4-Butyl-4''-ethyl-2',3'-difluor-1,1':4',1''-terphenyl

Endpoint summary

Description of key information

Skin irritation: No skin irritating potential could be detected for the read-across source substance.

Eye irritation: No eyeirritating potential could be detected for the read-across source substance.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation / corrosion, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Justification for type of information:

For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 404. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Remarks on result:

no indication of irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation, other

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Justification for type of information:

For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 437. See chapter 13 report for a more detailed justification.

Reason / purpose for cross-reference:

read-across source

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

1.88

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

No study data with the test item is available for this endpoint. Therefore, a read-across to the read-across source substance with a very similar chemical structure and comparable physico-chemical parameters is used to evaluate the endpoint for the test item.

 

Skin irritation

To test for primary skin irritation, 0.5 g of the test material, was mixed with some drops of Aqua pro injectione to ensure good contact with the skin. Afterwards the test material was spread onto 6 cm² patches and applied to the intact skin of previously shaven rabbits for a 4 hours period under semiocclusive conditions. The study was started as an initial test with 1 animal and followed by the confirmatory test with 2 further animals. The first examination of the treated skin sites followed 1 hour after removal of the patches. Thereafter, examinations were performed daily for a further 7 days.

Under the conditions of the present study, no signs of irritation were seen.  Body weight development of the treated rabbits was inconspicuous.

No skin irritating potential could be detected.

 

Eye irritation

This in vitro study was performed to assess the corneal irritation and damage potential of the test material by means of the BCOP assay using fresh bovine corneae. Damage is assessed by quantitative measurements of changes in corneal opacity and permeability with an opacitometer and a visible light spectrophotometer, respectively. Both measurements are used to calculate an in vitro irritation score, which is used to assign an in vitro irritancy category.

The test item did not cause any opacity or permeability of the corneae compared with the results of the negative control. The calculated mean in vitro irritation score was 1.88 and therefore, the test item was classified as non eye irritant.

In conclusion, the test item is not considered to be an eye irritant in this study and under the experimental conditions reported.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin and eye irritation/corrosion it is not considered to be classified according Regulation (EC) No 1272/2008.