Registration Dossier

Administrative data

Description of key information

Skin Corrosivity: The purpose of this test was to evaluate the corrosivity potential of the test material using the EPISKIN(TM) in vitro Reconstituted Human Epidermis (RHE) Model after treatment periods of 3, 60 and 240 minutes. This method was designed to meet the requirements of the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004).
The test material was considered to be Non-Corrosive to the skin and accredited the EU risk phrase of No label and a UN packing group Non-Corrosive.
Skin irritancy: The purpose of this test was to evaluate the skin irritation potential of the test material using the EPISKINTM reconstituted human epidermis model after a treatment period of 15 minutes followed by a post exposure incubation period of 42 hours.
The test material was considered to be Non-Irritant (NI).
Eye irritancy: The purpose of the study was to assess the ocular irritancy potential of the test material in the rabbit following application onto the cornea of the enucleated eye. The results of the study are believed to be of value in predicting the ocular irritation potential of the test material in man. According to the protocol followed the test material was considered to be a Non-Irritant (NI)

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)

Additional information

Skin:

There are two key in vitro studies for this endpoint.

- The first study (Warren, 2010) assesses skin corrosivity designed to meet the requirements of the OECD Guideline for the Testing of Chemicals No. 431 “In Vitro Skin Corrosion: Human Skin Model Test” (adopted 13 April 2004).

A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997 as this was conducted to a guideline study and GLP.

- The second study (Warren, 2010) assesses skin irritancy according to a validated in vitro method following the EPISKINTM reconstituted human epidermis model.

A reliability rating of 1 was assigned according to the criteria of Klimisch, 1997 as this was conducted to a validated in vitro method and GLP.

Eye: One key was available for the assessment of this endpoint (Warren, 2010). The study was performed using an in vitro method using RHC tissues

A reliability score of 2 was assigned to the study according to the criteria outlined in Klimisch, 1997.

Justification for classification or non-classification

Skin corrosivity:

The test material was considered to be Non-Corrosive to the skin and accredited the EU risk phrase of No label and a UN packing group Non-Corrosive.

Skin irritancy:

Classification of irritation potential is based upon relative tissue viability following the 15 Minute exposure period followed by the 42 Hour post-exposure incubation period according to the following table:

Criteria forin vitrointerpretation

Classification

Mean tissue viability is ≤50%

Irritant (I) R38

Mean tissue viability is >50%

Non-Irritant (NI)

The relative mean viability of the test material treated tissues was 100.8% after the 15 Minute exposure period.

The in vitro data indicates that the substance is considered a Non-Irritatant to the skin and so it will therefore not be classified for this endpoint.

Eye:

According to the protocol followed the test material was considered to be a Non-Irritant (NI).