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EC number: 939-368-0 | 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:
- from 30 March 2012 to 04 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to EU / OECD guidelines and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 19/07/2011
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda
- EC Number:
- 939-368-0
- Cas Number:
- 1322-93-6
- Molecular formula:
- Not applicable (a generic molecular formula can not be provided for this specific UVCB substance)
- IUPAC Name:
- Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): Supragil WP
- Storage condition of test material: In dark at room temperature
Constituent 1
Method
- Target gene:
- Histidine gene
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from the liver of rats treated with Aroclor 1254
- Test concentrations with justification for top dose:
- The dose-levels selected for the preliminary tests were 10, 100, 500, 1000, 2500 and 5000 µg/plate (expressed in terms of active ingredient i.e the three forms of sodium isopropylnaphtalenesulphonate: mono, di and tri => equivalent to 13.3, 133, 665, 1330, 3325 and 6650 µg/plate in terms of registered substance (100% UVCB)).
The selected treatment-levels were 312.5, 625, 1250, 2500 and 5000 µg/plate (expressed in terms of active ingredient i.e the three forms of sodium isopropylnaphtalenesulphonate: mono, di and tri => equivalent to 415.6, 831.3, 1662.5, 3325 and 6650 µg/plate in terms of registered substance (100% UVCB)) for the five strains in both mutagenicity experiments, with and without S9 mix. - Vehicle / solvent:
- Vehicle(s)/solvent(s) used: water for injection
- Justification for choice of solvent/vehicle: the test item was not soluble in any of the vehicles usually used for in vitro tests.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Remarks:
- without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Anthramine
- Remarks:
- With S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: All experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method
DURATION
- Preincubation period: 60 minutes, 37°C
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATES: three plates/dose-level
DETERMINATION OF CYTOTOXICITY
- Method: The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
OTHER: SCORING METHOD: automated
Positive controls:
Without S9 mix:
- sodium azide (NAN3) for strains TA 1535 and TA 100 (1 µg/plate),
- 9-Aminoacridine (9AA) for strain TA 1537 (50 µg/plate),
- 2-Nitrofluorene (2NF) for strain TA 98 (0.5 µg/plate),
- Mitomycin C (MMC) for strain TA 102 (0.5 µg/plate).
With S9 mix:
- 2-Anthramine (2AM) for strains TA 1535, TA 1537, TA 98 (2 µg/plate) and TA102 (10 µg/plate),
- Benzo(a)pyrene (BAP) for strain TA 100 (5 µg/plate). - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained.
- Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- See tables 7.6.1/1 and 7.6.1/2
- Cytotoxicity / choice of top concentrations:
- other: In the second experiment with S9 mix (pre-incubation method), a moderate to strong toxicity was noted in the five strains used at the dose-level of 5000 µg/plate (See table 7.6.1/2).
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Other confounding effects: In the second experiment with S9 mix (pre-incubation method), a moderate to strong toxicity was noted in the five strains used at the dose-level of 5000 µg/plate.
RANGE-FINDING/SCREENING STUDIES:
To assess the toxicity of the test item to the bacteria, six dose-levels (one plate/dose-level) were tested in the TA 98, TA 100 and TA 102 strains, with and without S9 mix. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels.
No noteworthy toxicity (decrease in the number of revertants or thinning of the bacterial lawn) was noted towards the three strains used, either with or without S9 mix.
COMPARISON WITH HISTORICAL CONTROL DATA: The control data reported in these report are in the range of the historical control data observed in the laboratory. The study was therefore considered valid. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 7.6.1/1:First experiment (direct plate incorporation) - Mean revertant colony counts
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||||||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
10 |
14 |
No |
7 |
7 |
No |
20 |
29 |
No |
115 |
140 |
No |
294 |
468 |
No |
312.5 |
14 |
16 |
No |
6 |
6 |
No |
26 |
28 |
No |
130 |
141 |
No |
280 |
559 |
No |
625 |
10 |
11 |
No |
4 |
7 |
No |
15 |
31 |
No |
144 |
164 |
No |
348 |
465 |
No |
1250 |
12 |
14 |
No |
5 |
10 |
No |
18 |
29 |
No |
125 |
136 |
No |
318 |
508 |
No |
2500 |
14 |
10 |
No |
6 |
6 |
No |
19 |
27 |
No |
132 |
162 |
No |
312 |
466 |
No |
5000 |
7 |
12 |
No |
8 |
7 |
No |
18 |
23 |
No |
122 |
154 |
No |
276 |
403 |
No |
NAN3 |
718 |
- |
- |
- |
- |
- |
- |
- |
- |
513 |
- |
- |
- |
- |
- |
2AM |
- |
215 |
- |
- |
108 |
- |
- |
828 |
- |
- |
- |
- |
- |
3415 |
- |
9AA |
- |
- |
- |
277 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2NF |
- |
- |
- |
- |
- |
- |
107 |
- |
- |
- |
- |
- |
- |
- |
- |
BAP |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
776 |
- |
- |
- |
- |
MMC |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2554 |
- |
- |
*solvent control with water for injection
MA: metabolic activation
NaN3: sodium azide
9AA :9-Aminoacridine
2NF:2-Nitrofluorene
MMC:Mitomycin C
2AM:2-Anthramine
BAP:Benzo(a)pyrene
Table 7.6.1/2:Second experiment (direct plate incorporation without S9 mix and preincubation with S9 mix) - Mean revertant colony count
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
||||||||||
Conc. |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
- MA |
+ MA |
Cytotoxic |
0* |
18 |
15 |
No |
8 |
14 |
No |
24 |
29 |
No |
134 |
142 |
No |
332 |
585 |
No |
312.5 |
9 |
13 |
No |
6 |
16 |
No |
25 |
31 |
No |
130 |
168 |
No |
328 |
654 |
No |
625 |
17 |
9 |
No |
10 |
18 |
No |
25 |
35 |
No |
148 |
145 |
No |
392 |
609 |
No |
1250 |
13 |
13 |
No |
6 |
8 |
No |
29 |
30 |
No |
138 |
141 |
No |
379 |
465 |
No |
2500 |
19 |
10 |
No |
12 |
6 |
No |
19 |
36 |
No |
135 |
124 |
No |
357 |
348 |
No |
5000 |
11 |
19 |
Yes (Mt) |
7 |
15 |
Yes (Mt) |
19 |
39 |
Yes (Mt) |
112 |
101 |
Yes (Mt) |
368 |
180 |
Yes (St) |
NAN3 |
610 |
- |
- |
- |
- |
- |
- |
- |
- |
485 |
- |
- |
- |
- |
- |
2AM |
- |
83 |
- |
- |
186 |
- |
- |
859 |
- |
- |
- |
- |
- |
3394 |
- |
9AA |
- |
- |
- |
353 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2NF |
- |
- |
- |
- |
- |
- |
103 |
- |
- |
- |
- |
- |
- |
- |
- |
BAP |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
510 |
- |
- |
- |
- |
MMC |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
- |
2766 |
- |
- |
*solvent control with water for injection
MA: metabolic activation
NaN3: sodium azide
9AA :9-Aminoacridine
2NF:2-Nitrofluorene
MMC:Mitomycin C
2AM:2-Anthramine
BAP:Benzo(a)pyrene
Mt: Moderate toxicity
St: Strong toxicity
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under these experimental conditions, the test item Reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium. - Executive summary:
This study was performed to investigate the potential of the test item, reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda, to induce reverse mutation in Salmonella typhimurium. The study was performed according to OECD guideline no. 471 and EC guideline n° B13/14 and in compliance with the Principles of Good Laboratory Practice.
A preliminary toxicity test was performed to define the dose-levels of reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda to be used for the mutagenicity study. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver post‑mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254.
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the pre-incubation method (60 minutes,37°C).
Five strains of bacteria Salmonella typhimuriumTA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to five dose-levels of the test item (three plates/dose‑level). After 48 to 72 hours of incubation at37°C, the revertant colonies were scored.
The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item was dissolved in water for injections.
Since the test item was freely soluble and non-cytotoxic in the preliminary test, the highest dose‑level selected for the main experiments was 5000 µg/plate, according to the criteria specified in the international guidelines.The selected treatment-levels were 312.5, 625, 1250, 2500 and 5000 µg/plate (doses expressed in terms of active ingredient i.e the three forms of sodium isopropylnaphtalenesulphonate: mono, di and tri => equivalent to 415.6, 831.3, 1662.5, 3325 and 6650 µg/plate in terms of registered substance (100% UVCB)) for the five strains in both mutagenicity experiments, with and without S9 mix. The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered to be valid.
No precipitate was observed in the Petri plates when scoring the revertants at any dose-levels. No noteworthy toxicity was noted at any dose-levels in the absence of S9 mix (in either experiments) or in the presence of S9 mix when using the direct plate incorporation method (first experiment). In the second experiment with S9 mix (pre-incubation method), a moderate to strong toxicity was noted in the five strains used at the dose-level of 5000 µg/plate.The test item did not induce any noteworthy increase in the number of revertants, either with or without S9 mix, in any of the five strains.
In conclusion, the test item did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium, in the absence or in the presence of a rat metabolising system therefore reaction product of naphthalene, propan-2-ol, sulfonated and neutralized by caustic soda is not classified according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
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