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EC number: 205-471-8 | CAS number: 141-23-1
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- GLP compliance:
- yes
- Type of assay:
- other: chromosomal aberrations
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
- Test material form:
- liquid
- Details on test material:
- Dodecanoic acid methyl ester [methyl laurate, CAS No. 111-82-0], manufactured by Tokyo Chemical Industry Co., Ltd., Lot. No. GD 01, content 99.2%, molecular weight 214.35, melting point 5 ° C., boiling point 141 ° C., specific gravity 0.8706 (20 ° C.). Colorless and transparent liquid
Constituent 1
- Specific details on test material used for the study:
- Dodecanoic acid methyl ester (abbreviation: MD, CAS No.:111-82-0, lot number: GB01, manufactured by Tokyo Chemical Industry Co., Ltd.) is a colorless transparent liquid and has a melting point of 5 ° C, a boiling point of 141 ° C. (15 mmHg) , Molecular formula C13 H26 O2, molecular weight 214.35, purity 98% (impurity unknown).
Method
- Target gene:
- chromosomes
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- CHL/IU cells derived from Chinese hamster, obtained from Research · Resource Bank (JCRB) (February 1988, at passage: 4th passage, now 12th) were used in the test within 10 years of thawing succession age.
- Cytokinesis block (if used):
- colcemid
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction from livers of rats induced with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- A preliminary toxicity test was conducted based on cell proliferation rates. The proliferation inhibitory action of the test substance on CHL/IU cells was determined by measuring the proliferation of each group using a monolayer culture cell densitometer (Monocellater ™ , Olympus Optical Co., Ltd.), and the solvent control group as baseline.
- Vehicle / solvent:
- acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Details on test system and experimental conditions:
- DURATION
-Exposure duration:
a) Continuous treatment: 24 hrs, 48 hrs
b) Short-term treatment: 6hrs; 18 hrs for recovery
-Fixation time (start of exposure up to fixation or harvest of cells):
a) Continuous treatment: 24 hrs, 48 hrs
b) Short-term treatment: 24 hrs
SPINDLE INHIBITOR: Colcemid
STAIN: Giemsa stain
NUMBER OF CELLS EVALUATED:
Stractural aberrations: 200 cells/group
Polyploidy: 800 cells/group
DETERMINATION OF CYTOTOXICITY:
-Method: relative total growth - Rationale for test conditions:
- guideline
- Evaluation criteria:
- Criteria for a positive call: a statistically significant increase in the frequency of cells with chromosomal aberrations in the treated group compared with that of the solvent control group, and a statistically significant difference in the dose trend test. An inconclusive result will be designated when there is a significant increase in the frequency of cells with aberrations without a postive dose response trend test.
The test will be considered negative when there is no significant difference in frequency of cells with chromosomal aberrations.
The test is inconclusive when the number of cells observed has fewer than 100 structural aberrations, and less than 400 polyploidy due to cytotoxicity. - Statistics:
- Fisher's direct probability method is used to distinguish between the solvent background chromosomal aberration levels and those of the test substance- treated group, with a significance level of p <0.05. In addition, when significant differences were found by Fisher's exact stochastic method, the Cochran-Armitage's trend test is applied (p <0.05) to test for significance of the dose dependency.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- In the preliminary toxicity screening test, concentrations up to 2.0 mg/ml resulted in significant decrease in cell growth in the 24 and 48 hour continuous cultures with and without S9, and in the 6 hour culture with S9. Cells in the 6-hour culture without S9 tolerated the test material with growth rates above 50%. Therefore, the maximum concentration of the test substance used in the continuous exposure assay was 0.06 mg / ml, and was 0.1 mg / ml in the short-term assay in the presence of S9 mix. In the short term assay without S9 mix, 2.1 mg / ml (10 mM) was the maximum concentration tested. Toxicity was observed (> 50 mitotic index) in the main study of continuous exposure at the high dose of 0.06 mg/ml, but not in the other modules of the study.
Any other information on results incl. tables
Table 1: Continuous
Group |
Concentration (mg/ml) |
Time of Exposure (h) |
No of Cells analysed |
No. of structural aberrations |
Others3) |
No. of cells with aberrations |
Polyploid4)(%) |
Trend test5) |
||||||||
|
|
|
gap |
ctb |
cte |
csb |
cse |
mul2) |
total |
TAG (%) |
TA (%) |
|
SA |
NA |
||
Control |
|
|
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.13 |
NT |
NT |
Solvent1) |
0 |
24 |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0(0.0) |
0.38 |
||
MD |
0.015 |
24 |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.13 |
||
MD |
0.03 |
24 |
200 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 (0.5) |
0 (0.0) |
0.25 |
||
MD |
0.06 |
24 |
173 |
0 |
1 |
0 |
1 |
0 |
0 |
2 |
1 |
2 (1.2) |
2 (1.2) |
0.556) |
||
MC |
0.00005 |
24 |
200 |
11 |
40 |
133 |
2 |
3 |
0 |
189 |
2 |
110 (55.0) |
105 (52.5) |
0.00 |
||
|
||||||||||||||||
Solvent1) |
0 |
48 |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 (0.0) |
0 (0.0) |
0.00 |
NT |
NT |
MD |
0.015 |
48 |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 (0.0) |
0 (0.0) |
0.25 |
||
MD |
0.03 |
48 |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.13 |
||
MD |
0.06 |
48 |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.63 |
||
MC |
0.00005 |
48 |
200 |
6 |
35 |
137 |
4 |
6 |
20 |
208 |
6 |
94 (47.0) |
94 (47.0) |
0.25 |
Table 2: Short-term
Group |
Concentration (mg/ml) |
S9 mix |
Time of Exposure (h) |
No of cells analyzed |
No. of structural aberrations |
Others3) |
No. of cells with aberrations |
Polyploid4)(%) |
Trend test5) |
||||||||
|
|
|
|
gap |
ctb |
cte |
csb |
cse |
mul2) |
total |
TAG (%) |
TA (%) |
|
SA |
NA |
||
Control |
|
|
|
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.63 |
NT |
NT |
Solvent1) |
0 |
- |
6-(18) |
200 |
0 |
0 |
1 |
0 |
1 |
0 |
2 |
0 |
2 (1.0) |
2 (1.0) |
0.63 |
||
MD |
0.53 |
- |
6-(18) |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.25 |
||
MD |
1.1 |
- |
6-(18) |
200 |
1 |
1 |
0 |
0 |
0 |
0 |
2 |
0 |
2 (1.0) |
1 (0.5) |
0.25 |
||
MD |
2.1 |
- |
6-(18) |
200 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
1 (0.5) |
1 (0.5) |
0.25 |
||
CPA |
0.005 |
- |
6-(18) |
200 |
0 |
1 |
0 |
0 |
0 |
0 |
1 |
0 |
1 (0.5) |
1 (0.5) |
0.13 |
||
|
|||||||||||||||||
Solvent1) |
0 |
+ |
6-(18) |
200 |
1 |
0 |
1 |
0 |
0 |
0 |
2 |
1 |
2 (1.0) |
1 (0.5) |
0.25 |
NT |
NT |
MD |
0.025 |
+ |
6-(18) |
200 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 (0.0) |
0 (0.0) |
0.5 |
||
MD |
0.05 |
+ |
6-(18) |
200 |
1 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
1 (0.5) |
0 (0.0) |
0.75 |
||
MD |
0.1 |
+ |
6-(18) |
200 |
0 |
0 |
2 |
0 |
0 |
0 |
2 |
0 |
1 (0.5) |
1 (0.5) |
1.38 |
||
CPA |
0.005 |
+ |
6-(18) |
200 |
7 |
40 |
126 |
1 |
2 |
0 |
176 |
0 |
95 (47.5) |
93 (46.5) |
0.25 |
Applicant's summary and conclusion
- Conclusions:
- A guideline OECD 473-compliant chromosomal aberration test was undertaken with the test material in acetone, with and without rat liver S9 fraction, with valid positive controls. Cytotoxicity was seen at the higher doses in a preliminary dose-range finding study. There were no increase in the number of chromosome aberrations (excluding gaps) or polyploidy observed. The test substance does not induce chromosomal aberrations in CHL/IU cells under the conditions of this study.
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