Oxirane, 2-methyl-, (2R)-

Genetic toxicity: in vivo

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 for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

propylene oxide

IUPAC Name:

propylene oxide

Constituent 2

Reference substance name:

Methyloxirane

EC Number:

200-879-2

EC Name:

Methyloxirane

Cas Number:

75-56-9

IUPAC Name:

2-methyloxirane

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.