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EC number: 306-523-3 | CAS number: 97281-24-8
- 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:
- 01 Mar - 11 Mar 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study with acceptable restrictions (no analytical purty reported; no E.coli strain tested)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1983
- Deviations:
- yes
- Remarks:
- no analytical purty reported; no E.coli strain tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane
- EC Number:
- 306-523-3
- EC Name:
- Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane
- Cas Number:
- 97281-24-8
- Molecular formula:
- For NPG esters: C21H40O4 to C25H48O4 For TMP esters: C30H56O6 to C36H68O6
- IUPAC Name:
- Fatty acids, C8-10 (even numbered), mixed esters with neopentyl glycol and trimethylolpropane
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 1538
- 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:
- Experiment I+II:
- 8, 40, 200, 1000 and 5000 µg/plate (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80 / water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: With and Without S9: sodium azide (2 µg/plate) for TA100 and TA1535; 9-aminoacridine (80 µg/plate) for TA1537; 4-nitro-o-phenylendiamine (40 µg/plate) for TA98 and TA1538. With and without S9: 2 aminoanthracene (2-AA; 2.5 or 5 µg/plate) for 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 - Evaluation criteria:
- The test material was considered positive in this test system if the following criteria were met:
- The plate background from the non revertant bacteria showed no growth reduction in comparison to the correspondent negative control.
- The spontaneous mutation rate of the strains tested was within the characteristic range of the spontaneous mutation.
- The positive controls showed mutation rates that exceeded the control values of the TA100 at least by a factor 2.0 and the other tester strains, at least by a factor 3.0.
- For the test item, two-fold increases in mean revertant numbers were observed at more then one dose level in TA 100. For the other strains, an increase in the mutation rate greater than three-fold in comparison to the correspondent negative control was observed. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- 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) |
|||||||||||||
Base-pair substitution type |
Frameshift type |
||||||||||||||
TA 100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||||||||||
– |
0 |
70.3 ± 8.7 |
8.6 ± 1.8 |
15.3 ± 2.2 |
15.8 ± 5.8 |
7.8 ± 1.1 |
|||||||||
– |
8 |
70.3 ± 9.2 |
6.0 ± 1.7 |
6.0 ± 1.0 |
15.3 ± 3.7 |
3.0 ± 1.0 |
|||||||||
– |
40 |
73.6 ± 6.3 |
8.3 ± 2.0 |
5.3 ± 1.5 |
14.6 ± 1.5 |
5.3 ± 2.5 |
|||||||||
– |
200 |
77.0 ± 5.2 |
9.0 ± 1.0 |
6.0 ± 2.6 |
12.6 ± 3.2 |
5.0 ± 1.7 |
|||||||||
– |
1000 |
71.6 ± 2.0 |
8.3 ± 1.1 |
8.6 ± 1.5 |
13.3 ± 1.5 |
7.0 ± 2.6 |
|||||||||
– |
5000 |
78.6 ± 13.0 |
5.0 ± 1.7 |
7.6 ± 2.8 |
11.0 ± 4.0 |
3.3 ± 1.1 |
|||||||||
Positive controls, –S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
235 ± 30.6 |
69.6 ± 1.5 |
255.3 ± 24.8 |
6.3 ± 0.57 |
844.0 ± 54.6 |
9.6 ± 4.7 |
370.0 ± 14.7 |
16.6 ± 3.5 |
146.0 ± 9.6 |
4.6 ± 1.5 |
|||||
+ |
0 |
83.5 ± 11.5 |
10.5 ± 2.5 |
14.5 ± 2.0 |
20.8 ± 3.9 |
7.6 ± 0.51 |
|||||||||
+ |
8 |
76.3 ± 2.0 |
9.6 ± 1.1 |
14.0 ± 3.0 |
17.6 ± 3.5 |
5.3 ± 2.5 |
|||||||||
+ |
40 |
74.6 ± 5.6 |
8.3 ± 1.1 |
13.6 ± 1.5 |
15.3 ± 1.5 |
6.3 ± 2.5 |
|||||||||
+ |
200 |
82.6 ± 0.57 |
10.0 ± 1.0 |
12.6 ± 2.8 |
19.6 ± 0.6 |
5.6 ± 3.0 |
|||||||||
+ |
1000 |
90.3 ± 5.5 |
13.6 ± 4.7 |
11.3 ± 3.2 |
19.6 ± 6.1 |
7.3 ± 3.2 |
|||||||||
+ |
5000 |
80.3 ± 16.1 |
12.6 ± 1.5 |
9.0 ± 1.7 |
22.3 ± 3.7 |
7.6 ± 0.6 |
|||||||||
Positive controls, + S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
125.3 ± 9.6 |
1292.6 ± 100.4 |
44.0 ± 8.8 |
223.6 ± 47.0 |
793.6 ± 50.0 |
441.0 ± 49.3 |
450.0 ± 32.0 |
643.3 ± 137.3 |
61.6 ± 2.8 |
75.6 ± 7.5 |
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) |
|||||||||||||
Base-pair substitution type |
Frameshift type |
||||||||||||||
TA 100 |
TA1535 |
TA1538 |
TA98 |
TA1537 |
|||||||||||
– |
0 |
90.0 ± 6.8 |
9.5 ± 4.7 |
11.1 ± 3.8 |
16.8 ± 1.9 |
5.8 ± 1.1 |
|||||||||
– |
8 |
86.0 ± 6.2 |
9.0 ± 2.0 |
7.6 ± 3.0 |
17.6 ± 0.6 |
5.3 ± 3.2 |
|||||||||
– |
40 |
89.0 ± 14.7 |
11.6 ± 2.0 |
7.0 ± 3.4 |
15.6 ± 4.0 |
6.6 ± 2.0 |
|||||||||
– |
200 |
100.6 ± 14.2 |
5.0 ± 2.0 |
9.6 ± 2.5 |
12.0 ± 2.6 |
4.3 ± 1.1 |
|||||||||
– |
1000 |
90.0 ± 10.8 |
10.0 ± 2.6 |
12.0 ± 5.1 |
14.0 ± 3.4 |
5.6 ± 3.0 |
|||||||||
– |
5000 |
97.0 ± 17.4 |
7.3 ± 2.0 |
8.0 ± 2.0 |
12.6 ± 3.0 |
5.6 ± 2.8 |
|||||||||
Positive controls, –S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
318.0 ± 22.2 |
104.0 ± 6.2 |
340.3 ± 14.5 |
10.3 ± 4.0 |
1009.0 ± 44.3 |
7.0 ± 1.7 |
441.6 ± 19.3 |
20.0 ± 1.7 |
211.6.± 20.5 |
7.3 ± 2.0 |
|||||
+ |
0 |
96.5± 15.8 |
10.3 ± 1.9 |
16.3 ± 3.1 |
17.1 ± 4.0 |
7.8 ± 2.4 |
|||||||||
+ |
8 |
94.3 ± 10.0 |
10.0 ± 2.6 |
17.0 ± 2.0 |
17.3 ± 1.1 |
7.3 ± 1.1 |
|||||||||
+ |
40 |
94.0 ± 4.3 |
10.6 ± 2.5 |
17.0 ± 4.5 |
16.6 ± 1.1 |
5.3 ± 0.6 |
|||||||||
+ |
200 |
105.0 ± 4.5 |
8.6 ± 3.0 |
13.6 ± 1.5 |
16.6 ± 4.0 |
7.0 ± 2.0 |
|||||||||
+ |
1000 |
108.6 ± 7.3 |
12.3 ± 5.0 |
14.3 ± 4.0 |
18.6 ± 2.5 |
6.3 ± 1.5 |
|||||||||
+ |
5000 |
112.0 ± 9.6 |
10.3 ± 1.1 |
9.60 ± 1.5 |
16.3± 7.0 |
4.6 ± 1.5 |
|||||||||
Positive controls, + S9 |
Name |
NaA |
2AA |
NaA |
2AA |
4NOPD
|
2AA |
4NOPD
|
2AA |
9AA
|
2AA |
||||
Concentrations (μg/plate) |
2.0 |
5.0 |
2.0 |
2.5 |
40.0 |
5.0 |
40.0 |
5.0 |
80 |
2.5 |
|||||
Mean No. of colonies/plate (average of 3) |
156.6 ± 14.2 |
884.6 ± 109.5 |
95.3 ± 6.4 |
114.3 ± 45.2 |
1204.6 ± 38.0 |
569.0 ± 62.0 |
635.3 ± 27.7 |
421.3 ± 30.0 |
88.3 ± 33.2 |
54.3 ± 16.0 |
9AA = 9-aminoacridine
2AA = 2-Aminoanthracene
NaA= Sodiumazide
4NOPD= 4-Nitro-o-phenylendiamin
Applicant's summary and conclusion
- Conclusions:
- negative
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