Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
supporting study
Study period:
2002
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Cited experiments were summarized in the European Chemicals Bureau Methyloxirane (Propylene Oxide) Risk Assessment Report. The original studies were not reviewed.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
2002

Materials and methods

GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): positive
Propylene oxide has been tested in the mouse bone marrow micronucleus assay. No increase in the number of micronucleated cells was observed after oral administration of propylene oxide. However, there was a significant increase in micronucleated cells in mice receiving 2,300 mg/kg by the IP route, compared to vehicle controls. This study demonstrated that propylene oxide has the potential to induce mutagenic lesions in somatic cells in vivo. The positive result following IP injection is considered to indicate the potential for mutagenicity at sites of initial contact in the body.

The genotoxicity of propylene oxide to mouse bone marrow following IP injections was confirmed in studies in other laboratories.