Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 269-495-0 | CAS number: 68258-72-0
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- 09 Jan - 07 Feb 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP -guideline study with acceptable restrictions (no analytical purity reported)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- no analytical purity reported
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 2000
- Deviations:
- yes
- Remarks:
- no analytical purity reported
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, esters with trimethylolpropane
- Cas Number:
- 403507-18-6
- Molecular formula:
- not applicable, substance is a UVCB
- IUPAC Name:
- Fatty acids, C16-18 and C18-unsatd., branched and linear, esters with trimethylolpropane
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: dark amber, slightly viscous liquid
- Analytical purity: no data
- Stability under test conditions: room temperature, in the dark
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 phonobarbitone/beta-naphthoflavone
- Test concentrations with justification for top dose:
- First and second experiment: 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: N-ethyl-N´-nitro-N-nitrosoguanidine (ENNG, 3 or 5 µg/plate) for TA 100 and TA 1535; 9-Aminoacridine (9AA, 80 µg/plate) for TA 1537; mitomycin C (MMC, 0.5 µg/plate) for TA 102; 4-Nitroquinoline-1-oxide (4NQO, 0.2 µg/plate) for TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: +S9: 2-Aminoanthracene (2AA, 1 or 2 µg/plate) for TA 100, TA 1535 and TA 1537; Benzo(a)pyrene (BP, 5 µg/plate) for TA 98; 1,8-Dihydroxyanthraquinone (DAN, 10 µg/plate) for TA 102
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn - Evaluation criteria:
- The test material may be considered positive mutagenic in this test system if the following criteria are met: the test item should induce a reproducible, dose-related and statistically significant increase in the revertant count in at least one strain of bacteria.
- 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, but tested up to precipitating 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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 (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 |
||
– |
0 |
80 ± 5.7 |
24 ± 6.1 |
294 ± 18.1 |
24 ± 4.6 |
18 ± 2.5 |
– |
50 |
81 ± 6.1 |
22 ± 5.9 |
297 ± 19.3 |
23 ± 1.0 |
14 ± 2.1 |
– |
150 |
86 ± 3.1 |
23 ± 3.2 |
310 ± 18.2 |
21 ± 4.6 |
15 ± 4.7 |
– |
500 |
82 ± 11.0 |
23 ± 2.1 |
330 ± 31.5 |
22 ± 4.2 |
19 ± 4.4 |
– |
1500 |
89 ± 1.5 |
23 ± 4.0 |
311 ± 14.0 |
29 ± 5.7 |
16 ± 3.2 |
– |
5000 |
85 ± 5.9 P |
30 ± 2.6 P |
321 ± 34.6 P |
28 ± 4.2 P |
16 ± 4.6 P |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
MMC |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
0.5 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
439 ± 33.5 |
464 ± 29.4 |
740 ± 113.4 |
96 ± 5.9 |
1510 ± 150.1 |
|
+ |
0 |
92 ± 10.4 |
25 ± 4.7 |
339 ± 24.3 |
40 ± 3.2 |
23 ± 0.6 |
+ |
50 |
109 ± 11.5 |
23 ± 7.2 |
375 ± 14.6 |
39 ± 9.2 |
18 ± 2.0 |
+ |
150 |
99 ± 18.0 |
19 ± 1.5 |
359 ± 22.4 |
45 ± 1.2 |
24 ± 3.1 |
+ |
500 |
94 ± 17.7 |
15 ± 2.6 |
358 ± 23.7 |
45 ± 4.6 |
26 ± 1.5 |
+ |
1500 |
102 ± 9.6 |
23 ± 5.6 |
358 ± 32.1 |
35 ± 2.0 |
21 ± 5.2 |
+ |
5000 |
102 ± 6.8 |
22 ± 4.7 |
369 ± 72.2 |
39 ± 4.6 |
25 ± 2.1 |
Positive controls, +S9 |
Name |
2AA |
2AA |
DAN |
BP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
2112 ± 97.7 |
269 ± 37.8 |
706 ± 32.6 |
232 ± 19.2 |
217 ± 12.4 |
Table 2. Test results of experiment 2 (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 |
||
– |
0 |
82 ± 8.1 |
21 ± 4.0 |
249 ± 20.7 |
18 ± 0.6 |
10 ± 2.6 |
– |
50 |
70 ± 13.1 |
15 ± 2.6 |
269 ± 9.8 |
24 ± 1.5 |
12 ± 5.5 |
– |
150 |
79 ± 15.5 |
18 ± 1.5 |
279 ± 34.8 |
24 ± 4.5 |
6 ± 2.3 |
– |
500 |
81 ± 7.8 |
19 ± 6.4 |
268 ± 2.3 |
22 ± 6.1 |
7 ± 1.0 |
– |
1500 |
88 ± 8.0 |
22 ± 6.1 |
275 ± 8.3 |
27 ± 7.0 |
13 ± 3.5 |
– |
5000 |
75 ± 12.1 P |
21 ± 3.6 P |
290 ± 50.2 P |
24 ± 2.9 P |
10 ± 6.4 P |
Positive controls, –S9 |
Name |
ENNG |
ENNG |
MMC |
4NQO |
9AA |
Concentrations (μg/plate) |
3 |
5 |
0.5 |
0.2 |
80 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
679 ± 29.4 |
933 ± 340.6 |
1167 ± 40.7 |
188 ± 11.7 |
2357 ± 179.5 |
|
+ |
0 |
87 ± 21.1 |
10 ± 4.4 |
330 ± 21.2 |
40 ± 2.1 |
19 ± 3.8 |
+ |
50 |
86 ± 7.2 |
13 ± 4.0 |
369 ± 18.9 |
33 ± 4.6 |
17 ± 2.6 |
+ |
150 |
105 ± 10.4 |
11 ± 4.4 |
349 ± 27.5 |
42 ± 1.0 |
14 ± 7.1 |
+ |
500 |
80 ± 8.0 |
15 ± 6.1 |
364 ± 8.3 |
35 ± 2.5 |
18 ± 3.6 |
+ |
1500 |
85 ± 6.7 |
12 ± 3.0 |
369 ± 34.9 |
38 ± 2.0 |
18 ± 1.5 |
+ |
5000 |
88 ± 12.9 P |
11 ± 2.5 P |
365 ± 15.0 P |
36 ± 8.2 P |
19 ± 4.4 P |
Positive controls, +S9 |
Name |
2AA |
2AA |
DAN |
BP |
2AA |
Concentrations (μg/plate) |
1 |
2 |
10 |
5 |
2 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
3159 ± 145.2 |
313 ± 14.5 |
1021 ± 104.5 |
312 ± 32.4 |
222 ± 10.2 |
ENNG = N-ethyl-N-nitro-N-nitrosoguanidine
MMC = mitomycin C
4NQO = 4-nitroquinoline-N-oxide
9AA = 9-aminoacridine
2AA = 2 -aminoanthracene
BP = benzo(a)pyrene
DAN = 1,8 -dihydroxanthraquinone
P = Precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
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.
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.