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Description of key information

No irritating or corrosive property to skin of the test item was determined by the two 3D skin models used (Wingenroth, 2010).
The irritant / corrosive potential of the test substance was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002 and the EEC Directive No. 440/2008 Part B - Method BA. According to classification criteria the test substance is not an irritant to the skin (Gmelin, 2010).
The test substance was identified as "non irritant" to the Chorioallantoic membrane (Irritation Score (IS) = O)in a HET-CAM assay (Wingenroth, 2010).
The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days (Gmelin, 2010 DRAFT).

Key value for chemical safety assessment

Additional information

A study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin was performed. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, ST. Katharinen, Germany) for detection of topically applied skin corrosives with the test item. Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. A 100% concentration was tested on the skin/ epidermal equivalents in triplicate. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min. respectively. Thus the study was conducted in accordance with the 431 guideline as well as with an EC guideline (amending Council Directive 67/548/EEC, B.40 Skin Corrosion) using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion". To check the reliability of this test procedure a blinded positive/negative control study is conducted at regular interval in the lab. The reliability check is always performed by two technicians, in two laboratories in parallel using the same batches of the control test items.

The test item was applied at a 100% concentration, i.e. 25 mg per insert (plus 50µl 0.9% NaCl to moisten and ensure good contact with the skin).

The test result shows that no corrosive property of the test item was determined by the assay used (Wingenroth, 2010).

Another study which allows the hazard identification of irritant substances in accordance with UN GHS category 2, was performed. The experiment was carried out according to EU Test Method B.46 using commercially available reconstructed human epidermis (RHS) model EST-1000 (CellSystems, St.Katharinen, Germany). Undiluted test substance was applied topically to the RHS model, i.e. 30 mg per insert (plus 30 µg 0.9% NaCI to moisten and ensure good contact with the skin; three replicates). After an exposure period of 20 minutes, followed by a 42 hours post treatment incubation period, the cell viability was measured to be 99.56% in the MIT (Methylthiazoletetrazolium) conversion assay. The results of the concurrent negative control (NC, 0.9% NaCI) and positive control (PC, 5% SOS) demonstrated the viability (NC) and sensitivity (PC) of the test model. Thus, the results show that the test substance is considered to have no skin irritation category (Wingenroth, 2010).

The irritant / corrosive potential of the test substance was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002 and the EEC Directive No. 440/2008 Part B - Method BA. According to classification criteria the test substance is not an irritant to the skin. There were no systemic intolerance reactions (Gmelin, 2010).

Hen's egg tests are used to determine the potential irritant/ corrosive property of a test compound using an in vitra alternative to the Draize methodology (OECD405). The test substance was tested by observing possible adverse changes after application onto the Chorioallantoic membrane (HET-CAM). After the application of the test item blood vessels and albumin were examined and scored for the following irritant effects: vasodilatation, slight hemorrhage; vessel lysis, strong hemorrhage; blood coagulation, albumen coagulation for a period of 300 seconds. 300 µl of the test item was applied per egg directly on the Chorioallantoic membrane. The test substance was identified as "non irritant" to the Chorioallantoic membrane (Irritation Score (IS) = O) under the conditions of this assay.

The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days. There were no systemic intolerance reactions (Gmelin, 2010 DRAFT).

Justification for classification or non-classification

According to classification criteria the test substance is not an irritant to the skin and needs no classification as an skin irritant or as skin corrosive.

The Compound is labeled with R41 (risk of serious damage to eyes); according to REACH TGD ´Guidance on information requirements and chemical safety assessment, Part E: Risk Characterization, May 2008´ this translates to the “moderate hazard band”.