Rosetal A

Endpoint summary

Description of key information

Skin corrosion: not corrosive based on OECD TG 431.

Skin irritation: the substance causes skin irritation based on OECD TG 439.

Eye irritation: not irritant based on OECD TG 438

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (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. Fifty μL test substance was applied directly on top of 0.6 cm2 cultured skin. The positive control had a mean relative tissue viability of 11% 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 TG 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 tissue replicates was ≤ 15%, indicating that the test system functioned properly. The test item showed color interference in aqueous conditions. The OD of the treated tissues without MTT assay was subtracted from the ODs of the test item treated viable tissues with MTT assay. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test item compared to the negative control tissues was 101% and 94%, 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 to skin.

 

Skin irritation

An in vitro skin irritation test was performed according to OECD TG 439 and in accordance with GLP principles. The test item was applied undiluted (25 μL), directly on top of the skin tissue for 15 ± 0.5 minutes. After a 42 hour post-incubation period, determination of the cytotoxic (irritancy) effect was performed. The positive control had a mean cell viability of 16 ± 2.6% 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 ≤ 11%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 15 ± 0.5 minutes treatment with the test item compared to the negative control tissues was 25 ± 7.7%. Since the mean relative tissue viability for the test item was below 50% after 15 ± 0.5 minutes treatment, the test item is considered to be irritant to skin.

 

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. No significant corneal swelling change (mean = 1.1%) was observed during the four-hour observation period on test item treated eyes. No significant cornea opacity change (severity 0.5 on one eye and no cornea opacity change on two eyes) was observed. No significant fluorescein retention change (severity 0.5 on two eyes and no fluorescein retention change on one eye) was noted. 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, Corneal opacity and Fluorescein retention were assigned ICE CLASS I and the substance is therefore not irritating to eyes. 

Justification for classification or non-classification

The substance has to be classified for skin irritation and shall be labelled with H315: Causes skin irritation, but is not classified for eye irritation according to EU CLP (EC No. 1272/2008 and its amendments).