Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via inhalation route

Endpoint conclusion
Dose descriptor:
discriminating conc.
21 000 mg/m³

Additional information

Acute toxicity: oral - waived as inhalation data are avaiable.

Acute toxicity: dermal - waived as inhalation is the more important exposure pathway.

Acute toxicity: Inhalation

A single four hours nose-only exposure of reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) to CRL: (WI) BR rat followed by a 14-day observation period at a dose level 21.0 mg/L was not associated with any test item-related macroscopic findings.

Justification for classification or non-classification

The criteria for classification as acute toxic (inhalative) of reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) according to the Directive 67/548/EEC and Regulation (EC) 1272/2008 are not met.

Narcotic effects of reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) were observed during testing of acute inhalation toxicity (nose-only) with the test item according to the OECD 403 guideline under GLP.

One hour after the exposure all animals slept. All male and female animals were symptom-free from first day of observation period. Consequently, reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) has to be classified as Category 3 (H336) for narcotic effects according to Directive 1999/45/CE and Regulation (EC) 1272/2008. This classification is further corroborated by official classification with H336 of DIPE, a main constituent present at ca. 30%.