Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Data on physical and chemical properties, eco-toxicity and toxicity can be used for read-across from 2,4-TDI to 2,6-TDI and mixed TDI isomers (i.e. 80/20, 65/35, 2,4/2,6 ratios).  2,4 TDI is the major component of the TDI mixed isomers and so has the major influence on their properties and effects. The reactivity of the 2,6-TDI isomer is somewhat less than that of 2,4-TDI but is of the same order of magnitude. It may therefore be concluded that the effects of 2,6-TDI will be similar to those of 2,4-TDI. This is in fact observed where there are overlapping data.

The toxicity on fertility of TDI was investigated in a two generation study in rats (Tyl et al. 1989). The study was performed in accordance to the OECD 416 guildeline under GLP. Vapor atmospheres of 0.02, 0.08 or0.3 ppm did not

effect any of the reproduction parameters which were evaluated. The only signs of toxicity were transient irritations of the upper respiratory tract. Therefore, under the conditions of this study, there was no evidence of effects on reproduction at the highest exposures tested which was 0.3ppm.

Short description of key information:

No effects on fertility in a 2-Gen study. (OECD-guideline 416 , GLP).

Effects on developmental toxicity

Description of key information

No effects on development in a developmental toxicity study. (OECD-guideline 414, GLP).

Additional information

Data on physical and chemical properties, eco-toxicity and toxicity can be used for read-across from 2,4-TDI to 2,6-TDI and mixed TDI isomers (i.e. 80/20, 65/35, 2,4/2,6 ratios).  2,4 TDI is the major component of the TDI mixed isomers and so has the major influence on their properties and effects. The reactivity of the 2,6-TDI isomer is somewhat less than that of 2,4-TDI but is of the same order of magnitude. It may therefore be concluded that the effects of 2,6-TDI will be similar to those of 2,4-TDI. This is in fact observed where there are overlapping data.

Developmental toxicity of TDI was investigated by exposing mated female rats to TDI vapors of 0.02, 0.1, 0.5 ppm (Tyl et al., 1988).The study was performed in accordance to the OECD guildeline 414 under GLP.

No embryotoxicity or teratogenicity was observed at any exposure concentration employed. Exposure to toluene diisocyanate vapour by inhalation during organogenesis in rats resulted primary in irritation of the respiratory tract at the highest tested dose level (0.5 ppm). Most likely secondary to this irritation maternal toxicity and minimal fetotoxicity were observed (decreased food consumtion and bw).

Justification for classification or non-classification

Not classified as toxic to reproduction according to Directive 67/548/EEC is R52-53 and Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008).

Additional information

Categories Display