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EC number: 269-142-0 | CAS number: 68188-14-7
- 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:
- Okt. 2019 - Jan. 2020
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21. Jul 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Resin acids and Rosin acids, barium salts
- EC Number:
- 269-142-0
- EC Name:
- Resin acids and Rosin acids, barium salts
- Cas Number:
- 68188-14-7
- Molecular formula:
- N/A
- IUPAC Name:
- Resin acids and Rosin acids, barium salts
- Test material form:
- solid
- Details on test material:
- Specific details on test material used for the study
SOURCE OF TEST MATERIAL
- Batch number of test material: EXP NR.3757-01
- Expiration date of the lot/batch: 31 Dec 2029
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Stability under storage conditions: The stability of the test substance under storage conditions is
guaranteed until 31 Dec 2029 as indicated by the sponsor, and the sponsor holds this responsibility.
- Stability under test conditions: no data
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch number of test material: EXP NR.3757-01
- Expiration date of the lot/batch: 31 Dec 2029
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: refrigerator
- Stability under storage conditions: The stability of the test substance under storage conditions is guaranteed until 31 Dec 2029 as indicated by the sponsor.
- Solubility and stability of the test substance in the solvent/dispersant/vehicle/test medium: The stability of the test substance in the vehicle DMSO was not determined analytically, because the test substance was administered immediately after preparation and is usually stable.
- Reactivity of the test substance with the solvent/vehicle /test medium (if applicable): Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: Test substance dissolved in dimethyl sulfoxide and used immediately after preparation
- Final preparation of a solid: The test substance was weighed and topped up with the chosen vehicle to achieve the required concentration of the stock solution. The test substance was suspended in dimethyl sulfoxide (DMSO). To achieve homogeneity of the test substance in the vehicle, the test substance preparation was treated with ultrasonic waves and was shaken thoroughly. The further concentrations were diluted according to the planned doses. To keep the test substance homogeneously in the vehicle, the test substance preparation was carefully pipetted before removal. All test substance formulations were prepared immediately before use.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : no difference
Method
- Target gene:
- his, trp
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 : liver of 5 adult male Wistar rats induced by a combination of phenobarbital and ß-naphthoflavone
- method of preparation of S9 mix: 24 hours after the last administration, the rats were sacrificed, and the livers were prepared. The livers were weighed, washed and homogenized in KCl solution. After centrifugation of the homogenate, portions of the supernatant (S9 fraction) were stored at -70°C to -80°C. The S9 mix was prepared freshly prior to each experiment. For this purpose, a sufficient amount of S9 fraction was thawed at room temperature and 1 part of S9 fraction is mixed with 9 parts of S9 supplement (cofactors). This mixture of both components (S9 mix) was kept on ice until used.
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL S9 mix
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): To demonstrate the efficacy of the S9 mix in this assay, the S9 batch was characterized with benzo(a)pyrene. - Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1000; 2500 and 5000 μg/plate
In agreement with the recommendations of current guidelines 5 mg/plate or 5 μL/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to the insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene (2.5 μg/plate, 60 μg/plate; dissolved in DMSO; with S9-mix); N-methyl-N'-nitro-N-nitrosoguanidine (5 μg/plate; dissolved in DMSO; without S9-mix); 4-nitro-o-phenylenediamine (10 μg/plate; dissolved in DMSO; without S9-mix)
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration : triplicate
- Number of independent experiments : 2
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Fresh cultures of bacteria were grown up to late exponential or early stationary phase of growth (approximately 10^9 cells per mL). These cultures grown overnight were kept in iced water from the beginning of the experiment until the end in order to prevent further growth.
- Test substance added: Standard plate test, Preincubation Test
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: about 20 minutes
- Exposure duration/duration of treatment: 48 – 72 hours
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method, e.g.: background growth inhibition - Evaluation criteria:
- Generally, the experiment was considered valid if the following criteria were met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies compatible with the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 10^9 cells per mL were used.
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test resultsopen allclose all
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Data on pH: no data
- Data on osmolality: no data
- Water solubility: insoluble
- Precipitation and time of the determination: Test substance precipitation was observed at and above 2500 μg/plate with and without S9 mix.
RANGE-FINDING/SCREENING STUDIES (if applicable):
1st Experiment
Strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
Doses: 0; 33; 100; 333; 1000; 2500 and 5000 μg/plate
Type of test: Standard plate test with and without S9 mix
Number of plates: 3 test plates per dose or per control
STUDY RESULTS
- Concurrent vehicle negative and positive control data : see Tab. 1, 2 and 3
Ames test:
- Signs of toxicity : see Tab. 1, 2 and 3
- Individual plate counts : see Tab. 1, 2 and 3
- Mean number of revertant colonies per plate and standard deviation : see Tab. 1, 2 and 3
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
see Tab. 4 and 5
Any other information on results incl. tables
Tab. 1: Assay conditions: Standard plate test ( Experiment: 1st_SPT)
Key to plate postfix codes
P Precipitation
T Technical fault
Without metabolic activation |
||||||
Strain |
Test group |
Dose (μg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
19.7 |
5.5 |
- |
14, 20, 25 |
|
Test item |
33 |
9.0 |
5.3 |
0.5 |
15, 5, 7 |
|
|
100 |
7.3 |
1.2 |
0.4 |
8, 6, 8 |
|
|
333 |
10.0 |
1.0 |
0.5 |
9, 10, 11 |
|
|
1000 |
12.0 |
1.0 |
0.6 |
13, 12, 11 |
|
|
2500 |
6.3 |
2.1 |
0.3 |
4 P, 7 P, 8 P |
|
|
5000 |
6.7 |
1.5 |
0.3 |
8 P, 7 P, 5 P |
|
MNNG |
5.0 |
3988.7 |
655.2 |
202.8 |
4489, 4230, 3247 |
TA 100 |
DMSO |
- |
96.0 |
1.0 |
- |
96, 95, 97 |
|
Test item |
33 |
90.0 |
1.0 |
0.9 |
91, 89, 90 |
|
|
100 |
100.3 |
14.2 |
1.0 |
107, 110, 84 |
|
|
333 |
104.3 |
2.1 |
1.1 |
102, 106, 105 |
|
|
1000 |
99.0 |
10.6 |
1.0 |
107, 87, 103 |
|
|
2500 |
118.0 |
5.6 |
1.2 |
119 P, 123 P, 112 P |
|
|
5000 |
102.0 |
33.9 |
1.1 |
78 P, - T P, 126 P |
|
MNNG |
5.0 |
1984.7 |
139.5 |
20.7 |
1825, 2046, 2083 |
TA 1537 |
DMSO |
- |
12.0 |
6.1 |
- |
8, 9, 19 |
|
Test item |
33 |
9.7 |
3.1 |
0.8 |
13, 7, 9 |
|
|
100 |
8.7 |
1.5 |
0.7 |
9, 10, 7 |
|
|
333 |
10.3 |
2.5 |
0.9 |
8, 10, 13 |
|
|
1000 |
9.7 |
2.1 |
0.8 |
9, 12, 8 |
|
|
2500 |
4.3 |
1.2 |
0.4 |
5 P, 5 P, 3 P |
|
|
5000 |
4.7 |
3.1 |
0.4 |
8 P, 4 P, 2 P |
|
AAC |
100 |
760.7 |
197.6 |
63.4 |
844, 903, 535 |
TA 98 |
DMSO |
- |
22.0 |
2.6 |
- |
20, 25, 21 |
|
Test item |
33 |
18.3 |
3.1 |
0.8 |
19, 15, 21 |
|
|
100 |
14.3 |
2.5 |
0.7 |
17, 12, 14 |
|
|
333 |
22.3 |
4.5 |
1.0 |
22, 18, 27 |
|
|
1000 |
18.7 |
2.9 |
0.8 |
17, 22, 17 |
|
|
2500 |
18.3 |
4.0 |
0.8 |
16 P, 23 P, 16 P |
|
|
5000 |
17.7 |
3.2 |
0.8 |
14 P, 20 P, 19 P |
|
NOPD |
10 |
804.7 |
43.3 |
36.6 |
819, 839, 756 |
E. coli |
DMSO |
- |
29.0 |
1.7 |
- |
31, 28, 28 |
|
Test item |
33 |
34.3 |
8.6 |
1.2 |
42, 25, 36 |
|
|
100 |
31.7 |
12.0 |
1.1 |
20, 44, 31 |
|
|
333 |
23.7 |
9.1 |
0.8 |
32, 25, 14 |
|
|
1000 |
19.7 |
2.3 |
0.7 |
21, 21, 17 |
|
|
2500 |
21.3 |
3.5 |
0.7 |
25 P, 21 P, 18 P |
|
|
5000 |
20.0 |
5.3 |
0.7 |
24 P, 22 P, 14 P |
|
4-NQO |
5 |
1368.7 |
190.8 |
47.2 |
1589, 1255, 1262 |
With metabolic activation |
||||||
Strain |
Test group |
Dose (μg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
11.7 |
2.3 |
- |
13, 13, 9 |
|
Test item |
33 |
6.5 |
3.5 |
0.6 |
9, - C, 4 |
|
|
100 |
8.7 |
3.2 |
0.7 |
11, 10, 5 |
|
|
333 |
10.3 |
3.5 |
0.9 |
14, 7, 10 |
|
|
1000 |
11.0 |
4.6 |
0.9 |
16, 10, 7 |
|
|
2500 |
9.3 |
6.1 |
0.8 |
4 P, 8 P, 16 P |
|
|
5000 |
8.0 |
1.7 |
0.7 |
9 P, 9 P, 6 P |
|
2-AA |
2.5 |
264.7 |
23.1 |
22.7 |
238, 278, 278 |
TA 100 |
DMSO |
- |
104.7 |
23.6 |
- |
107, 80, 127 |
|
Test item |
33 |
93.7 |
5.9 |
0.9 |
87, 96, 98 |
|
|
100 |
108.0 |
2.6 |
1.0 |
110, 105, 109 |
|
|
333 |
104.3 |
10.2 |
1.0 |
97, 100, 116 |
|
|
1000 |
97.3 |
9.6 |
0.9 |
87, 106, 99 |
|
|
2500 |
100.3 |
8.0 |
1.0 |
92 P, 108 P, 101 P |
|
|
5000 |
100.7 |
9.9 |
1.0 |
96 P, 112 P, 94 P |
|
2-AA |
2.5 |
2801.3 |
134.5 |
26.8 |
2913, 2839, 2652 |
TA 1537 |
DMSO |
- |
13.7 |
2.1 |
- |
16, 12, 13 |
|
Test item |
33 |
8.3 |
2.9 |
0.6 |
10, 10, 5 |
|
|
100 |
7.3 |
2.5 |
0.5 |
10, 7, 5 |
|
|
333 |
6.0 |
4.0 |
0.4 |
6, 2, 10 |
|
|
1000 |
9.3 |
3.2 |
0.7 |
8, 7, 13 |
|
|
2500 |
7.3 |
1.2 |
0.5 |
6 P, 8 P, 8 P |
|
|
5000 |
6.3 |
3.1 |
0.5 |
9 P, 3 P, 7 P |
|
2-AA |
2.5 |
168.7 |
9.7 |
12.3 |
171, 177, 158 |
TA 98 |
DMSO |
- |
25.7 |
3.1 |
- |
25, 29, 23 |
|
Test item |
33 |
21.0 |
3.0 |
0.8 |
18, 21, 24 |
|
|
100 |
24.7 |
2.5 |
1.0 |
27, 25, 22 |
|
|
333 |
20.0 |
4.4 |
0.8 |
17, 25, 18 |
|
|
1000 |
20.3 |
2.5 |
0.8 |
18, 23, 20 |
|
|
2500 |
12.3 |
1.5 |
0.5 |
12 P, 14 P, 11 P |
|
|
5000 |
13.3 |
1.5 |
0.5 |
15 P, 13 P, 12 P |
|
2-AA |
2.5 |
1997.0 |
344.7 |
77.8 |
1599, 2196, 2196 |
E. coli |
DMSO |
- |
24.7 |
6.7 |
- |
17, 28, 29 |
|
Test item |
33 |
28.3 |
2.5 |
1.1 |
28, 26, 31 |
|
|
100 |
25.7 |
11.1 |
1.0 |
27, 14, 36 |
|
|
333 |
22.7 |
1.5 |
0.9 |
21, 23, 24 |
|
|
1000 |
33.3 |
5.5 |
1.4 |
33, 28, 39 |
|
|
2500 |
24.0 |
5.6 |
1.0 |
30 P, 23 P, 19 P |
|
|
5000 |
19.0 |
4.4 |
0.8 |
21 P, 22 P, 14 P |
|
2-AA |
60 |
191.3 |
12.4 |
7.8 |
199, 198, 177 |
Tab. 2: Assay conditions: Standard plate test ( Experiment: 2nd-SPT)
Key to plate postfix codes
P Precipitation
Without metabolic activation |
||||||
Strain |
Test group |
Dose (μg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
9.7 |
1.2 |
- |
9, 9, 11 |
|
Test item |
33 |
9.0 |
2.6 |
0.9 |
6, 10, 11 |
|
|
100 |
8.0 |
1.7 |
0.8 |
6, 9, 9 |
|
|
333 |
7.0 |
1.0 |
0.7 |
8, 6, 7 |
|
|
1000 |
7.3 |
1.2 |
0.8 |
8, 8, 6 |
|
|
2500 |
7.3 |
2.3 |
0.8 |
10 P, 6 P, 6 P |
|
|
5000 |
9.3 |
0.6 |
1.0 |
10 P, 9 P, 9 P |
|
MNNG |
5.0 |
5816.3 |
326.2 |
601.7 |
5746, 5531, 6172 |
Tab. 3: Assay conditions: Preincubation test ( Experiment: 3rd-PIT)
Key to plate postfix codes
P Precipitation
B Reduced background growth
Without metabolic activation |
||||||
Strain |
Test group |
Dose (μg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
6.0 |
1.0 |
- |
6, 5, 7 |
|
Test item |
33 |
5.7 |
2.5 |
0.9 |
3, 8, 6 |
|
|
100 |
6.3 |
2.1 |
1.1 |
7, 4, 8 |
|
|
333 |
6.7 |
1.5 |
1.1 |
7, 5, 8 |
|
|
1000 |
5.3 |
2.3 |
0.9 |
8, 4, 4 |
|
|
2500 |
6.7 |
5.5 |
1.1 |
13 P, 3 P, 4 P |
|
|
5000 |
5.3 |
1.2 |
0.9 |
6 P, 6 P, 4 P |
|
MNNG |
5.0 |
4658.3 |
735.6 |
776.4 |
5502, 4322, 4151 |
TA 100 |
DMSO |
- |
90.7 |
2.5 |
- |
93, 91, 88 |
|
Test item |
33 |
95.7 |
15.2 |
1.1 |
93, 112, 82 |
|
|
100 |
93.3 |
7.5 |
1.0 |
89, 102, 89 |
|
|
333 |
77.0 |
6.0 |
0.8 |
77, 71, 83 |
|
|
1000 |
77.0 |
12.5 |
0.8 |
73, 91, 67 |
|
|
2500 |
95.0 |
11.0 |
1.0 |
106 P, 84 P, 95 P |
|
|
5000 |
93.7 |
9.8 |
1.0 |
88 P, 88 P, 105 P |
|
MNNG |
5.0 |
2707.0 |
67.4 |
29.9 |
2720, 2634, 2767 |
TA 1537 |
DMSO |
- |
5.7 |
3.8 |
- |
4, 10, 3 |
|
Test item |
33 |
6.0 |
1.0 |
1.1 |
6, 7, 5 |
|
|
100 |
3.3 |
2.5 |
0.6 |
3, 6, 1 |
|
|
333 |
4.0 |
1.7 |
0.7 |
3, 6, 3 |
|
|
1000 |
3.7 |
2.9 |
0.6 |
2, 2, 7 |
|
|
2500 |
4.0 |
1.0 |
0.7 |
4 P B, 3 P B, 5 P B |
|
|
5000 |
0.0 |
0.0 |
0.0 |
0 P B, 0 P B, 0 P B |
|
AAC |
100 |
640.0 |
204.4 |
112.9 |
876, 527, 517 |
TA 98 |
DMSO |
- |
17.3 |
1.2 |
- |
18, 18, 16 |
|
Test item |
33 |
14.0 |
3.0 |
0.8 |
11, 17, 14 |
|
|
100 |
15.0 |
3.5 |
0.9 |
11, 17, 17 |
|
|
333 |
12.7 |
4.7 |
0.7 |
11, 9, 18 |
|
|
1000 |
14.0 |
2.0 |
0.8 |
16, 14, 12 |
|
|
2500 |
14.3 |
3.2 |
0.8 |
12 P, 13 P, 18 P |
|
|
5000 |
18.3 |
3.5 |
1.1 |
15 P, 22 P, 18 P |
|
NOPD |
10 |
874.0 |
38.6 |
50.4 |
837, 914, 871 |
E. coli |
DMSO |
- |
20.3 |
3.1 |
- |
21, 23, 17 |
|
Test item |
33 |
19.0 |
1.0 |
0.9 |
20, 18, 19 |
|
|
100 |
18.3 |
7.1 |
0.9 |
26, 12, 17 |
|
|
333 |
21.0 |
2.0 |
1.0 |
19, 23, 21 |
|
|
1000 |
15.0 |
1.0 |
0.7 |
15, 14, 16 |
|
|
2500 |
23.7 |
5.5 |
1.2 |
29 P, 24 P, 18 P |
|
|
5000 |
20.7 |
5.0 |
1.0 |
26 P, 20 P, 16 P |
|
4-NQO |
5 |
692.7 |
25.4 |
34.1 |
721, 672, 685 |
With metabolic activation |
||||||
Strain |
Test group |
Dose (μg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
7.3 |
2.9 |
- |
9, 4, 9 |
|
Test item |
33 |
7.0 |
3.0 |
1.0 |
10, 7, 4 |
|
|
100 |
9.7 |
2.1 |
1.3 |
9, 8, 12 |
|
|
333 |
8.7 |
5.0 |
1.2 |
8, 4, 14 |
|
|
1000 |
7.7 |
1.2 |
1.0 |
7, 7, 9 |
|
|
2500 |
6.7 |
1.2 |
0.9 |
8 P, 6 P, 6 P |
|
|
5000 |
7.7 |
3.8 |
1.0 |
12 P, 6 P, 5 P |
|
2-AA |
2.5 |
257.3 |
10.5 |
35.1 |
247, 268, 257 |
TA 100 |
DMSO |
- |
87.3 |
9.3 |
- |
90, 77, 95 |
|
Test item |
33 |
97.3 |
10.1 |
1.1 |
92, 109, 91 |
|
|
100 |
90.3 |
6.0 |
1.0 |
91, 96, 84 |
|
|
333 |
94.0 |
3.6 |
1.1 |
97, 90, 95 |
|
|
1000 |
96.3 |
12.7 |
1.1 |
90, 111, 88 |
|
|
2500 |
96.0 |
4.4 |
1.1 |
94 P, 101 P, 93 P |
|
|
5000 |
125.7 |
8.5 |
1.4 |
132 P, 129 P, 116 P |
|
2-AA |
2.5 |
2436.0 |
80.7 |
27.9 |
2412, 2526, 2370 |
TA 1537 |
DMSO |
- |
5.3 |
1.5 |
- |
5, 7, 4 |
|
Test item |
33 |
4.3 |
3.1 |
0.8 |
5, 7, 1 |
|
|
100 |
5.3 |
2.9 |
1.0 |
7, 7, 2 |
|
|
333 |
4.0 |
1.0 |
0.8 |
4, 5, 3 |
|
|
1000 |
4.3 |
1.2 |
0.8 |
3, 5, 5 |
|
|
2500 |
3.3 |
1.2 |
0.6 |
4 P, 2 P, 4 P |
|
|
5000 |
3.0 |
1.7 |
0.6 |
5 P, 2 P, 2 P |
|
2-AA |
2.5 |
170.7 |
17.8 |
32.0 |
190, 167, 155 |
TA 98 |
DMSO |
- |
22.0 |
5.0 |
- |
22, 17, 27 |
|
Test item |
33 |
23.0 |
5.3 |
1.0 |
19, 21, 29 |
|
|
100 |
18.0 |
4.6 |
0.8 |
17, 14, 23 |
|
|
333 |
16.3 |
6.0 |
0.7 |
10, 22, 17 |
|
|
1000 |
15.0 |
4.4 |
0.7 |
13, 20, 12 |
|
|
2500 |
19.0 |
2.0 |
0.9 |
21 P, 17 P, 19 P |
|
|
5000 |
18.3 |
3.5 |
0.8 |
22 P, 15 P, 18 P |
|
2-AA |
2.5 |
2271.3 |
74.0 |
103.2 |
2270, 2198, 2346 |
E. coli |
DMSO |
- |
19.0 |
1.7 |
- |
20, 20, 17 |
|
Test item |
33 |
24.0 |
1.0 |
1.3 |
25, 24, 23 |
|
|
100 |
24.0 |
2.0 |
1.3 |
22, 26, 24 |
|
|
333 |
18.7 |
2.9 |
1.0 |
17, 17, 22 |
|
|
1000 |
20.3 |
10.5 |
1.1 |
10, 31, 20 |
|
|
2500 |
20.3 |
6.1 |
1.1 |
15 P, 19 P, 27 P |
|
|
5000 |
18.3 |
4.9 |
1.0 |
24 P, 16 P, 15 P |
|
2-AA |
60 |
73.3 |
7.4 |
3.9 |
79, 76, 65 |
Tab. 4: Historical Negative Controls
Strain S9 Mix |
Vehicle |
No. of |
No. of Values |
Min |
Max |
Mean |
SD
|
TA 1535 Without |
(All) |
222 |
84 |
8 |
19 |
13 |
2.3 |
With |
(All) |
222 |
84 |
7 |
19 |
12 |
2.3 |
|
|
|
|
|
|
|
|
TA 100 Without |
(All) |
231 |
84 |
18 |
133 |
110 |
14.3 |
With |
(All) |
231 |
86 |
82 |
145 |
110 |
12.0 |
|
|
|
|
|
|
|
|
TA 1537 Without |
(All) |
228 |
84 |
5 |
15 |
10 |
2.1 |
With |
(All) |
225 |
84 |
6 |
16 |
10 |
1.9 |
|
|
|
|
|
|
|
|
TA 98 Without |
(All) |
228 |
85 |
14 |
30 |
20 |
3.4 |
With |
(All) |
234 |
85 |
16 |
37 |
26 |
4.4 |
|
|
|
|
|
|
|
|
E. coli Without |
(All) |
216 |
83 |
13 |
40 |
27 |
4.7 |
With |
(All) |
216 |
83 |
17 |
39 |
27 |
3.7 |
Tab. 5: Historical Positive Controls
Strain |
S9 Mix |
Positive |
No. of |
No. of |
Min |
Max |
Mean |
SD |
|
|
control |
Plates |
Values |
|
|
|
|
TA 1535 Without |
MNNG |
180 |
66 |
1517 |
6912 |
4122 |
1569.6 |
With |
2-AA |
180 |
66 |
97 |
421 |
207 |
76.5 |
|
|
|
|
|
|
|
|
TA 100 Without |
MNNG |
183 |
66 |
573 |
6005 |
3058 |
1305.3 |
With |
2-AA |
186 |
68 |
816 |
3693 |
1826 |
687.5 |
|
|
|
|
|
|
|
|
TA 1537 Without |
AAC |
183 |
66 |
187 |
1400 |
829 |
198.7 |
With |
2-AA |
180 |
66 |
66 |
270 |
151 |
50.7 |
|
|
|
|
|
|
|
|
TA 98 Without |
NOPD |
186 |
67 |
531 |
1148 |
857 |
109.2 |
With |
2-AA |
192 |
67 |
392 |
2791 |
1457 |
641.4 |
|
|
|
|
|
|
|
|
E. coli Without |
4-NQO |
174 |
66 |
348 |
1638 |
1090 |
408.3 |
With |
2-AA |
171 |
66 |
81 |
278 |
215 |
39.2 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse
mutation assay.
STRAINS: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
DOSE RANGE: 33 μg - 5000 μg/plate (SPT); 33 μg - 5000 μg/plate (PIT)
TEST CONDITIONS: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).
SOLUBILITY: Precipitation of the test substance was observed at and above 2500 μg/plate with and without S9 mix.
TOXICITY: A bacteriotoxic effect was observed depending on the strain and test conditions at and above 1000 μg/plate.
MUTAGENICITY: A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.
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