Registration Dossier
Registration Dossier
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 298-190-5 | CAS number: 93778-52-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The Category member 3, 2 -decyltetradecanoic acid, was examined for mutagenic activity by assaying for reverse mutation to histidine prototrophy in the prokaryotic organism Salmonella typhimurium in an OECD 471 test. The five tester strains TA1535, TA1537, TA98, TA100 and TA102 were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. Based on this test is concluded that 2-decyltetradecanoic acid does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions. Additionally 2-decyltetradecanoic acid
was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y. In conclusion, in the described mutagencity test according to OECD 476 under the experimental conditions reported, the Category Member 3 is considered to be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells. The Source substance 2, docosanoic acid, did not induce structural chromosomal aberrations in the absence or presence of an exogenous metabolic activation system in a test according to OECD 473.Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2002-03-29 to 2002-04-19
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 homogenate
- Test concentrations with justification for top dose:
- 5000, 2500, 1250, 625 and 313 µg/plate.
- Vehicle / solvent:
- acetone
- Details on test system and experimental conditions:
- SYSTEM OF TESTING
- Species/cell type: Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Deficiencies/Proficiencies: histidine auxotroph
- Metabolic activation system: rat liver S9 of Phenobarbital/beta-Naphthoflavone induced male Sprague-Dawley rats
ADMINISTRATION:
- Dosing:
experiment I and II:
313, 625, 1250, 2500 and 5000 µg/plate
- Number of replicates: 3
- Application:
Experiment I (plate-incorporation method): The first experiment was perfonned using a plate-incorporation method. The components of the assay (the tester strain bacteria, the test item and S9 mix or phosphate buffer) were added to molten overlay agar and vortexed. The mixture was
then poured onto the surface of a minimal medium agar plate, and allowed to solidify prior to incubation.
The overlay mixture was composed as follows:
(i) Overlay agar (held at 45°C) 2 ml
(ii) Test or control item solution 0.1 ml
(iii) S9 mix or phosphate buffer (pH 7.4, 0.1 M) O.S ml
(iv) Bacterial suspension 0.1 ml
Experiment II and III (pre-incubation method): Since acetone is known to be toxic at 50 Ill/plate when used for the pre-incubation method, 25
Ill/plate of solvent or test item solution were used.
The components were added in turn to an empty test-tube:
(i) Bacterial suspension 0.1 ml
(ii) Test item solution or its solvent 0.025ml
Positive control solution or its solvent O.OSOml
(iii) S9 mix or phosphate buffer (PH 7.4, 0.1 M) O.S ml
The incubate was vortexed and placed at 37°C for 30 minutes. Two ml of overlay agar was then added and the mixture vortexed again and poured onto the surface of a minimal medium agar plate and allowed to solidify. - Evaluation criteria:
- The test item is considered as a mutagen if at least a two-fold increases in mean revertant numbers are observed at two consecutive dose-levels or at the highest practicable dose level only. In addition there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose-levels.
- Statistics:
- regression analysis
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- Interpretation of result:
negative
The test item does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions. - Executive summary:
The test item was examined for mutagenic activity by assaying for reverse mutation to histidine prototrophy in the prokaryotic organism Salmonella typhimurium. The five tester strains TA1535, TA1537, TA98, TA100 and TA102 were used. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone. Test item solutions were prepared using acetone. In the toxicity test, the test item was assayed at a maximum dose-level of 5000 flg/plate and at four lower dose-levels spaced at approximately half-log intervals: 1580, 500, 158 and 50.0 flg/plate. No signs of toxicity were observed at any doselevel tested, in any tester strain, in the absence or presence of S9 metabolic activation. Two main experiments were performed. In Main Assay I, using the plate incorporation method, the test item was assayed at a maximum dose-level of 5000 flg/plate and at four lower dose-levels, separated by two-fold dilutions: 2500,1250,625 and 313 flg/plate. As no increases in revertant numbers were observed, all treatments of Main Assay II included a pre-incubation step and used the same dose-levels as Main Assay I. The test item did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism. It is concluded that the test item does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- January to March, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well documented study performed according to OECD Guideline and GLP
- Justification for type of information:
- see Category Approach
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- thymidine kinase locus/TK+/-
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media:
Complete culture medium: RPMI 1640 medium supplemented with 10% heat-inactivated horse serum, 100 U/100 µg/mL penicillin/streptomycin, 1mM sodium pyruvate, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/mL amphotericin B
Treatment medium: RPMI medium supplemented with 5% heat-inactivated horse serum (in case of short term exposure) resp. 7.5% heat-inactivated horse serum (in case of long term exposure), 100 U/100 µg/mL penicillin/streptomycin, 1mM sodium pyruvate, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/mL amphotericin B
Selective medium: RPMI 1640 medium supplemented with 20% heat-inactivated horse serum, 100 U/100 µg/mL penicillin/streptomycin, 1mM sodium pyruvate, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/mL amphotericin B, 5 µg/mL trifluorothymidine (TFT)
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 microsomal fraction of phenobarbital (80 mg/kg bw) and ß-naphthoflavone (100 mg/kg bw) induced male Wistar rats
- Test concentrations with justification for top dose:
- Pre-experiment for toxicity: 0.2/1.0/2.6/5.3/8.0 and 10.6 mM for experiment I with and without S9 mix, 0.05/0.1/0.2/0.5/1.0 and 1.5 mM for experiment II, long term exposure, without S9 mix
Experiment I: 0.05/0.1/0.2/0.5/0.7/0.9/1.1, and 1.3 mM without S9 mix, 0.02/0.05/0.1/0.2/0.5/1.0/1.2 and 1.4 mM with S9 mix
Experiment II: 0.002/0.005/0.01/0.02/0.05/0.1/0.2 and 0.5 mM without S9 mix, 0.15/0.3/0.7/0.9/1.1/1.2/1.3 and 1.4 mM with S9 mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: in the absence of metabolic activation: ethyl methanesulphonate (EMS, 200/300 µg/mL) and methyl methanesulphonate (MMS, 8/10µg/mL); in the presence of metabolic activation: benzo[a]pyrene (B[a]P, 2.5 µg/ml)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Experiment 1: 4 h
Experiment 2: 24 h (without metabolic activation) and 4 h (with metabolic activation)
- Expression time (cells in growth medium): 2 days
- Selection time (incubation with the selection agent): 14 days (mutation selection assay)
SELECTION AGENT: trifluorothymidine (TFT)
NUMBER OF REPLICATIONS: 1 (test item and positive controls, 2 (negative control)
NUMBER OF CELLS EVALUATED: mutation selection assay: cells from each experimental group were seeded in four 96-well plates at a density of 200 cells/well in 200 µL selective medium; cloning efficiency assay: seeding a statistical number of 1.6 cells per well in two 96-well plates
DETERMINATION OF CYTOTOXICITY
- Method: measuring the colony-forming ability and the growth rate of cultures (relative suspension growth, recorded over 2 days following treatment)
OTHER EXAMINTATIONS
- Colony sizing: ratio of small to large type mutants - Evaluation criteria:
- The assay is considered acceptable if it meets the following criteria:
- at least three out of four of the negative and/or solvent controls is in the range 65% - 120%
- the spontaneous mutant frequency in the negative and/or solvent controls is in the range 50-170 mutants per 10E6 cells
- the cell number of the negative/solvents controls should undergo 8-32 fold increase during a 2 day growth period (short-term treatment) or 32-180 fold increase during a 3 day growth period (long-term treatment)
- the clastogenic positive controls (MMS and B[a]P) have to produce an induced mutant frequency (total mutant frequency minus concurrent negative control mutant frequency) of at least 300 mutants per 10E6 cells with at least 40% of the colonies being small colonies or with an induced small colony mutant frequency of at least 150 mutants per 10E6 cells. The relative total growth (RTG) must be greater than 10%.
Criteria for a positive result:
- the induced mutant frequency meets or exceeds the Global Evaluation factor (GEF) of 126 mutants per 10E6 cells
- a dose-dependent increase in mutant frequency is detected.
Additionally, combined with a positive effect in the mutant frequency, an increased occurence of small colonies (>= 40% of total colonies) is an indication for potential clastogenic effects and/or chromosomal aberrations. The biological relevance is considered first for the interpretation of results. Statistical methods might be used an aid in evaluation of the test result.
Criteria for a negative result:
a test item is considered negative if the induced mutant frequency is below the GEF and the trend of the test is negative. - Statistics:
- Statistical significance of mean mutant frequency was evaluated at the 5% level (p<0.05) by means of the non-parametric Mann-Whitney test.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- for details see tables 1 and 2 below
- 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
- Water solubility: no data, the test substance was soluble in cell culture medium after being treated with ultrasound for 3 minutes at 37°C
- Precipitation: no precipitation was noticed
- Other confounding effects: none
COMPARISON WITH HISTORICAL CONTROL DATA: All values found in the test were within the range of the historical laboratory control data - Conclusions:
- Interpretation of results:
negative without metabolic activation
negative with metabolic activation
In the described mutagencity test under the experimental conditions reported, the test item Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid is considered to be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells. - Executive summary:
The test item Reaction mass of 2 -butylheptanoic acid and 2 -ethylnonanoic acid and 2 -methyldecanoic acid and 2 -proyloctanoic acid was assessed for its potential to induce mutations at the mouse lymphoma thymidine kinase locus using the cell line L5178Y.
The selection of the concentrations used in the main experiments was based on data from the pre-experiment. In experiment I 1.3 mM (without metabolic activation) and 1.4 mM (with metybolic activation) were selected as the highest concentrations. In experiment II 0.5 mM (without metabolic activation) and 1.4 mM (with metabolic activation ) were selected as the highest concentrations. Experiment I without and with metabolic activation and experiment II with metabolic activation were performed as a 4 h short-term exposure assay. Experiment II without metabolic activation was performed as a 24 h long-term exposure assay.
The test item was investigated at the following concentrations:
Experiment I without metabolic activation: 0.05, 0.1, 0.2, 0.5, 0.7, 0.9, 1.1 and 1.3 mM and with metabolic activation: 0.02, 0.05, 0.1 ,0.2, 0.5, 1.0, 1.2 and 1.4 mM
Experiment II without metabolic activation: 0.002, 0.005, 0.01, 0.02, 0.05, 0.1, 0.2 and 0.5 mM and with metabolic activation: 0.15, 0.3, 0.7, 0.9, 1.1, 1.2, 1.3 and 1.4 mM.
No precipitation of the test item was noted in the experiments. Growth inhibition was observed in experiment I and II without and with metabolic activation.
In experiment I without metabolic activation the relative total growth (RTG) was 21.8% for the highest concentration (1.3 mM) evaluated. The highest concentration evaluated with metabolic activation was 1.4 mM with a RTG of 10.1%. In experiment II without metabolic activation the relative total growth was 20.3% for the highest concentration (0.5 mM) evaluated. The two highest concentrations evaluated with metabolic activation were 1.3 and 1.4 mM with a RTG of 31.8% and 8.7% respectively.
In experiment I and II no biologically relevant increase of mutants was found after treatment with the test item (with and without metabolic activation). The Global Evaluation Factor (GEF, defined as the mean of the negative/vehicle mutant frequency plus one standard deviation; data gathered from ten laboratories) was not exceeded by the induced mutant frequency at any concentration. No dose-response relationship was observed. Aditionally, in experiment I and II colony sizing showed no clastogenic effects induced by the test item under the experimental condition (with and without metabolic activation).
Ethylmethanesulfonate (EMS), methylmethanesulfonate (MMS) and benzo[a]pyrene (B[a]P) were used as positive controls and showed distinct and biologically relevant effects in mutation frequency. Additionally, MMS and B[a)P significantly increased the number of small colonies, thus proving the efficiency of the test system to indicate potential clastogenic effects.
In conclusion, in the described mutagencity test under the experimental conditions reported, the test item Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid is considered to be non-mutagenic in the in vitro mammalian cell gene mutation assay (thymidine kinase locus) in mouse lymphoma L5178Y cells.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Justification for type of information:
- The carbon chain length of this acid and that of the Category member 2-decyltetradecanoic acid, is very similar. Both substances are long chain acids which have no other funcitional group. Based on the similar structure and therefore similar expected toxicokinetic it is likely that the test result of this substance is also valid for the Category member (Please see attached Category Approach.)
- Reason / purpose for cross-reference:
- other: Category Approach
- Key result
- Species / strain:
- mammalian cell line, other: Chinese hamster lung (CHL) cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Referenceopen allclose all
Table 1a: Pre-experiment for Toxicity, without metabolic activation | ||||||||
Test group | Concentration mM |
Suspension Growth | Relative Suspension Growth* [%] | |||||
Negative control | 0 | 16.5 | 100.0 | |||||
0 | 16.4 | |||||||
1 | 0.2 | 15.5 | 94.2 | |||||
2 | 1.1 | 7.7 | 46.8 | |||||
3 | 2.6 | 0.3 | 1.9 | |||||
4 | 5.3 | no viable cells | - | |||||
5 | 8.0 | no viable cells | - | |||||
6 | 10.6 | no viable cells | - | |||||
Table 1b: Pre-experiment for Toxicity, with metabolic activation | ||||||||
Test group | Concentration mM |
Suspension Growth | Relative Suspension Growth* [%] | |||||
Negative control | 0 | 13.4 | 100.0 | |||||
0 | 13.6 | |||||||
1 | 0.2 | 12.2 | 90.1 | |||||
2 | 1.1 | 9.1 | 67.7 | |||||
3 | 2.6 | 0.3 | 1.9 | |||||
4 | 5.3 | no viable cells | - | |||||
5 | 8.0 | no viable cells | - | |||||
6 | 10.6 | no viable cells | - | |||||
Table 1c: Pre-experiment II for Toxicity, long-term exposure, without metabolic activation | ||||||||
Test group | Concentration mM |
Suspension Growth | Relative Suspension Growth* [%] | |||||
Negative control | 0 | 35.9 | 100.0 | |||||
0 | 33.9 | |||||||
1 | 0.05 | 32.9 | 94.3 | |||||
2 | 0.1 | 31.5 | 90.2 | |||||
3 | 0.2 | 23.0 | 65.7 | |||||
4 | 0.5 | 6.0 | 17.2 | |||||
5 | 1.0 | 0.3 | 0.8 | |||||
6 | 1.5 | 0.1 | 0.4 | |||||
* = (Suspension Growth/Suspension Growth of corresponding controls) x100 | ||||||||
Table 2a: Experiment I, without metabolic activation | ||||||||
Test group | Concentration | CE | RCE | RTG | MF | IMF | GEF exceeded | colony sizing |
mM | % | % | % | mutants/106cells | mutants/106cells | % small colonies | ||
Negative control | 0 | 101.2 | 100.0 | 100.0 | 80.1 | / | / | 15.8 |
108.2 | / | / | 14.8 | |||||
3 | 0.05 | 104.6 | 99.9 | 97.9 | 71.1 | -8.8 | - | n.d. |
4 | 0.1 | 112.0 | 106.9 | 109.1 | 66.5 | -13.6 | - | n.d. |
5 | 0.2 | 112.0 | 106.9 | 97.6 | 63.8 | -16.3 | - | n.d. |
6 | 0.5 | 84.1 | 80.3 | 75.2 | 94.0 | 13.9 | - | n.d. |
7 | 0.7 | 98.0 | 93.6 | 81.1 | 50.3 | -29.8 | - | n.d. |
8 | 0.9 | 95.0 | 90.7 | 61.9 | 89.7 | 9.6 | - | 18.3 |
9 | 1.1 | 114.0 | 108.8 | 58.2 | 79.2 | -0.9 | - | 22.2 |
10 | 1.3 | 130.0 | 124.1 | 21.8 | 63.3 | -16.8 | - | 24.1 |
EMS | 300 µg/mL | 93.5 | 89.3 | 68.9 | 690.8* | 610.7* | + | n.d. |
MMS | 10 µg/mL | 80.5 | 76.8 | 59.4 | 511.6* | 431.5* | + | 41.9 |
CE: Cloning efficiency, CE = (-ln ((96 - (mean value of plates)) / 1.6) x 100 | ||||||||
RCE: Relative Cloning Efficiency, RCE = (CE of dose group/CE of corresponding controls)x100 | ||||||||
RTG: Relative Total Growth, RTG = (RSG x RCE)/100 | ||||||||
MF: Mutant Frequency | ||||||||
GEF: Global Evaluation Factor (126): + = GEF exceeded, - = GEF not exceeded | ||||||||
* statistical significant increase in mutant frequency compared to negative controls | ||||||||
Table 2b: Experiment II, without metabolic activation (24 h treatment) | ||||||||
Test group | Concentration | CE | RCE | RTG | MF | IMF | GEF exceeded | colony sizing |
mM | % | % | % | mutants/106cells | mutants/106cells | % small colonies | ||
Negative control | 0 | 114.0 | 100.0 | 100.0 | 56.7 | / | / | 6.1 |
102.9 | / | / | 22.5 | |||||
1 | 0.002 | 96.5 | 89.0 | 87.1 | 60.3 | 3.5 | - | n.d. |
2 | 0.005 | 90.7 | 83.6 | 127.2 | 75.8 | 10.9 | - | n.d. |
3 | 0.01 | 85.4 | 78.7 | 107.5 | 101.4* | 44.7* | - | n.d. |
4 | 0.02 | 106.4 | 98.1 | 92.7 | 67.2 | 10.5 | - | n.d. |
5 | 0.05 | 112.0 | 103.3 | 112.6 | 69.6 | 12.9 | - | n.d. |
6 | 0.1 | 102.9 | 94.9 | 74.3 | 52.1 | -4.6 | - | 15.4 |
7 | 0.2 | 102.9 | 94.9 | 72.2 | 62.0 | 5.3 | - | 13.0 |
8 | 0.5 | 101.2 | 93.4 | 20.3 | 67.6 | 10.9 | - | 16.3 |
EMS | 200 µg/mL | 32.0 | 29.5 | 19.4 | 3673.2* | 3616.5* | + | n.d. |
MMS | 8 µg/mL | 38.9 | 35.9 | 25.0 | 1191.8* | 1135.1* | + | 51.1 |
CE: Cloning efficiency, CE = (-ln ((96 - (mean value of plates)) / 1.6) x 100 | ||||||||
RCE: Relative Cloning Efficiency, RCE = (CE of dose group/CE of corresponding controls)x100 | ||||||||
RTG: Relative Total Growth, RTG = (RSG x RCE)/100 | ||||||||
MF: Mutant Frequency | ||||||||
GEF: Global Evaluation Factor (126): + = GEF exceeded, - = GEF not exceeded | ||||||||
* statistical significant increase in mutant frequency compared to negative controls | ||||||||
Table 2c: Experiment I, with metabolic activation | ||||||||
Test group | Concentration | CE | RCE | RTG | MF | IMF | GEF exceeded | colony sizing |
mM | % | % | % | mutants/106cells | mutants/106cells | % small colonies | ||
Negative control | 0 | 90.7 | 100.0 | 100.0 | 81.0 | / | / | 10.9 |
110.7 | / | / | 20.8 | |||||
2 | 0.02 | 80.5 | 80.2 | 90.2 | 109.8 | 28.9 | - | n.d. |
3 | 0.05 | 101.2 | 100.9 | 110.3 | 89.1 | 8.1 | - | n.d. |
4 | 0.1 | 86.6 | 86.3 | 99.7 | 96.4 | 15.5 | - | n.d. |
5 | 0.2 | 75.9 | 75.6 | 77.3 | 100.1 | 19.1 | - | n.d. |
6 | 0.5 | 90.7 | 90.3 | 92.7 | 92.1 | 11.2 | - | n.d. |
7 | 1.0 | 93.5 | 93.2 | 73.4 | 95.9 | 15.0 | - | 22.2 |
8 | 1.2 | 93.5 | 93.2 | 46.4 | 83.0 | 2.0 | - | 21.8 |
9 | 1.4 | 93.5 | 93.2 | 10.1 | 121.4* | 40.5* | - | 20.5 |
B[a]P | 2.5 µg/mL | 92.1 | 91.7 | 57.7 | 593.8* | 512.8* | + | 42.9 |
CE: Cloning efficiency, CE = (-ln ((96 - (mean value of plates)) / 1.6) x 100 | ||||||||
RCE: Relative Cloning Efficiency, RCE = (CE of dose group/CE of corresponding controls)x100 | ||||||||
RTG: Relative Total Growth, RTG = (RSG x RCE)/100 | ||||||||
MF: Mutant Frequency | ||||||||
GEF: Global Evaluation Factor (126): + = GEF exceeded, - = GEF not exceeded | ||||||||
* statistical significant increase in mutant frequency compared to negative controls | ||||||||
Table 2d: Experiment II, with metabolic activation | ||||||||
Test group | Concentration | CE | RCE | RTG | MF | IMF | GEF exceeded | colony sizing |
mM | % | % | % | mutants/106cells | mutants/106cells | % small colonies | ||
Negative control | 0 | 110.1 | 100.0 | 100.0 | 72.2 | / | / | 14.3 |
95.0 | / | / | 18.4 | |||||
5 | 0.15 | 90.7 | 88.4 | 79.9 | 75.6 | 3.5 | - | n.d. |
6 | 0.3 | 95.0 | 92.6 | 100.1 | 78.5 | 6.3 | - | n.d. |
7 | 0.7 | 125.0 | 121.9 | 103.3 | 68.1 | -4.1 | - | n.d. |
8 | 0.9 | 98.0 | 95.6 | 81.9 | 66.7 | -5.5 | - | n.d. |
9 | 1.1 | 82.1 | 89.8 | 56.2 | 79.2 | 7.1 | - | n.d. |
10 | 1.2 | 120.3 | 117.4 | 57.4 | 63.0 | -9.2 | - | 11.1 |
11 | 1.3 | 120.3 | 117.4 | 31.8 | 64.7 | -7.5 | - | 12.7 |
12 | 1.4 | 104.6 | 102.0 | 8.7 | 77.2 | 5.1 | - | 17.5 |
B{a]P | 2.5 µg/mL | 85.4 | 83.3 | 59.2 | 477.9* | 405.7* | + | 42.1 |
CE: Cloning efficiency, CE = (-ln ((96 - (mean value of plates)) / 1.6) x 100 | ||||||||
RCE: Relative Cloning Efficiency, RCE = (CE of dose group/CE of corresponding controls)x100 | ||||||||
RTG: Relative Total Growth, RTG = (RSG x RCE)/100 | ||||||||
MF: Mutant Frequency | ||||||||
GEF: Global Evaluation Factor (126): + = GEF exceeded, - = GEF not exceeded | ||||||||
* statistical significant increase in mutant frequency compared to negative controls | ||||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
