Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Additional information

Skin irritation

Desmodur VP.PU 60WF14 was irritating to the skin of rabbits under semiocclusive dressings for 4 hours according to OECD TG 404 (Gmelin, 2010a). All signs were fully reversible within two weeks. No relevant systemic intolerance reactions were observed. In addition, a test using an artificial 3D-Skin model (OECD TG 431) revealed no corrosive properties of Desmodur VP.PU 60WF14 in vitro (Wingenroth, 2010a).

 

According to classification criteria Desmodur VP.PU 60WF14 is an irritant to the skin.

 

Eye irritation

Desmodur VP.PU 60WF14 was identified as "non irritant" to the chorioallantoic membrane (irritation score (IS) = 0) in the in vitro HET-CAM test according to a protocol recommended by ICCVAM, November 2006 (Wingenroth, 2010b). However, the test item was irritating to the eyes of rabbits after instillation for 24 hours according to OECD TG 405 (Gmelin, 2010b). In one animal effects at cornea and conjunctivae (redness and chemosis) were not reversible within the 28-day recovery period. No systemic intolerance reactions were observed.

 

According to classification criteria Desmodur VP.PU 60WF14 caused serious damage to the eyes without reversibility within 28 days.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

According to CLP Regulation (EC) No 1272/2008 the classification of 2,4-/2,6-TDI (CAS No 26471-62-5) was considered for the classification of TDI Biuret since TDI Biuret contains >= 50 % of 2,4-/2,6-TDI.

 

Skin irritation

2,4-/2,6-TDI is classified under Annex I of Directive 67/548/EEC with R38 (irritating to skin). This classification corresponds to Category 2 (causes skin irritation) according to Annex VI-1 of CLP Regulation (EC) No 1272/2008. A dermal irritation/corrosion study in rabbits with Desmodur VP.PU 60WF14 (TDI Biuret) confirms this classification.

 

Eye irritation

2,4-/2,6-TDI is classified under Annex I of Directive 67/548/EEC with R36 (irritating to eye). This classification corresponds to Category 2 (causes serious eye irritation) according to Annex VI-1 of CLP Regulation (EC) No 1272/2008. Differing from this the irreversible damage to the eyes of rabbits after instillation of Desmodur VP.PU 60WF14 (TDI Biuret) leads to the following classification according to Annex I of CLP Regulation (EC) No 1272/2008: Category 1 (causes serious eye damage).

 

Respiratory irritation

Due to respiratory irritation effects 2,4-/2,6-TDI was classified under Annex I of Directive 67/548/EEC with R37 (irritating to respiratory system). This classification corresponds to STOT-SE Category 3 (may cause respiratory irritation) according to Annex VI-1 of CLP Regulation (EC) No 1272/2008.