in all surviving animals treated with 300 mg/kg body weight, during the 14 day observation period, as compared to day 0. At 300 mg/kg, all six animals were observed normal throughout the experiment period. No external gross pathological changes were seen in all six animals treated with 300 mg/kg body weight at terminal sacrifice. At 2000 mg/kg, one animal was observed with no abnormalities, whereas two animals were observed with wet around mouth. No internal gross pathological changes were seen in all the six animals treated with 300 mg/kg body weight during terminal sacrifice. At 2000 mg/kg, all three animals were observed with severe red discoloration of all lobes lungs and test item was observed in stomach and intestine.
Based on these data, it was concluded that the acute oral LD50 of tetrabutylammonium bromide exceeded 500 mg/kg body weight. This result is read across to SAM-3, as described in the read across rationale attached in section 13.
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