(Z)‐ethyl 2‐methylpent‐3‐enoate

Endpoint summary

Description of key information

Skin corrosion: Not corrosive based on an OECD TG 431 test.

Skin irritation: Not irritating based on an OECD TG 439 test.

Eye irritation: Not irritating based on an OECD TG 438 test.

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)

Additional information

Skin corrosion

In an in vitro skin corrosion test using a human skin model (EpiDerm Skin Model) performed according to OECD TG 431 and GLP principles, the influence of the test substance on the viability of human skin was tested. The test item was applied undiluted (50 μL) was applied directly on top of the skin tissue. The positive control had a mean relative tissue viability of 7.2% after the 1-hour exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the acceptance limits of OECD 431 (lower acceptance limit ≥0.8 and upper acceptance limit ≤2.8) and the laboratory historical control data range. In the range of 20 - 100% viability the Coefficient of Variation between replicates of the negative control tissues was ≤ 14%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 98% and 65%, respectively. Because the mean relative tissue viability for the test item was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test item is considered to be not corrosive. In conclusion, the test substance is not corrosive to the skin in accordance with EU CLP (EC no1272/2008 and its amendments).

Skin irritation

In an in vitro skin irritation test using a human skin model (EPISKIN Standard Model), the influence of the test substance on the viability of human skin was tested. The test item was applied undiluted (25 μL), directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 ± 1 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. Skin irritation is expressed as the remaining cell viability after exposure to the test item. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 94%. Since the mean relative tissue viability for the test item was above 50% after 15 ± 0.5 minutes treatment the test item is considered to be non-irritant. The positive control had a mean cell viability of 5.4% after 15 ± 0.5 minutes exposure. The absolute mean OD570 (optical density at 570 nm) of the negative control tissues was within the laboratory historical control data range. The standard deviation value of the percentage viability of three tissues treated identically was ≤ 4.2%, indicating that the test system functioned properly. In conclusion, the test substance is not irritating to the skin in accordance with EU CLP (EC no1272/2008 and its amendments).

Eye irritation

An Isolated Chicken Eye Test (ICET) was performed with the Substance according to OECD guideline 438 and in accordance with GLP principles. Thirty µL of the Substance was applied to corneas (n=3). After 10 seconds exposure time, the surface of the eyes was rinsed with physiological saline solution. Slight corneal swelling change (mean = -8.5%) was observed during the four-hour observation period on test item treated eyes. Slight cornea opacity change (severity 0.5 on one eye and severity 1 on two eyes) was observed. No fluorescein retention change was noted on all eyes. No other morphological effect was observed. The negative control and positive control results were within the historical data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Based on the results, the endpoints Corneal swelling and Corneal opacity were assigned ICE CLASS II and the Fluorescein retention endpoint was assigned ICE CLASS I. According to EU CLP (EC 1272/2008 and its amendments), the substance is non irritant.

Justification for classification or non-classification

Based on the results of the available in vitro skin and eye studies, the substance does not need to be classified for skin and eye irritation according to EU CLP (EC 1272/2008 and its amendments).