2-Propenamide, 3-(1,3-benzodioxol-5-yl)-N,N-diphenyl-, (2E)-

Endpoint summary

Description of key information

Skin corrosion: not corrosive (OECD 431, GLP)
Skin irritation: not irritating (draft OECD 439, GLP)
Eye irritation: not irritating (OECD 437 (2013); GLP)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

WoE, Skin irritation in vitro, RL2

In an in vitro skin irritation study, the substance was tested for its skin irritation potential according to OECD guideline 439 (draft 2008) by the means of the human skin model test using EpiDerm™. Triplicates of EpiDerm™ tissues were exposed to either the substance (25 µL) with the vehicle (25 µL), the positive control (5 % sodium lauryl sulphate; 30 µL), or the negative control (sterile PBS; 30 µL) for 1 hour. The substance and the positive and negative controls were washed off the skin tissues after treatment. After further incubation for about 42 hours the tissues were treated with the MTT solution for 3 hours. The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol for at least 2 hours followed by the measurement of the optical density (OD570).

After an 1 hour exposure period with the test item the relative tissue viability increased (105 %) (threshold for irritation: 50 %). Therefore, the substance is not considered to possess an irritant potential.The controls confirmed the validity of the study.

According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance does not require classifiication as skin irritant.

 

WoE, Skin corrosion in vitro, RL1

In an in vitro skin corrosion study, the substance was tested for its skin corrosive potential according to the OECD guideline 431 (2004) by the means of the human skin model test using EpiDerm™. Duplicates of EpiDerm™ tissues were exposed to either the substance (25 µL) with the vehicle (25 µL), the positive control (8 n potassium hydroxide; 50 µL) or the negative control (highly de-ionised water; 50 µL) for each of two different exposure periods: 3 minutes and 1 hour. Afterwards the test and the control items were rinsed off the tissues, and a 3 hour incubation period with MTT solution followed.

After incubation, tissues were washed and the formazan produced by the tissues was extracted with isopropanol overnight. This was followed by the measurement of the optical density (OD570).

After an exposure period of 3 minutes the relative tissue viability increased to 123 % (threshold for corrosivity: 50 %). After an exposure period of 1 hour the relative tissue viability increased to 104 % (threshold for corrosivity: 15 %). Therefore, the substance was not considered to be corrosive. The controls confirmed the validity of the study.

According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not corrosive to the skin.

 

Key, In Vitro Eye irritation, RL1

In an in vitro eye irritation study, the substance was tested for its eye irritation potential according to the OECD guideline 437 (2013) using fresh bovine corneae. Three corneae were exposed to either the test item as 20 % suspension (w/v) (0.75 mL), the positive control ( 10% (w/v) Benzalkonium chloride in 0.9% (w/v) NaCl (saline)); 0.75 mL), or the negative control (saline; 0.75 mL) for 240 minutes (incubation temperature: 32 ± 1 °C). After the incubation phase the substance, the positive control, and the negative control were each rinsed from the corneae. Next, the corneal opacity and permeability were measured and the In vitro Irritancy Score (IVIS) was calculated for the test item and the controls.

Relative to the negative control, the substance did not cause an increase of the corneal opacity or permeability.

The calculated mean IVIS was 2.62 (threshold for serious eye damage: IVIS≥ 55). According to OECD 437 (2013) a chemical that induces an IVIS ≤ 3 is considered as not requiring classification for eye irritation or serious eye damage. According to the Regulation (EC) No 1272/2008 and subsequent adaptations, the substance is not irritating to the eye.

Justification for classification or non-classification

Skin irritation

The substance does not possess a skin irritating or corrosive potential based on in vitro OECD 431 and OECD 439 tests and does not require classification as skin corrosive according to Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.

 

Eye irritation

The substance does not possess an eye irritation potential according to an in vitro OECD 437 test and does not require classification as eye irritant according to Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.