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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: 84/449/EWG, B.12 (Mikrokerntest); OECD 474
Qualifier:
according to guideline
Guideline:
OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
Deviations:
no
GLP compliance:
yes
Type of assay:
micronucleus assay

Test material

Constituent 1
Chemical structure
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.