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EC number: 221-779-5 | CAS number: 3234-02-4
Acute oral toxicity study of trans-2,3-Dibromo-2-Butene-1,4-Diol in Wistar rats was performed as per Organization for Economic Co-operation and Development (OECD) Guidelines for Testing of
Chemicals, Section 4, No. 423 - Acute Oral Toxicity - Acute Toxic Class Method, adopted by the council on 17 December, 2001. The method uses pre-defined doses and the results allow a
substance to be ranked and classified according to the Globally Harmonised System (GHS) for classification of chemicals which cause acute toxicity. In this study, single oral administration of trans-2,3-Dibromo-2-Butene-1,4-Diol was made to groups of three female Wistar rats in step-wise manner to assess its acute toxicity. The test item was formulated in analytical grade water with 0.2% Tween 80 to obtain concentrations of 30 mg/ml and 5 mg/ml. In step-1 of the study, when three female rats were administered the test item, at the dose of 300 mg/kg, test item induced abnormal clinical signs of hypoactivity in two females on day 1 after treatment. Two female rats died during the first day of the observation, whereas one female rat died during the second day of the observation. No gross pathological changes were observed except one female rat. Therefore histological examination was carried out of the same. Analysis of the sample of the dose formulated for Step-1 treatment revealed that the average
measured concentration of trans-2,3-Dibromo-2-Butene-1,4-Diol was 30.62 mg/ml against the nominal concentration of 30 mg/ml. The small observed difference of 2.07 confirmed that the rats
received an adequate dose of the test item. In step-2 and step-3, when further tested at the dose of 50 mg/kg body weight, trans-2,3-Dibromo-2-Butene-1,4-Diol did not induce any abnormal clinical signs and mortality in treated rats. The body weight gain of female rats was not affected during the observation period. No gross pathological changes were observed in any of the rats, as evident at terminal necropsy.
Based on these results, and according to the "Globally Harmonised System (GHS) for classification of chemicals which cause acute toxicity; Seventh Revised Edition (ST/SG/AC.10/30/Rev.7); United
Nations, New York and Geneva, 2017; eISBN 978-92-1-060457-4, United Nations, 2017 and the EC Requirements for Classification and Labelling of Dangerous Substances (Commission Directive
2001/59/EC of 6th August 2001 adapting to technical progress for the 28th time Council Directive 67/548/EEC on the approximation of the laws, regulations and administrative provisions relating to
the Classification, Packaging and Labelling of Dangerous Substances. Official Journal of the European Communities OJL 225 pp. 1-333), the test item, trans-2,3-Dibromo-2-Butene-1,4-Diol,
is classified in GHS Category 3 for the obligatory labelling requirement for oral toxicity. This category corresponds to an LD50 value lying between 50 < ATE ≤ 300 mg/kg body weight, while the corresponding LD50 cut-off value for this product was observed to be 200 mg/kg body weight.
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