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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:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
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:
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. certificate)
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 2 (irritating to eyes) based on GHS criteria
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)

Additional information

Justification for classification or non-classification