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EC number: 701-015-1 | CAS number: 2156592-72-0
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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Nov. 13, 1989-Jan. 19, 1990
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Benzene, mono-C10-14-alkyl derivs., fractionation bottoms
- EC Number:
- 285-591-5
- EC Name:
- Benzene, mono-C10-14-alkyl derivs., fractionation bottoms
- Cas Number:
- 85117-41-5
- IUPAC Name:
- 85117-41-5
- Reference substance name:
- Benzene, mono-C10-14-alkyl derivatives, fractionation bottoms
- IUPAC Name:
- Benzene, mono-C10-14-alkyl derivatives, fractionation bottoms
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from Aroclor 1254 induced rat liver
- Test concentrations with justification for top dose:
- 5.0 - 80.0 nl/ml
- Vehicle / solvent:
- ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ethylmethanesulfonate, cyclophosphamide
- Details on test system and experimental conditions:
- The study was conducted using standard OECD protocols. Preparation of chromosomes was done 7 hours (high dose), 24 hours (low, medium, and high dose) and 30 hours (high dose) after start of treatment with the test material. The treatment interval was 4 hours. Treatment was performed with the following test concentrations, with and without S9 activation:
7h: 10, 30, 60, 80 nL/mL
24h: 1, 5, 10, 30, 60, 80 nL/mL
30h: 10, 30, 60, 80 nL/mL
In each experimental group two parallel cultures were used. - Evaluation criteria:
- Per culture 100 metaphases were scored for structural chromosomal aberrations.
- Statistics:
- Statistical significance was evaluated using the chi-square test (p<0.05).
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No significant differences between aberration rates in the treatments vs. the controls was observed. The mitotic index was not, or only slightly, reduced after treatment with the highest dose level.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Results of Cytogenicity Assay in CHO Cells
Dose per ml |
S9 |
% aberrant cells including gaps |
% aberrant cells including gaps |
Cell exchanges |
7 hrs |
||||
Solvent |
No |
3.50 |
1.50 |
0.00 |
80 nl |
No |
5.00 |
2.00 |
0.50 |
Solvent |
Yes |
15.00 |
5.00 |
1.00 |
80 nl |
Yes |
10.00 |
3.50 |
0.00 |
24 hrs |
||||
Control |
No |
7.00 |
2.50 |
1.50 |
Solvent |
No |
4.00 |
3.00 |
1.00 |
EMS 0.72 mg |
No |
17.00 |
16.00 |
11.00 |
5.0 nl/ml |
No |
2.50 |
2.00 |
0.00 |
30 nl/ml |
No |
2.50 |
2.00 |
0.50 |
80 nl/ml |
No |
4.50 |
3.50 |
0.50 |
Control |
Yes |
9.50 |
4.50 |
1.00 |
Solvent |
Yes |
3.00 |
3.00 |
0.50 |
CPA 4.2 ug |
Yes |
60.50 |
58.50 |
33.00 |
5.0 nl |
Yes |
5.50 |
2.00 |
1.50 |
30 nl |
Yes |
4.50 |
2.50 |
1.00 |
80 nl |
Yes |
4.00 |
3.00 |
0.00 |
30 hrs |
||||
Solvent |
No |
6.00 |
3.50 |
1.00 |
60.0 nl |
No |
4.50 |
0.00 |
0.00 |
Solvent |
Yes |
8.50 |
5.00 |
0.50 |
80.0 nl |
Yes |
2.00 |
0.00 |
0.00 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test substance was not mutagenic in either the presence or absence of metabolic activation. - Executive summary:
This study examined the potential for the test substance to cause mutations. Chinese hamster ovary (CHO) cells were exposed to concentrations of 5.0 - 80.0 nL/mL of test substance both in the presence and absence of metabolic activation. After the exposure period, the cells were examined for chromosomal aberrations. Ethylmethanesulfonate and cyclophosphamide were used as positive control substances. No increases in chromosomal aberrations were seen in either the presence or absence of metabolic activation. The test substance is not mutagenic.
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