Registration Dossier
Registration Dossier
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EC number: 441-100-8 | CAS number: 351197-46-1
Endpoint summary
Administrative data
Description of key information
oral, rat 300 mg/kg bw < LD50 < 2000 mg/kg bw
dermal, rat LD50 > 2000 mg/kg bw
Key value for chemical safety assessment
Additional information
Oral
In an acute oral toxicity GLP study according to OECD 423, three groups, each consisting of 3 female RccHan:WIST (SPF) rats, were treated by oral gavage with UAX-1179 at 300 (2 groups) and 2000 mg/kg body weight (Sieber, 2011). The test item was applied in a volume of 10 mL/kg bw. All animals treated with 300 mg/kg bw (Groups 1 and 3) survived the observation period. All animals treated with 2000 mg/kg bw (Group 2) died after treatment on test day 1. All animals of the highest dose group (2000 mg/kg bw) showed marked shivering, muscle twitching, markedly decreased activity, prostration and marked dyspnea prior to their death within 1 hour after treatment. Animals in Group 1 treated with 300 mg/kg body weight showed slightly to moderately ruffled fur on test Days 1-2. Otherwise, no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The oral LD50 value of UAX-1179 after single administration to female rats, observed over a period of 14 days is considered to be between 300 and 2000 mg/kg body weight.
In a second study, UAX-1179 was tested under GLP according to OECD-Guideline 423 for oral acute toxicity in HanBrl: WIST (SPF) rats (Damme, 2002). Two of three females treated with 2000 mg/kg body weight of the test item by gavage died within two hours after administration. All animals treated with 200 mg/kg bw survived the end of the study period. Slight to moderate convulsions, sedation and ventral recumbency were observed at the highest dose group. No macroscopic findings were observed at necropsy. The oral LD50 value of UAX-1179 is considered to be between 200 and 2000 mg/kg body weight in rat.
Inhalation
Taking into account UAX-1179 has a very slow vapour pressure of 0.0014 Pa the substance is not inhalable. The formation of aerosol can be excluded by uses (see 3.5). No acute inhalation toxicity is expected.
Dermal
After dermal application of 2000 mg/kg bw of the undiluted test item for 24 hours, no deaths occurred during the GLP-Guideline study (Arcelin, 2002). Slight erythema was observed in all male and female animals from test day 2 after removal of the dressing to test day 5, and persisted until test day 6 in two male animals and until test day 9 in one male and three female animals. The median lethal dose of UAX-1179 after single dermal administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight.
Justification for classification or non-classification
In accordance with EEC Directive 67/548 the test item UAX-1179 is to be classified as harmful, if swallowed (Xn, R22).
In accordance with the Globally Harmonised System (Regulation (EC) No 1272/2008), UAX-1179 is classified as acute tox cat 4 as harmful, if swallowed (H302).
DSD: Xn, R22, harmful, if swallowed
CLP: Acute tox. cat. 4, H302, harmful if swallowed, with the signal word: warning
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