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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
Eye irritation
Administrative data
- Endpoint:
- eye 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
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 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 2nd October, 2012
- Principles of method if other than guideline:
- The objective of the study was to assess the irritant and/or corrosive effects of “Tetrabutylammonium bromide (CAS No. - 1643-19-2)” on eye, when exposed by the ocular route in rabbits.
- GLP compliance:
- yes
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
- 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)
- Lot/batch No.:Lot 1/02
- AI Content:99.9 %
- Storage condition of test material:The test item was stored in a cool, dry place and kept in a closed.
- Other:
Handling and Disposal
Safety precautions : Aprons, masks, caps, gloves and goggles were used to ensure the health and safety of the personnel.
Disposal : No test item was disposed during the conduct of the study and the same was documented in the raw data.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Rabbiroof, Hyderabad, India.
- Age at study initiation: Appr. 4.5 - 5.5 months
- Weight at study initiation: 1.932 kg- 2.438 kg
- Health Status: Healthy young adult, females were nulliparous and non pregnant.
- Housing: The animals were housed individually in stainless steel cages.
- Diet: All animals were provided conventional laboratory rabbit diet (Nutrivet Life Sciences, Pune), ad libitum.
- Water: Aqua guard filtered tap water, ad libitum.
- Acclimation period: At laeast 6 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 22.7
- Humidity (%): 41.2 - 67.3
- Air changes (per hr): More than 12
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied:100 mg
- Test Item Application Procedure: Test item (pulverized) was placed in the conjunctival sac of eye in three rabbits, after gently pulling the lower lid away from the eyeball. The lids were held together to prevent loss of test item. Other eye which was untreated, served as control. Treated and control eyes of rabbits were examined with the help of ophthalmoscope at one hour after instillation of test item. - Duration of treatment / exposure:
- Single instillation
- Observation period (in vivo):
- 1, 24, 48, 72 hours and at day7 after instillation of test item
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: The treated eye of rabbit was washed with normal saline
- Time after start of exposure: 24 hours
Both the eyes of rabbit were further examined for corneal epithelial cell damage with the help of fluorescent strips. The strips were wetted with one drop of normal saline and placed in both the eyes one by one, gently closed for 30 seconds and then washed with normal saline. The area of corneal epithelial cell damage was scored using ophthalmoscope (Ri-Mini2, 5 V-guru; Model No. 3002). Initially, a single rabbit was used for testing. The residual test item was removed after 24 hours and the response was graded. No severe lesions were observed after test item application, hence additional two rabbits (Animal No. 2 and 3) were used to confirm the response.
SCORING SYSTEM: Draize Method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal: all 3 rabbits
- Time point:
- other: 24, 48, 72 hours and day 7
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- The following were observed in treated rabbits.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity was seen in animal no. 1 and 3 whereas scattered or diffuse areas of opacity (other than slight dulling of normal lustre) details of iris clearly visible was seen in animal no. 2; Area of Opacity- Zero in animal no. 1 and 3 whereas one quarter (or less) but not zero was seen in animal no.2; Iris: Normal in all the animals. Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible in animal no. 2 and some blood vessels definitely hyperaemic (injected) animal no. 1 and 3; Chemosis: Some swelling above normal (includes nictitating membranes) in animal no. 1 and obvious swelling with partial eversion of lids was observed in animal no. 2 and 3.
Observation at 24 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- Greater than one quarter, but less than half was seen in animal no. 1 and 2 whereas one quarter (or less) but not zero was seen in animal no.3; Iris: Normal in all the animals. Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was seen in all 3 animals; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in animal no.1 whereas obvious swelling with partial eversion of lids was seen in animal no.2 and 3.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 50%, 60% and 45% damage in animal no. 1, 2 and 3 respectively.
Observation at 48 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero was seen in animal no.1 and 3 whereas greater than one quarter, but less than half was seen in animal no. 2; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was seen in animal no. 1 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2 and 3; Chemosis: Obvious swelling with partial eversion of lids was seen in all 3 animals.
Observation at 72 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was seen in all 3 animals; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in animal no. 1 and 3 whereas obvious swelling with partial eversion of lids was seen in animal no. 2.
Observation on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero percent was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels normal was seen in all 3 animals; Chemosis: No swelling (Normal) was seen in all the 3 animals.
The individual mean score for animal nos. 1, 2 and 3 at 24, 48, 72 hours for corneal opacity, iris, conjunctiva and chemosis were found 1.33, 0.00, 1.67, 1.33; 1.67, 0.00, 2.00, 2.00; 1.00, and 1.00 0.00, 2.00, 1.67, respectively.
Observation at 1 hour after instillation of test item revealed: Cornea- No ulceration or opacity was seen in animal no. 1 and 3 whereas scattered or diffuse areas of opacity (other than slight dulling of normal lustre) details of iris clearly visible was seen in animal no. 2; Area of Opacity- Zero in animal no. 1 and 3 whereas one quarter (or less) but not zero was seen in animal no.2; Iris: Normal in all the animals. Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible in animal no. 2 and some blood vessels definitely hyperaemic (injected) animal no. 1 and 3; Chemosis: Some swelling above normal (includes nictitating membranes) in animal no. 1 and obvious swelling with partial eversion of lids was observed in animal no. 2 and 3.
Observation at 24 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- Greater than one quarter, but less than half was seen in animal no. 1 and 2 whereas one quarter (or less) but not zero was seen in animal no.3; Iris: Normal in all the animals. Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was seen in all 3 animals; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in animal no.1 whereas obvious swelling with partial eversion of lids was seen in animal no.2 and 3.
At 24 hours observation the rabbits were examined for corneal epithelium cell damage using sodium fluorescein strips and noticed 50%, 60% and 45% damage in animal no. 1, 2 and 3 respectively.
Observation at 48 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero was seen in animal no.1 and 3 whereas greater than one quarter, but less than half was seen in animal no. 2; Iris: Normal in all the animals. Conjunctivae - Some blood vessels definitely hyperaemic (injected) was seen in animal no. 1 whereas diffuse, crimson color; individual vessels not easily discernible was seen in animal no. 2 and 3; Chemosis: Obvious swelling with partial eversion of lids was seen in all 3 animals.
Observation at 72 hours after instillation of test item revealed: Cornea- Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible in all 3 animals; Area of Opacity- One quarter (or less) but not zero was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Diffuse, crimson color; individual vessels not easily discernible was seen in all 3 animals; Chemosis: Some swelling above normal (includes nictitating membranes) was seen in animal no. 1 and 3 whereas obvious swelling with partial eversion of lids was seen in animal no. 2.
Observation on day 7 after instillation of test item revealed: Cornea- No ulceration or opacity in all 3 animals; Area of Opacity- Zero percent was seen in all 3 animals; Iris: Normal in all the animals. Conjunctivae - Blood vessels normal was seen in all 3 animals; Chemosis: No swelling (Normal) was seen in all the 3 animals.
No effects were seen in the untreated eyes. - Other effects:
- Clinical Observation
No systemic toxicity was observed in treated rabbits during the experimental period.
Mortality
No mortality was observed during the observation period.
Body weight
All rabbits gained weight during experimental period.
Any other information on results incl. tables
Table 1 : Individual Animal Eye Irritation Scores
In Treated area Dose:100 mg of test item Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||||||||||||||||||||||||||
Application Side |
Left |
Right |
Right |
||||||||||||||||||||||||||||||||||||
Eye Reactions |
At hour |
Day |
At hour |
Day |
At hour |
Day |
|||||||||||||||||||||||||||||||||
* |
1 |
24 |
48 |
72 |
7 |
* |
1 |
24 |
48 |
72 |
7 |
* |
1 |
24 |
48 |
72 |
7 |
||||||||||||||||||||||
Corneal Opacity |
0 |
0 |
1 |
1 |
1 |
0 |
0 |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
|||||||||||||||||||||
Area of Opacity |
0 |
0 |
2 |
1 |
1 |
0 |
0 |
1 |
2 |
2 |
1 |
0 |
0 |
0 |
1 |
1 |
1 |
0 |
|||||||||||||||||||||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||||||||||||||||
Conjunctiva |
0 |
2 |
2 |
1 |
2 |
0 |
0 |
1 |
2 |
2 |
2 |
0 |
0 |
1 |
2 |
2 |
2 |
0 |
|||||||||||||||||||||
Chemosis |
0 |
1 |
1 |
2 |
1 |
0 |
0 |
2 |
2 |
2 |
2 |
0 |
0 |
2 |
2 |
2 |
1 |
0 |
|||||||||||||||||||||
Corneal Damage% |
50% |
60% |
45% |
||||||||||||||||||||||||||||||||||||
Dose:Untreated (Control Eye) Sex:Female
Animal Numbers |
1 |
2 |
3 |
||||||||||||||||||
Application Side |
Right |
Left |
Left |
||||||||||||||||||
Eye Reactions |
At hour |
Day |
At hour |
Day |
At hour |
Day |
|||||||||||||||
* |
1 |
24 |
48 |
72 |
7 |
* |
1 |
24 |
48 |
72 |
7 |
* |
1 |
24 |
48 |
72 |
7 |
||||
Corneal Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Area of Opacity |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Conjunctiva |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Chemosis |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Corneal Damage% |
0 |
0 |
0 |
||||||||||||||||||
Key:*= Pre-exposure eye examination.
Table 1 Continued…
Eye Irritation Scores - Mean Values after 24, 48, 72 Hours (Treated eye)
Animal No. Eye Reaction |
1 |
2 |
3 |
Corneal Opacity |
1.33 |
1.67 |
1.00 |
Iris |
0.00 |
0.00 |
0.00 |
Conjunctiva |
1.67 |
2.00 |
2.00 |
Chemosis |
1.33 |
2.00 |
1.67 |
Formula :
Mean Eye Irritation Score =
Sum of the Individual Animal Score for eye reactionat24, 48 and 72 hours
Number of the Observations (3)
Table 2 : Individual AnimalClinicalSigns
Sex:Female
Animal No. |
Days (Post application observation) |
|||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
|
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
3 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Key:1 = Normal
Table 3: Individual Animal Body Weight
Sex :Female
Animal No. |
Animal Body Weight (kg) |
|
Prior to application |
At termination |
|
1 |
2.208 |
2.387 |
2 |
1.932 |
2.214 |
3 |
2.438 |
2.646 |
Key:kg = Kilogram
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on the results of an acute Eye Irritation/Corrosion Study was performed according to OECD guideline with tetrabutylammonium bromide, it is concluded that tetrabutylammonium bromide is “Mildly Irritating to Eyes” and is being classified as an eye irritant in 'category 2' as per the CLP regulation. This result is read across to SAM-3.
- Executive summary:
Based on the results of an acute Eye Irritation/Corrosion Study was performed according to OECD guideline with tetrabutylammonium bromide, it is concluded that tetrabutylammonium bromide is “Mildly Irritating to Eyes” and is being classified as an eye irritant in 'category 2' as per the CLP regulation. This result is read across to SAM-3.
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