Reaction mass of benzyldodecylbis(2-hydroxypropyl)ammonium chloride and benzylbis(2-hydroxypropyl)tetradecylammonium chloride

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

other: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: guideline study

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Report date:

2011

Materials and methods

Principles of method if other than guideline:

In vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Benzyldodecylbis(2-hydroxypropyl)ammonium chloride

EC Number:

265-345-3

EC Name:

Benzyldodecylbis(2-hydroxypropyl)ammonium chloride

Cas Number:

65059-91-8

Molecular formula:

C25H46NO2.Cl

IUPAC Name:

N-benzyl-N,N-bis(2-hydroxypropyl)dodecan-1-aminium chloride

Details on test material:

Content of components of Katalysator WAZ 5596-8:
content of quaternary propoxylated fatty amine 54.6%
content of propoxylated fatty amine 1.3%
content of hvdrochloride propoxylated fatty amine 14.6 %
propane-1,2-diol 5.1%
a-chlorotoluene 12.9 %
sulfated ash <0.05%
water content 8.3 %
content of chloride 6.0%

Test animals / tissue source

Species:

other: not applicable - human corneal epithelial model (HCE)

Strain:

other: not applicable - human corneal epithelial model (HCE)

Test system

Vehicle:

other: not applicable - human corneal epithelial model (HCE)

Controls:

other: not applicable - human corneal epithelial model (HCE)

Duration of treatment / exposure:

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was measured

Observation period (in vivo):

not applicable - human corneal epithelial model (HCE)

Number of animals or in vitro replicates:

not applicable - human corneal epithelial model (HCE)

Results and discussion

In vivo

Results

Irritation parameter:

other: cell viability

Basis:

mean

Time point:

other: 60 minutes followed by a 16 h post-treatment period

Score:

1.22

Max. score:

100

Reversibility:

other: not applicable - human corneal epithelial model (HCE)

Remarks on result:

other: irritant - scores in [%] viability

Any other information on results incl. tables

A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is < 50%.

As can be seen from the information in the Table below the test substance Katalysator WAZ 5596 B was detected as irritant to the cornea epithelium in this test model.

Compound                     Cell viability [%] Evaluation

Katalysator WAZ 5596 B               1.22     irritant

Positive control                             8.70        irritant

Negative control                      100.00        non-irritant

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information

Executive summary:

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2011. The model used is standardized and commercially available (SkinEthic™ Human Cornea I Epithelial Model (HCE); SkinEthic,

France).

Undiluted Katalysator WAl 5596 B was applied topically to the HCE tissue, i.e. 30 µl per insert.

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 1.22% as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control (PC, 1 H-1 ,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that Katalysator WAZ 5596 B is predicted as ocular irritant under the conditions of this test method.