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EC number: 246-929-7 | CAS number: 25383-99-7
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 18 Sept - 02 Oct 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 2-stearoyllactate
- EC Number:
- 246-929-7
- EC Name:
- Sodium 2-stearoyllactate
- Cas Number:
- 25383-99-7
- Molecular formula:
- This reference substance is a UVCB of the NCS type. It is a complex mixture of compounds and therefore molecular formula, molecular weight, SMILES, InChI and structural formula cannot be given.
- IUPAC Name:
- sodium 2-hydroxy-2-methyl-3-oxoicosanoate
Constituent 1
Method
- Target gene:
- his operon for S. typhimurium strains and trp operon for E. coli strain
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/β-naphthoflavone
- concentration or volume of S9 mix and S9 in the final culture medium: 500 µL
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Each batch of S9 was routinely tested for its capability to activate the known mutagens benzo[a]pyrene and 2-aminoanthracene in the Ames test.
- Lot no.: 060619K
- protein concentration: 29.3 mg/mL - Test concentrations with justification for top dose:
- Pre-experiment/experiment I:
3, 10, 33, 100, 333, 1000, 2500, and 5000 μg/plate with and without metabolic activation
Experiment II:
Strains TA 1535 and WP2 uvrA: 33, 100, 333, 1000, 2500 and 5000 μg/plate with and without metabolic activation
Strains TA 1537 and TA 98: 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate with and without metabolic activation
Strain TA 100: 3, 10, 33, 100, 333, 1000, 2500 and 5000 μg/plate with and without metabolic activation
5000 µg/plate was selected as the highest test concentration based on the results of a range-finding study (pre-experiment / experiment I). Since toxic effects were observed in the pre-experimentexperiment I, a minimum of six concentrations were tested in experiment II. The concentration range included two logarithmic decades. - Vehicle / solvent:
- - Vehicle used: deionised water
- Justification for choice of solvent/vehicle: The solvent was chosen based on the solubility properties of the test substance and its nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (4-NOPD), 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments: two (pre-experiment/experiment I and experiment II)
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): 10E08 - 10E09 cells/mL
- Test substance added in agar (plate incorporation) in pre-experiment/experiment I; preincubation in experiment II
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: 48 h
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: Inspection of the background growth inhibition - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
Two-fold or above (strains TA 98, TA 100, and WP2 uvrA) or threefold or above (strains TA 1535 and TA 1537) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. An increase of revertant colonies equal or above the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. 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 values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation was observed at concentrations of 2500 µg/plate and above (experiment I + experiment II)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity was observed at concentrations of 5000 µg per plate (-S9/+S9, experiment I) and 1000 µg/plate and above (-S9, experiment II)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity was observed at concentrations of 5000 µg per plate (-S9, experiment II); precipitation at 2500 µg/plate and above in both experiments.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- cytotoxicity was observed at concentrations of 333 µg per plate and above (-S9, experiment I), 2500 µg/plate and above (+S9, experiment I) and 1000 µg/plate and above (-S9, experiment II); precipitation at 2500 µg/plate and above in experimetn II.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- precipitation was observed at concentrations of 2500 µg/plate and above (experiment I + experiment II)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test substance is poorly soluble in water; therefore, it was suspended in deionised water.
- Precipitation and time of the determination: The test item precipitated in the overlay agar in the test tubes from 1000 to 5000 μg/plate in experiment I and from 2500 to 5000 μg/plate in experiment II. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 μg/plate in both experiments. The undissolved particles had no influence on the data recording.
RANGE-FINDING/SCREENING STUDY
To evaluate the toxicity of the test item a pre-experiment was performed with all strains. Eight concentrations in the range 3 - 5000 µg/plate were tested for toxicity and mutation induction with three plates each. The experimental conditions in this pre-experiment fulfilled all acceptance criteria. Therefore, the pre-experiment was also considered as experiment I. Since toxic effects were observed in the pre-experiment/experiment I, a minimum of six concentrations were tested in experiment II. 5000 μg/plate was chosen as maximal concentration.
STUDY RESULTS
- Concurrent vehicle negative and positive control data : Please refer to 'Any other information on results incl. tables'.
Ames test:
- Individual plate counts : Please refer to 'Any other information on results incl. tables'.
- Mean number of revertant colonies per plate and standard deviation: Please refer to 'Any other information on results incl. tables'.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
Please refer to 'Any other information on results incl. tables'.
Any other information on results incl. tables
Table 1: Summary of experiment I
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Without Activation |
Deionised water |
|
10 ± 4 |
10 ± 2 |
29 ± 3 |
117 ± 16 |
47 ± 10 |
Untreated |
|
16 ± 3 |
14 ± 4 |
28 ± 8 |
110 ± 3 |
44 ± 9 |
|
Test substance |
3 µg |
12 ± 1 |
12 ± 0 |
25 ± 8 |
109 ± 13 |
34 ± 7 |
|
10 µg |
14 ± 5 |
12 ± 3 |
29 ± 6 |
100 ± 13 |
45 ± 12 |
||
33 µg |
10 ± 3 |
12 ± 5 |
29 ± 9 |
103 ± 11 |
44 ± 3 |
||
100 µg |
12 ± 2 |
8 ± 2 |
33 ± 2 |
90 ± 11 |
37 ± 1 |
||
333 µg |
11 ± 4 |
8 ± 2 |
28 ± 8 |
39 ± 8 |
46 ± 12 |
||
1000 µg |
13 ± 5 |
6 ± 0 |
20 ± 1 |
33 ± 2 |
49 ± 5 |
||
2500 µg |
11 ± 3 P M |
5 ± 1 P M |
15 ± 2 P M |
32 ± 1 P |
44 ± 8 P |
||
5000 µg |
10 ± 1 P M |
3 ± 1 P M |
12 ± 2 P M |
22 ± 2 P M |
49 ± 11 P |
||
NaN3 |
10 µg |
1080 ± 47 |
|
|
1654 ± 91 |
|
|
4-NOPD |
10 µg |
|
|
395 ± 8 |
|
|
|
50 µg |
|
72 ± 10 |
|
|
|
||
MMS |
2.0 µL |
|
|
|
|
1051 ± 12 |
|
With Activation |
Deionised water |
|
11 ± 5 |
14 ± 5 |
34 ± 3 |
116 ± 7 |
43 ± 16 |
Untreated |
|
10 ± 1 |
10 ± 1 |
35 ± 3 |
100 ± 19 |
53 ± 9 |
|
Test substance |
3 µg |
12 ± 3 |
14 ± 6 |
42 ± 7 |
112 ± 19 |
55 ± 8 |
|
10 µg |
12 ± 2 |
11 ± 1 |
44 ± 7 |
124 ± 4 |
52 ± 6 |
||
33 µg |
13 ± 3 |
15 ± 6 |
32 ± 4 |
109 ± 10 |
48 ± 4 |
||
100 µg |
13 ± 2 |
15 ± 2 |
33 ± 3 |
110 ± 15 |
45 ± 6 |
||
333 µg |
11 ± 5 |
17 ± 3 |
37 ± 6 |
87 ± 9 |
53 ± 2 |
||
1000 µg |
12 ± 3 |
10 ± 2 |
43 ± 4 |
69 ± 3 |
51 ± 6 |
||
2500 µg |
10 ± 3 P M |
14 ± 2 P |
32 ± 8 P |
48 ± 7 P M |
49 ± 9 P |
||
5000 µg |
9 ± 3 P M |
6 ± 2 P M |
23 ± 4 P M |
45 ± 7 P M |
48 ± 9 P |
||
2-AA |
2.5 µg |
350 ± 19 |
415 ± 5 |
2845 ± 71 |
3939 ± 86 |
|
|
10.0 µg |
|
|
|
|
297 ± 29 |
Key to positive controls: |
Key to plate postfix codes: |
||
NaN3 |
Sodium azide |
P |
Precipitate |
2-AA |
2-Aminoanthracene |
M |
Manual count |
4-NOPD |
4-Nitro-o-phenylenediamine |
|
|
MMS |
Methylmethanesulfonate |
|
|
Table 2: Summary of experiment II
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
Without Activation |
Deionised water |
|
12 ± 2 |
17 ± 2 |
26 ± 1 |
118 ± 15 |
43 ± 9 |
Untreated |
|
12 ± 3 |
14 ± 5 |
31 ± 3 |
114 ± 7 |
51 ± 8 |
|
Test substance |
3 µg |
|
|
|
112 ± 10 |
|
|
10 µg |
|
17 ± 3 |
24 ± 2 |
118 ± 8 |
|
||
33 µg |
14 ± 5 |
15 ± 0 |
29 ± 9 |
106 ± 2 |
45 ± 13 |
||
100 µg |
13 ± 3 |
12 ± 3 |
30 ± 3 |
102 ± 3 |
40 ± 4 |
||
333 µg |
14 ± 3 |
12 ± 2 |
26 ± 6 |
64 ± 10 |
38 ± 2 |
||
1000 µg |
11 ± 1 |
7 ± 2 |
24 ± 3 |
48 ± 3 |
38 ± 4 |
||
2500 µg |
14 ± 3 P |
7 ± 2 P M |
23 ± 8 P |
49 ± 8 P |
42 ± 9 P |
||
5000 µg |
10 ± 3 P M |
7 ± 3 P M |
18 ± 1 P M |
34 ± 6 P M |
30 ± 2 P |
||
NaN3 |
10 µg |
1224 ± 71 |
|
|
1885 ± 83 |
|
|
4-NOPD |
10 µg |
|
|
400 ± 16 |
|
|
|
50 µg |
|
89 ± 1 |
|
|
|
||
MMS |
2.0 µL |
|
|
|
|
854 ± 57 |
|
With Activation |
Deionised water |
|
12 ± 2 |
14 ± 3 |
34 ± 6 |
114 ± 13 |
49 ± 2 |
Untreated |
|
14 ± 2 |
14 ± 1 |
44 ± 5 |
130 ± 21 |
49 ± 8 |
|
Test substance |
3 µg |
|
|
|
110 ± 19 |
|
|
10 µg |
|
14 ± 3 |
40 ± 4 |
117 ± 6 |
|
||
33 µg |
11 ± 5 |
14 ± 2 |
45 ± 3 |
110 ± 6 |
53 ± 4 |
||
100 µg |
11 ± 3 |
13 ± 2 |
34 ± 1 |
110 ± 9 |
52 ± 6 |
||
333 µg |
11 ± 2 |
14 ± 2 |
36 ± 4 |
113 ± 9 |
52 ± 6 |
||
1000 µg |
13 ± 3 |
15 ± 1 |
32 ± 9 |
87 ± 22 |
56 ± 9 |
||
2500 µg |
11 ± 2 P M |
16 ± 2 P |
29 ± 4 P M |
74 ± 15 P |
53 ± 10 P |
||
5000 µg |
12 ± 2 P M |
11 ± 3 P M |
29 ± 4 P M |
63 ± 3 P M |
59 ± 4 P |
||
2-AA |
2.5 µg |
441 ± 33 |
455 ± 13 |
2763 ± 218 |
4196 ± 204 |
|
|
10.0 µg |
|
|
|
|
313 ± 13 |
Key to positive controls: |
Key to plate postfix codes: |
||
NaN3 |
Sodium azide |
P |
Precipitate |
2-AA |
2-Aminoanthracene |
M |
Manual count |
4-NOPD |
4-Nitro-o-phenylenediamine |
|
|
MMS |
Methylmethanesulfonate |
|
|
Table 3: Historical control data
Strain |
|
|
without S9 mix |
|
|
with S9 mix |
|
||
Mean |
SD |
Min |
Max |
Mean |
SD |
Min |
Max |
||
|
Solvent control |
11 |
2.3 |
6 |
22 |
12 |
2.3 |
7 |
22 |
TA 1535 |
Untreated control |
11 |
2.9 |
6 |
28 |
12 |
2.8 |
7 |
23 |
|
Positive control |
1245 |
161.4 |
367 |
1791 |
398 |
61.0 |
183 |
613 |
|
Solvent control |
10 |
2.2 |
6 |
19 |
13 |
3.2 |
7 |
30 |
TA 1537 |
Untreated control |
10 |
2.7 |
5 |
21 |
14 |
3.6 |
6 |
29 |
|
Positive control |
94 |
30.0 |
48 |
231 |
170 |
64.8 |
81 |
421 |
|
Solvent control |
26 |
4.2 |
13 |
43 |
36 |
6.1 |
12 |
56 |
TA 98 |
Untreated control |
27 |
4.7 |
14 |
40 |
39 |
6.4 |
12 |
59 |
|
Positive control |
421 |
176.8 |
196 |
2068 |
3908 |
815.0 |
223 |
5918 |
|
Solvent control |
160 |
29.3 |
79 |
214 |
148 |
31.3 |
76 |
216 |
TA 100 |
Untreated control |
181 |
26.1 |
80 |
235 |
171 |
27.7 |
87 |
218 |
|
Positive control |
2074 |
262.7 |
511 |
2850 |
3626 |
981.9 |
553 |
5860 |
|
Solvent control |
39 |
6.4 |
26 |
60 |
48 |
7.3 |
28 |
69 |
WP2 uvrA |
Untreated control |
40 |
5.8 |
22 |
61 |
51 |
7.4 |
32 |
87 |
|
Positive control |
865 |
340.9 |
346 |
4732 |
426 |
111.2 |
184 |
1265 |
Mean: mean value of revertants/plate
SD: standard deviation
Min: minimal value
Max: maximal value
These data represent the laboratory´s historical control data from November 2016 until August 2018 representing approx. 600 experiments (for WP2 uvrA the historical data are based on approx. 400 experiments).
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: 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.