Registration Dossier
Registration Dossier
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EC number: 211-309-7 | CAS number: 637-92-3
Immunotoxicity
Administrative data
Description of key information
The available data indicate that ETBE was without effect on complement and anti-body-dependent aspects of immunization in the rat, with a sub-acute (28-day) NOAEL of 1000 mg/kg bw/day, the highest dose tested.
Key value for chemical safety assessment
Additional information
T-cell dependent antibody responses (assessed using a splenic antibody-forming cell assay) were determined in female rats administered ETBE by oral gavage at treatment levels up to 1000 mg/kg bw/day for 28-days (WIL Research Laboratories, 2010; Banton et al., 2011). The study was guideline (OPPTS 870.7800) and GLP-compliant, and measured the activity of IgM antibody-forming cells produced following immunisation with sheep red blood cells. No difference in spleen cell numbers or reduction in the IgM antibody-forming cell response was observed relative to that measured in untreated controls, whereas the positive control substance (cyclophosphamide) resulted in statistically significant decreases in mean spleen cell numbers with no detectable antibody-forming response present. This assay demonstrates that ETBE was without effect on complement and antibody-dependent aspects of immunization (NOAEL = 1000 mg/kg bw/day p.o.).
Justification for classification or non-classification
In accordance to Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, no classification is necessary.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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