Registration Dossier

Administrative data

Description of key information

The test item “K-36” shows no irritant or corrosive effects in different skin irritation /corrosion and eye irritation tests according to current OECD 
guidelines .

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

Based on the evaluable findings of the in-vitro-study, it was revealed only, that the test item K-36 (Batch: 1 ERF-12013) does not cause necrosis or formation of oedema. As a result, a corrosive effect (category 1) can be excluded.

However, the assessment of the potential for skin irritation (category 2) according to the criteria of the regulation (EC) No 1272/2008 (2008) was not possible due to the problem of discolouration of skin.

In the in-vivo-model, the test item “K-36” was additionally considered to be non-corrosive to skin according to OECD Guideline 431.

The test item K-36 showed no irritating effects or serious eye damage on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is -0.182. According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

Furthermore, the potential eye irritant effect of K-36 after the single application in the rabbit eye was studied. The present study has been conducted according to the method of the OECD Guideline 405 (2012).

Based on the overall irritation score of 0, the test item K-36 shall not be considered as irritating to eyes.

Justification for classification or non-classification

Based on the results of the skin and eye irritation studies, the test item K-36 shall not be considered as irritating or corrosive to skin or irritating to eyes and shall not be classified according to the category 1 or 2 of the regulation (EC) No 1272/2008 (2008).