Reaction mass Benzyldodecyldimethylammonium bromide and Tetradecylbenzyldimethylammonium bromide and 1,2-Diphenyl-1-(dimethylamino)ethane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2001

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

publication

Title:

The Mucosal Toxicity of Different Benzalkonium Chloride Analogues Evaluated with an Alternative Test Using Slugs

Author:

Els Adriaens, Kristof Dierckens,
Tiene G. M. Bauters, Hans J. Nelis,
Freddy van Goethem, Phillipe Vanparys, and Jean Paul Remon

Year:

2001

Bibliographic source:

Pharmaceutical Research, Vol. 18, No. 7, 2001

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Principles of method if other than guideline:

Methodology followed is the one described in publication : P. Vanparys, G. Deknudt, M. Sysmans, G. Teuns, W. Coussement, and H. Vancauteren. Evaluation of the bovine corneal opacity permeability assay as an in vitro alternative to the Draize eye irritation test. Toxicol. Vitro 7:471–476 (1993)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride

Cas Number:

8001-54-5

Molecular formula:

C22H40ClN

IUPAC Name:

N-Benzyl-N,N-dimethyl-1-tridecanaminium chloride

additive 1

Reference substance name:

Water

EC Number:

231-791-2

EC Name:

Water

Cas Number:

7732-18-5

Molecular formula:

H2O

IUPAC Name:

water

Specific details on test material used for the study:

3 test materials : Benzalkonium chloride (BAC-mix) (60–70% C12, 30–40% C14, and < 5% C16), benzyldimethylhexadecylammoniumchloride (BAC-C16), benzyldimethyltetradecylammoniumchloride (BAC-C14), and benzyldimethyldodecylammoniumbromide (BAC-C12)

Test animals / tissue source

Species:

cattle

Strain:

not specified

Details on test animals or tissues and environmental conditions:

Bovine eyes were excised in the slaughterhouse and used within 3 hours after killing. The eyes were immersed in Hanks’ balanced salt solution. Three corneas were used per treatment. The corneas were dissected with a 2–3 mm rim of sclera and mounted in the cornea holders with the endothelial side downward. The anterior and posterior compartment of the cornea holder were filled with Minimal Essential Medium (MEM). After an incubation period of 1 h in a water bath at 32°C the MEM solution was removed from both compartments and replaced with fresh medium.

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

20%

Duration of post- treatment incubation (in vitro):

After an incubation period of 10 min the test medium was removed and the epithelium was washed with Minimal Essential Medium Medium solution

Number of animals or in vitro replicates:

3 for each test material

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

in vitro irritation score

Run / experiment:

BAC-C16 20% (g/g)

Value:

ca. 89.4

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

IVS +/- 20.3

Results 2

Irritation parameter:

in vitro irritation score

Run / experiment:

BAC-C14 20% (g/g)

Value:

ca. 124.6

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

IVS +/- 3.4

Results 3

Irritation parameter:

in vitro irritation score

Run / experiment:

BAC-C12 20% (g/g)

Value:

ca. 198.1

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

IVS +/- 13.1

Results 4

Irritation parameter:

in vitro irritation score

Run / experiment:

BAC-mix 20% (g/g)

Value:

ca. 150.8

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

IVS +/- 21.0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

These results confirmed severe eye irritant potential with the in vitro BCOP assay in which the following rank order of increasing corneal injury was obtained: BAC-C16

Executive summary:

In an in vitro study which protocol is similar with OECD 437 (BCOP), various alkyl chain length benzalkonium chlorides were showed to be very severe eye irritant at 20%.