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

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Validated in vitro assay - the MTT Time Course Assay using the EpiDerm™ Skin Model (cited in OECD 439); GLP study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Report date:

2010

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

The EpiDerm™ Skin Model was used to assess the dermal irritation potential of the substance. Reduction of MTT dye to a blue precipitate was used to
assess cellular metabolism after exposure to the test article for various exposure times. The time of exposure resulting in a 50% decrease in MTT
conversion (ET50) in test article-treated EpiDerm™ cultures, relative to control cultures, was determined.

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 animals

Species:

other: Not applicable

Strain:

other: Not applicable

Test system

Details on study design:

The EpiDermTM cultures were treated in duplicate with the test article at four exposure times of 4, 8, 16, and 24 hours. The positive control, 1% Triton®-X-100, was also exposed in duplicate for 4 and 8 hours. The negative control was exposed in duplicate for 4 and 24 hours.

Results and discussion

In vivo

Irritant / corrosive response data:

After 24 hours more than 50% of the cells (54.6%) treated with the test substance remained viable indicating the ET50 was greater than 24 hours, reflective of a very low order of skin irritation potential. The ET50 of the positive control was 5.83 hours, in the range of historical control values.

Any other information on results incl. tables

ET50 Data

Test Substance ET50 (hours) = > 24 hrs

Positive Control ET50 (hours) = 5.83 hrs

Applicant's summary and conclusion

Interpretation of results:

other: Very low order of skin irritation potential

Conclusions:

The ET50 result collected on the test article did not cause > 50 % relative toxicity to the tissues up to the longest prescribed exposure time of 24 hours (ET50 > 24 hours). This is indicative of a very low order of skin irritation potential.

Executive summary:

The EpiDerm™ Skin Model was used to assess the dermal irritation potential of the test substance. Reduction of MTT dye to a blue precipitate was used to assess cellular metabolism after exposure to the test article for various exposure times. The time of exposure resulting in a 50% decrease in MTT conversion (ET₅₀) in test article-treated EpiDerm™ cultures, relative to control cultures, was determined.

The EpiDerm^TMcultures were treated in duplicate with the test article at four exposure times of 4, 8, 16, and 24 hours. The positive control, 1% Triton®-X-100, was also exposed in duplicate for 4 and 8 hours. After 24 hours more than 50% of the cells (54.6%) treated with the test substance remained viable indicating the ET₅₀was greater than 24 hours, reflective of a very low order of skin irritation potential.

The ET₅₀of the positive control was 5.83 hours, in the range of historical control values.