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EC number: - | CAS number: -
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Three reliable in vitro test for genetic toxicity were available (Amen, Mouse Lympoma assay, Micronucleaus test). All three test were negative.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- All Salmonella strains contain mutations in the histidine operon, thereby imposing a requirement for histidine in the growth medium. They contain the deep rough (rfa) mutation, which deletes the polysaccharide side chain of the lipopolysaccharides of the bacterial cell surface. This increases cell permeability of larger substances. The other mutation is a deletion of the uvrB gene coding for a protein of the DNA nucleotide excision repair system resulting in an increased sensitivity in detecting many mutagens. This deletion also includes the nitrate reductase (chi) and biotin (bio) genes (bacteria require biotin for growth).The tester strains TA 98 and TA 100 contain the R-factor plasmid, pl(M101. These strains are reverted by a number of mutagens that are detected weakly or not at all with the non R-factor parent strains. plcM101 increases chemical and spontaneous mutagenesis by enhancing an error-prone DNA repair system which is normally present in these organisms (6), (9).The tester strain E. coli WP2 uvrA carries the defect in one of the genes for tryptophan biosynthesis. Tryptophan-independent mutants (revertants) can arise either by a base change at the site of the original alteration or by a base change elsewhere in the chromosome so that the original defect is suppressed. This second possibility can occur in several different ways so that the system seems capable of detecting all types of mutagens which substitute one base for another. Additionally, the strain is deficient in the DNA nucleotide excision repair system.
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 50 - 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: DMSO is an established solvent - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and pre-incubation test
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: other:
revertant colony numbers and the inhibition of the background lawn
- Evaluation criteria:
- The colonies were counted visually, the numbers were recorded. A spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The increase factor f(I) of revertant induction (mean revertants divided by mean spontaneous revertants) and the absolute number of revertants (“Rev. abs.”, mean revertants less mean spontaneous revertants) were also calculated.
A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity. - Statistics:
- none applied
- Species / strain:
- S. typhimurium TA 102
- 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
- Species / strain:
- S. typhimurium TA 100
- 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
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 97a
- 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
- Species / strain:
- S. typhimurium TA 1535
- 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
- Conclusions:
- In a GLP study according to OECD Test Guideline 471 (Ames test), the registered substance was not mutagenic.
- Executive summary:
The mutagenic potential of CARDOLITE NC-513 was determined with the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14. Two valid experiments were performed.
First Experiment:
Five concentrations of the test item, dissolved in dimethyl sulfoxide (DMSO) (ranging from 5004 to 50 µg/plate) were used. Five genetically manipulated strains ofSalmonella typhimurium(TA 97a, TA 98, TA 100, TA 102 and TA 1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9) for 48 hours, using the plate incorporation method.
None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item didn’t show any mutagenic effects in the first experiment.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Second Experiment:
To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item (ranging from 5041 to 316 µg/plate) and a modification in study performance (pre-incubation method).
The test item didn’t show mutagenic effects in the second experiment, either.
No signs of toxicity towards the bacteria could be observed.
The sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Under the conditions of the test, the test item did not show mutagenic effects towards Salmonella typhimurium ,strains TA 97a, TA 98, TA 100, TA 102 and TA 1535.
The test item CARDOLITE NC-513 is considered as “not mutagenic under the conditions of the test”.
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- several (see 'Overall remarks')
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- TK locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 0.04 µL/mL – 0.0003 µL/mL (with metabolic activation) and 1.25 µL/mL to 0.01 µL/mL (without metabolic activation).
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: standard vehicle - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4h and 24h (experiment 2, without S9)
SELECTION AGENT (mutation assays): trifluorothymidine
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Cell Numbers
Cell numbers in suspension were determined using an aliquot of the well homogenised suspension whose cell number was determined in a cell counter.
Colonies
Colonies were counted manually. In accordance with their size, the colonies were classified into two groups. The colony size distribution was determined in the controls and at all evaluated concentrations of the test item. Criteria to determine colony size were the absolute size of the colony (more than 1/3 of a well for large colonies) and the optical density of the colonies (the optical density of the small colonies is generally higher than the optical density of the large ones).
All generated data of each experiment (test item, solvent control and positive control) were recorded in the raw data.
The test item is considered to have mutagenic effects if:
the induced mutation frequency reproducibly exceeds a threshold of 126 colonies1 per 106 cells above the corresponding solvent control.
the relative increase of the mutation frequency shows a dose relationship.
A mutagenic response is considered to be reproducible if it occurs in both parallel cultures.
Results of test groups are generally rejected if the relative total growth is less than 10% of the solvent control.
The biological relevance of the results was always considered first. Appropriate statistical methods were used as an aid in evaluating the test results. However, the results of statistical testing were assessed with respect to dose-response relationship. Reproducibility and historical data was also taken into consideration.
Statistical significance was confirmed by means of the non-parametric χ2 test (chapter Statistical Analysis, page 62). However, both biological and statistical significance were considered together. - Statistics:
- χ2 test
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- In a GLP-study according to OECD Test Guideline 476, the registered substance was negative in the L5178Y/TK+/- Mouse Lymphoma Assay.
- Executive summary:
The test article, CARDOLITE NC-513, was tested in the L5178Y/TK+/-Mouse Lymphoma Mutagenesis Assay in the absence and presence of metabolic activation with a 4hour exposure. The mutagenesis assay was used to evaluate the mutagenic potential of the test article.
First, a pre-experiment was performed in order to determine a potential cytotoxic effect.
The mutagenicity assay was performed in in two independent experiments (experiment I and II), using two parallel cultures each based on the results of the pre-experiment. The first main experiment (experiment I) was performed with and without metabolic activation (liver enzyme S9 fraction) and a treatment period of 4 h. The second experiment (experiment II) was performed with a treatment period of 24 hours in the absence of metabolic activation and 4 hours in the presence of metabolic activation.
The highest concentration (5 µL/mL) applied was chosen with regard to the solubility of the test item in DMSO. In the pre-experiment a strong cytotoxic effect was detected in the concentrations from 1.25 µL/mL to 0.08 µL/mL in the approach with metabolic activation. In the approach without metabolic activation a cytotoxic effect was detected at the concentration of 0.63 µL/mL. Based on the results of the pre-experiment, the concentrations in experiment I and II were re-adjusted to 0.04 µL/mL – 0.0003 µL/mL (with metabolic activation) and 1.25 µL/mL to 0.01 µL/mL (without metabolic activation).
The tested concentrations are described in table Test Item-a. The evaluated experimental points and the results are summarised in table 3-a and 3-b.
No substantial and reproducible dose dependent increase in mutant colony numbers was observed in both main experiments. No relevant shift of the ratio of small versus large colonies was observed up to the maximal concentration of the test item.
In conclusion, it can be stated that in the mutagenicity test described and under the experimental conditions reported, the test item did not induce mutations in the mouse lymphoma thymidine kinase locus assay using the cell line L5178Y in the absence and presence of metabolic activation.
Therefore, CARDOLITE NC-513 is considered to be “non-mutagenic under the conditions of the mouse lymphoma assay”.
.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Deviations:
- yes
- Remarks:
- some minor not critical deviations
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- lymphocytes: human peripheral blood lymphocytes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- preliminary test: 0.04 - 5 µl/ml in culture
Main experiments (without and with S9): 0.04, 0.02 and 0.01 µL/mL nominal - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Well established solvent for this test - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Preincubation period:
- Exposure duration:
with S9: 4 ± 1 hrs
without S9 (short): 4 ± 1 hrs
without S9 (extended): 1.5 - 2 cell cycles
NUMBER OF REPLICATIONS: duplicate
NUMBER OF CELLS EVALUATED: 2000 binucleated cells per concentration
DETERMINATION OF CYTOTOXICITY
- Method: Cytokinesis-block proliferation index
Cytokinesis was blocked with Cytochalasin B - Evaluation criteria:
- The test item is considered to have no genotoxic effects if:
- the number of micronucleated cells in all evaluated dose groups is in the range of the laboratory’s historical control data of the solvent control
- no statistically significant or concentration-related increase in the number of micronucleated cells is observed.
The test item is considered to have genotoxic effects if:
- the number of micronucleated cells in all evaluated dose groups is above the range of the historical laboratory control data
- either a concentration-related increase of micronucleated cells or a statistically significant increase in the number of cells containing micronuclei is observed - Statistics:
- Fisher’s exact test
- Species / strain:
- lymphocytes: human peripheral blood
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Conclusions:
- In a GLP-study according to OECD test guideline 487, the registered substance did not exhibit clastogenic or aneugenic activity in cultured human peripheral blood lymphocytes and is therefore considered negative.
- Executive summary:
The genotoxic potential of CARDOLITE NC-513 with the In VitroMammalian Cell Micronucleus Test following OECD 487 was determined.
This study was performed in order to evaluate the mutagenic potential of CARDOLITE NC-513 to induce formation of micronuclei in human lymphocytes. The lymphocytes, in whole blood culture, were stimulated to divide by addition of phytohaemagglutinin and exposed to the test item both in absence and presence of an exogenous metabolic activation system (liver S9 mix from male rats, treated with Aroclor 1254). The proportion of cells containing micronuclei was determined.
Two independent experiments were performed. In each experimental group, all cell cultures were set up in duplicate. In order to assess the toxicity of the test item to cultured human lymphocytes, the cytokinesis-block proliferation index was calculated in a pre-experiment. The test item showed high cytotoxicity down to a concentration of 0.08 µL/mL in both experimental parts (with and without metabolic activation). Therefore, experiment I and experiment II were performed with the following concentrations of the test item: 0.04, 0.02, 0.01, 0.005, 0.003, 0.001, 0.0006 and 0.0003 µL/mL nominal. Again, the cytokinesis-block proliferation index was calculated and on the basis of this data, the following concentrations were selected for micronuclei scoring:
Experiment I
Without S9 mix / 4 ± 1 hours exposure: 0.04, 0.02 and 0.01 µL/mL nominal
With S9 mix / 4 ± 1 hours exposure: 0.04, 0.02 and 0.01 µL/mL nominal
Experiment II
Without S9 mix / 22 ± 2 hours exposure: 0.04, 0.02 and 0.01 µL/mL nominal
With S9 mix / 4 hours exposure: 0.04, 0.02 and 0.01 µL/mL nominal
All positive control compounds – at least in the higher concentrations - caused large, statistically significant increases in the proportion of micronucleated cells, demonstrating the sensitivity of the test system.
In conclusion, under the experimental conditions reported, CARDOLITE NC-513 does not induce the formation of micronuclei in human lymphocytesin vitro.
The test item CARDOLITE NC-513 is considered as “not genotoxic under the conditions of the test”.
Referenceopen allclose all
Mean Revertants First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
106 |
107 |
20 |
18 |
80 |
78 |
134 |
138 |
18 |
17 |
sd |
9 |
8 |
2 |
2 |
11 |
10 |
7 |
4 |
2 |
1 |
|
DMSO |
Mean |
110 |
115 |
18 |
17 |
75 |
96 |
133 |
135 |
16 |
16 |
sd |
6 |
4 |
2 |
2 |
14 |
10 |
8 |
8 |
2 |
2 |
|
Positive |
Mean |
505 |
542 |
196 |
211 |
553 |
570 |
551 |
569 |
210 |
214 |
sd |
52 |
23 |
11 |
12 |
11 |
37 |
28 |
30 |
7 |
9 |
|
f(I) |
4.59 |
4.71 |
10.89 |
12.41 |
6.91 |
5.94 |
4.14 |
4.21 |
11.67 |
13.38 |
|
5004 µg/pl. |
Mean |
120 |
126 |
16 |
17 |
84 |
92 |
126 |
134 |
14 |
18 |
sd |
7 |
11 |
1 |
2 |
9 |
6 |
8 |
5 |
3 |
3 |
|
f(I) |
1.09 |
1.10 |
0.89 |
1.00 |
1.12 |
0.96 |
0.95 |
0.99 |
0.88 |
1.13 |
|
1501 µg/pl. |
Mean |
116 |
125 |
14 |
17 |
78 |
92 |
123 |
136 |
17 |
18 |
sd |
2 |
2 |
3 |
1 |
6 |
5 |
4 |
4 |
2 |
2 |
|
f(I) |
1.05 |
1.09 |
0.78 |
1.00 |
1.04 |
0.96 |
0.92 |
1.01 |
1.06 |
1.13 |
|
500 µg/pl. |
Mean |
108 |
119 |
19 |
15 |
18 |
93 |
114 |
126 |
16 |
16 |
sd |
6 |
4 |
2 |
4 |
2 |
3 |
3 |
10 |
3 |
2 |
|
f(I) |
0.98 |
1.03 |
1.06 |
0.88 |
0.24 |
0.97 |
0.86 |
0.93 |
1.00 |
1.00 |
|
150 µg/pl. |
Mean |
113 |
117 |
18 |
18 |
18 |
86 |
135 |
138 |
17 |
18 |
sd |
4 |
2 |
2 |
1 |
2 |
3 |
5 |
4 |
2 |
3 |
|
f(I) |
1.03 |
1.02 |
1.00 |
1.06 |
0.24 |
0.90 |
1.02 |
1.02 |
1.06 |
1.13 |
|
50 µg/pl. |
Mean |
111 |
116 |
14 |
20 |
17 |
85 |
135 |
124 |
15 |
17 |
sd |
4 |
2 |
1 |
1 |
2 |
12 |
7 |
8 |
1 |
1 |
|
f(I) |
1.01 |
1.01 |
0.78 |
1.18 |
0.23 |
0.89 |
1.02 |
0.92 |
0.94 |
1.06 |
Mean Revertants Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
105 |
124 |
20 |
17 |
86 |
90 |
133 |
123 |
17 |
14 |
sd |
6 |
3 |
6 |
2 |
3 |
9 |
10 |
8 |
2 |
2 |
|
DMSO |
Mean |
107 |
117 |
20 |
18 |
90 |
93 |
133 |
125 |
16 |
16 |
sd |
11 |
6 |
3 |
2 |
14 |
3 |
5 |
6 |
3 |
1 |
|
Positive |
Mean |
524 |
477 |
205 |
220 |
481 |
487 |
516 |
450 |
188 |
211 |
sd |
38 |
35 |
9 |
13 |
22 |
40 |
34 |
8 |
9 |
16 |
|
f(I) |
4.90 |
4.08 |
10.25 |
12.22 |
5.59 |
5.24 |
3.88 |
3.60 |
11.06 |
13.19 |
|
5041 µg/pl. |
Mean |
116 |
115 |
14 |
13 |
96 |
102 |
134 |
130 |
17 |
14 |
sd |
4 |
2 |
5 |
4 |
5 |
8 |
5 |
10 |
2 |
3 |
|
f(I) |
1.08 |
0.98 |
0.70 |
0.72 |
1.07 |
1.10 |
1.01 |
1.04 |
1.06 |
0.88 |
|
2521 µg/pl. |
Mean |
116 |
115 |
15 |
19 |
101 |
91 |
142 |
140 |
14 |
14 |
sd |
3 |
5 |
5 |
8 |
8 |
14 |
6 |
5 |
1 |
2 |
|
f(I) |
1.08 |
0.98 |
0.75 |
1.06 |
1.12 |
0.98 |
1.07 |
1.12 |
0.88 |
0.88 |
|
1261 µg/pl. |
Mean |
113 |
106 |
14 |
17 |
88 |
89 |
140 |
136 |
14 |
16 |
sd |
6 |
6 |
6 |
4 |
8 |
8 |
2 |
3 |
2 |
2 |
|
f(I) |
1.06 |
0.91 |
0.70 |
0.94 |
0.98 |
0.96 |
1.05 |
1.09 |
0.88 |
1.00 |
|
631 µg/pl. |
Mean |
114 |
111 |
11 |
18 |
82 |
89 |
125 |
134 |
16 |
13 |
sd |
3 |
5 |
3 |
2 |
9 |
2 |
5 |
7 |
2 |
1 |
|
f(I) |
1.07 |
0.95 |
0.55 |
1.00 |
0.91 |
0.96 |
0.94 |
1.07 |
1.00 |
0.81 |
|
316 µg/pl. |
Mean |
111 |
107 |
13 |
12 |
82 |
86 |
134 |
124 |
17 |
15 |
sd |
7 |
6 |
4 |
3 |
9 |
6 |
8 |
6 |
2 |
2 |
|
f(I) |
1.04 |
0.91 |
0.65 |
0.67 |
0.91 |
0.92 |
1.01 |
0.99 |
1.06 |
0.94 |
f(I) = increase factor
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
The substance did not show genotoxic potential in an Ames test, in a Mammalian Cell Micronucleus Test and in a Mammalian Cell Gene Mutation Test.
Based on these in vitro results, the substance is considered to be not genotoxic and does not require classification according to Regulation (EC) No. 1272/2008.
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.
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