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EC number: 946-103-2 | CAS number: -
In accordance to OECD guideline 436 and GLP, the acute inhalation toxicity of the test substance was examined in Wistar rats. Three rats per sex were exposed for four hours to a target limit concentration of 5 g/m3 and were kept for an observation period of 14 days. To detect adverse effects, clinical observations were made during and after exposure, body weight was determined before exposure (days -1 and 0) and on days 1, 3, 7 and 14, and animals were examined for gross pathological changes at the end of the observation period. The mean actual concentration during exposure was 5.31 (± 0.46) g/m3, based on gravimetric analysis. The mass median aerodynamic diameter of the particles in the aerosol was 3.07 and 3.05 μm (duplicate measurements) and the distribution of particle sizes had a geometric standard deviation of 2.49 and 2.33, respectively. All animals survived until scheduled sacrifice at the end of the 14-day observation period. During exposure, all animals showed moderate dyspnoea and shallow breathing, which was first observed about 1.5 hours after the start of exposure. In addition, a slightly decreased breathing rate was noticed in all animals at the last hourly observation. Multiple breathing abnormalities – such as sniffing, grunting, dyspnoea, shallow and irregular breathing at an increased rate – and general signs of discomfort (e.g. hypoactive behaviour, hunched posture, piloerection, blepharospasm) were observed shortly after exposure, which generally persisted until the next day. Several animals also showed a discharge from the nose and/or eyes, and nasal encrustations. Over the following days, the incidence of clinical abnormalities gradually decreased. Recovery of clinical abnormalities was observed by day 3-4 in most animals; one female displayed breathing abnormalities until day 6. All animals showed exposure-related loss of body weight on the day after exposure. By day 3, all animals had gained weight, and recovery of the initial body weight loss was by day 7. The animals displayed a normal growth in the second week of the observation period. Macroscopic examination at necropsy revealed white spots on the left lung lobe of the female rat with breathing abnormalities until day 6.The remaining three males and two females did not show any gross lesions at necrospy. It was concluded that the 4-hour LC50 of the test substance in rats is above 5.31 g/m3.
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