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EC number: 241-029-0 | CAS number: 16958-92-2
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study (Draft)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(tridecyl) adipate
- EC Number:
- 241-029-0
- EC Name:
- Bis(tridecyl) adipate
- Cas Number:
- 16958-92-2
- Molecular formula:
- C28H54O4 - C36H70O4
- IUPAC Name:
- 1,6-ditridecyl hexanedioate
- Details on test material:
- - Name of test material (as cited in study report): Bis(tridecyl)adipate
- Physical state: clear colourless liquid
- Analytical purity: 100% (UVCB)
- Lot/batch No.: J08120
- Expiration date of the lot/batch: 2014-06-07
- Storage condition of test material: room temperature in the dark
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains) and trp operon (for E. coli strain)
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats with induced with Phenobarbitone/β-Naphthoflavone at 80/100 mg/kg/day, orally, for 3 days prior to preparation on day 4
- Test concentrations with justification for top dose:
- Preliminary toxicity test (in TA 100 and WP2 uvrA): 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 μg/plate with and without metabolic activation
Main Assay (Experiment I and II): 50, 150, 500, 1500 and 5000 μg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: the test item was insoluble in sterile distilled water and dimethyl sulphoxide at 50 mg/mL, but was fully soluble in dimethyl formamide at the same concentration and in acetone at 100 mg/mL and tetrahydrofuran at 200 mg/mL. Acetone was selected as the vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- -S9: ENNG (2-5 µg/mL for WP2 uvrA, TA 100, TA1535); 9-AA (80 μg/plate for TA 1537); 4NQO (0.2 μg/plate for TA98); +S9: 2-AA (1-10 µg/plate for TA 100, TA 1535, TA 1537 and WP2 uvrA); BP (5 μg/plate for TA98)
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Remarks:
- ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; 9-AA:9-Aminoacridine; 4-NQO: 4-nitroquinoline-1-oxide; 2-AA: 2-aminoanthracene; BP: benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium (Preliminary toxicity test and Experiment I); preincubation (Experiment II)
DURATION
- Preincubation period: 20 min (Experiment II)
- Exposure duration: 48 h (all experiments)
NUMBER OF REPLICATIONS: triplicates in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method determination of the number of revertant colonies and inspection of the bacterial background lawn - Evaluation criteria:
- There were several criteria for determining a positive result. Any, one, or all of the following were used to determine the overall result of the study:
-a dose-related increase in mutant frequency over the dose range tested.
- a reproducible increase at one or more concentrations.
- biological relevance against historical control ranges.
- statistical analysis of data as determined by UKEMS.
- fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response).
A test item was considered non-mutagenic (negative) in the test system if the above criteria were not met. - Statistics:
- Mean values and standard deviations of the mean number of revertants were calculated. Statistical analysis of data was performed according to guidelines from UKEMS.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: a test item precipitate (globular in appearance) was noted by eye at and above 1500 μg/plate, this observation did not prevent the scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES: in the Preliminary toxicity test, the test item was non-toxic to strains TA 100 and WP2 uvrA up to the maximum concentration of 5000 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: the mean number of revertants of vehicle and positive controls was within the normal range of the respective historical control data. - 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 I (plate incorporation)
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (mutation factor) (n=3 ± SD) |
|||||
EXPERIMENT I (plate incorporation) |
|||||
S9-Mix |
Without
|
||||
Concentration (per plate) |
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA 1537 |
SC |
108 ± 14 |
14 ± 2 |
19 ± 2 |
21 ± 4 |
10 ± 1 |
Test material |
|
|
|
|
|
50 µg |
91 ± 12 |
13 ± 2 |
18 ± 6 |
19 ± 2 |
7 ± 4 |
150 µg |
95 ± 21 |
15 ± 2 |
22 ± 2 |
18 ± 5 |
8 ± 4 |
500 µg |
91 ± 7 |
14 ± 4 |
21 ± 5 |
16 ± 1 |
8 ± 2 |
1500 µg |
94 ± 6 |
13 ± 1 |
18 ± 10 |
22 ± 8 |
6 ± 2 |
5000 µg |
93 ± 3 |
10 ± 2 |
20 ± 2 |
16 ± 3 |
8 ± 3 |
PC |
|
|
|
|
|
ENNG |
614 ± 28 |
442 ± 54 |
937 ± 42 |
- |
- |
4-NQO |
- |
- |
- |
239 ± 30 |
- |
9-AA |
- |
- |
- |
- |
912 ± 96 |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA 1537 |
NC |
91 ± 2 |
11 ± 3 |
26 ± 8 |
27 ± 3 |
11 ± 0 |
Test material |
|
|
|
|
|
50 µg |
101 ± 12 |
11 ± 2 |
25 ± 4 |
24 ± 4 |
9 ± 3 |
150 µg |
96 ± 11 |
11 ± 1 |
28 ± 6 |
31 ± 2 |
10 ± 1 |
500 µg |
104 ± 11 |
10 ± 1 |
29 ± 4 |
23 ± 8 |
10 ± 4 |
1500 µg |
89 ± 3 |
11 ± 1 |
22 ± 7 |
23 ± 10 |
12 ± 5 |
5000 µg |
99 ± 10 |
12 ± 1 |
24 ± 8 |
24 ± 6 |
10 ± 2 |
PC |
|
|
|
|
|
2-AA |
1238 ± 270 |
231 ± 11 |
286 ± 14 |
- |
237 ± 12 |
BP |
- |
- |
- |
199 ± 11 |
- |
SC = Solvent control; PC = Positive control substances; SD = standard deviation; ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; 9-AA:9-Aminoacridine; 4-NQO: 4-nitroquinoline-1-oxide; 2-AA: 2-aminoanthracene; BP: benzo(a)pyrene |
Table 2. Test results of experiment II (pre-incubation)
Bacterial Reverse Mutation Assay, mean revertant colonies/plate (mutation factor) (n=3 ± SD) |
|||||
EXPERIMENT II (pre-incubation) |
|||||
S9-Mix |
Without
|
||||
Concentration (per plate) |
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA 1537 |
SC |
79 ± 6 |
15 ± 5 |
26 ± 3 |
15 ± 3 |
10 ± 4 |
Test material |
|
|
|
|
|
50 µg |
72 ± 2 |
12 ± 2 |
24 ± 5 |
26 ± 12 |
9 ± 1 |
150 µg |
82 ± 13 |
12 ± 2 |
27 ± 5 |
16 ± 3 |
11 ± 3 |
500 µg |
66 ± 1 |
8 ± 2 |
18 ± 1 |
22 ± 5 |
11 ± 1 |
1500 µg |
74 ± 3 |
13 ± 4 |
27 ± 5 |
16 ± 1 |
5 ± 1 |
5000 µg |
79 ± 1 |
11 ± 4 |
23 ± 6 |
21 ± 7 |
11 ± 4 |
PC |
|
|
|
|
|
ENNG |
728 ± 131 |
892 ± 86 |
946 ± 35 |
- |
- |
4-NQO |
- |
- |
- |
118 ± 8 |
- |
9-AA |
- |
- |
- |
- |
534 ± 206 |
S9-Mix
|
With |
||||
Concentration (per plate) |
TA 100 |
TA1535 |
WP2 uvrA |
TA98 |
TA 1537 |
NC |
75 ± 5 |
14 ± 6 |
34 ± 9 |
24 ± 4 |
9 ± 2 |
Test material |
|
|
|
|
|
50 µg |
75 ± 4 |
12 ± 3 |
25 ± 0 |
21 ± 1 |
7 ± 3 |
150 µg |
83 ± 22 |
10 ± 2 |
22 ± 9 |
26 ± 2 |
12 ± 4 |
500 µg |
70 ± 18 |
10 ± 7 |
29 ± 4 |
21 ± 2 |
8 ± 2 |
1500 µg |
76 ± 12 |
11 ± 6 |
24 ± 2 |
21 ± 3 |
11 ± 2 |
5000 µg |
76 ± 22 |
10 ± 2 |
29 ± 5 |
26 ± 3 |
10 ± 3 |
PC |
|
|
|
|
|
2-AA |
1506 ± 102 |
201 ± 30 |
246 ± 22 |
- |
316 ± 32 |
BP |
- |
- |
- |
130 ± 7 |
- |
SC = Solvent control; PC = Positive control substances; SD = standard deviation; ENNG: N-ethyl-N'-nitro-N-nitrosoguanidine; 9-AA:9-Aminoacridine; 4-NQO: 4-nitroquinoline-1-oxide; 2-AA: 2-aminoanthracene; BP: benzo(a)pyrene |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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