Tetraoctylammonium bromide

Endpoint summary

Description of key information

Skin Irritation:

The dermal irritation potential of Tetraoctylammonium bromide was estimated using OECD QSAR toolbox v3.4 with logPow as the primary descriptor.

Tetraoctylammonium bromide was estimated to be irritating to the skin of New Zealand White rabbits.

Based on the estimated results, Tetraoctylammonium bromide can be considered to be irritating to skin and can be classified under the category “Category 2” as per CLP regulation.

Eye Irritation:

The study was terminated after 6 hours since translucent corneal opacity, iridal inflammation and severe conjunctivitis with petechial hemorrhage scattered over nictitating membrane and blood stained discharge was observed in rabbit. Animal sacrificed due to severity of reaction.Based on these observations, tetraoctylammonium bromide was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

(Q)SAR

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

data is from OECD QSAR toolbox v3.4 and the QMRF report has been attached

Qualifier:

according to guideline

Guideline:

other: estimated data

Principles of method if other than guideline:

Prediction was done using OECD QSAR toolbox v3.4

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of the test material: Tetraoctylammonium bromide
- IUPAC name: Tetraoctylammonium bromide
- Molecular formula: C32H68NBr
- Molecular weight: 546.8002 g/mol
- Smiles: CCCCCCCC[N+](CCCCCCCC)(CCCCCCCC)CCCCCCCC.[Br-]
- Inchi : 1S/C32H68N.BrH/c1-5-9-13-17-21-25-29-33(30-26-22-18-14-10-6-2,31-27-23-19-15-11-7-3)32-28-24-20-16-12-8-4;/h5-32H2,1-4H3;1H/q+1;/p-1
- Substance type: Organic
- Physical form: Solid powder (off white)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

no data available

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5ml

Duration of treatment / exposure:

4 hours

Observation period:

14 days

Number of animals:

3

Details on study design:

no data available

Other effects / acceptance of results:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Irritation was observed

Estimation method: Takes mode value from the 5 nearest neighbours
Domain  logical expression:Result: In Domain

((((((((("a" or "b" or "c" or "d" )  and "e" )  and ("f" and ( not "g") )  )  and "h" )  and ("i" and ( not "j") )  )  and "k" )  and "l" )  and "m" )  and ("n" and "o" )  )

Domain logical expression index: "a"

Referential boundary: The target chemical should be classified as Ammonium salt by Organic Functional groups

Domain logical expression index: "b"

Referential boundary: The target chemical should be classified as Ammonium salt AND Overlapping groups by Organic Functional groups (nested)

Domain logical expression index: "c"

Referential boundary: The target chemical should be classified as Aliphatic Carbon [CH] OR Aliphatic Carbon [-CH2-] OR Aliphatic Carbon [-CH3] OR Nitrogen, single bonds  [N{v+5}] by Organic functional groups (US EPA) ONLY

Domain logical expression index: "d"

Referential boundary: The target chemical should be classified as Anion AND Cation AND Quaternary ammonium salt by Organic functional groups, Norbert Haider (checkmol)

Domain logical expression index: "e"

Referential boundary: The target chemical should be classified as High (Class III) by Toxic hazard classification by Cramer (extension) ONLY

Domain logical expression index: "f"

Referential boundary: The target chemical should be classified as (!Undefined)Group All Lipid Solubility < 0.01 g/kg AND (!Undefined)Group CN Lipid Solubility < 0.4 g/kg AND Group All log Kow > 9 AND Group All Melting Point > 200 C AND Group CN Aqueous Solubility < 0.0001 g/L AND Group CN Aqueous Solubility < 0.1 g/L AND Group CN log Kow > 4.5 AND Group CN log Kow > 5.5 AND Group CN Melting Point > 180 C AND Group CN Molecular Weight > 290 g/mol AND Group CN Molecular Weight > 540 g/mol AND Group CN Vapour Pressure < 0.001 Pa by Skin irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "g"

Referential boundary: The target chemical should be classified as (!Undefined)Group All log Kow < -3.1 OR (!Undefined)Group All log Kow > 9 OR (!Undefined)Group All Melting Point > 200 C OR (!Undefined)Group C Surface Tension > 62 mN/m OR (!Undefined)Group CNHal Lipid Solubility < 4 g/kg OR (!Undefined)Group CNHal Lipid Solubility < 400 g/kg OR (N/A) OR Exclusion rules not met OR Group All log Kow < -3.1 OR Group C Aqueous Solubility < 0.0001 g/L OR Group C Melting Point > 55 C OR Group C Molecular Weight > 350 g/mol OR Group C Vapour Pressure < 0.0001 Pa OR Group CHal Melting Point > 65 C OR Group CNHal Aqueous Solubility < 0.001 g/L OR Group CNHal Aqueous Solubility < 0.1 g/L OR Group CNHal log Kow > 3.8 OR Group CNHal Molecular Weight > 370 g/mol OR Group CNHal Molecular Weight > 380 g/mol OR Group CNS log Kow < 0.5 OR Group CNS log Kow < -2 OR Group CNS Melting Point > 120 C OR Group CNS Melting Point > 50 C OR Group CNS Molecular Weight > 620 g/mol by Skin irritation/corrosion Exclusion rules by BfR

Domain logical expression index: "h"

Referential boundary: The target chemical should be classified as Not bioavailable by Lipinski Rule Oasis ONLY

Domain logical expression index: "i"

Referential boundary: The target chemical should be classified as Halogens AND Non-Metals by Groups of elements

Domain logical expression index: "j"

Referential boundary: The target chemical should be classified as Alkali Earth OR Transition Metals by Groups of elements

Domain logical expression index: "k"

Similarity boundary:Target: CCCCCCCCN{+}(.Br{-})(CCCCCCCC)(CCCCCCCC)CCCCCCCC
Threshold=20%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "l"

Similarity boundary:Target: CCCCCCCCN{+}(.Br{-})(CCCCCCCC)(CCCCCCCC)CCCCCCCC
Threshold=60%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "m"

Similarity boundary:Target: CCCCCCCCN{+}(.Br{-})(CCCCCCCC)(CCCCCCCC)CCCCCCCC
Threshold=80%,
Dice(Atom centered fragments)
Atom type; Count H attached; Hybridization

Domain logical expression index: "n"

Parametric boundary:The target chemical should have a value of log Kow which is >= 6.12

Domain logical expression index: "o"

Parametric boundary:The target chemical should have a value of log Kow which is <= 12.5

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

Tetraoctylammonium bromide was estimated to be irritating to the skin of New Zealand White rabbits.

Executive summary:

The dermal irritation potential of Tetraoctylammonium bromide was estimated using OECD QSAR toolbox v3.4 with logPow as the primary descriptor.

Tetraoctylammonium bromide was estimated to be irritating to the skin of New Zealand White rabbits.

Based on the estimated results, Tetraoctylammonium bromide can be considered to be irritating to skin and can be classified under the category “Category 2” as per CLP regulation.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

data is from peer reviewed journals

Qualifier:

according to guideline

Guideline:

other: Draize test

Principles of method if other than guideline:

To assess the ocular irritation potential of tetraoctylammonium bromide in rabbits according to Draize method

GLP compliance:

not specified

Specific details on test material used for the study:

- Name of the test material: Tetraoctylammonium bromide
- IUPAC name: Tetraoctylammonium bromide
- Molecular formula: C32H68NBr
- Molecular weight: 546.8002 g/mol
- Smiles: CCCCCCCC[N+](CCCCCCCC)(CCCCCCCC)CCCCCCCC.[Br-]
- Inchi : 1S/C32H68N.BrH/c1-5-9-13-17-21-25-29-33(30-26-22-18-14-10-6-2,31-27-23-19-15-11-7-3)32-28-24-20-16-12-8-4;/h5-32H2,1-4H3;1H/q+1;/p-1
- Substance type: Organic
- Physical form : Solid powder (off white)
- Obtained from: Sigma Aldrich
- Purity: 98%

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

no data available

Duration of treatment / exposure:

Single exposure

Observation period (in vivo):

From 1 hour till 21 days after instillation of test chemical

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

1

Details on study design:

SCORING SYSTEM: Draize method
Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical

Other effects / acceptance of results:

no data available

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 6 hours

Reversibility:

not reversible

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

Study was terminated after 6 hours since Translucent corneal opacity, iridal inflammation and severe conjunctivitis with petechial hemorrhage scattered over nictitating membrane and blood stained discharge was observed in rabbit. Animal sacrificed due to severity of reaction.

Table: Draize eye test reference database

Name of the test chemical	CAS number	Substance class	Physical state	Purity	Commercial source	UN GHS category	Number of animals	Comments
Tetraoctyl ammonium bromide	14866-33-2	Ammonium salt	Solid	98%	Sigma –Aldrich	CAT 1	1/1	Study was terminated after 6 hours since translucent corneal opacity, iridal inflammation and severe conjunctivitis with petechial hemorrhage scattered over nictitating membrane and blood stained discharge was observed in rabbit. Animal sacrificed due to severity of reaction.

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The study was terminated after 6 hours since translucent corneal opacity, iridal inflammation and severe conjunctivitis with petechial hemorrhage scattered over nictitating membrane and blood stained discharge was observed in rabbit. Animal sacrificed due to severity of reaction.
Based on these observations, tetraoctylammonium bromide was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.

Executive summary:

An eye irritation study in rabbits was conducted to assess the irritation potential of tetraoctylammonium bromide. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method.Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical.

The study was terminated after 6 hours since translucent corneal opacity, iridal inflammation and severe conjunctivitis with petechial hemorrhage scattered over nictitating membrane and blood stained discharge was observed in rabbit. Animal sacrificed due to severity of reaction.

Based on these observations, tetraoctylammonium bromide was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin Irritation:

In different studies, Tetraoctylammonium bromide has been investigated for potential for dermal irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with predicted data for target chemical and its structurally similar read across substances, Tetrabutylammonium bromide[CAS:1643-19-2] and N,N,N-trimethylhexadecan-1 -aminium chloride [CAS:112-02-7]. The predicted data using the OECD QSAR toolbox has also been compared with the experimental data.

In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the skin irritation potential was estimated for Tetraoctylammonium bromide. Tetraethylammonium chloride was estimated to be irritating to the skin of New Zealand White rabbits.

This result was supported by the study conducted in an OECD GLP laboratory (Sustainability Support Services (Europe) AB has the letter of access) for the structurally similar read across substance, Tetrabutylammonium bromide[CAS: 1643-19-2]. This study was performed as per OECD guideline No. 404.In the initial test one healthy rabbit of body weight 1.80kg±200gm selected for study after acclimatization. The test compound in the amount of 0.5 gm was applied at the different sites on the shaven back skin of animal. The hairs of back sides were removed (approximately 6 cm2) one day earlier before the treatment. The site of application was covered with impervious dressing secured in position with adhesive tape. The first patch was applied on the shaven back skin of rabbit and removed after three minutes. No serious reaction was observed at the site of application. The second patch was applied on the different shaven back side and removed after one hour. There were no signs of skin reaction observed at this site of application. Finally, a third patch was applied at a different site and was removed after four hour. The test compound produced slight erythema at the site of application. Finally, the animal was observed for 14 days, for any irritation and corrosion. The test compound Tetrabutylammonium bromide produced slight erythema on skin at 24 hrs. Based on the above observations, a confirmatory test was performed using two additional animals following same procedure. In the confirmatory test; the test compound in the amount of 0.5 gm after moistened with water was applied on the shaven back skin of two animals, each with one patch, for an exposure period of four hours.After four hours the patch was removed and the skin reactions were graded according to Draize’s method. The test compound Tetrabutylammonium bromide applied on the shaven area of skin of New Zealand white rabbits in the amount of 0.5 gm showed slight skin erythema at the site of application. The skin irritation index of test compound Tetrabutylammonium bromide was calculated as 0.50.

The results obtained from present study concluded that Tetrabutylammonium bromide was slightly irritating to skin of New Zealand white rabbits.

These results are also supported by the experimental study summarized in INVENTORY MULTITIERED ASSESSMENT AND PRIORITISATION (IMAP) – NICNAS, 7/3/2017; for the functionally similar read across substance, N,N,N-trimethylhexadecan-1-aminium chloride [CAS:112-02-7]. 24-26% of test chemical was applied to the intact skin of 3 New Zealand White rabbits for 4 hours exposure period and observed for 14 days. The mean score values at the 24, 48 and 72hours post application readings were 3 for erythema and 1.9 for oedema. At days seven and 14, grade 2–3 erythema and grade 1–2 oedema were found. At day 14, oedema was observed only in one animal.

Based on the observations and scores, Trimethylhexadecylammonium chloride was considered to be moderately irritating to the skin of New Zealand White rabbits.

Based on the available data for the target and read across substances and applying the weight of evidence approach, Tetraoctylammonium bromide can be considered to be irritating to skin.

Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 2”.

Eye Irritation:

In different studies, Tetraoctylammonium bromide has been investigated for potential for ocular irritation to a greater or lesser extent. The studies are based on in vivo experiments in rabbits along with in vitro data for target chemical. The results are summarized as follows:

An eye irritation study in rabbits was conducted Nathalie Alépée et.al (Archives of toxicology, 91(2), 521-547) to assess the irritation potential of tetraoctylammonium bromide. The study was performed according to Draize method. Undiluted test chemical was instilled in the eyes of 1 rabbit and observed for signs of irritation till 7 days. The reactions observed were scored according to Draize method. Mean scores are calculated for each animal from gradings at 24, 48, and 72 h after instillation of the test chemical and these “severity scores” are then used to determine the classification of the test chemical. The study was terminated after 6 hours since translucent corneal opacity, iridal inflammation and severe conjunctivitis with petechial hemorrhage scattered over nictitating membrane and blood stained discharge was observed in rabbit. Animal sacrificed due to severity of reaction.

Based on these observations, tetraoctylammonium bromide was considered to highly irritating and causing irreversible damage to rabbit eyes, was classified under the category “Category 1”.

EpiOcular-EIT tissue model was used by Kaluzhny Yulia et.al (Alternatives to laboratory animals: ATLA 43, no. 2 (2015): 101-127) to assess the irritation potential of tetraoctyl ammonium bromide. The EpiOcular tissue model (OCL-200] was obtained from MATTEK Corporation was used for this assay. EpiOcular tissues were transferred from the agarose into 6-well plates containing 1ml of assay medium (provided with the testing kit) and pre-incubated for 1 hour underStandard culture conditions (SCC), which are defined as an atmosphere with a relative humidity of 95 ± 3%, 5 ± 0.5% (v/v) Carbon dioxide, and a temperature of 37 ± 1°C. After 1 hour, the medium was changed and the EpiOcular cultures were further pre-incubated overnight (16–18 hours) under Standard culture conditions (SCC). On day 1 of the test, the tissues were pre-treated for 30 minutes with 20μl of calcium and magnesium- free DPBS [Dulbecco’s Phosphate Buffered Saline]. If the DPBS did not spread across the tissue surface, the plate was tapped to ensure that the entire tissue surface was in contact with the liquid. Next, 50μl of the Negative Control (ultrapure H2O), the Positive Control (methyl acetate) or approximately 50 mg of tetraoctyl ammonium bromide was topically applied to the EpiOcular tissues. Each chemical [test and controls] were tested in duplicates. The treated tissues were incubated under Standard culture conditions (SCC) for 90 minutes. For rinsing the tissues, three 150ml beakers were filled with 100ml DPBS for each test article. After a 90-minute exposure to the test articles or controls, each pair of duplicate tissues was successively rinsed by dipping, swirling, and decanting through its set of three beakers. After the final rinse and decanting, the tissues were immersed in 5ml of EpiOcular assay medium in a 12-well plate for 12 minutes (post-soak) at room temperature. After the post-soak period, the medium was decanted from thecell culture inserts [CCIs] and thecell culture inserts [CCIs] containing the tissues were transferred to a 6-well plate containing 1ml of warm medium (37°C) and post-incubated for 2 hours under Standard culture conditions [SCC].The tissues exposed to test chemical were post- incubated for 18 hours.After the 18-hour post-incubation period, tissue viability was determined by using the MTT assay.

The test chemicals were classified as an irritant (GHS Category 1 or 2), if the tissue viability was ≤ 60%, and as a non-irritant (GHS unclassified), if the viability was > 60%. Since the Cell culture insert[CCI] insert 1 exhibited poor performance to some chemicals, EIT studies were conducted and results were reported for EpiOcular tissues grown on the other three alternative Cell culture inserts[CCI]. The mean viabilities (%) obtained from these Cell culture inserts [CCI] were compared with that of Cell culture inserts[CCI] insert 1 and very almost similar. The mean percent tissue viability for tetraoctyl ammonium bromide in the EpiOcular-EIT assay was 14.94%.According to the GHS classification criteria, tetraoctyl ammonium bromide can be classified under the category “Category 1”.

In an another in-vitro study EpiOcular™ RhT model was used by U. Pfannenbecker et.al (Toxicology in Vitro, 27 (2013), 619–626) to assess the eye irritation potential of tetraoctyl ammonium bromide .A total of seven laboratories, 4 laboratories from the EU region and 3 from America, took part in the study. EpiOcular™ OCL-200 tissues were purchased from MatTek Corporation from routine production stock and subjected to normal lot release evaluations. Each EpiOcular™ tissue was inspected and selected tissues were transferred to a 6-well plate containing 1.0 mL of pre-warmed assay medium. Tissues were then incubated overnight at 37 ± 1°C in a humidified atmosphere of 5 ± 1% CO2 in air (standard culture conditions; SCC). After this incubation, tissues were pre-wetted with 20 µL Dulbecco’s Phosphate Buffered Saline and incubated for 30 ± 2 min, prior to exposure to the test chemical. This procedure was used to fully hydrate the tissues and to mimic conditions of the human cornea. Next, 50μl of the Negative Control (ultrapure H2O), the Positive Control (methyl acetate) or approximately 50 mg of tetraoctyl ammonium bromide was topically applied to the EpiOcular tissues. Each chemical [test and controls] were tested in duplicates. The treated tissues were incubated under Standard culture conditions (SCC) for 90±5 minutes. For rinsing the tissues, three 150ml beakers were filled with 100ml DPBS for each test article. After 90±5 minutes exposure to the test articles or controls, each pair of duplicate tissues was successively rinsed its set of three beakers. After the final rinse and decanting, the tissues were immersed in 5ml of EpiOcular assay medium in a 12-well plate for 12±2 minutes (post-soak) at room temperature. Tissues were then transferred to a 6-well plate containing 1 mL warm assay medium (37°C) and post-incubated for18 ± 0.25 hours under Standard culture conditions [SCC]. Tissue viability was determined by tetrazolium dye (MTT) reduction.Plates were analysed spectro - photometrically at a wavelength between 540 and 590 nm with a plate reader.

The test chemicals were classified as an irritant (GHS Category 1 or 2), if the tissue viability was ≤ 60%, and as a non-irritant (GHS unclassified), if the viability was > 60%. The mean percent tissue viability for tetraoctyl ammonium bromide in the EpiOcular-EIT assay was 16.9%. According to the GHS classification criteria, tetraoctyl ammonium bromide can be classified under the category “Category 1”.

SkinEthic™ Reconstituted Human Corneal Epithelium (HCE) assay was used by N. Alépée(Toxicology in Vitro, 27 (2013), 1476–1488) to assess the irritation potential of tetraoctyl ammonium bromide. Cosmetics Europe, The Personal Care Association conducted a program of technology transfer and assessment of Within/Between Laboratory (WLV/BLV) reproducibility of the SkinEthic™ Reconstituted Human Corneal Epithelium (HCE) assay.WLV of the SkinEthic™ HCE test method SE and LE treatment procedures was assessed in a single laboratory and BLV of the SkinEthic™ HCE test method LE treatment application was assessed in three laboratories.Identical protocols were used by each laboratory.The SkinEthic™ HCE test method involves two exposure time treatment procedures – one for short time exposure (10 min – SE) and the other for long time exposure (60 min – LE) of tissues to test substance.The SkinEthic™ HCE model consists of immortalized human corneal epithelial cells cultured in a chemically defined medium on an inert permeable insert at the air–liquid interface.Phosphate-buffered saline and Triton X-100 were used as negative and batch controls, respectively.HCE tissues were topically exposed to undiluted test substance, After treatment, tissues were rinsed three times with 5 ml of phosphate buffer solution (PBS) in order to remove the residual test substance from the tissue surface.HCE tissues, treated for 1 h with the test substance, were then incubated with new maintenance medium for an additional 16 hours period at 37°C, 5% CO2 in a humidified incubator. At least two independent batches for the test substance were used. At the end of the incubation period, triplicate tissues were assessed for tissue viability using MTT Assay. The percentage viability of each of the treated cultures was calculated from the percentage MTT conversion in the treated cultures relative to the corresponding negative controls (100% viability). Results were expressed as mean OD and mean % viability with standard deviations (SDs) linked to mean viabilities. The SkinEthic™ HCE test method PM for both SE and LE treatment procedures was based on the relative tissue viability of the test material-treated tissue compared to the negative control-treated tissue as follows: Non-irritant (GHS NC): Relative viability > 50%; Irritant (GHS Category 2/Category1): Relative viability ≤ 50%.

The mean tissue viability for tetraoctyl ammonium bromide in the SkinEthic™ HCE – Long exposure assay was 10.3%.According to the GHS classification criteria, tetraoctyl ammonium bromide can be classified under the category “Category 1”.

The results from the in-vivo and in-vitro experiments were in agreement with each other, indicating a strong possibility of tetraoctyl ammonium bromide being highly irritating causing irreversible damage to eyes.

Based on the available data for the target, Tetraoctylammonium bromide can be considered to be highly irritating causing irreversible damage to eyes. Comparing the above annotations with the criteria of CLP regulation, it can be classified under the category “Category 1”.

Justification for classification or non-classification

Based on the available information, Tetraoctylammonium bromide is likely to cause severe irritation to eyes and skin.

Hence, Tetraoctylammonium bromide can be classified under the category “Category 2” for skin irritation and “Category 1” for eye irritation as per CLP regulation.