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EC number: 249-044-4 | CAS number: 28472-97-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP - Guideline study, tested with the source substance bis(2-ethylhexyl)nonanedioate (CAS 103-24-2). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
- Reference Type:
- publication
- Title:
- Reverse Mutation Test of Bis(2-ethylhexyl) azelate in Bacteria
- Author:
- Miwa, Y.
- Year:
- 2 004
- Bibliographic source:
- Toxicity Testing Reports of Environmental Chemicals, 11, 287-320
- Reference Type:
- secondary source
- Title:
- Bis(2-ethylhexyl) azelate
- Author:
- OECD
- Year:
- 2 006
- Bibliographic source:
- SIDS Initial Assessment Report for SIAM 22, Paris, France, 18-21 April, 2006
- Reference Type:
- secondary source
- Title:
- Diesters Category of the Aliphatic Esters Chemicals (Test Plan and Robust Summaries for Substances in the HPV Test Plan)
- Author:
- US-EPA (American Chemistry Council's Aliphatic Esters Panel)
- Year:
- 2 010
- Bibliographic source:
- High Production Volume (HPV) Chemical Challenge Program (201-16837A and 201-16837B)
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 103-24-2 (analytical purity 77.2%)
- IUPAC Name:
- 103-24-2 (analytical purity 77.2%)
- Details on test material:
- - Name of test material (as cited in study report): Bis(2-ethylhexyl)nonanedioate
- Analytical purity: 77.2%
- Impurities (identity and concentrations):
Bis(2-ethylhexyl)glutarate 2.2%,
Bis(2-ethylhexyl)adipate 2.4%,
Bis(2-ethylhexyl)pimelate 2.8%,
Bis(2-ethylhexyl)suberate 3.8%,
Bis(2-ethylhexyl)sebacate 3.3%,
Bis(2-ethylhexyl) 1-,9-nonamethylenedicarboxylate 5.3%,
Bis(2-ethylhexyl)1-,10-decamethylenedicarboxylate 0.6%,
Bis(2-ethylhexyl)1-,11-undecamethylenedicarboxylate 0.3%
- Lot/batch No.: N-31101
Constituent 1
Method
- Target gene:
- His operon (S. typhimurium)
Trp operon (E. coli)
Species / strainopen allclose all
- 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
Controls
- 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.
Results and discussion
Test resultsopen allclose all
- 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. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
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
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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