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EC number: 945-069-6 | 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
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- 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
Bis(2-ethylhexyl) azelate was tested negative in an Ames test (with and without metabolic activation in Samonella typhimurium TA 98, TA100, TA1535 and TA 1537 and E.coli WP2 urv A (Miwa 2004).
In a mouse lymphoma study according to OECD 476 diester of isodecanol with azelaic acid was tested in ethanol up to precipitating concentrations. No increased incidence of mutations was observed in presence and absence of metabolic activation (Verspeek 2010).
In a chromosome aberration assay in Chinese Hamster Lung cells bis(2-ethylhexyl) azelate was tested up to cytotoxic concentration in presence and absence of metabolic activation. No increased number of aberrations was observed at any of the doses tested (Miwa 2004).
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - 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
- Target gene:
- His operon (S. typhimurium)
Trp operon (E. coli) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- Range finding test:
1.22, 4.88, 19.5, 78.1, 312.5, 625, 1250 and 5000 µg/plate with and without metabolic activation
Main test:
312.5, 625, 1250, 2500 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (AF2; 0.01 µg/plate: TA100, WP2uvrA; 0.1 µg/plate: TA98); sodium azide (SA; 0.5 µg/plate: TA1535); 9-aminoacridine (9AA; 80 µg/plate: TA1537); +S9: 2-aminoanthracene (2AA; up to 10 µg/plate all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- If the number of colonies with revertants was as double as that of control group and dose response was observed, the interpretation of the result was positive.
- Statistics:
- Mean values and standard deviation were calculated.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: There were colorless clear fine oil drop-like precipitations and oil membrane-like precipitations on the surface of agar in any test concentration.
RANGE-FINDING: No cytotoxicity was observed in a range finding study with doses up to 5000 µg/plate. - Conclusions:
- negative
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- Not applicable
- Species / strain / cell type:
- mammalian cell line, other: Chinese hamster lung (CHL/IU) cell
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Eagles's MEM modified with NaHCO3 and HCl (pH 7.0 - 7.1). Fetal calf serum was added up to 10%.
- Properly maintained: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone.
- Test concentrations with justification for top dose:
- 6 h treatment: 150, 300, 600, 1200, 2400 µg/mL with and without metabolic activation.
24 h treatment: 37.5, 75, 150, 300, 600 µg/mL without metabolic activation. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: Mitomycin C (MMC, 0.1 µg/mL ); +S9: Dimethylnitrosamin (DMN; 500 µg/mL)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 6 h and 24 h
NUMBER OF REPLICATIONS: duplicates in single experiment
NUMBER OF CELLS EVALUATED: 200
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- Evaluation was made on the basis of incidence as; -: negative (less than 5.0%); ±: equivocal (5.0% or higher to less than 10.0%); +: positive (10.0% or higher)
- Species / strain:
- mammalian cell line, other: Chinese hamster lung (CHL/IU) cell
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: There were colorless clear fine oil drop-like precipitations and oil membrane-like precipitations in the culture fluid in petri plate at the concentrations of 1200 µg/mL or more.
RANGE-FINDING: The maximum concentration was established, based on the growth inhibition test. In this test, 50% growth inhibition was observed at 1859.0 µg/mL with S9 and at 1555.5 µg/mL without S9 for 6 h short treatment and 534.2 µg/mL without S9 for 24 h continuous treatment. - Conclusions:
- negative with and without metabolic activation
- 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:
- 7 Jan - 16 Feb 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions; analytical purity of test substance not indicated by the sponsor
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- Analytical purity of test substance not indicated
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- thymidine kinase (TK) locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0.03, 0.1, 0.3, 1, 3, 10, 33 and 100 µg/mL
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: (-S9): methylmethanesulfonate: 15 and 5 µg/mL; (+S9): cyclophosphamide: 7.5 µ/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
1st experiment: 3 h exposure with and without S9 mix
2nd experiment: 3 h exposure with S9 mix and 24 h without S9 mix
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 11 to 12 days
- Fixation time: 14 to 16 days
SELECTION AGENT (mutation assays): 5 µg/mL TFT (trifluorothymidine)
NUMBER OF CELLS EVALUATED: five 96-well microtiter plates with 2000 cells per well; each in 2 individual experiments
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency; relative total growth - Evaluation criteria:
- A test substance is considered positive (mutagenic) in the mutation assay if it induces a mutation frequency (MF) of more than 126 in a dose-dependent manner. An observed increase should be biologically relevant and will be compared with the historical control data range. A test substance is considered equivocal (questionable) in the mutation assay if no clear conclusion for positive or negative result can be made after an additional confirmation study.
A test substance is considered negative (not mutagenic) in the mutation assay if:
a) None of the tested concentrations reaches a mutation frequency of more than 126.
b) The results are confirmed in an independently repeated test. - Statistics:
- The global evaluation factor (GEF) has been defined by the IWTG as the mean of the negative/solvent MF distribution plus one standard deviation. For the micro well version of the assay the GEF is 126 (Moore M.M., 2006).
The mutation frequency was expressed as the number of mutants per 10^6 viable cells. The plating efficiencies of both mutant and viable cells (CE day 2) in the same culture were determined and the mutation frequency (MF) was calculated as follows: MF = {-ln P(0)/number of cells plated per well}/CE day2 x 10^6. Small and large colony mutation frequencies were calculated in an identical manner. - Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: Diisodecyl azelate precipitated in the exposure medium at concentrations of 100 µg/mL and above. Diisodecyl azelate was tested beyond the limit of the solubility to obtain adequate cytotoxicity data, the concentration used as the highest test substance concentration for the dose range finding test was 333 µg/mL.
RANGE-FINDING/SCREENING STUDIES: In order to select appropriate dose levels for mutagenicity testing, cytotoxicity data were obtained by treating cells with a number of test substance concentrations increasing with approximately half log steps. In the dose range finding test, L5178Y mouse lymphoma cells were treated with a test substance concentration range of 3 to 333 µg/mL in the absence of S9-mix with a 3 and 24 hour treatment period and in the presence of S9-mix with a 3 hour treatment period.
COMPARISON WITH HISTORICAL CONTROL DATA: The spontaneous mutation frequencies in the soIvent-treated control cultures were between the
minimum and maximum value of the historical control data range. - Conclusions:
- negative with and without metabolic activation
Referenceopen allclose all
Table 1. Test results of experiment 1 (plate incorporation)
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
|||||
|
Base-pair substitution type |
cross-linking type |
Frameshift type |
|||
|
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
|
– |
0 (aqua dest.) |
102 ± 8.1 |
9 ± 2.6 |
35 ± 2.6 |
20 ± 3.5 |
5 ± 0.6 |
– |
0 (vehicle) |
110 ± 14 |
13 ± 6.2 |
27 ± 2.1 |
29 ± 4.2 |
7 ± 2.3 |
– |
312.5 |
100 ± 9.3P |
8 ± 2.1P |
25 ± 7.0P |
23 ± 0.6P |
13 ± 3.1P |
– |
625 |
106 ± 2.6P |
11 ± 2.6P |
31 ± 6.5P |
23 ± 4.2P |
11 ± 0.6P |
– |
1250 |
112 ± 12.1P |
10 ± 1.2P |
26 ± 5.5P |
29 ± 2.1P |
6 ± 0.6P |
– |
2500 |
94 ± 2.5P |
9 ± 2.5P |
29 ± 2.6P |
27 ± 4.0P |
10 ± 3.5P |
– |
5000 |
92 ± 11.5P |
7 ± 1.0P |
24 ± 1.5P |
23 ± 5.0P |
4 ± 0.6P |
Positive controls, |
Name |
AF2 |
SA |
AF2 |
AF2 |
9AA |
Concentrations (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
548 ± 7.8 |
525 ± 7.1 |
132 ± 6.5 |
421 ± 11.2 |
334 ± 87.7 |
|
+ |
0 (medium) |
106 ± 12.1 |
11 ± 0.6 |
24 ± 3.5 |
30 ± 3.0 |
13 ± 1.0 |
+ |
0 (vehicle) |
105 ± 12 |
10 ± 4.0 |
33 ± 7.2 |
27 ± 3.5 |
16 ± 3.8 |
+ |
312.5 |
103 ± 8.1P |
7 ± 4.4P |
30 ± 6.1P |
25 ± 4.6P |
13 ± 1.7P |
+ |
625 |
96 ± 8.1P |
7 ± 2.6P |
31 ± 4.6P |
31 ± 8.0P |
11 ± 1.5P |
+ |
1250 |
97 ± 15.6P |
9 ± 2.6P |
31 ± 5.0P |
31 ± 6.4P |
14 ± 1.5P |
+ |
2500 |
96 ± 9.7P |
6 ± 3.2P |
33 ± 2.6P |
25 ± 7.5P |
11 ± 2.0P |
+ |
5000 |
90 ± 3.2P |
7 ± 4.2P |
32 ± 5.8P |
32 ± 5.5P |
12 ± 2.9P |
Positive controls, |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1036 ± 46.9 |
327± 18.4 |
969 ± 142.3 |
437 ± 30.3 |
181 ± 29.5 |
AF2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
9AA = 9-aminoacridine
2AA = 2-aminoanthracene
SA = sodium azide
P = Precipitate
Table 2. Test results of experiment 2 (plate incorporation)
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
||||
(μg/plate) |
(average of 3 plates ± Standard deviation) |
|||||
|
Base-pair substitution type |
cross-linking type |
Frameshift type |
|||
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA1537 |
||
– |
0 (aqua dest.) |
132 ± 15.5 |
8 ± 1.0 |
39 ± 2.5 |
23 ± 8.1 |
9 ± 5.5 |
– |
0 (vehicle) |
131 ± 14.5 |
9 ± 3.1 |
41 ± 6.1 |
31 ± 6.9 |
9 ± 3.0 |
– |
312.5 |
129 ± 17.1P |
7 ± 2.1P |
38 ± 7.0P |
27 ± 4.2P |
10 ± 1.5P |
– |
625 |
124 ± 5.2P |
7 ± 1.2P |
33 ± 7.8P |
30 ± 11P |
14 ± 5.2P |
– |
1250 |
127 ± 10.4P |
8 ± 1.5P |
34 ± 4.0P |
30 ± 2.1P |
13 ± 1.0P |
– |
2500 |
128 ± 16.8P |
8 ± 3.8P |
38 ± 3.2P |
25 ± 1.0P |
13 ± 3.6P |
– |
5000 |
124 ± 4.0P |
10 ± 2.5P |
38 ± 0.0P |
27 ± 4.0P |
10 ± 2.5P |
Positive controls, |
Name |
AF2 |
SA |
AF2 |
AF2 |
9AA |
Concentrations (μg/plate) |
0.01 |
0.5 |
0.01 |
0.1 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
569 ± 27.5 |
589 ± 36.5 |
137 ± 17.6 |
446 ± 19.1 |
411 ± 100.1 |
|
+ |
0 (medium) |
137 ± 16.1 |
7 ± 2.5 |
33 ± 3.2 |
31 ± 7.8 |
12 ± 3.0 |
+ |
0 (vehicle) |
132 ± 5.2 |
7 ± 3.2 |
46 ± 7.2 |
31 ± 6.1 |
16 ± 2.1 |
+ |
312.5 |
125 ± 22.4P |
7 ± 1.5P |
39 ± 2.6P |
23 ± 1.2P |
12 ± 1.5P |
+ |
625 |
123 ± 10.0P |
8 ± 2.1P |
41 ± 5.1P |
31 ± 2.5P |
14 ± 6.5P |
+ |
1250 |
125 ± 14.0P |
9 ± 3.2P |
40 ± 5.7P |
23 ± 4.5P |
14 ± 4.2P |
+ |
2500 |
116 ± 3.5P |
8 ± 2.1P |
39 ± 12.5P |
31 ± 1.2P |
17 ± 5.1P |
+ |
5000 |
121 ± 7.6P |
11 ± 3.8P |
46 ± 4.0P |
35 ± 2.5P |
13 ± 2.1P |
Positive controls, |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
0.5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
999 ± 117.8 |
289 ± 6.1 |
995 ± 77.9 |
420 ± 33.7 |
135 ± 13.1 |
AF2 = 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
9AA = 9-aminoacridine
2AA = 2-aminoanthracene
SA = sodium azide
P = Precipitate
Table 1. Test results
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
in µg/mL |
in % |
with gaps |
without gaps |
Exposure period 6 h, without S9 mix |
||||
Medium |
|
99 |
0.5 |
0.5 |
Ethanol |
|
100 |
1 |
1 |
MMC |
0.1 |
83 |
55.5 |
55.5 |
Test substance |
150 |
99 |
0 |
0 |
300 |
88 |
0 |
0 |
|
600 |
70 |
0.5 |
0.5 |
|
1200 P |
51 |
1 |
1 |
|
2400 P |
39 |
0.5 |
0.5 |
|
Exposure period 6 h, fixation time 24 h, with S9 mix |
||||
Medium |
|
100 |
0 |
0 |
Ethanol |
|
100 |
0 |
0 |
DMN |
500 |
78 |
65.5 |
65.5 |
Test substance |
150 |
99 |
1 |
1 |
300 |
80 |
0 |
0 |
|
600 |
64 |
0.5 |
0.5 |
|
1200 P |
48 |
0 |
0 |
|
2400 P |
35 |
0 |
0 |
|
Exposure period 24 h, fixation time 24 h, without S9 mix |
||||
Medium |
|
97 |
0.5 |
0.5 |
Ethanol |
|
100 |
1 |
1 |
MMC |
0.05 |
86 |
44.5 |
44.5 |
Test substance |
37.5 |
97 |
1.5 |
1.5 |
75 |
98 |
0 |
0 |
|
150 |
87 |
0 |
0 |
|
300 |
56 |
1 |
1 |
|
600 |
35 |
0 |
0 |
MMC: Mitomycin C
DMN: Dimethylnitrosamine
P: Colorless clear fine oile drop-like precipitations were noted in the culture fluid in petri plate.
Table 1: Dose range finding test: Cytotoxicity (3 hours treatment)
Dose
(µg/mL) |
Cell count after 3 h of treatment (cells/mLx1E6) |
Cell count after 24 h of subculture (cells/mLx1E6) |
Cell count after 48 h of subculture (cells/mLx1E6) |
Suspension growth
(%) |
Relative suspension growth (%) |
Without S9 mix |
|||||
SC |
6.5 |
5.1 |
7.8 |
166 |
100 |
3 |
6.7 |
5.6 |
8.0 |
191 |
115 |
10 |
6.2 |
5.4 |
8.0 |
173 |
104 |
33 |
6.3 |
5.4 |
7.6 |
167 |
101 |
100 |
6.4 |
4.9 |
7.6 |
153 |
92 |
333 |
6.4 |
4,9 |
7.8 |
148 |
89 |
With S9 mix |
|||||
SC |
6.6 |
5.4 |
7.0 |
161 |
100 |
3 |
6.4 |
5.6 |
7.0 |
159 |
99 |
10 |
7.2 |
5.5 |
7.0 |
179 |
112 |
33 |
6.9 |
5.6 |
7.5 |
184 |
115 |
100 |
7.2 |
5.0 |
7.2 |
166 |
103 |
333 |
7.0 |
4.8 |
7.1 |
153 |
95 |
SC = solvent control (ethanol)
Table 2: Dose range finding test: Cytotoxicity (24 hours treatment)
Dose
(µg/mL) |
Cell count after 24 h of treatment (cells/mLx1E6) |
Cell count after 24 h of subculture (cells/mLx1E6) |
Suspension growth
(%) |
Relative suspension growth (%) |
Without S9 mix |
||||
SC |
6.5 |
6.3 |
33 |
100 |
3 |
6.1 |
6.4 |
31 |
94 |
10 |
5.7 |
5.6 |
25 |
77 |
33 |
6.3 |
5.6 |
28 |
84 |
100 |
6.9 |
5.4 |
30 |
90 |
333 |
6.6 |
5.2 |
27 |
83 |
SC = solvent control (ethanol)
Table 3: Main test: Results
Dose
(µg/mL) |
Relative suspension growth (%) |
Cloning efficiency (%) |
Relative survival (day 2) (%) |
Relative total growth (%) |
Total mutation frequency (1/1xE6) |
Without metabolic activation: 3 hours treatment |
|||||
SC1 |
100 |
104 |
100 |
100 |
70 |
SC2 |
116 |
64 |
|||
0.03 |
104 |
105 |
96 |
100 |
62 |
0.1 |
104 |
111 |
101 |
105 |
72 |
0.3 |
104 |
88 |
80 |
83 |
71 |
1 |
111 |
95 |
87 |
96 |
65 |
3 |
106 |
90 |
82 |
87 |
83 |
10 |
98 |
108 |
98 |
97 |
71 |
100 |
106 |
107 |
97 |
102 |
63 |
333 |
96 |
94 |
85 |
82 |
74 |
MMS |
63 |
84 |
76 |
48 |
717 |
With 8% metabolic activation: 3 hours treatment |
|||||
SC1 |
100 |
83 |
100 |
100 |
103 |
SC2 |
84 |
98 |
|||
0.03 |
103 |
83 |
99 |
102 |
92 |
0.1 |
94 |
88 |
105 |
98 |
86 |
0.3 |
87 |
97 |
116 |
101 |
83 |
1 |
99 |
86 |
104 |
103 |
93 |
3 |
97 |
85 |
102 |
99 |
101 |
10 |
96 |
95 |
115 |
110 |
73 |
33 |
96 |
90 |
108 |
104 |
82 |
100 |
97 |
101 |
121 |
117 |
73 |
CP |
54 |
62 |
75 |
40 |
1064 |
Without metabolic activation: 24 hours treatment |
|||||
SC1 |
100 |
90 |
100 |
100 |
73 |
SC2 |
95 |
76 |
|||
0.03 |
104 |
93 |
100 |
104 |
59 |
0.1 |
100 |
89 |
96 |
96 |
66 |
0.3 |
103 |
89 |
96 |
98 |
62 |
1 |
105 |
95 |
103 |
108 |
73 |
3 |
102 |
91 |
99 |
101 |
54 |
10 |
83 |
108 |
117 |
97 |
63 |
100 |
102 |
99 |
107 |
110 |
59 |
333 |
98 |
93 |
100 |
98 |
71 |
MMS |
83 |
70 |
76 |
63 |
910 |
With 12% metabolic activation: 3 hours treatment |
|||||
SC1 |
100 |
98 |
100 |
100 |
124 |
SC2 |
91 |
119 |
|||
0.03 |
105 |
91 |
96 |
101 |
103 |
0.1 |
116 |
98 |
104 |
120 |
101 |
0.3 |
110 |
115 |
121 |
133 |
109 |
1 |
111 |
99 |
105 |
117 |
145 |
3 |
115 |
98 |
104 |
119 |
106 |
10 |
113 |
88 |
92 |
105 |
110 |
33 |
105 |
90 |
95 |
100 |
94 |
100* |
110 |
84 |
89 |
97 |
163 |
CP |
68 |
72 |
77 |
52 |
1201 |
SC = solvent control; MMS = methylmethansulfonate; CP = cyclophosphamide
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Based on data on two analogue substances and in a weight of evidence approach, it can be concluded that diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid is not mutagenic or clastogenic (see also rationale for read-across in section 13)
Justification for classification or non-classification
Based on the outcome of the available studies on the analogue substances, no classification for diesters of alcohols, C7-9-iso-, C8-rich, 2-ethylhexyl and nonanedioic acid is considered according to EC No 1272/2008.
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