Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 827-581-0 | CAS number: -
- 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:
- 19 January 2011 to 10 February 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to read-across justification document for SCMI in section 13
Cross-reference
- Reason / purpose for cross-reference:
- assessment report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (1997)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- (2008)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 2-(dodecanoyloxy)propane-1-sulfonate
- EC Number:
- 700-150-3
- Cas Number:
- 156572-81-5
- Molecular formula:
- C15H29NaO5S
- IUPAC Name:
- Sodium 2-(dodecanoyloxy)propane-1-sulfonate
- Details on test material:
- - Name of test material (as cited in study report): Sodoium lauroyl methyl isethionate, CAS No 156572-81-5
- Physical state: Off white solid
- Analytical purity: >80%
- Impurities (identity and concentrations):
- Purity test date: Not stated
- Lot/batch No.: Not supplied
- Expiration date of the lot/batch: 15 December 2011
- Stability under test conditions: Assumed stable for 4h
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbiotone/¿-naphthoflavone induced S9
- Vehicle / solvent:
- Sterile, distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile, distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- -S9 Migrated to IUCLID6: WP2uvrA; TA100; TA1535
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- -S9 Migrated to IUCLID6: TA1537
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- -S9 Migrated to IUCLID6: TA98
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: TA100; TA1537; TA1537; WPsuvrA
- Remarks:
- +S9
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- +S9 Migrated to IUCLID6: TA98
- Details on test system and experimental conditions:
- Preliminary toxicity test:
Conducted to determine the toxicity of the test article. Concentrations tested were in the range of 0 ¿ 5 mg/plate. The test was performed by mixing bacterial culture (TA100 or WP2uvrA), molten trace histidine or typtophan supplemented top agar, test material formulation and S9 or PBS and overlaying onto sterile plates of Vogel-Bonner minimal agar. Sterility of the test item was assessed (test article formulation alone added to agar (as described above). Following 48h incubation at 37°C plates were assessed for numbers of revertant colonies sing a Domino colony counter and examined for effects on the growth of the background lawn.
Initial toxicity-mutation assay:
Plate incorporation method used (i.e. soft agar, bacteria, TA and S9 / buffer mixed prior to immediate incorporation on to agar plate) test followed the directions of Ames et al.,(1973, 1975). Vehicle and positive controls and seven dose levels of the test material were plated in triplicate/dose. All strains listed above were tested in the presence and absence of S9 mix.
Plates were incubated for approximately 48 hours at 37°C.
Confirmatory mutagenicity assay:
Pre-incubation method used (i.e. bacterial strain, test article formulation and S9 or phosphate buffer were incubated for 20 minutes at 37°C). following incubation the bacterial/test article formulation etc. mix was plated on to minimal agar. Vehicle and positive controls and seven dose levels of the test material were plated in triplicate/dose, dosing being adjusted based on the results of the initial experiment. . Again plates were incubated for at 48 hours at 37°C. Means and standard deviations were calculated for the both the initial and confirmatory test. - Evaluation criteria:
- The test material was considered positive: dose related increase in mutant frequency over the dose range tested, reproducible increase at 1 or more concentrations, biological relevance against in-house historical control ranges, fold increase greater than 2 times the concurrent solvent control for any tester strain.
Toxicity was assessed by reduction in the background lawn; dose-dependent reduction in the mutant count/plate (concurrent vehicle control). - Statistics:
- Statistical analysis was performed as described by UKEMS (Mahonet al., 1989)
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
INITIAL TOXICITY-MUTATION ASSAY:
Six doses of the test material ranging from 5 to 5000 ug/plate±S9 or 15 to 5000 ug/plate±S9 were evaluated in the plate incorporation test inSalmonellaandE.coli strains, respectively.. No precipitation was observed up to the limit dose, 5000 ug/plate. Toxicity was observed in all strains at 500 ¿g/plate and above.
Table 1: Bacterial mutation assay, summary of results¿ Initial (plate incorporation) test
Dose (ug/plate) |
0 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
Positive control |
REVERTANTS/PLATE |
|||||||||
TA1535 ¿S9 |
24±2.1 |
24±1.5 |
20±1.2 |
25±0.6 |
22±2.6 |
25±5.2S |
17±3.1S |
6±2.1V |
921±56.0 |
TA1535 +S9 |
16±1.5 |
13±2.0 |
16±1.5 |
13±1.7 |
17±4.4 |
17±2.1 |
13±4.9S |
9±2.5V |
264±31.5 |
TA100 ¿S9 |
111±1.7 |
110±9.1 |
115±13.1 |
112±8.2 |
109±6.4 |
93±5.8S |
46±16.8S |
18±6.2V |
379±46.8 |
TA100 +S9 |
99±6.5 |
99±9.5 |
112±6.5 |
106±16.1 |
105±20.5 |
82±8.0 |
53±3.8S |
14±6.4V |
1195±5.5 |
TA1537 ¿S9 |
14±3.2 |
14±1.2 |
14±1.2 |
17±1.2 |
17±3.6 |
13±1.2 |
6±3.2S |
0±0.0T |
798±200.3 |
TA1537 +S9 |
15±2.6 |
14±2.1 |
16±.7 |
15±2.3 |
13±1.5 |
15±2.6 |
3±2.1S |
0±0.0T |
208±4.6 |
TA98 ¿S9 |
29±3.5 |
30±1.2 |
32±3.8 |
28±2.1 |
27±3.1 |
30±1.0 |
7±2.6 |
3±1.5 |
214±15.7 |
TA98 +S9 |
31±5.9 |
33±1.0 |
25±1.0 |
31±2.6 |
31±6.1 |
2±1.7 |
12±6.5S |
3±2.0V |
208±10.5 |
WP2uvrA ¿S9 |
35±1.5 |
N/T |
32±3.8 |
28±2.1 |
27±3.1 |
30±1.0 |
7±2.6 |
3±1.5 |
214±15.7 |
WP2uvrA +S9 |
44±5.2 |
N/T |
37±7.9 |
39±3.5 |
39±4.0 |
38±1.5 |
33±4.4 |
21±9.0 |
332±18.0 |
CONFIRMATORY MUTAGENICITY ASSAY:
Again no precipitation was observed in any of the strains tested. Cytotoxicity was observed in allSalmonellastrains in the absence and presence of S9.
Table 2A: Bacterial mutation assay, summary of results¿ confirmatory (pre-incubation) test ¿ TA1535 & TA100 ¿S9
Dose (ug/plate) |
0 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
Positive control |
REVERTANTS/PLATE |
|||||||||
TA1535 -S9 |
25±0.6 |
20±1.0 |
25±7.1 |
26±2.9 |
23±8.4 |
26±0.6S |
12±2.1V |
0±0.0V |
708±82.1 |
TA100 -S9 |
93±10.5 |
91±4.2 |
95±7.2 |
97±7.2 |
103±8.5 |
101±3.6S |
83±22.6V |
44±5.9V |
1799±198.6 |
Table 2B: Bacterial mutation assay, summary of results¿ confirmatory (pre-incubation) test ¿ TA1537, TA98 & WP2uvrA¿S9
Dose (ug/plate) |
0 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
Positive control |
REVERTANTS/PLATE |
|||||||||
TA1537 -S9 |
9±2.9 |
8±0.6 |
10±1.0 |
7±4.0 |
6±2.3 |
6±1.7S |
0±0.0T |
0±0.0V |
2079±280.0 |
TA98 -S9 |
26±4.4 |
31±3.1 |
22±1.7 |
15±1.5 |
16±1.7 |
9±1.5S |
5±3.2V |
0±0.0V |
187±15.5 |
WP2uvrA -S9 |
26±4.5 |
N/T |
31±4.6 |
25±3.5 |
28±1.0 |
26±3.2 |
27±3.5 |
15±3.8 |
976±62.4 |
Table 2C: Bacterial mutation assay, summary of results¿ confirmatory (pre-incubation) test All strains +S9
Dose (ug/plate) |
0 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
Positive control |
REVERTANTS/PLATE |
|||||||||
TA1535 +S9 |
16±7.09 |
12±1.7 |
15±3.2 |
14±0.6 |
15±1.2 |
8±0.6S |
7±1.2V |
0±0.0V |
258±16.8 |
TA100 +S9 |
99±8.4 |
75±11.0 |
81±9.1 |
87±2.5 |
87±5.3 |
51±4.9S |
40±0.6V |
0±0.0V |
938±63.0 |
TA1537 +S9 |
11±2.1 |
12±2.5 |
11±1.5 |
13±1.5 |
6±1.2 |
7±1.0S |
2±1.0 |
0±0.0V |
221±51.2 |
TA98 +S9 |
30±6.7 |
34±4.0 |
31±0.6 |
27±2.0 |
31±8.4 |
12±4.0 |
9±1.7V |
0±0.0V |
231±17.3 |
WP2uvrA +S9 |
31±7.8 |
N/T |
28±5.5 |
31±22.6 |
29±9.6 |
38±0.6 |
36±8.3 |
16±0.6 |
353±17.1 |
N/T Not treated
S Sparse background lawn
T Toxic, no background lawn
V Very weak background lawn
The test material was tested up to either the maximum recommended dose level (5000 ¿g/plate) or the toxic limit, depending on the bacterial strain type. No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation or exposure method.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Based on the results from this study,sodium lauroyl methyl isethionatewas not mutagenic in the bacterial strains tested, either in the presence or absence of metabolic activation when tested up either 5000 ug/plate (the maximum dose in accordance with regulatory guidelines) or cytotoxic concentrations. - Executive summary:
In a reverse gene mutation assay in bacteria,Salmonella typhimuriumstrains TA98, TA100, TA1535, and TA1537 andEscherichiacoli WP2uvrAwere exposed to sodium lauroyl methyl isethionate formulated in sterile, distilled water. The assay was performed in two phases, using the plate incorporation and the pre-incubation method.
In an initial test, the plate incorporation method was used with dose levels of 5 to 5000 ug/plate (depending on strain) in the presence and absence of S9 activation. In the confirmatory test, the pre-incubation method was used. The same dose range was used. No precipitation was observed in any strain tested. The test material was tested up to either the maximum recommended dose level (5000 ¿g/plate) or the toxic limit, depending on the bacterial strain type. No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation or exposure method.
Based on the results from this study,sodium lauroyl methyl isethionatewas not mutagenic in the bacterial strains tested, either in the presence or absence of metabolic activation when tested up either 5000 ug/plate (the maximum dose in accordance with regulatory guidelines) or cytotoxic concentrations.
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.