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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:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of assay:
mammalian cell gene mutation assay

Test material

Constituent 1
Reference substance name:
Tridecylamine, branched and linear
EC Number:
289-185-9
EC Name:
Tridecylamine, branched and linear
Cas Number:
86089-17-0
Molecular formula:
C10-15 H21-31 NH2
IUPAC Name:
tridecylamine, branched and linear
Constituent 2
Reference substance name:
Amines, C11-C13 (linear and branched) alkyl
EC Number:
701-381-2
IUPAC Name:
Amines, C11-C13 (linear and branched) alkyl
Details on test material:
- Name of test material (as cited in study report): TRIDECYLAMINE MIXTURE OF ISOMERS
- Physical state: Liquid, Colourless, clear
- Analytical purity: 99.7 corr. area-% as a mixture of isomers (see analytical report, BASF study code 10L00059)
- Lot/batch No.: 00/0693-2 Batch: 000STD77L0
- Expiration date of the lot/batch: January 26, 2012
- Stability under test conditions: yes
- Storage condition of test material: At room temperature

Method

Target gene:
HPRT (hypoxanthine-guanine phosphoribosyl transferase)
Species / strain
Species / strain / cell type:
Chinese hamster lung fibroblasts (V79)
Details on mammalian cell type (if applicable):
- Type and identity of media: Thawed stock cultures are propagated at 37 °C in 80 cm2 plastic flasks (GREINER, 72632 Frickenhausen, Germany). About 5×105 cells are seeded into each flask with 15 mL of MEM (minimal essential medium; SEROMED, 12247 Berlin, Germany) supplemented with 10 % foetal calf serum (FCS, PAA Laboratories GmbH, 35091 Cölbe, Germany) and 1 % neomycin. The cells are subcultured twice weekly. The cell cultures are incubated at 37 °C in a 4.5 % carbon dioxide atmosphere (95.5 % air).
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: yes


Metabolic activation:
with and without
Metabolic activation system:
Mammalian Microsomal Fraction S9 Mix
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO; ethanol; Nutrient medium
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
Ethanol
True negative controls:
no
Positive controls:
yes
Positive control substance:
7,12-dimethylbenzanthracene
ethylmethanesulphonate
Evaluation criteria:
A test item is classified as positive if it induces either a concentration-related increase of the mutant frequency or a reproducible positive response for one of the test points.
A test item producing neither a concentration-related increase of the mutant frequency nor a reproducible positive response at any of the test points is considered to be non-mutagenic in this system.
A mutagenic response is described as follows:
The test item is classified as mutagenic if it induces reproducibly with one of the concen-trations a mutation frequency that is three times higher than the spontaneous mutation fre-quency in the experiment.
The test item is classified as mutagenic if there is a reproducible concentration-related increase of the mutation frequency. Such evaluation may be considered also in the case that a threefold increase of the mutant frequency is not observed.
However, in a case by case evaluation this decision depends on the level of the corre-sponding solvent control data. If there is by chance a low spontaneous mutation rate in the range normally found (0.6 – 31.7 mutants per 106 cells), a concentration-related in-crease of the mutations within this range has to be discussed. The variability of the muta-tion rates of solvent controls within all experiments of this study is also taken into consideration.
Statistics:
A linear regression (least squares) will be performed to assess a possible dose dependent increase of mutant frequencies using SYSTAT®11 (SYSTAT Software, Inc., 501, Canal Boulevard, Suite C, Richmond, CA 94804, USA) statistics software. The number of mutant colonies obtained for the groups treated with the test item will be compared to the solvent control groups. A trend is judged as significant whenever the p-value (probability value) is below 0.05. However, both, biological and statistical significance will be considered to-gether.

Results and discussion

Test results
Species / strain:
Chinese hamster lung fibroblasts (V79)
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
True negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Excessive cytotoxicity at 2 or 4µg/mL without S9 after treatment for 4h or 24h, respectively, and at 14µg/mL with S9

Any other information on results incl. tables

      relative relative mutant   relative relative mutant  
  conc. µg S9 cloning cloning colonies/ induction cloning cloning colonies/ induction
  per mL mix efficiency I efficiency II 10^6 cells factor efficiency I efficiency II 10^6 cells factor
      % %     % %    
Column 1 2 3 4 5 6 7 8 9 10
Experiment I / 4 h treatment     culture I culture II
Solvent control with ethanol   - 100.0 100.0 12.4 1.0 100.0 100.0 9.4 1.0
Positive control with EMS 150.0 - 99.8 53.6 178.2 14.3 80.8 88.7 96.5 10.3
Test item 0.13 - 101.3 78.0 19.6 1.6 98.7 98.5 5.3 0.6
Test item 0.25 - 105.6 94.2 13.2 1.1 95.8 97.6 16.6 1.8
Test item 0.5 - 94.2 34.5 39.5 3.2 100.3 44.5 12.8 1.4
Test item 1.0 - 77.1 37.7 32.2 2.6 77.4 41.1 35.6 3.8
Test item 2.0 - 6.5 55.9 16.1 1.3 7.3 66.0 5.6 0.6
Test item 3.0 - culture was not continued## culture was not continued##
Test item 4.0 - culture was not continued## culture was not continued##
Solvent control with ethanol     100.0 100.0 15.6 1.0 100.0 100.0 31.5 1.0
Positive control with DMBA 1.1 + 84.3 97.5 1033.2 66.3 73.1 88.3 1083.7 34.4
Test item 0.5 + 102.8 culture was not continued# 130.6 culture was not continued#
Test item 1.0 + 36.8 79.6 19.7 1.3 81.1 104.7 37.5 1.2
Test item 2.0 + 38.0 85.8 33.1 2.1 38.2 98.9 10.8 0.3
Test item 4.0 + 31.9 105.3 36.2 2.3 35.4 91.5 18.7 0.6
Test item 8.0 + 23.4 86.4 30.2 1.9 34.7 91.3 17.0 0.5
Test item 12.0 + 16.5 67.2 20.4 1.3 4.8 88.9 12.6 0.4
Test item 16.0 + 0.0 culture was not continued## 0.0 culture was not continued##
Experiment II / 24 h treatment     culture I culture II
Solvent control with ethanol   - 100.0 100.0 23.8 1.0 100.0 100.0 14.1 1.0
Positive control with EMS 150.0 - 108.5 99.5 384.0 16.2 106.6 108.7 350.6 24.9
Test item 0.13 - 107.4 culture was not continued# 105.1 culture was not continued#
Test item 0.25 - 92.2 103.9 22.2 0.9 104.2 98.3 17.4 1.2
Test item 0.5 - 102.5 85.8 25.2 1.1 115.1 70.0 19.8 1.4
Test item 1.0 - 99.3 103.6 16.2 0.7 96.1 92.9 29.8 2.1
Test item 2.0 - 92.9 97.2 28.0 1.2 66.6 96.8 22.0 1.6
Test item 3.0 - 26.6 89.4 29.3 1.2 12.7 101.0 14.5 1.0
Test item 4.0 - 0.0 culture was not continued## 0.0 culture was not continued##
Experiment II / 4 h treatment        
Solvent control with ethanol   + 100.0 100.0 12.4 1.0 100.0 100.0 12.0 1.0
Positive control with DMBA 1.1 + 52.1 90.7 880.1 70.8 39.7 73.3 731.9 60.8
Test item 1.0 + culture was not continued#   culture was not continued#  
Test item 2.0 + 84.3 100.7 16.8 1.4 41.6 93.3 33.3 2.8
Test item 4.0 + 86.3 106.5 17.4 1.4 42.9 71.4 40.7 3.4
Test item 8.0 + 71.6 96.6 20.8 1.7 39.1 100.8 15.7 1.3
Test item 10.0 + 56.2 93.8 38.3 3.1 19.4 72.5 17.2 1.4
Test item 12.0 + 42.8 91.4 14.7 1.2 17.8 86.3 36.4 3.0
Test item 14.0 + 1.6 culture was not continued## 0.8 culture was not continued##

# culture was not continued since a minimum of only four analysable concentrations is required

## culture was not continued due to strong toxic effects

Applicant's summary and conclusion