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EC number: 453-490-7 | 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
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 23 Mar - 03 May 2006
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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)
- Remarks:
- Groupe Interministeriel des Produit Chimiques, France; Agence Française de Sécurité Sanitaire des Aliments (AFSSA), France
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- EC Number:
- 282-775-7
- EC Name:
- Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol
- Cas Number:
- 84418-63-3
- IUPAC Name:
- 84418-63-3
Constituent 1
Method
- Target gene:
- his-operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- 312.5, 625, 1250, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (1 μg/plate, TA1535 and TA100); 9-amino-acridine (50 µg/plate, TA 1537); 2-nitrofluorene (0.5 µg/plate, TA 98); mitomycin C (0.5 µg/plate, TA 102) +S9: 2-amino-anthracene (10 µg/plate, TA 102, 2 μg/plate, all other strains)
- Remarks:
- the positive controls were dissolved in DMSO, except for mitomycin C which was dissolved in distilled water
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation), experiment 1, with and without S9, experiment 2, without S9; preincubation, experiment 2, with S9
DURATION
- Exposure duration: 48 - 72 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: decrease in number of revertant colonies/thinning of bacterial lawn - Evaluation criteria:
- Reproducible 2-fold (TA 98, TA 100, TA 102) or 3-fold (TA 1535, TA 1537) increase in number of revertants in comparison to the vehicle control and/or dose-response correlation.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium 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:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- 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
- Species / strain:
- S. typhimurium TA 1537
- 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
- Species / strain:
- S. typhimurium TA 1535
- 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
- Species / strain:
- S. typhimurium TA 102
- 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: moderate to marked emulsion at dose levels ≥ 1250 µg/plate
RANGE-FINDING/SCREENING STUDIES: Yes, no cytotoxicity up to the maximum of solubility
COMPARISON WITH HISTORICAL CONTROL DATA: valid
Any other information on results incl. tables
Table 1. Test results of experiment 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
||
– |
vehicle (ethanol) |
134 ± 9 |
25 ± 5 |
363 ± 21 |
27 ± 4 |
11 ± 5 |
– |
312.5 |
98 ± 6 |
27 ± 4 |
330 ± 15 |
38 ± 15 |
8 ± 3 |
– |
625 |
110 ± 20 |
35 ± 2 |
438 ± 91 |
44 ± 11 |
11 ± 3 |
– |
1250 |
103 ± 14 |
30 ± 6 |
407 ± 93 |
34 ± 8 |
13 ± 6 |
– |
2500 |
135 ± 22 |
31 ± 1 |
408 ± 22 |
31 ± 11 |
13 ± 4 |
– |
5000 |
148 ± 63 |
31 ± 6 |
324 ± 16 |
32 ± 14 |
9 ± 3 |
Positive controls, –S9 |
Name |
SA |
SA |
MMC |
2NF |
9AA |
Concentrations (μg/plate) |
1.0 |
1.0 |
0.5 |
0.5 |
50 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
877 ± 38 |
630 ± 74 |
2450 ± 103 |
171 ± 16 |
966 ± 27 |
|
+ |
vehicle (ethanol) |
135 ± 22 |
30 ± 6 |
587 ± 10 |
44 ± 13 |
16 ± 6 |
+ |
312.5 |
130 ± 39 |
28 ± 9 |
533 ± 28 |
49 ± 4 |
9 ± 8 |
+ |
625 |
119 ± 6 |
26 ± 3 |
565 ± 21 |
49 ± 5 |
16 ± 10 |
+ |
1250 |
118 ± 7 |
28 ± 9 |
605 ± 38 |
43 ± 6 |
20 ± 9 |
+ |
2500 |
111 ± 6 |
27 ± 6 |
584 ± 97 |
43 ± 6 |
15 ± 6 |
+ |
5000 |
112 ± 5 |
34 ± 5 |
571 ± 29 |
43 ± 10 |
20 ± 5 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.0 |
2.0 |
10 |
2.0 |
2.0 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1154 ± 180 |
419 ± 10 |
4419 ± 435 |
1208 ± 84 |
123 ± 16 |
SA: Sodium azide
9AA : 9-Aminoacridine
2NF : 2-Nitrofluorene
MMC: Mitomycine C
2AA: 2-Aminoanthracene
Table 2. Test results of experiment 2 (-S9: plate incorporation, +S9: pre-incubation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
TA102 |
TA98 |
TA1537 |
||
– |
vehicle (ethanol) |
126 ± 3 |
12 ± 5 |
343 ± 75 |
45 ± 14 |
6 ± 2 |
– |
312.5 |
140 ± 17 |
15 ± 10 |
312 ± 40 |
25 ± 1 |
10 ± 1 |
– |
625 |
183 ± 17 |
13 ± 6 |
454 ± 98 |
33 ± 3 |
8 ± 4 |
– |
1250 |
153 ± 13 |
10 ± 4 |
317 ± 41 |
46 ± 9 |
5 ± 1 |
– |
2500 |
144 ± 26 |
11 ± 4 |
359 ± 17 |
40 ± 13 |
5 ± 3 |
– |
5000 |
175 ± 66 |
18 ± 44 |
420 ± 70 |
56 ± 18 |
8 ± 3 |
Positive controls, –S9 |
Name |
SA |
SA |
MMC |
2NF |
9AA |
Concentrations (μg/plate) |
1.0 |
1.0 |
0.5 |
0.5 |
50 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
527 ± 83 |
711 ± 104 |
1258 ± 165 |
147 ± 22 |
1442 ± 287 |
|
+ |
vehicle (ethanol) |
176 ± 7 |
9 ± 2 |
538 ± 13 |
43 ± 6 |
9 ± 2 |
+ |
312.5 |
145 ± 28 |
12 ± 3 |
728 ± 66 |
45 ± 3 |
10 ± 7 |
+ |
625 |
140 ± 21 |
19 ± 2 |
491 ± 41 |
35 ± 8 |
7 ± 1 |
+ |
1250 |
185 ± 16 |
11 ± 3 |
643 ± 128 |
30 ± 7 |
8 ± 2 |
+ |
2500 |
166 ± 16 |
14 ± 3 |
575 ± 11 |
35 ± 13 |
10 ± 4 |
+ |
5000 |
145 ± 22 |
16 ± 6 |
622 ± 74 |
43 ± 2 |
10 ± 5 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.0 |
2.0 |
10 |
2.0 |
2.0 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
705 ± 142 |
202 ± 25 |
2678 ± 1940 |
1259 ± 94 |
99 ± 27 |
SA: Sodium azide
9AA : 9-Aminoacridine
2NF : 2-Nitrofluorene
MMC: Mitomycine C
2AA: 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- negative
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.
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