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EC number: 938-147-6 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium cocoyl glycinate (SCG) [INCI]
- IUPAC Name:
- Sodium cocoyl glycinate (SCG) [INCI]
- Details on test material:
- - Physical state: Liquid
- Stability under test conditions: Stable in water for days at room temperature (not quantified)
- Storage condition of test material: At room temperature
Constituent 1
Method
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:
- induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I and experiment II
- Vehicle / solvent:
- Deionised water
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar plate incorporation; preincubation
DURATION
- Preincubation period: 1 hour
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed .
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration .
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
Any other information on results incl. tables
Summary Tabellen
Summary of Results Pre-Experiment and Experiment I
Study Name: 1211000 |
Study Code: Harlan CCR 1211000 |
Experiment: 1211000 VV Plate |
Date Plated: 17/09/2008 |
Assay Conditions: |
Date Counted: 24/09/2008 |
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
||||
Without Activation |
Deionised water |
20 ± 3 |
11 ± 3 |
35 ± 2 |
137 ± 5 |
55 ± 4 |
||
Untreated |
18 ± 3 |
13 ± 3 |
37 ± 10 |
126 ± 4 |
47 ± 3 |
|||
Hostapon SG |
3 µg |
20 ± 3 |
11 ± 4 |
29 ± 1 |
134 ± 12 |
50 ± 4 |
||
10 µg |
19 ± 4 |
14 ± 2 |
33 ± 5 |
124 ± 8 |
52 ± 6 |
|||
33 µg |
18 ± 3 |
11 ± 4 |
35 ± 6 |
132 ± 10 |
55 ± 1 |
|||
100 µg |
19 ± 4 |
8 ± 0 |
37 ± 6 |
139 ± 16 |
52 ± 4 |
|||
333 µg |
13 ± 2 |
10 ± 4 |
32 ± 8 |
122 ± 15 |
63 ± 3 |
|||
1000 µg |
17 ± 2 |
7 ± 1 |
25 ± 5 |
84 ± 11 R |
62 ± 2 |
|||
2500 µg |
8 ± 2 M R |
2 ± 2 M R |
19 ± 2 M R |
36 ± 5 M R |
59 ± 2 |
|||
5000 µg |
2 ± 2 M R |
0 ± 1 M R |
5 ± 2 M R |
27 ± 3 M R |
58 ± 2 |
|||
NaN3 |
10 µg |
2009 ± 31 |
2369 ± 114 |
|||||
4-NOPD |
10 µg |
424 ± 9 |
||||||
4-NOPD |
50 µg |
83 ± 3 |
||||||
MMS |
3.0 µL |
1017 ± 33 |
||||||
With Activation |
Deionised water |
23 ± 3 |
20 ± 5 |
37 ± 4 |
148 ± 5 |
68 ± 4 |
||
Untreated |
24 ± 6 |
19 ± 7 |
42 ± 8 |
148 ± 14 |
64 ± 9 |
|||
Hostapon SG |
3 µg |
24 ± 3 |
19 ± 5 |
39 ± 5 |
129 ± 14 |
64 ± 4 |
||
10 µg |
21 ± 5 |
17 ± 5 |
44 ± 8 |
135 ± 3 |
71 ± 2 |
|||
33 µg |
25 ± 3 |
19 ± 3 |
43 ± 6 |
132 ± 9 |
60 ± 11 |
|||
100 µg |
23 ± 1 |
15 ± 2 |
38 ± 4 |
134 ± 5 |
60 ± 4 |
|||
333 µg |
22 ± 5 |
13 ± 2 |
47 ± 6 |
136 ± 13 |
73 ± 11 |
|||
1000 µg |
15 ± 4 |
16 ± 3 |
35 ± 3 |
116 ± 13 |
69 ± 3 |
|||
2500 µg |
9 ± 3 M R |
8 ± 1 M R |
28 ± 2 M R |
48 ± 7 M R |
66 ± 1 |
|||
5000 µg |
5 ± 1 M R |
1 ± 1 M R |
13 ± 2 M R |
34 ± 5 M R |
59 ± 4 |
|||
2-AA |
2.5 µg |
245 ± 16 |
191 ± 30 |
1267 ± 70 |
1506 ± 43 |
|||
2-AA |
10.0 µg |
232 ± 24 |
||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
R M |
Reduced background growth Manual count |
Summary of Results Experiment II
Study Name: 1211000 |
Study Code: Harlan CCR 1211000 |
Experiment: 1211000 HV2 Pre |
Date Plated: 01/10/2008 / 14/10/2008* |
Assay Conditions: |
Date Counted: 08/10/2008 / 17/10/2008* |
Metabolic Activation |
Test Group |
Dose Level (µg/plate) |
Revertant Colony Counts (Mean ±SD) |
|||||
TA 1535 |
TA 1537 |
TA 98* |
TA 100 |
WP2 uvrA |
||||
Without Activation |
Deionised water |
19 ± 6 |
12 ± 4 |
22 ± 2 |
131 ± 5 |
51 ± 8 |
||
Untreated |
16 ± 6 |
10 ± 2 |
24 ± 4 |
137 ± 12 |
46 ± 8 |
|||
Hostapon SG |
3 µg |
17 ± 4 |
14 ± 5 |
23 ± 2 |
131 ± 8 |
55 ± 1 |
||
10 µg |
18 ± 4 |
15 ± 2 |
24 ± 2 |
127 ± 9 |
52 ± 8 |
|||
33 µg |
18 ± 3 |
11 ± 6 |
24 ± 4 |
122 ± 1 |
55 ± 6 |
|||
100 µg |
22 ± 6 |
14 ± 3 |
23 ± 1 |
101 ± 15 R |
56 ± 2 |
|||
333 µg |
12 ± 5 |
10 ± 4 |
15 ± 2 |
75 ± 7 R |
47 ± 4 |
|||
1000 µg |
5 ± 2 R M |
2 ± 3 M R |
10 ± 1 M R |
39 ± 5 M R |
49 ± 5 |
|||
2500 µg |
2 ± 2 M R |
0 ± 0 M R |
3 ± 2 M R |
31 ± 10 M R |
46 ± 5 |
|||
5000 µg |
1 ± 1 M R |
0 ± 0 M R |
0 ± 0 M R |
5 ± 2 M R |
37 ± 7 |
|||
NaN3 |
10 µg |
1799 ± 67 |
1998 ± 31 |
|||||
4-NOPD |
10 µg |
1637 ± 116 |
||||||
4-NOPD |
50 µg |
105 ± 5 |
||||||
MMS |
3.0 µL |
418 ± 20 |
||||||
With Activation |
Deionised water |
17 ± 4 |
16 ± 5 |
26 ± 3 |
138 ± 9 |
58 ± 5 |
||
Untreated |
18 ± 4 |
19 ± 7 |
29 ± 3 |
142 ± 37 |
64 ± 7 |
|||
Hostapon SG |
3 µg |
19 ± 4 |
17 ± 4 |
27 ± 0 |
131 ± 11 |
59 ± 3 |
||
10 µg |
22 ± 4 |
17 ± 4 |
25 ± 2 |
132 ± 8 |
58 ± 3 |
|||
33 µg |
20 ± 2 |
19 ± 3 |
24 ± 2 |
141 ± 15 |
59 ± 6 |
|||
100 µg |
21 ± 1 |
15 ± 3 |
22 ± 5 |
140 ± 7 |
57 ± 5 |
|||
333 µg |
18 ± 4 |
14 ± 4 |
19 ± 3 |
110 ± 5 R |
53 ± 2 |
|||
1000 µg |
11 ± 3 M R |
12 ± 2 M R |
10 ± 2 M R |
74 ± 7 R |
54 ± 1 |
|||
2500 µg |
9 ± 3 M R |
8 ± 2 M R |
4 ± 3 M R |
31 ± 2 M R |
59 ± 4 |
|||
5000 µg |
0 ± 0 M R |
0 ± 0 M R |
0 ± 0 M R |
31 ± 4 M R |
61 ± 3 |
|||
2-AA |
2.5 µg |
256 ± 8 |
105 ± 10 |
1616 ± 151 |
1346 ± 157 |
|||
2-AA |
10.0 µg |
334 ± 24 |
||||||
Key to Positive Controls |
Key to Plate Postfix Codes |
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
R M |
Reduced background growth Manual count |
* Repeated experiment
Applicant's summary and conclusion
- Conclusions:
- The registration substance Hostapon SG is not mutagenic in Ames test.
- Executive summary:
The registration substance Hostapon SG was investigated for its mutagenicity in bacterial mutation reverse assay according to the Guideline OECD 471. Up to the concentration of 5000 µg/plate no mutagenic property was found without and with metabolic activation in strains TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA in two indepedant experiments. Hostapon SG is not mutagenic in Ames test.
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.
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