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EC number: 204-680-1 | CAS number: 124-10-7
- 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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1992-03-25 to 1992-04-02
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- , analytical purity of test material not specified; incomplete strain selection;
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl laurate
- EC Number:
- 203-911-3
- EC Name:
- Methyl laurate
- Cas Number:
- 111-82-0
- Molecular formula:
- C13H26O2
- IUPAC Name:
- methyl laurate
- Details on test material:
- - Name of test material (as cited in study report): Lauric acid methyl ester
- Substance type: Fatty acid methyl ester
- Physical state: colourless liquid
- Analytical purity: not given
- Storage condition of test material: RT
Constituent 1
Method
- Target gene:
- Genes involved in Histidine synthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa-; uvrB- (R+ for TA 98 and TA 100)
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- other: rfa-; uvrB-
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (Wistery rats, male, Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000 and 5000 µg/plate in both experiments
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
To prevent toxic effects of the solvent medium the stock solution of the test substance was doubled and 50 µL/plate instead of 100 µl/plate was introduced in the test
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- culture media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 and TA 1535 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- culture media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- culture media
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine
- Remarks:
- TA 98 and TA 1538 without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- For all strainn with metabolic activation (S9 mix, Aroclor induced)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
- Expression time (cells in growth medium): 48 h
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn
NUMBER OF REPLICATIONS: triplicates
OTHER: The spontaneous mutation rates of each tester strain were within the characteristic spontaneous mutation rates - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.
All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls. - Statistics:
- Mean 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:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 5000 µg/plate
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
-
COMPARISON WITH HISTORICAL CONTROL DATA: Yes
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenicity on bacteria - experiment I
With or without S9-Mix |
Test substance concentration (¿g/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
TA 1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
|
Buffer |
14 |
132 |
12 |
9 |
21 |
- |
Solvent (Acetone) |
15 |
133 |
10 |
13 |
26 |
- |
8 |
11 |
122 |
9 |
6 |
18 |
- |
40 |
10 |
96 |
8 |
12 |
16 |
- |
200 |
10 |
109 |
8 |
11 |
16 |
- |
1000 |
9 |
92 |
13 |
11 |
18 |
|
5000 |
10 |
122 |
10 |
11 |
13 |
Positive controls - S9 |
Name |
SA |
SA |
9AA |
4ND |
4ND |
Concentrations (¿g/plate) |
2 |
2 |
80 |
40 |
40 |
|
Number of colonies/plate |
590 |
659 |
771 |
2408 |
1813 |
|
+ |
Buffer |
16 |
158 |
11 |
28 |
35 |
+ |
Solvent (Acetone) |
17 |
153 |
7 |
32 |
41 |
+ |
8 |
16 |
126 |
13 |
34 |
24 |
+ |
40 |
13 |
209 |
8 |
32 |
22 |
|
200 |
13 |
102 |
9 |
31 |
28 |
+ |
1000 |
13 |
112 |
7 |
18 |
24 |
+ |
5000 |
7 |
70 |
5 |
16 |
18 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (¿g/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Number of colonies/plate |
112 |
1532 |
137 |
1146 |
1555 |
9AA = 9-Aminoacridine
2AA = 2-Aminoanthracene
SA = Sodium Acide
4ND = 4-Nitro-o-phenylendiamine
Table 2: Mutagenicity on bacteria - experiment II
With or without S9-Mix |
Test substance concentration (¿g/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
||||
TA 1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
|
Buffer |
20 |
133 |
10 |
6 |
26 |
- |
Solvent (Acetone) |
20 |
123 |
12 |
6 |
16 |
- |
8 |
16 |
128 |
9 |
8 |
21 |
- |
40 |
16 |
115 |
7 |
6 |
15 |
- |
200 |
13 |
109 |
7 |
8 |
21 |
- |
1000 |
14 |
132 |
13 |
9 |
19 |
|
5000 |
17 |
110 |
11 |
11 |
28 |
Positive controls - S9 |
Name |
SA |
SA |
9AA |
4ND |
4ND |
Concentrations (¿g/plate) |
2 |
2 |
80 |
40 |
40 |
|
Number of colonies/plate |
465 |
652 |
978 |
2055 |
1816 |
|
+ |
Buffer |
18 |
125 |
11 |
23 |
42 |
+ |
Solvent (Acetone) |
23 |
102 |
7 |
23 |
35 |
+ |
8 |
27 |
137 |
7 |
13 |
43 |
+ |
40 |
17 |
125 |
5 |
24 |
31 |
|
200 |
21 |
119 |
5 |
22 |
30 |
+ |
1000 |
19 |
105 |
8 |
18 |
27 |
+ |
5000 |
6 |
39 |
4 |
12 |
22 |
Positive controls + S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (¿g/plate) |
2.5 |
5 |
2.5 |
5 |
5 |
|
Number of colonies/plate |
104 |
1127 |
137 |
738 |
831 |
9AA = 9-Aminoacridine
2AA = 2-Aminoanthracene
SA = Sodium Acide
4ND = 4-Nitro-o-phenylendiamine
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative Under the tested experimental conditions the test substance did not induce gene mutations in S. typhimurium strains up to the maximum dose.
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