Registration Dossier
Registration Dossier
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EC number: 221-221-0 | CAS number: 3033-77-0
Endpoint summary
Administrative data
Description of key information
Annex VII requires only data for the oral route.
The key oral study, conducted in a manner similar to (the now deleted) OECD 401 involved gavage administration of one of five doses of a 20% solution of EPTAC (diluted from 71.9% aqueous EPTAC as delivered) to male and female rats. An LD50 value of 1.34 ml/kg bw (or 1513 mg/kg bw) was reported for 71.9% EPTAC, equivalent to 1088 mg/kg bw for pure EPTAC.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 088 mg/kg bw
Acute toxicity: via dermal route
Endpoint conclusion
- Dose descriptor:
- LD50
- Value:
- 1 600 mg/kg bw
Additional information
The key oral study was chosen from four studies of similar potential classification as the most reliable study. This study was of reliability 2 (reliable with restrictions); the others were all reliability 4.The findings from the three supporting studies, in some cases apparently well conducted studies but for which full study data were not available for review during entry to IUCLID5, were broadly similar to those of the key study, with LD50 values ranging from 400-800 mg/kg bw to 1000-2000 mg/kg bw.
For the dermal route, sufficient information is lacking for both studies to be able to select a key study. However, the results of both studies are consistent withe formal EU classification of acutely harmful via the dermal route.
Justification for classification or non-classification
EPTAC is formally classified in Annex VI of Regulation 1272/2008/EC as Harmful (R21/22) and Acute Toxic 4 (oral and dermal). The available in vivo data support this classification.
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