1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 84/449/EWG, B.12 (Mikrokerntest); OECD 474

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

Deviations:

no

GLP compliance:

yes

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

EC Number:

411-930-5

EC Name:

1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine

Cas Number:

106917-31-1

Molecular formula:

C27H48N2O3

IUPAC Name:

1-(1-acetyl-2,2,6,6-tetramethylpiperidin-4-yl)-3-dodecylpyrrolidine-2,5-dione

Test material form:

liquid

Test animals

Species:

mouse

Strain:

other: BOR:NMRI (SPF Han.)

Sex:

male/female

Details on test animals or test system and environmental conditions:

41 male, 41 female mice

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Duration of treatment / exposure:

Limit test

Frequency of treatment:

once

Post exposure period:

24 and 48 h

Doses / concentrations

Dose / conc.:

2 000 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 24 hours Male: 2000 mg/kg; No. of animals: 5; Sacrifice time: 48 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 24 hours Female: 2000 mg/kg; No. of animals: 5; Sacrifice times: 48 hours

Control animals:

yes

Positive control(s):

cyclophosphamide
- Justification for choice of positive control(s): commonly accepted
- Route of administration: gavage
- Doses / concentrations: 100 mg/kg bw

Examinations

Tissues and cell types examined:

bone mark from femurs

Details of tissue and slide preparation:

CRITERIA FOR DOSE SELECTION: MTD derived from pretest

TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): single application; sample times: 24 and 48 h after treatment

DETAILS OF SLIDE PREPARATION:
Cell suspension was washed by cellulose-chromatography, centrifuged and resuspended in FBS/EDTA. Slide preparation per animal, 24 h drying and staining with May-Grünwald/Giemsa solution.

METHOD OF ANALYSIS:
Analysis by application of "Micronucleus Test V 4.00", Leitz MIAMED)

OTHER:
anaylsis of min. 2000 PCE
- PCE/NCE ratio
- frequency of micro nuclei in polychrmoatic and normochromatic erythrocytes

Statistics:

Application of "Statgraphics, Version 5.0" (Statistical Graphics Corporation)

Results and discussion

Test results

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

not examined

Additional information on results:

Observations:
No statistically significant increase in number of polychromatic erythrocytes.
No cytotoxicity observed (PCE/NCE).

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): negative
Under the test conditions described above, the test substance showed to be non-mutagenic.

Executive summary:

The mutagenic potential of the test substance was investigated in an in vivo mouse micronucleus tests according to OECD Guideline 474. In this test, the substance showed to be non-mutagenic.