N,N'-bis[2-hydroxy-3-(2,2,3,3-tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2-diaminium dichloride

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Validated in vitro ocular irritation screening study. GLP compliant (FDA, EPA, OECD).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The EpiOcular™ Human Cell Construct was used to assess the ocular irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure for various exposure times. The duration of exposure resulting in a 50% decrease in MTT conversion (ET50) in test article-treated EpiOcular™ human cell constructs, relative to control cultures, was determined.

The EpiOcular™ cultures were treated in duplicate with the test article at four exposure times of 0.33, 1, 2, and 4 hours. Duplicate cultures of the positive control, 100 µL of 0.3% Triton®-X-100, were exposed for 15 and 45 minutes.

GLP compliance:

yes

Remarks:

FDA, EPA, OECD

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride

IUPAC Name:

N,N'-bis[2-hydroxy-3-(2,2,3,3- tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2- diaminium dichloride

Constituent 2

Reference substance name:

1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride

EC Number:

700-737-4

Cas Number:

1220100-43-5

Molecular formula:

C18H34F8N2O4.2Cl

IUPAC Name:

1,1,2,2,17,17,18,18-octafluoro-6,13-dihydroxy-8,8,11,11-tetramethyl-4,15-dioxa-8,11-diazaoctadecane-8,11-diium dichloride

Details on test material:

- Physical state: Solid, white
- Storage condition of test material: Room temperature, protected from light

Test system

Details on study design:

The EpiOcular™ Human Cell Construct was used to assess the ocular irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure for various exposure times. The duration of exposure resulting in a 50% decrease in MTT conversion (ET50) in test article-treated EpiOcular™ human cell constructs, relative to control cultures, was determined.

The EpiOcular™ cultures were treated in duplicate with the test article at four exposure times of 0.33, 1, 2, and 4 hours. Duplicate cultures of the positive control, 100 µL of 0.3% Triton®-X-100, were exposed for 15 and 45 minutes.

Results and discussion

In vivo

Irritant / corrosive response data:

After 4 hours more than 50% of the cells (72.4%) treated with the test substance remained viable indicating the ET50 was greater than 4 hours, reflective of a low order of eye irritation potential. The ET50 of the positive control was 30.4 minutes, in the range of historical control values.

Any other information on results incl. tables

ET50 Data

Test Substance ET50 (hours) = > 4 hrs

Positive Control ET50 (minutes) = 30.4 minutes

Applicant's summary and conclusion

Interpretation of results:

other: Low order of eye irritation potential

Conclusions:

In this assay, the EpiOcular™ Human Cell Construct determined that the test substance has a low order of ocular irritation potential.

Executive summary:

The EpiOcular™ Human Cell Construct was used to assess the ocular irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure for various exposure times. The duration of exposure resulting in a 50% decrease in MTT conversion (ET₅₀) in test article-treated EpiOcular™ human cell constructs, relative to control cultures, was determined.

The EpiOcular™ cultures were treated in duplicate with the test article at four exposure times of 0.33, 1, 2, and 4 hours. Duplicate cultures of the positive control, 100 µL of 0.3% Triton^®-X-100, were exposed for 15 and 45 minutes. After 4 hours more than 50% of the cells (72.4%) treated with the test substance remained viable indicating the ET₅₀was greater than 4 hours, reflective of a low order of eye irritation potential.

The ET₅₀of the positive control was 30.4 minutes, in the range of historical control values. The corrected mean OD₅₅₀ value for the minimum negative control exposure time was within 20 % of the corrected mean OD₅₅₀ value for the maximum negative control exposure time. Validity test criteria were therefore met.