2,2,6,6-tetramethylpiperidin-4-ol

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study

Data source

Reference

Reference Type:

review article or handbook

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes

Remarks:

Shin Nippon Biomedical Laboratories, LTD. (Japan)

Type of assay:

micronucleus assay

Test material

Test material information

Constituent 1

Reference substance name:

2,2,6,6-tetramethylpiperidin-4-ol

EC Number:

219-291-2

EC Name:

2,2,6,6-tetramethylpiperidin-4-ol

Cas Number:

2403-88-5

Molecular formula:

C9H19NO

IUPAC Name:

2,2,6,6-tetramethylpiperidin-4-ol

Details on test material:

- Name of test material (as cited in study report): 2,2,6,6-tetramethylpiperidin-4-ol

Test animals

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Japan, Inc
- Age at study initiation: 7 weeks old
- Weight at study initiation: 273-299g
- Acclimation period: 6 days

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

- Vehicle(s)/solvent(s) used: water

Duration of treatment / exposure:

2 days

Frequency of treatment:

2

Post exposure period:

24 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
0, 250, 500, 1000, 1500 mg/kg
Basis:
actual ingested

No. of animals per sex per dose:

6

Control animals:

yes, concurrent vehicle

Positive control(s):

cyclophosphamide
- Route of administration: oral: gavage
- Doses / concentrations: 20 mg/kg

Examinations

Tissues and cell types examined:

immature erythrocytes (IE)
micronucleated immature erythrocytes (MNIE)
erythrocytes

Details of tissue and slide preparation:

DETAILS OF SLIDE PREPARATION: The bone marrow cells suspension was smeared onto a clean slide. The slides were stained with acridine orange solution.

METHOD OF ANALYSIS: The coded smear slides were observed under a microscope.

Statistics:

The IE ratio, an indicator of suppression of bone marrow cell growth, was analyzed by Student's t-test. For the incidence of MNIE's, tables of Kastenbaum and Bowman were applied.

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

yes

Remarks:

1 of 6 animals died at 1500mg/kg

Vehicle controls validity:

valid

Negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

The micronucleated immature erythrocytes (MNIE) % values of this substance treatment groups were within 0.08 to 0.12% and no significant difference was observed in comparison with the negative control group (0.07%).

The immature erythrocytes (IE) % values were 47.30% at 250 mg/kg, 45.47% at 500 mg/kg, 43.90% at 1000 mg/kg and 39.96% at 1500 mg/kg, respectively, and these displayed significant differences in comparison with the negative control group (50.87%).

MNIE % and IE % were 3.50% and 40.20%, respectively in the positive control group, and showed significant differences in comparison with the negative control group. The negative control incidences of MNIE among tests was within the range of the laboratory background data and positive control ones showed remarkable increase.

This chemical dose not induce micronuclei under the test conditions employed.

Applicant's summary and conclusion

Conclusions:

Interpretation of results: negative