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Administrative data

Description of key information

Acute toxicity data indicate low toxicity: in rats the oral LD50 was > 2000 mg/kg bw; in rabbits the dermal LD50 (24h) was approximately 8000 mg/kg bw. Inhalation exposure for 8 hours to vapour saturated with DIPA failed to cause any deaths in rats (LC50 was not determined). A 3-hour inhalation exposure to 500-2069 mg/m3 DIPA (aerosol) did not cause any mortality in mice.

Key value for chemical safety assessment

Additional information

Oral toxicity

An OECD TG 401 study conducted in rats (1993, RL (realiability) = 1) was identified as the key study. The reported LD50 was greater than 2000 mg/kg bw, but few details were provided. In another study, an LD50 of approximately 6000 mg/kg bw was reported for rats. In animals of the highest dose group (i.e. 6400 mg/kg bw) intermittent respiration and apathy was noted one day after exposure, and a dilated stomach filled with black liquid and intestinal irritation were found at necropsy (1965, RL2).

 

Dermal toxicity

Male albino rabbits were administered undiluted test material via dermal application to their trunk area under impervious sheeting on clipped intact skin for 24 hours (1973, RL2). The LD50 was calculated to be approximately 8000 mg/kg bw. Significant irritation of the skin was reported at 4000 mg/kg bw and higher. At necropsy, congestion of lungs, livers, spleens and kidneys, mottled livers and opaque stomachs were observed.  

 

Inhalation toxicity

Due to its relatively low volatility, there is a lack of data documenting the acute inhalation toxicity. As good quality data for the oral and dermal route are available, in accordance with column 2 of REACH Annex VIII, a study regarding the inhalation route is not required. One limited report stated that whole-body exposure of rats to a saturated DIPA atmosphere (concentration not given) at 20°C for 8 hours failed to cause any deaths, therefore no LC50 value has been determined for this compound (1965, RL3). In a study on respiratory irritation, mice were exposed to aerosol concentrations of 500 to 2069 mg/m3 DIPA (Detwiler-Okabayashi, 1996; RL2). The 3-hour exposure caused sensory irritation (immediate onset) and little pulmonary irritation (delayed onset). No mortality was observed. Post-exposure recovery of the breathing frequency was poor.

Justification for classification or non-classification

Based on the results of the acute oral, dermal and inhalation toxicity studies, DIPA does not need to be classified according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.