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EC number: 216-699-2 | CAS number: 1643-19-2
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- To dertermine the skin irritation potential of test chemical.
- GLP compliance:
- 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:
- tetrabutylazanium bromide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material: Tetrabutylammonium bromide
- Molecular formula: C16H36N.Br
- Molecular weight: 322.368 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source : Institute for Industrial Research & Toxicology
Age : 10 to 12 weeks
Sex : Female
Body weight range : 1.80kg±200g
Identification : By cage tag and corresponding colour body marking
Environmental conditions : Air conditioned rooms with 10-15 air changes per hour, temperature between 22-25 deg C, relative humidity 40-60% and illumination cycle set to 12 hours artificial fluorescent light and 12 hours dark.
Accommodation : Animals were housed individually in stainless steel cages provided with stainless steel mesh bottom and facilities for food and water bottle.
Diet : Pelleted feed supplied by Pranav agro Industries Ltd., B7/6 Ramesh Nagar, Delhi
Water : Community tap water passed through ‘Aqua Guard on line water filter’, was kept in glass bottles, ad libitum
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 gm of test compound
- Duration of treatment / exposure:
- no data
- Observation period:
- upto 14 days after application
- Number of animals:
- Three
Results and discussion
In vivo
Results
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- other: 3 min - 14 days
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible
- Remarks on result:
- other: The skin irritation index of test compound Tetrabutylammonium bromide was calculated as: 2.00/4 = 0.50
- Irritant / corrosive response data:
- Very slight erythema after 4th to 24 hrs of application of test compound. There were no other signs of edema and other irritation. These responses were graded according to Draize’s Scoring method.
- Other effects:
- The test compound Tetrabutylammonium bromide applied on the shaven back skin of rabbit did not produce any clinical signs of toxicity throughout the examination period of 14 days.
Any other information on results incl. tables
TABLE – 1
INDIVIDUAL ANIMAL DERMAL IRRITATION SCORES
Rabbit No. |
Sex |
INTACT SKIN |
|||||||||||
3 Min. |
4 Hours |
24 Hours |
48 Hours |
72 Hours |
14 days |
||||||||
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
Erythema |
Oedema |
||
01 |
F |
0 |
0 |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02 |
F |
- |
- |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
03 |
F |
- |
- |
1 |
0 |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Total |
0 |
0 |
3 |
0 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Mean |
0 |
0 |
1.00 |
0 |
1.00 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Grand Total |
2.00 |
Dermal Irritation Index: 2.00/4 = 0.50
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- The result obtained from present study concludes that the test chemical is slightly irritatant on intact skin of New Zealand white rabbit under the test condition and has therefore been classified in the category of Skin irritant 2
- Executive summary:
The skin irritation study of test chemical was performed as per OECD Guidelines 404 in three female New Zealand White rabbits and complying with the GLP procedures. The animals were prepared 24 hours prior to application of test product. The furs from the dorsal area of trunk of animals were removed with electric clippers exposing an area measuring approximately 6 cm2 of body surface area of animal. The care was taken such that abrasion penetrated the Stratum corneum only and not dermis. 500gm (0.5g) of test compound was applied on a small area (approximately 6 cm2) of intact skin site. Each site of application was covered with impervious dressing which was secured in position with adhesive tape. The intact skin site of application of each animal was observed for signs of erythema and oedema at 60 min., 24, 48 and 72 hours after application and the responses were scored according to Draize method. Very slight erythema was observed after 4th to 24 hours of application of test compound. The skin irritation index of test compound was calculated as 0.50. Hence, under the test conditions,the test substancecan be concluded to be slightly irritating to New Zealand White rabbit skin.
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