Registration Dossier
Registration Dossier
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EC number: 203-661-5 | CAS number: 109-28-4
Endpoint summary
Administrative data
Description of key information
Acute oral and dermal toxicity were tested in rats according to OECD guidelines 423 and 402, respectively. The LD50 values for both routes were >2000 mg/kg body weight.
Key value for chemical safety assessment
Additional information
The acute toxicity of Trennmittel ZM121 via the oral and the dermal route was assessed in two GLP-compliant studies conducted to OECD guideline 423 and 402, respectively.
In the oral study (Phycher, 2007), the test item was administered as a single dose of 2000 mg/kg bw via gavage to 6 female Sprague Dawley rats with a post-administration observation period of 14 days. Mortality was observed in one animal treated with the test substance 48 hours after administration of the test substance. Macroscopical examination of this animal revealed red coloration on the corpus and the presence of red/dark foci on the forestomach.
A general decrease of spontaneous activity was observed in all treated animals on day 2 and day 3 of the study and piloerection in 2 treated animals on day 2 of the study. Body weight changes of the treated rats decreased by 10.1% 48 hours after administration of the test item but recovered thereafter. Macroscopical examination of the surviving animals at the end of the study revealed a white granular thickening on the forestomach. In conclusion, the LD50 was determined to be >2000 mg/kg bw via the oral route.
In the dermal study (Bioassay, 2008), the test substance was applied at a single dose of 2000 mg/kg body weight to the clipped skin of five male and five female rats and covered by a semi-occlusive dressing for 24 hours. The animals were observed for 14 days after application of the test substance. No mortality occurred. Most of the animals showed transiently impaired general state, dyspnoea and piloerection on study day 1. The following skin effects were observed at the application site: erythema (grade 1-3), edema (grade 2), eschar formation (crust), squamation, squamation beyond the area of exposure, necrotic areas at the skin, brown discoloration of application site and skin obduration of application site. Mean body weights of the female and male animals were slightly decreased during the first post-exposure observation week but increased during the second week. Upon necropsy of the animals after 14 days, no pathological abnormalities were detected. Under the conditions of this study, the LD50 was found to be greater than 2000 mg/kg body weight.
Justification for classification or non-classification
The LD50 values for oral and dermal application was found to be >2000 mg/kg body weight in rats. Therefore, no classification for acute dermal toxicity according to Regulation (EC) No 1272/2008 (CLP) is required.
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