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EC number: 213-485-0 | CAS number: 957-68-6
An acute inhalation toxicity study according to the OECD guideline 436 was performed. The only study group, consisting of 6 Wistar rats (3 males and 3 females), was exposed to the target concentration of 5 mg test substance/L as an aerosol. The animals were exposed for 4 hours using a nose-only exposure system, followed by a 14-day observation period. Aerosol concentration was measured gravimetrically. The particle size distribution of the test aerosol was determined regularly during the exposure period. Clinical observations and bodyweights were recorded throughout the study and at the end of the scheduled period the animals were euthanised and subjected to a gross examination post mortem.
Gravimetric results of the test atmosphere analysis: The mean achieved concentration in the study was 5.24 mg/L. The mass median aerodynamic diameter (MMAD) was 3.65 μm with a geometric standard deviation (GSD) 2.84.
Mortality: No animals died during the study.
Clinical observations: Only dyspnoea (3/3 m, 3/3 f) and fur stating by test item (3/3 m, 3/3 f) were recorded in the animals during and/or shortly after the exposure. All animals recovered and were symptom-free from Day 2 until the end of the observation period.
Dyspnoe and reddish staining around snout were reported in each of the last 8 reports of the same testing facility on acute inhalation toxicity, with partly quite different test items. It is therefore likely that these signs are not expressions of local or systemic toxicity of the test items but that they are signs of discomfort of the rats restricted in the inhalation tubes.
Bodyweight: Normal bodyweight gain was noted in the exposed animals during two weeks observation period, with the exception of two female rats (2204, 2207) where slight bodyweight loss was observed occasionally during the first week of the observation period.
Necropsy: No test item-related macroscopic alterations were detected.
The acute inhalation LC50 of the test substance in Wistar rats is >5.24 mg/L.
An acute oral toxicity study with rats was performed. The LD50 is above 2000 mg/kg bw.
The toxicokinetic behaviour of the test item was estimated from available data.
No evidence of an oral absorption was obtained from the available acute toxicity tests. A low oral absorption is also predicted from the phys.-chem. properties of the substance.
No evidence of an inhalation absorption was obtained from the available acute toxicity test. The dermal absorption is predicted to be lower compared to the oral route.
No evidence of a distribution or of the way of excretion was obtained.
No evidence of metabolisation was obtained from the mutagenicity tests with and without metabolising systems.
No bioaccumulation is expected, based on the low log Pow.
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