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EC number: 700-869-2
CAS number: -
Two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with the test item extract by oral gavage administration. The test item was extracted according to ISO 10993-12 using polar and nonpolar extraction medium and the test item extracts (100% concentration) were administered according to the body weight at a volume of 10 mL/kg bw.All animals used in the study after their entrance at BSL were allowed to acclimatise to the laboratory conditions for at least 5 days. The animals were observed on delivery, on inclusion in the study and before administration for mortality/morbidity and other clinical signs. All animals were examined for clinical signs several times on the day of dosing and once daily until the end of the observation period. Their body weights were recorded on day 1 (prior to the administration) and on days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the study without showing any test-item related signs of toxicity.The piloerection observed on day 1 in one animal (no. 8) of step 2 was not considered to be related to the test item but to the administration procedure and the possible stress induced. No further clinical signs were observed in this animals until the end of the observation period.With regard to the data reported it can be stated that the administration of two test item extracts produced no signs of acute toxicity. Administration of extracts was performed under the following conditions:Species/strain: healthy rats rat / WISTAR Crl: WI(Han) (full barrier)Number of animals: 12 (3 per step/extract, 2 steps per extracts were performed)Extraction media: physiological saline 0.9% NaCl (polar test item extract) cottonseed oil (nonpolar test item extract)Extraction ratio: 0.2 g/mLExtraction conditions: 37 ± 1 °C for 72 ± 2 h, under agitationDose level: 10 mL/kg body weightRoute of administration: oral (single exposure)Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain.At necropsy, no macroscopic findings were observed in any animal of any step.Therefore, according to ISO 10993-11, a sufficient estimation of the acute toxicity of the test item is provided.
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