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Description of key information

Skin Corrosion

A study was performed in vitro to assess the corrosive potential of the test material. Under the conditions of this study, the test material was determined to be non-corrosive to the skin.

Skin Irritation

A study was performed in vitro to assess the irritancy potential of the test material. Under the conditions of the study, the test material was determined to be non irritating to the skin.

Eye Irritation

The eye irritancy potential of the test material was investigated in vitro in a study conducted through The Bovine Corneal Opacity and Permeability (BCOP) Assay. Under the conditions of the study, the test material was found to be non-irritating to the eye.

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

The following corrosion and irritation studies were assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997).

Skin Corrosion

A study was performed in vitro to assess the corrosive potential of the test material in accordance with the standardised guidelines OECD 431 and EU Method B.40bis under GLP conditions.

Duplicate tissues were treated with the test material for exposure periods of 3 and 60 minutes. The test employed the use of the EpiDerm™ Human Skin Model. Negative and positive control groups were treated in duplicate for each exposure period. The test material was found to directly reduce MTT and therefore additional non-viable tissues were incorporated into the testing for correction purposes. At the end of the exposure period the test material was rinsed from each tissue before each tissue was taken for MTT-loading. After MTT loading each tissue was placed in 2 mL Isopropanol for MTT extraction.

At the end of the formazan extraction period each well was mixed thoroughly and triplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density (OD) was measured at 562 nm (OD562).

The mean OD562 for the negative control treated tissues was 1.884 for the 3 Minute exposure period and 1.886 for the 60 Minute exposure period. The relative mean tissue viability for the positive control treated tissues was 5.7 % relative to the negative control following the 3 Minute exposure period and 5.1 for the 60 minute exposure period. The Coefficient of Variation between the two tissue replicates of each treatment group did not exceed 30 %. The acceptance criterion was therefore satisfied. The relative mean viability of the test material treated tissues was 102.8 for the 3 minute exposure period and 111.1 for the 60 minute exposure period.The relative mean tissue viability (% of negative control) was greater than 50 % at 3 minutes and greater than 15 % at 60 mins, therefore under the conditions of this study, the test material was determined to be non-corrosive to the skin.

 

Skin Irritation

A study was performed in vitro to assess the irritancy potential of the test material. The study was conducted in accordance with the standardised guidelines OECD 439 and EU Method B.46 under GLP conditions.

The skin irritation potential of the test material was evaluated using the EPISKIN reconstructed human epidermis model. Triplicate tissues were treated with the test material for an exposure period of 15 minutes. The test material was found to directly reduce the yellow MTT tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) to a blue formazan salt, therefore additional non-viable tissues were incorporated into the testing to counteract false negative results. At the end of the exposure period each tissue was rinsed before incubating for 42 hours. At the end of the post-exposure incubation period each tissue was taken for MTT-loading. After MTT-loading a total biopsy of each epidermis was made and placed into micro tubes containing acidified isopropanol for extraction of formazan crystals out of the MTT-loaded tissues. At the end of the formazan extraction period each tube was mixed thoroughly and duplicate 200 µL samples were transferred to the appropriate wells of a pre-labelled 96-well plate. The optical density was then measured at 562 nm.

The acceptance criteria was met for negative and positive controls. The quality criteria required for acceptance of results in the test were not fully satisfied in that the standard deviation of the relative viability for the test material treated tissues was above the acceptance criterion of 18 %. However, as the test material gave an unequivocal non-irritant result it was considered unnecessary to repeat the test. The relative mean viability of the test material treated tissues was 90.7 % which is above the threshold of 50 %. Under the conditions of this study the test material was determined to be non irritating to the skin.

Eye Irritation

The eye irritancy potential of the test material was investigated in vitro in a study conducted through The Bovine Corneal Opacity and Permeability (BCOP) Assay in accordance with the standardised guidelines OECD 437 and EU Method B.47 under GLP conditions.

The undiluted test material was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). 

After test material exposure, the corneas treated with the test material or negative control item were clear post treatment and post incubation and the corneas treated with the positive control item were cloudy post treatment and post incubation. The negative and positive control acceptance criteria were satisfied as the negative control gave opacity of =2.9 and permeability =0.103 and the positive control In Vitro Irritancy Score was within the range of 29.6 to 52.0. The test material gave an opacity of 2.4 and permeability of 0.010 (Mean corrected values). The test material was classed to have an In Vitro Irritancy Score of 2.6.

Under the conditions of this study the test material was found to be non-irritating to the eye.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex I, Regulation (EC) No. 1272/2008, the substance does not require classification with respect to skin and eye irritation or corrosion.