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: 906-170-0 | 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

Genetic toxicity: in vitro
Administrative data
- 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:
- May 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: study similar to OECD 471
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- : only 4 of 5 recommended strains (TA1535, TA1537, TA98, TA100) were used in this study
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of dimethyl adipate and dimethyl glutarate and dimethyl succinate
- EC Number:
- 906-170-0
- Molecular formula:
- CH3CO2(CH2)nCO2CH3 Where n = 2, 3 and 4
- IUPAC Name:
- Reaction mass of dimethyl adipate and dimethyl glutarate and dimethyl succinate
- Test material form:
- other: liquid
- Details on test material:
- See information in the field "Confidential details on test material"
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver S9 mix
- Test concentrations with justification for top dose:
- 0, 100, 500, 1000, 5000, 10000 µg/plate for all bacterial strains with and without S9
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (all strains with S9), 9-aminoacridine (TA1537 without S9), N-methyl-N'-nitrosoguanidine (TA1535 and TA100 without S9), 2-nitrofluorene (TA98 without S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: as impregnation on paper disk (spot test in a closed system)
Experiments without S9 were performed by adding 10E8 bacteria (in 0.1 mL) to 2 mL of standard top agr, mixing immediately, and pouring on a Davis minimal agar plate. Experiments with S9 were performed in the same manner except that 0.5 mL of S9 mix was added before mixing.
A sterile disk saturated with test substance was placed in the center of one of two replicate plates. The plate with the disk was inverted and the other plate was stacked on top of it. Both plates were sealed in a plastic bag and incubated for 48 hours at 37°C. - Evaluation criteria:
- A chemical was judged to be mutagenic or nonmutagenic in the assay after considering the various pieces of information provided by the statistical analysis
- Statistics:
- The data points (number of revertants/plate = x) were transformed prior to analysis using the power transformation y = xE0.2. Two analyses were performed. In the first analysis, the response observed at each concentration was compared to the control by a t-test of significance to determine which dose levels produced significant increases in mutation frequency. In the second analysis, the significance of the dose-response relationship was tested. Linear, quadratic, and higher order dose-response effects were tested in an F-test of significance. In addition, an analysis was conducted to determine whether the dose-response relationship was different in different trials.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- up to the top concentration of 10000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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 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 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:
- E. coli WP2 uvr A
- Remarks:
- This strain was tested in another assay described in Groot 2019 endpoint of this dossier
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In an intial cytotoxicity experiment on strain TA1535, DBE was tested at concentrations up to 10000 µg/plate and induced no toxicity.
No indication of mutagenic activity was observed in the spot test. The mutation frequencies were not significantly greater than te solvent control values and significant dose-response effects were not observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenicity testing in strain TA1535
Test concentration (µg/plate) |
Number of revertants per plate (duplicate plates) |
|||
Trial 1 |
Trial 2 |
|||
Without metabolic activation |
||||
0 (DMSO) |
21 |
32 |
24 |
34 |
100 |
37 |
32 |
31 |
33 |
500 |
35 |
38 |
29 |
32 |
1000 |
40 |
30 |
27 |
25 |
5000 |
31 |
36 |
32 |
37 |
10000 |
40 |
37 |
35 |
39 |
Positive control |
1521 |
1876 |
700 |
1070 |
Without metabolic activation |
||||
0 (DMSO) |
9 |
22 |
15 |
21 |
100 |
15 |
23 |
20 |
18 |
500 |
12 |
20 |
16 |
18 |
1000 |
14 |
25 |
9 |
14 |
5000 |
13 |
28 |
25 |
19 |
10000 |
19 |
25 |
24 |
17 |
Positive control |
294 |
259 |
283 |
266 |
MNNG: N-methyl-N'-nitro-N-nistrosoguanidine2-AA: 2-aminoanthracene
Table 2: Mutagenicity testing in strain TA1537
Test concentration (µg/plate) |
Number of revertants per plate (duplicate plates) |
|||
Trial 1 |
Trial 2 |
|||
Without metabolic activation |
||||
0 (DMSO) |
11 |
15 |
11 |
8 |
100 |
13 |
15 |
10 |
13 |
500 |
14 |
8 |
18 |
9 |
1000 |
13 |
7 |
7 |
14 |
5000 |
6 |
13 |
9 |
14 |
10000 |
13 |
12 |
12 |
11 |
Positive control |
580 |
411 |
383 |
357 |
Without metabolic activation |
||||
0 (DMSO) |
12 |
11 |
10 |
9 |
100 |
8 |
12 |
10 |
13 |
500 |
11 |
9 |
11 |
9 |
1000 |
13 |
8 |
15 |
7 |
5000 |
9 |
10 |
12 |
8 |
10000 |
12 |
13 |
9 |
15 |
Positive control |
328 |
228 |
176 |
172 |
9-AAC: 9-aminoacridine 2-AA: 2-aminoanthracene
Table 3: Mutagenicity testing in strain TA98
Test concentration (µg/plate) |
Number of revertants per plate (duplicate plates) |
|||
Trial 1 |
Trial 2 |
|||
Without metabolic activation |
||||
0 (DMSO) |
31 |
34 |
37 |
32 |
100 |
26 |
22 |
28 |
30 |
500 |
20 |
27 |
30 |
26 |
1000 |
22 |
18 |
24 |
31 |
5000 |
26 |
23 |
30 |
31 |
10000 |
29 |
26 |
29 |
23 |
Positive control |
2772 |
2624 |
2619 |
2388 |
Without metabolic activation |
||||
0 (DMSO) |
47 |
41 |
43 |
39 |
100 |
37 |
42 |
45 |
48 |
500 |
39 |
35 |
41 |
48 |
1000 |
43 |
47 |
58 |
54 |
5000 |
40 |
36 |
47 |
38 |
10000 |
39 |
37 |
34 |
54 |
Positive control |
1200 |
1363 |
1166 |
1114 |
2-NF: 2-nitrofluorene 2-AA: 2-aminoanthracene
Table 4: Mutagenicity testing in strain TA100
Test concentration (µg/plate) |
Number of revertants per plate (duplicate plates) |
|||
Trial 1 |
Trial 2 |
|||
Without metabolic activation |
||||
0 (DMSO) |
115 |
112 |
143 |
104 |
100 |
129 |
114 |
141 |
143 |
500 |
130 |
124 |
113 |
129 |
1000 |
105 |
115 |
112 |
115 |
5000 |
116 |
90 |
136 |
105 |
10000 |
100 |
121 |
130 |
98 |
Positive control |
1908 |
1989 |
1430 |
17995 |
Without metabolic activation |
||||
0 (DMSO) |
146 |
127 |
143 |
172 |
100 |
120 |
115 |
139 |
114 |
500 |
146 |
117 |
130 |
138 |
1000 |
132 |
99 |
145 |
176 |
5000 |
117 |
114 |
126 |
136 |
10000 |
128 |
118 |
155 |
148 |
Positive control |
1102 |
820 |
863 |
1012 |
MNNG: N-methyl-N'-nitro-N-nistrosoguanidine2-AA: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
DBE is not mutagenic in the Ames reverse mutation assay (spot test format) with strains TA1535, TA1537, TA98 and TA100 up to the test concentration of 10000 µg/plate. - Executive summary:
The mutagenic potential of DBE has been assessed in the Salmonella typhimurium Ames test according to OECD guideline n° 471 and EC guideline n° B13/14.
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 were tested in presence and in absence of metabolic activation system from liver fraction of rats (S9 mix). The negative control was DMSO.
DBE was tested in 2 independent experiments performed according to the spot test method in which a sterile disk saturated with DBE was placed in the center of the plate.
Each strain of bacteria was exposed to dose-levels of 0, 100, 500, 1000, 5000 or 10000 µg/plate of the test item (two plates/dose-level). In each experiment, negative and positive controls were included using duplicate plates.
After 48 hours of incubation at 37°C in a sealed plastic bag, the number of revertant colonies per plate was scored in each experiment, for each strain and for each experimental point. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or thinning of the bacterial lawn.
No noteworthy toxicity was induced in an initial cytotoxicity experiment on TA1535.
Negative and positive controls responded adequately. The study was therefore considered valid.
The test substance DBE did not induce any noteworthy increase in the number of revertants which could be considered as relevant, either with or without S9 mix, in any of the 4 tester strains.
The test item did not demonstrate any in vitro mutagenic activity in this bacterial test system, therefore DBE is not classified according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
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.
