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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in mammalian cells
Remarks:
Type of genotoxicity: gene mutation
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to a test protocol that is comparable to the appropriate OECD test guideline. It was not compliant with GLP.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
publication
Title:
The toxicity of behenyl alcohol: I. Genotoxicity and subchronic toxicity in rats and dogs
Author:
Iglesias G, J J Hlywka, J E Berg, M H Khalil, L E Pope and D Tamarkin
Year:
2002
Bibliographic source:
Regulatory Tox. and Pharm. 36, 69-79 2002a

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
Principles of method if other than guideline:
Well-conducted study according to a protocol very similar to OECD guideline 476
GLP compliance:
not specified
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Docosan-1-ol
EC Number:
211-546-6
EC Name:
Docosan-1-ol
Cas Number:
661-19-8
Molecular formula:
C22H46O
IUPAC Name:
docosan-1-ol
Details on test material:
- Name of test material (as cited in study report): behenyl alcohol
- Substance type: colourless, waxy solid
- Physical state: solid
- Analytical purity: no data, but for repeated dose toxicity (oral), 98%
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data, but for repeated dose toxicity (oral), obtained from Condea, Germany
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
- Other:
- Melting point: 70 deg C
- Soluble in: ethanol and chloroform
- Insoluble in: water

Method

Target gene:
HGPRT
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
- Type and identity of media: no data
- Properly maintained: no data
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data
Metabolic activation:
with and without
Metabolic activation system:
no data, but for Ames test, liver microsomal fractions from male rats prepared by "established methods"
Test concentrations with justification for top dose:
2.0, 7.5, 15.0, and 20.0 ug/ml
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: ethanol, final concentration in culture medium <=1% v/v
- Justification for choice of solvent/vehicle: solubility
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
without metabolic activation
Positive control substance:
ethylmethanesulphonate
Remarks:
Migrated to IUCLID6: 1.0 ug/ml
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Remarks:
with metabolic activation
Positive control substance:
7,12-dimethylbenzanthracene
Remarks:
Migrated to IUCLID6: 15.4 ug/ml
Details on test system and experimental conditions:
METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: not applicable
- Exposure duration: 4 hours
- Expression time (cells in growth medium): no data
- Selection time (if incubation with a selection agent): no data
- Fixation time (start of exposure up to fixation or harvest of cells): no data

SELECTION AGENT (mutation assays): thioguanine

NUMBER OF REPLICATIONS:
- 2 independent experiments, both with and without metabolic activation

NUMBER OF CELLS EVALUATED: no data

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
Evaluation criteria:
To be considered positive, statistically significant concentration-related increase in mutant frequency, or a reproducible and statistically significant positive response for at least one concentration
Statistics:
no data

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: presumably >20 ug/ml
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: insoluble
- Precipitation: no data
- Other confounding effects: no data

RANGE-FINDING/SCREENING STUDIES: yes, but no data presented

COMPARISON WITH HISTORICAL CONTROL DATA: no data

ADDITIONAL INFORMATION ON CYTOTOXICITY:
- With metabolic activation: mean relative cell survival over the test concentrations ranged from 89.1% (20 ug/ml) to 93.8% (15 ug/ml).
- Without metabolic activation: mean relative cell survival ranged from 96% (15 ug/ml) to 120.2 % (20 ug/ml).
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Table 1 Results of mutagenicity in V79 cells (mean of 2 cultures)

Concentration µg/ml

Mean relative cell survival (%)

Mean mutants per culture

Mutant colonies per 10 E06 cells

-MA

+MA

-MA

+MA

-MA

+MA

Negative

105.1

98.2

2.7

4.8

8.65

47.4

0*

100

100

4.5

2.1

14.7

8.75

2

101.3

92.55

4.1

6.3

12.5

21.65

7.5

102.4

93.6

5.4

4.9

16.1

15.75

15

96.0

93.8

3.4

1.7

12.3

6.35

20

120.2

89.1

4.3

4.4

17.9

16.95

Positive control

67.3

104.6

156.7

39.1

1143.7

163.4

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

In a reliable study, behenyl alcohol (C22) did not increase the gene mutation rate in Chinese hamster V79 cells in the presence or absence of metabolic activation at concentrations up to 20 ug/ml. It is concluded that the test substance is negative for mutagenicity in mammalian cells under the conditions of this test.