2-hydroxy-1-[4-[4-(2-hydroxy-2-methylpropanoyl)phenoxy]phenyl]-2-methylpropan-1-one

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

Micronucleous test in rat bone marrow Annex V B.12 - OECD n.474

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)

Version / remarks:

Micronucleous test in rat bone marrow Annex V B.12 - OECD n.474

GLP compliance:

yes

Type of assay:

other: micronucleus assay and chromosome aberration

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

472-110-0

EC Name:

-

Cas Number:

71868-15-0

Molecular formula:

C20H22O5

IUPAC Name:

2-hydroxy-1-{4-[4-(2-hydroxy-2-methylpropanoyl)phenoxy]phenyl}-2-methylpropan-1-one

Test material form:

solid

Details on test material:

- Appearance: white powder

Test animals

Species:

mouse

Strain:

NMRI

Administration / exposure

Route of administration:

intraperitoneal

Vehicle:

cotton seed oil

No. of animals per sex per dose:

Male: 100 mg/kg; No. of animals: 5; Sacrifice time: hours
Male: 250 mg/kg; No. of animals: 5; Sacrifice time: hours
Male: 500 mg/kg; No. of animals: 5; Sacrifice time: hours
Female: 100 mg/kg; No. of animals: 5; Sacrifice times: hours
Female: 250 mg/kg; No. of animals: 5; Sacrifice times: hours
Female: 500 mg/kg; No. of animals: 5; Sacrifice times: hours

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

Observations:
The positive control was conducted using Cyclophosphamide (40 mg/kg bw).

Applicant's summary and conclusion

Conclusions:

Under the conditions of this study, the test substance at doses up to 500 mg/kg was concluded to be negative in both male and female mice in the Micronucleus assay.

Executive summary:

A study was conducted to investigate the test substance clastogenic activity and/or potential to induce disruption of mitotic apparatus by detecting micronuclei in polychromatic erythrocyte (PCE) cells in NMRI mouse, according to OECD Guideline 474 and EU Method B.12, in compliance with GLP. Five animals per sex per dose were treated via the intraperitoneal route at doses of 100, 250 and 500 mg/kg bw. The vehicle was cottonseed oil and the positive control was cyclophosphamide (40 mg/kg bw). Polychromatice erythrocytes (PCE; proportion among total) and micronucleated polychromatic erythrocyte values were in the range of negative control data at all doses, except for the highest doses at which toxicity was observed (known to induce micronuclei independently to any treatment and considered not relevant for the scope of the study). Under the conditions of the study, the test substance at doses up to 500 mg/kg bw was concluded to be negative in both male and female mice in the micronucleus assay (Bioservice, 2006).