Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study under GLP, according to international guidelines and with full documentation.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- The analysis was performed for the reference sample "Sample 2010" as defined in Section 1.4

Results and discussion

Any other information on results incl. tables

One hour after the exposure all animals slept. All male and female animals were symptom-free from first day of observation period.

Applicant's summary and conclusion

Conclusions:
Reaction mass of 2,2'-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) has to be classified as Category 3 for narcotic effects.
Executive summary:

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.