Reaction mass of ammonium(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) hydrogen phosphate and ammonium bis(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl) phosphate

Endpoint summary

Description of key information

The EpiDerm Standard Model (EPI-200) was used to assess the skin irritancy of the substance as sold commercially at a 28% active emulsion in water. It is not possible to carry out the test on a dried sample of the substance because drying causes the substance to alter with evolution of ammonia.

The test did not indicate evidence of skin irritation by this material in the commercially available form.

Iniitial in-vitro testing using the BCOP method showed some effect but insufficient to classify with confidence. The mean in vitro irritation score was calculated at 3.09, which is just above the no-effect criteria and there was some issue with the negative controls too. So, no prediction could be made regarding the classification of the test substance according to the evaluation criteria and further testing in another suitable method was required.

Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities obtained after treatment compared to the negative control tissues concurrently treated with Aqua dest. The test item is considered to be irritant to the eye but it cannot be differentiated between UN GHS“Category 1” or “Category 2”, if the relative tissue viability is less or equal to 60%. The value that the 28% active commercially avaiable substance recorded was 36.4% and is therefore considered to be an eye irritant.

Assessment of the results from both in-vitro methods would suggest that the irritancy effect lies at the lower end of the classification, so Category 2 has been assigned to this reaction mass substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot # W17033003. 28% active emulsion in water.
Thetawet FS-8250 is a 28% actives aqueous emulsion, water dispersible, low foam anionic fluorosurfactant
The active components are ammonium salts of [Mono & Di] 2-(Perfluorohexyl)ethyl-Phosphate. Found at ca. 10% and 18% respectively in the final product.
The substance is not possible to isolate from water and if attempted, there is decomposition with a loss of ammonia. The substance is also functionally surface active, forming emulsions in water and oil

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Source strain:

other: cultured human cells

Vehicle:

unchanged (no vehicle)

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Irritation / corrosion parameter:

% tissue viability

Value:

89.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Not possible to isolate from water without decomposition, so commercial product used for testing

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Lot #: W17033003 28% active aqueous emulsion.
Thetawet FS-8250 is a 28% active aqueous emulsion, water dispersible, low foam anionic fluorosurfactant
The active components are ammonium salts of [Mono & Di] 2-(Perfluorohexyl)ethyl-Phosphate. Found at ca. 10% and 18% respectively in the final product.
The substance is not possible to isolate from water and if attempted, there is decomposition with a loss of ammonia. The substance is also functionally surface active, forming emulsions in water and oil

Species:

human

Strain:

other: The model consists of normal, human-derived epidermal keratinocytes which have been cultured to form a stratified, highly differentiated squamous epithelium morphologically similar to that found in a human cornea.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

50 µL undiluted

Irritation parameter:

in vitro irritation score

Value:

36.4

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

Ocular irritation potential of the test item was predicted from the relative mean tissue viabilities obtained after treatment compared to the negative control tissues concurrently treated with Aqua dest. The test item is considered to be irritant to the eye but it cannot be differentiated between UN GHS [7] “Category 1” or “Category 2”, if the relative tissue viability is less or equal to 60%. The test item is considered to be non-irritant in accordance with UN GHS “No Category” if relative tissue viability is higher than 60%.

Since irritant substances are cytotoxic to the corneal epithelium after a short time exposure the cytotoxic effects of the test item on EpiOcular, a reconstituted three-dimensional human corneal epithelium model, were determined. Hereby, the test item was applied topically. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT after a 30 min exposure period and 120 min post-treatment period and compared to those of the concurrent negative controls.

The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.

The mixture of 50 µL test item per 1 mL A. dest. and per 2 mL isopropanol showed no colouring as compared to the solvent. Therefore, NSC living equalled 0%.

The test item showed irritant effects. The mean relative tissue viability (% negative control) was ≤ 60% (36.4%).

Interpretation of results:

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

Remarks:

Category 1 or 2 conclusion in the report

Conclusions:

Conclusion
In this study under the given conditions the test item showed irritant effects. The test item is classified as “irritant“ in accordance with UN GHS “Category 1” or “Category 2”

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)