Registration Dossier

Administrative data

Description of key information

Skin Irritation - In a skin irritation study the test material was determined to be non corrosive and non irritant to the skin

Eye Irritation - In a BCOP assay, the results proved to be inconclusive for eye irritation. The results showed that the test substance is not corrosive to the eye. Therefore, in the absence of conclusive data and taking a precautionary measure the test substance has been classifed as an eye irritant.

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:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Irritation

The skin irritation of the test material was evaluated in vitro using the EPISKIN reconstructed human epidermis model in accordance with the standardised guidelines OECD439 and EU Method B.46 under GLP conditions. I was assigned a reliabiity score of 1 in accordance with the criteria detailed by Klimisch (1997)

Triplicate tissues were treated with the test material for an exposure period of 15 minutes. At the end of the exposure period, each tissue was rinsed before incubating for 42 hours after which each tissue was taken for MTT loading. Duplicate tissues treated with PBS served as the negative controla nd duplicate tissues treated with 5% aqueous Sodium Dodecyl Sulphate in PBS served as the positive control. The optical density was measured at 562 nm

The relative mean viability of the test item treated tissues was 73.7% after the 15 minute exposure period and 42 hours post exposure incubation period.

Under the conditions of this study, the test material was determined to be non-irritating adn requires no classification in accordance with EU criteria

Eye Irritation

The irritation or corrosion efects of the test material were investigated in vitro in accordance with the standardised guidelines OECD 437, EU Method B.47 under GLP conditions.

The undiluted test item 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 fluorescin dye through the cornea (permability) were combined in an empirically derived formular to generate the in vitro irritancy score, The test item produced an IVIS score of 4.9.

No prediction of eye irritation can be made.

As no prediction for eye irritancy can be made, and in the absence of an in vivo study to confirm the irritation of the test substance the test substance will be classified as an eye irritant.

Justification for classification or non-classification

In accordance with the criteria for classification as defined in Annex 1, REgulation (EC) No. 1272/2008, the test material does not require classification for skin irritation but it is classified as an eye irritant.