Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Acute toxicity: via inhalation route

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

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%.