[No public or meaningful name is available]

Endpoint summary

Description of key information

The objective was to evaluate if the test substance was able to induce skin irritation, skin corrosion, eye irritation and/or eye corrosion in in vitro test models.

The test item was a colourless to light yellow high viscous liquid. The test item was heated to 78.5°C for 30 minutes to liquefy, however solidified immediately after taking out of the water bath.

Due to the physical characteristics of the test item the test item could be applied to the skin tissues and to the cornea.

Therefore it is concluded that the test item is not suitable to conduct the studies related to this endpoint in the in vitro test models.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vitro / ex vivo

Study period:

15 May 2017 - 3 October 2017

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

not specified

Interpretation of results:

study cannot be used for classification

Conclusions:

Batch 616F-2072 of test item was a colourless to light yellow high viscous liquid. The test item was heated to 78.5°C for 30 minutes to liquefy, however solidified immediately after taking out of the water bath in Test Facility No. 516833.
Due to the physical characteristics of the test item the test item cannot be applied to the skin tissues.
Therefore it is concluded that the test item is not suitable to perform this test.

Executive summary:

The objective of this study was to evaluate of the test substance was measured for its ability to induce skin irritation on a human three dimensional epidermal model (EPISKIN Small model (EPISKIN-SM^TM). 

Batch 616F-2072 of test item was a colourless to light yellow high viscous liquid. The test item was heated to 78.5°C for 30 minutes to liquefy, however solidified immediately after taking out of the water bath in Test Facility No. 516833.

Due to the physical characteristics of the test item the test item cannot be applied to the skin tissues.

Therefore it is concluded that the test item is not suitable to perform this test.

Reference 2

Endpoint:

skin corrosion: in vitro / ex vivo

Study period:

15 May 2017 - 3 October 2017

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Qualifier:

according to guideline

Guideline:

OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)

GLP compliance:

not specified

Test system:

human skin model

Source species:

human

Interpretation of results:

study cannot be used for classification

Conclusions:

Batch 616F-2072 of test item was a colourless to light yellow high viscous liquid. The test item was heated to 78.5°C for 30 minutes to liquefy, however solidified immediately after taking out of the water bath in Test Facility No. 516833.
Due to the physical characteristics of the test item the test item cannot be applied to the skin tissues.
Therefore it is concluded that the test item is not suitable to perform this test.

Executive summary:

The objective of this study was to evaluate of the test substance was measured for its ability to induce skin corrosion on a human three dimensional epidermal model (EpiDerm (EPI-200). For this purpose the test-item will be topically applied on a human three dimensional epidermal model.

Batch 616F-2072 of test item was a colourless to light yellow high viscous liquid. The test item was heated to 78.5°C for 30 minutes to liquefy, however solidified immediately after taking out of the water bath in Test Facility No. 516833.

Due to the physical characteristics of the test item the test item cannot be applied to the skin tissues.

Therefore it is concluded that the test item is not suitable to perform this test.

Reference 3

Endpoint:

skin irritation / corrosion, other

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

December 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Results derived from valid (Q)SAR models, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification. Additional information from read-across and Skin Irritation Corrosion Rules Estimation Tool.

Principles of method if other than guideline:

OECD QSAR toolbox, EPI (Estimation Programs Interface) Suite™, Read Across and SICRET (Skin Irritation Corrosion Rules Estimation Tool) were applied.

GLP compliance:

no

- EPI suite: the structures of the selected DD80 peaks are not included in QSAR domain: final SAR results are “undefined”

- Read Across cannot be applied, since no structures similar to the selected DD80 peaks – and with known toxicological information - were found in public sources. Looking at substructures of the peaks, no robust conclusion on skin irritating potential can be drawn.

- SICRET approach cannot be applied on DD80, because it does not cover substances containing a phosphor atom, as the peak 1 (and other peaks in the DD80). For peaks 2, 4+5 and 6+7, it is possible to exclude the skin corrosion, only based on their molecular weight, and not using the other parameters, which make the exclusion rather weak. Additionally, skin irritation cannot be excluded for peaks 2, 4 +5 or 6 +7.

Interpretation of results:

other: Inconclusive

Conclusions:

No conclusions could be drawn on skin irritation or corrosion from the predictive tools.

Executive summary:

OECD QSAR toolbox, EPI (Estimation Programs Interface) Suite™, Read Across and SICRET (Skin Irritation Corrosion Rules Estimation Tool) were applied.

No conclusions could be drawn on skin irritation or corrosion from the predictive tools.

Endpoint conclusion

Endpoint conclusion:

no study available

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation, other

Type of information:

other: QSAR and Read-Across; supoorting evidence

Adequacy of study:

supporting study

Study period:

December 2017

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Results derived from valid (Q)SAR models, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification. Additional information from read-across.

Principles of method if other than guideline:

OECD QSAR toolbox, EPI (Estimation Programs Interface) Suite™ and Read Across were applied.

GLP compliance:

not specified

- EPI suite: the structures of the selected peaks of the test substance are not included in QSAR domain: final SAR results are “undefined”

- Read Across cannot be applied, since no structures similar to the selected peaks of the testsusbtance – and with known toxicological information - were found in public sources. Looking at substructures of the peaks, no robust conclusion on eye irritating potential can be drawn.

Interpretation of results:

other: Inconclusive

Executive summary:

Due to the physical characteristics of the test item, testing on eye irritation according to OECD Guideline 437 was not possible

To gather some indication on the eye irritation potential of the test substance,OECD QSAR toolbox, EPI (Estimation Programs Interface) Suite™ and Read Acrosswere applied.

No conclusions could be drawn on eye irritation potential of the testsubstance from the predictive tools.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Study period:

7 April - 29 August 2017

Data waiving:

study technically not feasible

Justification for data waiving:

other:

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes

Species:

cattle

Vehicle:

unchanged (no vehicle)

Due to the physical charateristics of the test item, it could not be applied to the cornea. No conclusion can be drawn for this endpoint.

See attached Summary Report.

Interpretation of results:

study cannot be used for classification

Conclusions:

Due to the physical charateristics the test item, the test item could not be applied to the cornea. No conclusion can be drawn for this endpoint.

Executive summary:

The test substance is a viscous liquid that required heating to liquefy, however the liquid immediately sollified after taking it out from the water bath. Due to the physical charateristics the test item, the test item could not be applied to the cornea. No conclusion can be drawn for this endpoint.

Reference 3

Endpoint:

eye irritation: in vitro / ex vivo

Study period:

7 April - 29 August 2017

Data waiving:

study technically not feasible

Justification for data waiving:

other:

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)

Species:

other: Human Cornea-like-Epithelium

Vehicle:

unchanged (no vehicle)

Due to the physical charateristics of the test item, it could not be applied to the Epithelium tissue.

.

Interpretation of results:

study cannot be used for classification

Conclusions:

Due to the physical charateristics the test item, the test item could not be applied to the Epithelium tissue. No conclusion can be drawn for this endpoint.

Executive summary:

The test substance is a viscous liquid that required heating to liquefy, however the liquid immediately sollified after taking it out from the water bath. Due to the physical charateristics the test item, the test item could not be applied to the tissue. No conclusion can be drawn for this endpoint.

Endpoint conclusion

Endpoint conclusion:

no study available

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Due to the physical characteristics of the test substance, it could not be applied to the skin tissues and to the cornea in the in vitro tests.

In order to further investigate and clarify the ability of the UVCB substance to induce skin irritation, skin corrosion, eye irritation and/or eye corrosion in silico methods were applied on selected identified molecules.

OECD QSAR toolbox, EPI (Estimation Programs Interface) Suite™, Read Across and SICRET (Skin Irritation Corrosion Rules Estimation Tool) were applied.

No conclusions could be drawn on eye and skin irritation or corrosion from the predictive tools

Justification for classification or non-classification

Due to the physical characteristics of the test substance, the test substance could not be applied to the skin tissues and to the cornea in the in vitro tests.

Therefore it was concluded that the test substance is not suitable to perform these tests, and as a consequence no expirimental results could be obtained.

In addition no conclusions could be drawn on eye and skin irritation or corrosion neither from the predictive tools nor from read across.

The overall conclusion for this endpoint therefore is that no conclusion can be drawn on the ability of the UVCB substance to induce skin irritation, skin corrosion, eye irritation and/or eye corrosion.

Therefore no conclusion can be drawn on classification for the skin irritation, eye irritation and/or eye corrosion.