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Diss Factsheets

Administrative data

Description of key information

Skin irritation: non-corrosive, in vitro EpiDerm OECD TG 431, Wil Research B.V. 2015
Skin irritation: non-irritating, in vitro EpiSkin OECD TG 439, Wil Research B.V. 2015
Eye irritation: non-irritating, in vitro BCOP OECD TG 437, Wil Research B.V. 2015

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

Skin irritation:

In vitro, OECD TG 439, 2015 - The study was performed to OECD TG 439 and EU Method B.46 to assess the skin irritation potential of the test substance in accordance with GLP using a human three dimensional epidermal model (EPISKIN Small Model). The test was performed on a total of 3 tissues per test substance together with negative and positive controls. 10 μl of the undiluted test substance was added (with a pipette) into 12-well plates on top of the skin tissues. Three tissues were treated with 10 μl PBS (negative control) and 3 tissues with 10 μl 5% SDS (positive control) respectively. The positive control was re-spread after 7 minutes contact time. After the exposure period of 15 ± 0.5 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts were each dried carefully and moved to a new well on 2 ml pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 hours at 37°C. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate. Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. The positive control had a mean cell viability of 12% after 15 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 less than 12%, indicating that the test system functioned properly. The relative mean tissue viability obtained after 15 minutes treatment with the test substance compared to the negative control tissues was 76%. Since the mean relative tissue viability for the test substance was above 50% after 15 minutes treatment it is considered to be non-irritant. Under the conditions of this study the test material is not irritant in the in vitro skin irritation test.

 

Skin corrosion:

In vitro, OECD TG 431, 2015 - The study was performed to OECD TG 431 and EU Method B.40 BIS to assess the skin corrosion potential of the test substance in accordance with GLP using a human three dimensional epidermal model (EpiDerm (EPI-200)). The test was performed on a total of 4 tissues per test substance together with a negative control and positive control. Two tissues were used for a 3-minute exposure to the test substance and two for a 1-hour exposure. Fifty μl of the undiluted test substance was added (with a pipette) into the 6-well plates on top of the skin tissues. The remaining tissues were treated with 50 μl Milli-Q water (negative control) and with 50 μl 8N KOH (positive control), respectively. The positive control had a mean relative tissue viability of 14% after 3 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 maximum inter-tissue variability in viability between two tissues treated identically was less than 22% and the maximum difference in percentage between the mean viability of two tissues and one of the two tissues was less than 13%, indicating that the test system functioned properly. Skin corrosion is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 3-minute and 1-hour treatments with the test substance compared to the negative control tissues was 91% and 94%, respectively. Because the mean relative tissue viability for the test substance was not below 50% after the 3-minute treatment and not below 15% after the 1-hour treatment the test substance is considered to be not corrosive. Under the conditions of this study the test material is not corrosive in the in vitro skin corrosion test.

 

Eye irritation/corrosion:

In vitro, OECD TG 437, 2015 - The study was performed to OECD TG 437 and EU Method B.47 to assess the irritancy potential of the test material to the eye following exposure to bovine corneas in accordance with GLP. A total of 3 corneas per treatment group were used. A volume of 750 microlitres of the test material was placed the cornea. The negative control group received saline and the positive control group received 10% benzalkonium chloride. For each group the corneas were incubated for 10 ± 1 minutes at 32 ± 1°C. After the incubation the solutions were removed and the corneas were washed with MEM with phenol red (Eagle’s Minimum Essential Medium) and thereafter with cMEM. Possible pH effects of the test substance on the corneas were recorded. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently the corneas were incubated for 120 ± 10 minutes at 32 ± 1°C. After the completion of the incubation period opacity determination was performed. Each cornea was inspected visually for dissimilar opacity patterns. Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 149.5 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The test material did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of -0.4 after 10 minutes of treatment. All opacity and permeability responses were within the ranges of the individual negative controls. Based on these results the test material is considered to be not irritating or corrosive in the Bovine Corneal Opacity and Permeability test.


Justification for selection of skin irritation / corrosion endpoint:
two in vitro GLP compliant Klimisch 1 studies; selected study in accordance with sequential testing strategy of Regulation (EC) 440/2008 and its subsequent amendments.

Justification for selection of eye irritation endpoint:
one in vitro GLP compliant Klimisch 1 study; selected study in accordance with sequential testing strategy of Regulation (EC) 440/2008 and its subsequent amendments.

Justification for classification or non-classification

The substance does not meet the classification criteria under Regulation (EC) No 1272/2008 for skin irritation

The substance does not meet classification criteria under Regulation (EC) No 1272/2008 for eye irritation.