Registration Dossier
Registration Dossier
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EC number: 428-880-5 | CAS number: -
Endpoint summary
Administrative data
Description of key information
DS-2920A-E
no data available
Analogous substance DS-1115A-E-1 (EC No. 427-930-3)
oral: 28 d, rat, gavage: NOAEL systemic ≥ 1000 mg/kg bw/d (Safepharm Laboratories Ltd. 1235/113, 1999)
Key value for chemical safety assessment
Additional information
No data are available for the substance itself. However, data from a subacute study are available from the strucural analogous substance DS-1115A-E-1 (EC No. 427-930-3).
A GLP conform subacute toxicity study was performed with the test item DS-1115A-E-1 according to OECD test guideline 407 (Safepharm Laboratories Ltd. 1235/113, 1999).
The test item (purity unknown) was administered by gavage to three groups, each of five male and five female Sprague-Dawley rats, for twenty-eight consecutive days, at dose levels of 150, 500 and 1000 mg/kg bw/day. A control group of five males and five females was dosed with vehicle alone (distilled water).
Clinical signs, functional observations, bodyweight development and food and water consumption were monitored during the study. Haematology and blood chemistry were evaluated for all animals at the end of the study. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed.
No treatment-related relevant signs of toxicity were observed.
Therefore, the systemic, subacute "No Observed Adverse Effect Level" (NOAEL) of DS-1115A-E-1 after oral dosing to rats was considered to be
≥ 1000 mg/kg bw/day.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data for the structural analogous substance DS-1115A-E-1 (EC No. 427-930-3) is reliable and suitable for the purpose of classification of DS-2920A-E under Directive 67/548/EEC. Based on the data, classification for repeated dose toxicity is not warranted under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data for the structural analogous substance DS-1115A-E-1 (EC No. 427-930-3) are reliable and suitable for the purpose of classification of DS-2920A-E under Regulation (EC) No.1272/2008. Based on the data, classification for repeated dose toxicity is not warranted under Regulation (EC) No.1272/2008.
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