Nonene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-01-27 to 1983-02-07

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.

Justification for type of information:

A discussion and report on the read across strategy is given as an attachment in Section 13.

Cross-reference

Reason / purpose for cross-reference:

read-across: supporting information

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Principles of method if other than guideline:

While the study report does not provide a specific statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.

GLP compliance:

no

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Alkenes, C10/C11/C12/C13

IUPAC Name:

Alkenes, C10/C11/C12/C13

Details on test material:

- Name of test material (as cited in study report): Olefin 103 PQ/II
- Substance type: Alkenes C10/C11/C12/C13
- Physical state: Yellow liquid

Method

Target gene:

Not specified

Species / strain

Species / strain / cell type:

mammalian cell line, other: rat liver cells

Metabolic activation:

with and without

Test concentrations with justification for top dose:

5, 10, 20, or 25 µg/mL

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Ethanol/Tween 80
- Justification for choice of solvent/vehicle: Not provided

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: DMBA

Details on test system and experimental conditions:

METHOD OF APPLICATION: In medium


DURATION
- Preincubation period: 24 hours
- Exposure duration: 24 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 5 days




NUMBER OF CELLS EVALUATED: Colonies containing at least 50 cells

Statistics:

Statistical methods, if employed, are not reported in the study

Results and discussion

Test results

Species / strain:

mammalian cell line, other: rat liver cells

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

A concentration of 20 ug/mL reduced the plating efficiency to 85% and 25 ug/mL reduced the plating efficiency to 41% of the control values.

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

The rat liver assay using Olefin 103 PQ/11 did not induce chromosomal damage under the experimental conditions of the study.

Applicant's summary and conclusion

Conclusions:

negative

The rat liver assay using Olefin 103 PQ/11 did not induce chromosomal damage.

Executive summary:

In an in-vitro mammalian chromosome aberration assay, cultures of rat liver cells were exposed to Olefin 103 PQ/11 for 24 hours at concentrations equivalent to 5, 10, 15, 20, 25, 30, 35, or 40 µg/mL for the cytotoxicity assay. After 24 hours fresh medium was supplied and cells were plated and cultured for 5 days, then colonies containing at least 50 cells were counted. A concentration of 20 µg/mL caused a reduction of 15% in the cloning efficiency and 25 µg/mL caused a reduction of 59% in cloning efficiency; therefore, concentrations of 5, 10, 20, or 25 µg/mL were used for the chromosomal aberration assay.

 

The rat liver assay using Olefin 103 PQ/11 did not induce chromosomal damage under the experimental conditions of the study.

 

This study received a Klimisch score of 2 and is classified as “reliable with restrictions” because while there is no statement regarding whether this study was conducted according to GLP or equivalent, the study appears to be in general accordance with OECD guidelines.