Tetraoctylammonium bromide

Eye irritation

Administrative data

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

Data source

Reference

Reference Type:

publication

Title:

Cosmetics Europe compilation of historical serious eye damage/eye irritation in vivo data: the Draize eye test Reference Database (DRD)

Author:

João Barroso, Uwe Pfannenbecker, Els Adriaens, Nathalie Alépée, Magalie Cluzel, Ann De Smedt, Jalila Hibatallah, Martina Klaric, Karsten R. Mewes, Marion Millet, Marie Templier, Pauline McNamee

Year:

2017

Bibliographic source:

Archives of toxicology, 91(2), 521-547

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

Tetraoctylammonium bromide

EC Number:

238-936-9

EC Name:

Tetraoctylammonium bromide

Cas Number:

14866-33-2

Molecular formula:

C32H68NBr

IUPAC Name:

tetraoctylazanium bromide

Test material form:

solid: particulate/powder

Details on test material:

- 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)

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%

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

no data available

Test system

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

Results and discussion

In vitro

Other effects / acceptance of results:

no data available

In vivo

Results

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.

Any other information on results incl. tables

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.

Applicant's summary and conclusion

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”.