Acetone oxime

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to generally vaiid procedures and according to GLP guidelines. All parameters described are closely related or comparable to guidline methods.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.5385 (In Vivo Mammalian Cytogenetics Tests: Bone Marrow Chromosomal Analysis)

GLP compliance:

yes

Type of assay:

chromosome aberration assay

Test material

Test material information

Constituent 1

Reference substance name:

Butanone oxime

EC Number:

202-496-6

EC Name:

Butanone oxime

Cas Number:

96-29-7

IUPAC Name:

butan-2-one oxime

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): Methyl ethyl ketoxime
- Physical state: Liquid
- Analytical purity: 99.98%

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc., Frederick, MD
- Age at study initiation: 6-8 weeks
- Weight at study initiation: Males, 175-200 g; Females, 138-161 g
- Assigned to test groups randomly: yes
- Housing: Housed one per cage during study in plastic autoclavable cage
- Diet (e.g. ad libitum): Certified laboratory rodent chow, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.2-27.7
- Humidity (%): 50 +/- 20% relative humidity
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

Distilled water
- Amount of vehicle (if gavage or dermal): dose volumes were 0.326, 0.652 and 1.304 mL/kg bw.

Duration of treatment / exposure:

Single oral dose by gavage

Frequency of treatment:

Once

Post exposure period:

6, 24 and 48 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
300, 600 and 1200 mg/kg bw
Basis:
nominal in water

No. of animals per sex per dose:

5/dose

Control animals:

yes, concurrent vehicle

Positive control(s):

A single oral dose of cyclophoshamide at 25 mg/kg body weight; a dose volume of 1.2 mL/kg body weight was used.

Examinations

Tissues and cell types examined:

Bone marrow cells, arrested in metaphase and collected at 6, 24 and 48 hours after administration were examined microscopically for structural chromosome aberrations.

Results and discussion

Test results

Sex:

male/female

Genotoxicity:

negative

Toxicity:

yes

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Additional information on results:

No statistically significant increases in percentage of aberrant cells were observed in the test article treated groups, regardless of treatment or bone marrow collection time.
Clinical signs of toxicity were noted within 4 hours of dosing at each dose level tested.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Methyl ethyl ketoxime did not induce chromosomal aberrations in bone marrow cells of male or female rats.