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EC number: 209-099-7 | CAS number: 555-45-3
- 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:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 31 Jan - 10 Feb 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The test system included 5 S. typhimurium strains, but neither the tester strain TA102 nor an additional E. Coli strain were tested.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1983
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,3-dihydroxypropyl laurate
- EC Number:
- 205-526-6
- EC Name:
- 2,3-dihydroxypropyl laurate
- Cas Number:
- 142-18-7
- Molecular formula:
- C15H30O4
- IUPAC Name:
- 2,3-dihydroxypropyl laurate
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:
- First experiment: 8, 40, 200, 1000 and 5000 µg/plate with and without metabolic activation
Second experiment: 6.25, 12.5, 25, 50 and 100 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Tween 80/bidistilled water (0.1 mL/plate)
- Justification for choice of solvent/vehicle: The suspension medium Tween 80/bidist. water was chosen according to the solubility properties tested preliminary before start of the study.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated fresh cell suspensions
- Negative solvent / vehicle controls:
- yes
- Remarks:
- suspension medium Tween 80/bidist. water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 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 S9: 2 aminoanthracene (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: 3 replications in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: clearing or diminution of the background lawn - Evaluation criteria:
- A combination of the following criteria was considered as a positive result:
- The plate background of non-reverted bacteria did not show any growth reduction versus the respective negative controls.
- The spontaneous mutation rates of each tester strain per plate were within the characteristic spontaneous mutation range (see Table 1).
- As a rule, the positive control showed mutation rates exceeding the control values of TA100 at least by the factor 2.0 and those of the other tester strains at least by the factor 3.0.
- At more than one dose tested, the test substance caused at least a 2.0-fold increase in comparison with the negative controls in the tester strain TA100. For the other tester strains, an increase in the mutation rate of more than 3.0 above the corresponding negative controls was considered positive.
Reproducibility
If the test substance induces reverse mutations in only one test, and if this effect cannot be reproduced in one or several repeated tests, the initially positive test data will lose their significance.
The criteria for interpretation specified here do not apply absolutely. Other aspects in connection with this in vitro test system may as well be taken into account for the final assessment of the test substance. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- 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:
- cytotoxicity
- Remarks:
- at 40 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitations were not noted.
COMPARISON WITH HISTORICAL CONTROL DATA: number of revertants in the negative and vehicle controls (with and without S9) were all within the characteristic spontaneous mutation ranges of the test batches presented in Table 1.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- In the first experiment, the background lawn was reduced or completely cleared in:
TA100 from 40 µg/plate (-S9) and from 200 µg/plate (+S9)
TA1535 from 40 µg/plate (-S9) and from 200 µg/plate (+S9)
TA1537 from 40 µg/plate (-S9 and +S9)
TA1538 from 40 µg/plate (-S9) and from 200 µg/plate (+S9)
TA98 from 200 µg/plate (-S9 and +S9)
- In the second experiment, the background lawn was reduced or completely cleared in:
TA100 from 50 µg/plate (-S9) and from 100 µg/plate (+S9)
TA1535 from 100 µg/plate (-S9 and +S9)
TA1537 from 50 µg/plate (-S9 and +S9)
TA1538 from 50 µg/plate (-S9 and +S9)
TA98 from 100 µg/plate (-S9 and +S9)
Any other information on results incl. tables
Table 2. Group mean values of revertant colonies per treatment group (first experiment).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
|
|
TA 100 |
TA1535 |
TA1537 |
TA1538 |
TA98 |
– |
Untreated |
168 |
20 |
13 |
27 |
28 |
– |
Vehicle |
134 |
17 |
14 |
28 |
32 |
– |
8 |
119 |
16 |
9 |
29 |
28 |
– |
40 |
87 |
10 |
4 |
T |
24 |
– |
200 |
T |
T |
T |
T |
20 |
– |
1000 |
T |
T |
T |
T |
T |
– |
5000 |
T |
T |
T |
T |
T |
Positive controls, –S9 |
Name |
Sodium azide |
Sodium azide |
9-AA |
4-NOPD |
4-NOPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3) |
474 |
455 |
604 |
1675 |
1359 |
|
+ |
Untreated |
152 |
22 |
17 |
23 |
51 |
+ |
Vehicle |
159 |
18 |
13 |
31 |
38 |
+ |
8 |
126 |
18 |
12 |
23 |
32 |
+ |
40 |
132 |
13 |
12 |
25 |
30 |
+ |
200 |
96 |
15 |
5 |
23 |
27 |
+ |
1000 |
45 |
T |
T |
8 |
10 |
+ |
5000 |
20 |
T |
T |
T |
T |
Positive controls, + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
5 |
2.5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3) |
1562 |
183 |
87 |
1339 |
940 |
T = toxic
9-AA = 9-aminoacridine
4-NOPD = 4-nitro-o-phenylendiamine
2-AA = 2-aminoanthracene
Table 3. Group mean values of revertant colonies per treatment group (second experiment).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
|
|
TA 100 |
TA1535 |
TA1537 |
TA1538 |
TA98 |
– |
Untreated |
121 |
13 |
12 |
28 |
24 |
– |
Vehicle |
141 |
13 |
9 |
24 |
31 |
– |
6.25 |
135 |
20 |
14 |
26 |
26 |
– |
12.5 |
137 |
19 |
11 |
34 |
26 |
– |
25 |
112 |
12 |
7 |
30 |
29 |
– |
50 |
79 |
13 |
8 |
T |
28 |
– |
100 |
T |
T |
T |
T |
20 |
Positive controls, –S9 |
Name |
Sodium azide |
Sodium azide |
9-AA |
4-NOPD |
4-NOPD |
Concentrations (μg/plate) |
2 |
2 |
80 |
40 |
40 |
|
Mean No. of colonies/plate (average of 3) |
612 |
518 |
457 |
1741 |
1449 |
|
+ |
Untreated |
128 |
14 |
12 |
26 |
38 |
+ |
Vehicle |
129 |
16 |
17 |
27 |
26 |
+ |
6.25 |
135 |
14 |
14 |
27 |
42 |
+ |
12.5 |
114 |
13 |
12 |
30 |
27 |
+ |
25 |
129 |
17 |
13 |
28 |
26 |
+ |
50 |
119 |
15 |
8 |
21 |
28 |
+ |
100 |
111 |
15 |
12 |
T |
23 |
Positive controls, + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
5 |
2.5 |
2.5 |
5 |
5 |
|
Mean No. of colonies/plate (average of 3) |
1591 |
166 |
143 |
1499 |
780 |
T = toxic
9-AA = 9-aminoacridine
4-NOPD = 4-nitro-o-phenylendiamine
2-AA = 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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