Reaction mass of bis(polysubstituted hexanoic acid) bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) diphosphate and bis(polysubstituted hexanoic acid) 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl phosphate and polysubstituted hexanoic acid bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen diphosphate and polysubstituted hexanoic acid bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate and polysubstituted hexanoic acid 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl hydrogen phosphate

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)

Deviations:

no

Remarks:

Conducted according to guideline in effect at time of study conduct

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

TLF-11073

IUPAC Name:

TLF-11073

Details on test material:

- Purity: 22.82% solids in water

Test system

Details on study design:

The Skin Irritation Test using the EpiDerm™ Skin Model was used to predict the skin irritation potential of the test substance in the context of classification of skin irritation hazard according to the EU classification system (R38 or No Label). The test substance, positive control (5% Sodium Dodecyl Sulfate), and negative control (Dulbecco’s Phosphate Buffered Saline) were exposed to the EpiDerm™ tissues in triplicate for 60 minutes, with a post-exposure time of 42 hours. Irritation potential was determined by measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test substance for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%.

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

102.4

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other:

Remarks:

The test substance was not determined to directly reduce MTT.

In vivo

Irritant / corrosive response data:

The mean viability of the test substance was 102.4%. The test substance was not determined to directly reduce MTT.

Any other information on results incl. tables

The mean OD₅₇₀  of the negative control, sterile, Dulbecco’s Phosphate Buffered Saline, was 2.193. The mean viability of the positive control, SDS, was 8.5%. The standard deviation calculated from individual percent tissue viabilities of the 3 identically treated replicates was < 18% for the test substance, positive and negative control. Since the mean positive control result was an R38 classification (i.e. viability ≤ 50%) and the mean OD₅₇₀  value of the negative control was greater than 1.000 and less than 2.500, the assay results were considered valid.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
Not a skin irritant.

Executive summary:

The Skin Irritation Test using the EpiDerm™ Skin Model was used to predict the skin irritation potential of the test substance in the context of classification of skin irritation hazard according to the EU classification system (R38 or No Label). The test substance, positive control (5% Sodium Dodecyl Sulfate), and negative control (Dulbecco’s Phosphate Buffered Saline) were exposed to the EpiDerm™ tissues in triplicate for 60 minutes, with a post-exposure time of 42 hours. Irritation potential was determined by measuring the relative conversion of MTT (3-[4,5 - dimethylthiazol-2-yl] - 2,5 - diphenyltetrazolium bromide) in the test substance-treated tissues after exposure to the test substance for a 60-minute exposure period, followed by a 42-hour post-exposure expression period. Skin irritation potential of the test substance was predicted if the relative viability was less than or equal to 50%. The mean viability of the test substance was 102.4%. The test substance was not determined to directly reduce MTT. Based upon the results of this assay, the test substance was not predicted to be a skin irritant.