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EC number: 260-976-0 | CAS number: 57834-33-0
- 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
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- Oxidising properties
- Oxidation reduction potential
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- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
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- Dissociation constant
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
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- 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
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- Additional ecotoxological information
- Toxicological Summary
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- Acute Toxicity
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
According to OECD 471 test method, Eversorb EP4 was mutagenic in the reverse mutation analysis of Salmonella typhimurium.
According to OECD 473 test method, Eversorb EP4 was negative effect under the condition of in vitro mammalian chromosome aberration test.
According to OECD 490 test method, Eversorb EP4 is not mutagenic in the mouse lymphoma L5178Y test system under the experimentalc ondition of In Vitro Mammalian Cell Gene Mutation Tests.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From November 08, 2016 to December 28, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- 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 Mix
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- benzo(a)pyrene
- mitomycin C
- other: 2-Aminoanthracene
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not determined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- 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:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- 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:
- not determined
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 471 test method, Eversorb EP4 was mutagenic in the reverse mutation analysis of Salmonella typhimurium.
- Executive summary:
This test using the procedures outlined in the SuperLub Study Plan for M62-151100161001EN which is based on the SOP for the OECD 471 (SOPF-203) and OECD 471 (OECD, 1997). The results of this OECD 471 test for Eversorb EP4 show that test validity criteria was met.
Based on the preliminary assay results, 5mg/plate was set as the highest dose in this study. In the mutagenicity assay, five doses of Eversorb EP4 at 0.3125, 0.625, 1.25, 2.5 and 5mg/plate, concurrent negative and strain-specific positive controls were tested in tester strains TA98, TA100, TA102, TA1535 and TA1537 in triplicate with or without S9 Mix activation. At the highest dose with S9 Mix in tester strains of Salmonella typhimurium TA98 of test groups, the results showed that the number of revertants increase twice more than negative controls group. Based on the data obtained from this study, it was concluded that under the test condition, Eversorb EP4 was mutagenic in the reverse mutation analysis of Salmonella typhimurium.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 11, 2016 to March 1, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Metabolic activation system:
- The post-mitochondrial fraction (S9) of liver from Aroclor 1254 induced Sprague-Dawley rats
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Species / strain:
- Chinese hamster Ovary (CHO)
- Remarks:
- CHO-K1
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 473 test method, Eversorb EP4 was negative effect under the condition of in vitro mammalian chromosome aberration test.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65316025-GT and OECD 473 (OECD, 2016). The results of this OECD 473 test for Eversorb EP4 show that test validity criteria was met.
Based on the results of a preliminary concentration-range finding cytotoxicity test, 500 and 2000 μg/mL as the highest dosage were used to perform the test respectively in 3-hour or 20-hour treatment without S9 metabolic activation (Schemes I and III) and 3-hour treatment with S9 metabolic activation (Scheme II). In the chromosome aberration test, five doses of Eversorb EP4, negative and positive controls were tested in duplicate with or without S9 Mix. In test group, the cell proportions with abnormal chromosome in three Schemes were not higher than 3%. Based on the data obtained from this study, it was concluded that under the test condition, Eversorb EP4 was negative effect in mammalian chromosome aberration test (in vitro).
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 09, 2018 to Sep. 11, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Remarks:
- L5178Y/TK+/--3.7.2C
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Mix
- Untreated negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Species / strain:
- mouse lymphoma L5178Y cells
- Remarks:
- L5178Y/TK+/--3.7.2C
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- According to OECD 490 test method, Eversorb EP4 is not mutagenic in the TK mutation test system under the experimental condition of In Vitro Mammalian Cell Gene Mutation Tests.
- Executive summary:
The test was performed in the absence of S9-mix with 3 and 24 hour treatment periods and in the presence of S9-mix with a 3 hour treatment period.
The study procedures described in this report were based on the most recent OECD guideline.
In the first experiment, Eversorb EP4 was tested up to concentrations of 175 μg/mL in the absence and presence S9-mix. The incubation time was 3 hours. The Relative total growth (RTG) was reduced to 23% in the absence of S9-mix and no toxicity was observed at this
dose level in the presence of S9-mix. Eversorb EP4 precipitated in the culture medium at this dose level.
In the second experiment, Eversorb EP4 was tested up to concentrations of 115 μg/mL in the absence of S9-mix. The incubation time was 24 hours. The RTG was reduced to 9%.
Eversorb EP4 did not precipitate in the culture medium at this dose level.
In the absence of S9-mix, Eversorb EP4 did not induce a biologically relevant increase in the mutation frequency in the first experiment. This result was confirmed in an independent experiment with modification in the duration of treatment.
In the presence of S9-mix, Eversorb EP4 did not induce a biologically relevant increase in the mutation frequency.
In conclusion, Eversorb EP4 is not mutagenic in the mouse lymphoma L5178Y test system under the experimental condition of In Vitro Mammalian Cell Gene Mutation Tests.
Referenceopen allclose all
Table 1. Characteristics of five Salmonella typhimurium strains
Test strain |
Histidine requirement |
uvrB mutation |
rfa mutation |
Ampicillin resistance |
TA98 |
+ |
+ |
+ |
+ |
TA100 |
+ |
+ |
+ |
+ |
TA102 |
+ |
ϴ |
+ |
+ |
TA1535 |
+ |
+ |
+ |
ϴ |
TA1537 |
+ |
+ |
+ |
ϴ |
+ means had the characteristic; ϴ means did not have the characteristic
Table 2. Toxicity of the test article of Salmonella typhimurium TA100
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
With S9 Mix |
Negative control group |
236 |
Positive control groupa |
1532 |
|
Test group |
||
5 |
264 |
|
2.5 |
327 |
|
1.25 |
283 |
|
0.625 |
369 |
|
0.3125 |
326 |
|
Without S9 Mix |
Negative control group |
182 |
Positive control group |
725 |
|
Test group |
||
5 |
151 |
|
2.5 |
185 |
|
1.25 |
150 |
|
0.625 |
154 |
|
0.3125 |
164 |
a Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: Sodium azide (5μg/plate).
Table 3. Reverse mutation test of Salmonella typhimurium TA98
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
37 |
36 |
58 |
44 ± 12 |
Positive control groupb |
376 |
405 |
355 |
379 ± 25* |
|
Test group |
|||||
5 |
98 |
117 |
85 |
100 ± 16* |
|
2.5 |
71 |
87 |
81 |
80 ± 8 |
|
1.25 |
59 |
42 |
37 |
46 ± 12 |
|
0.625 |
44 |
44 |
72 |
53 ± 16 |
|
0.3125 |
24 |
40 |
48 |
37 ± 12 |
|
Without S9 Mix |
Negative control group |
33 |
41 |
36 |
37 ± 4 |
Positive control group |
381 |
345 |
341 |
356 ± 22* |
|
Test group |
|||||
5 |
37 |
39 |
39 |
38 ± 1 |
|
2.5 |
37 |
53 |
44 |
45 ± 8 |
|
1.25 |
28 |
27 |
41 |
32 ± 8 |
|
0.625 |
41 |
40 |
49 |
43 ± 5 |
|
0.3125 |
30 |
48 |
36 |
38 ± 9 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: Benzo [a] pyrene (4.0μg/plate).
Without S9 Mix: 4-Nitroquinoline-N-oxide (0.5μg/plate).
*Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 4. Reverse mutation test of Salmonella typhimurium TA100
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
216 |
221 |
243 |
277 ± 14 |
Positive control groupb |
1386 |
1535 |
1485 |
1469 ± 76* |
|
Test group |
|||||
5 |
232 |
322 |
363 |
306 ± 67 |
|
2.5 |
249 |
253 |
249 |
250 ± 2 |
|
1.25 |
214 |
198 |
269 |
227 ± 37 |
|
0.625 |
240 |
271 |
259 |
257 ± 16 |
|
0.3125 |
282 |
269 |
253 |
268 ± 15 |
|
Without S9 Mix |
Negative control group |
215 |
190 |
175 |
193 ± 20 |
Positive control group |
638 |
629 |
677 |
648 ± 26* |
|
Test group |
|||||
5 |
132 |
152 |
152 |
145 ± 12 |
|
2.5 |
153 |
192 |
194 |
180 ± 23 |
|
1.25 |
158 |
186 |
178 |
174 ± 14 |
|
0.625 |
153 |
144 |
154 |
150 ± 6 |
|
0.3125 |
166 |
250 |
248 |
221 ± 48 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: Sodium azide (5μg/plate).
*Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 5. Reverse mutation test of Salmonella typhimurium TA102
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
482 |
416 |
464 |
454 ± 34 |
Positive control groupb |
945 |
968 |
984 |
966 ± 20* |
|
Test group |
|||||
5 |
437 |
446 |
472 |
452 ± 18 |
|
2.5 |
470 |
426 |
453 |
450 ± 22 |
|
1.25 |
512 |
489 |
478 |
493 ± 17 |
|
0.625 |
498 |
473 |
515 |
495 ± 21 |
|
0.3125 |
451 |
517 |
521 |
496 ± 39 |
|
Without S9 Mix |
Negative control group |
407 |
416 |
382 |
402 ± 18 |
Positive control group |
838 |
861 |
802 |
834 ± 30* |
|
Test group |
|||||
5 |
347 |
334 |
388 |
356 ± 28 |
|
2.5 |
381 |
430 |
420 |
410 ± 26 |
|
1.25 |
344 |
353 |
376 |
358 ± 17 |
|
0.625 |
393 |
378 |
346 |
372 ± 24 |
|
0.3125 |
443 |
391 |
371 |
402 ± 37 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (10μg/plate).
Without S9 Mix: Mitomycin C (0.5μg/plate).
*Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 6. Reverse mutation test of Salmonella typhimurium TA1535
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
23 |
33 |
24 |
27 ± 6 |
Positive control groupb |
363 |
348 |
325 |
345 ± 19* |
|
Test group |
|||||
5 |
32 |
25 |
45 |
34 ± 10 |
|
2.5 |
15 |
23 |
20 |
19 ± 4 |
|
1.25 |
12 |
18 |
16 |
15 ± 3 |
|
0.625 |
20 |
17 |
15 |
17 ± 3 |
|
0.3125 |
14 |
17 |
24 |
18 ± 5 |
|
Without S9 Mix |
Negative control group |
30 |
26 |
24 |
27 ± 3 |
Positive control group |
224 |
230 |
154 |
236 ± 16* |
|
Test group |
|||||
5 |
19 |
26 |
21 |
22 ± 4 |
|
2.5 |
24 |
22 |
18 |
21 ± 3 |
|
1.25 |
17 |
17 |
26 |
20 ± 5 |
|
0.625 |
18 |
18 |
16 |
17 ± 1 |
|
0.3125 |
17 |
28 |
35 |
27 ± 9 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: Sodium azide (0.4μg/plate).
*Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 7. Reverse mutation test of Salmonella typhimurium TA1537
Group |
Test article (mg/plate) |
Reverse mutant colony number (CFU/plate) |
Average of coloniesa |
||
1 |
2 |
3 |
|||
With S9 Mix |
Negative control group |
26 |
12 |
13 |
17 ± 8 |
Positive control groupb |
486 |
438 |
422 |
449 ± 33* |
|
Test group |
|||||
5 |
17 |
25 |
18 |
20 ± 4 |
|
2.5 |
22 |
14 |
25 |
20 ± 6 |
|
1.25 |
13 |
15 |
12 |
13 ± 2 |
|
0.625 |
18 |
14 |
12 |
15 ± 3 |
|
0.3125 |
11 |
12 |
13 |
12 ± 1 |
|
Without S9 Mix |
Negative control group |
17 |
15 |
19 |
17 ± 2 |
Positive control group |
1013 |
1036 |
874 |
974 ± 88* |
|
Test group |
|||||
5 |
6 |
8 |
6 |
7 ± 1 |
|
2.5 |
5 |
11 |
7 |
8 ± 3 |
|
1.25 |
8 |
2 |
6 |
5 ± 3 |
|
0.625 |
2 |
5 |
7 |
5 ± 3 |
|
0.3125 |
4 |
9 |
15 |
9 ± 6 |
a Average of colonies was shown as Mean ± S.D., the data were triplicate.
b Positive control group: With S9 Mix: 2-Aminoanthracene (4.0μg/plate).
Without S9 Mix: 9-Aminoacridine (50.0μg/plate).
*Reverse mutant colony number were twice more than negative control group, ρ < 0.05 (One-Way ANOVA).
Table 1. Karyology Analysis of Chinese Hamster Ovary Cells
No. of chromosome |
<18 |
18 |
19 |
20 |
21 |
22 |
>22 |
No. of cells |
0 |
0 |
14 |
31 |
5 |
0 |
0 |
Table 2. Concurrent Cytotoxicity Analysis of Eversorb EP4 in Chinese Hamster Ovary Cells
Concentration (μg/mL) |
Cell Number (× 105cells) |
ICCa N-N0 |
RICCb (%) |
Cytotoxicityc (%) |
Before Treatment |
||||
Untreated (-S9) |
26.6 |
|
|
|
Untreated (+S9) |
23.0 |
|
|
|
After Treatment |
||||
Scheme I (-S9, 3h) |
||||
Negative Control |
58.4 |
31.8 |
100.0 |
0.0 |
7.5 |
59.8 |
33.2 |
104.4 |
0.0 |
21.44 |
56.6 |
30.0 |
94.3 |
5.7 |
61.25 |
50.2 |
23.6 |
74.2 |
25.8 |
175 |
37.0 |
10.4 |
32.7 |
67.3 |
500 |
30.4 |
3.8 |
11.9 |
88.1 |
Positive Controld |
48.0 |
21.4 |
67.3 |
32.7 |
Scheme II (+S9, 3h) |
||||
Negative Control |
156.2 |
133.2 |
100.0 |
0.0 |
7.5 |
153.6 |
130.6 |
98.0 |
2.0 |
21.44 |
162.6 |
139.6 |
104.8 |
0.0 |
61.25 |
136.0 |
113.0 |
84.8 |
15.2 |
175 |
21.0 |
-2.0 |
0.0 |
100.0 |
500 |
35.8 |
12.8 |
9.6 |
90.4 |
Positive Controle |
31.2 |
8.2 |
6.2 |
93.8 |
Scheme III (-S9, 20h) |
||||
Negative Control |
59.2 |
32.6 |
100.0 |
0.0 |
7.5 |
56.8 |
30.2 |
92.6 |
7.4 |
21.44 |
53.2 |
26.6 |
81.6 |
18.4 |
61.25 |
43.0 |
16.4 |
50.3 |
49.7 |
175 |
32.4 |
5.8 |
17.8 |
82.2 |
500 |
27.4 |
0.8 |
2.5 |
97.5 |
Positive Controlf |
49.0 |
22.4 |
68.7 |
31.3 |
a ICC: increased in cell counts = Cell No.After treatment(N) - Cell No.Before treatment(N0)
b RICC: relative increase in cell counts; RICC = (ICCtreatment/ICCcontrol) × 100
c Cytotoxicity (%) = 100 – RICC
d Positive control was 0.33mg/mL mitomycin C (MMC)
e Positive control was 11.2mg/mL cyclophosphamide (CPP)
f Positive control was 0.2mg/mL mitomycin C (MMC)
Table 3. Summary of Chromosome Aberrations in Chinese Hamster Ovary Cells for Eversorb EP4
Treatment |
Concentration (μg/mL) |
Treating Hour |
S9 (-/+) |
Aberrant Cells (%) |
Scheme I (-S9, 3h) |
||||
Negative Controla |
0 |
3 |
- |
0.00 |
Test Article |
7.5 |
3 |
- |
0.00 |
21.44 |
3 |
- |
0.00 |
|
61.25 |
3 |
- |
0.00 |
|
175 |
3 |
- |
0.67 |
|
500 |
3 |
- |
-* |
|
Positive Controlb |
0.33 |
3 |
- |
21.67** |
Scheme II (+S9, 3h) |
||||
Negative Controlc |
0 |
3 |
+ |
0.00 |
Test Article |
30 |
3 |
+ |
0.33 |
85.75 |
3 |
+ |
1.00 |
|
245 |
3 |
+ |
0.33 |
|
700 |
3 |
+ |
3.00 |
|
2000 |
3 |
+ |
0.00 |
|
Positive Controld |
11.2 |
3 |
+ |
30.67** |
Scheme III (-S9, 20h) |
||||
Negative Controla |
0 |
20 |
- |
0.00 |
Test Article |
7.5 |
20 |
- |
0.33 |
21.44 |
20 |
- |
0.00 |
|
61.25 |
20 |
- |
1.00 |
|
175 |
20 |
- |
-* |
|
500 |
20 |
- |
-* |
|
Positive Controlb |
0.2 |
20 |
- |
36.33** |
All data were scored from 300 metaphase cells of each treatment (duplicate cultures).
a Negative control was 1% DMSO in McCoy’s 5A medium.
b Positive control was mitomycin C (MMC).
c Negative control was 1% DMSO in S-9 mixture medium.
d Positive control was cyclophosphamide (CPP).
*: Too few metaphases
**: The frequency of aberrant cells was significantly higher than that of the negative control (One-tailed binomial test, α = 0.01).
Table 1
Dose-range Finding Test: Cytotoxicity of Eversorb EP4 (3 Hour Treatment)
Dose
(μg/ml) |
cell count after 24 hours of subculture (cells/ml x105) |
cell count after 48 hours of subculture (cells/ml x105) |
SG(1)
(x105cells/ml) |
RSG(2)
(%) |
without metabolic activation |
||||
SC |
5.2 |
7.4 |
19 |
100 |
16 |
4.8 |
8.4 |
20 |
105 |
31 |
2.2 |
8.8 |
10 |
50 |
63 |
1.6 |
8.0 |
6 |
33 |
125 |
0.8(4) |
4.8 |
2 |
10 |
250(3) |
0.5(4) |
1.6 |
0 |
2 |
with metabolic activation |
||||
SC |
2.9 |
5.4 |
8 |
100 |
16 |
3.8 |
5.0 |
10 |
121 |
31 |
3.1 |
5.3 |
8 |
105 |
63 |
2.9 |
6.6 |
10 |
122 |
125 |
3.0 |
6.6 |
10 |
126 |
250(3) |
3.3 |
6.3 |
10 |
133 |
Note: all calculations were made without rounding off
SC = solvent control = dimethyl sulfoxide
(1)= suspension growth
(2)= relative suspension growth
(3)= the test item precipitated in the exposure medium
(4)= since less than 1.25 x 105c/ml were present, no subculture was performed
SG = Suspension growth = [Cell count after 24 hour of subculture (Day 1) /1.6 x 105] x [Cell count after 48hours of subculture (Day 2)/1.25 x 105]*
* Or appropriate cell concentration
RSG = [SG(test)/SG(control)] x 100
Table 2
Dose-range Finding Test: Cytotoxicity of Eversorb EP4 (24 Hour Treatment)
Dose
(μg/ml) |
cell count after 24 hours of subculture (cells/ml x105) |
cell count after 24 hours of subculture (cells/ml x105) |
SG(1)
(x105cells/ml) |
RSG(2)
(%) |
without metabolic activation |
||||
SC |
9.7 |
6.3 |
39 |
100 |
16 |
9.8 |
6.7 |
42 |
107 |
31 |
8.8 |
6.9 |
39 |
99 |
63 |
5.2 |
5.9 |
20 |
50 |
125 |
1.9 |
2.5 |
3 |
8 |
250(3) |
0.2(4) |
0.2 |
0 |
0 |
Note: all calculations were made without rounding off
SC = solvent control = dimethyl sulfoxide
(1)= suspension growth
(2)= relative suspension growth
(3)= the test item precipitated in the exposure medium
(4)= since less than 1.25 x 105c/ml were present, no subculture was performed
SG = Suspension growth = [Day 0 cell count/1.25 x 105]* x [Day 1 cell count/1.25 x 105]*
* Or appropriate cell concentration
RSG = [SG(test)/SG(control)] x 100
Table 3
Experiment 1: Cytotoxic and Mutagenic Response of Eversorb EP4 in the Mouse Lymphoma L5178Y Test System
dose
(μg/ml) |
RSG
(%) |
CE day2
(%) |
RCE
(%) |
RTG
(%) |
mutation frequency per 106survivors total ( small large ) |
without metabolic activation 3 hour treatment |
|||||
SC1 |
100 |
97 |
100 |
100 |
83 ( 27 53 ) |
SC2 |
90 |
70 ( 25 43 ) |
|||
3.1 |
89 |
98 |
105 |
93 |
99 ( 42 53 ) |
6.3 |
98 |
102 |
110 |
107 |
75 ( 37 35 ) |
12.5 |
114 |
85 |
91 |
104 |
69 ( 46 21 ) |
25 |
94 |
99 |
107 |
100 |
79 ( 36 40 ) |
50 |
101 |
113 |
121 |
122 |
68 ( 26 39 ) |
100 |
70 |
88 |
94 |
66 |
68 ( 32 34 ) |
125 |
46 |
94 |
101 |
46 |
60 ( 23 36 ) |
175(1) |
30 |
70 |
75 |
23 |
95 ( 35 57 ) |
MMS |
95 |
41 |
44 |
42 |
505 ( 194 286 ) |
with metabolic activation 3 hour treatment |
|||||
SC1 |
100 |
91 |
100 |
100 |
76 ( 16 58 ) |
SC2 |
97 |
67 ( 21 44 ) |
|||
3.1 |
98 |
85 |
90 |
89 |
81 ( 19 61 ) |
6.3 |
93 |
91 |
97 |
90 |
93 ( 24 65 ) |
12.5 |
100 |
111 |
119 |
119 |
89 ( 35 49 ) |
25 |
105 |
102 |
109 |
114 |
81 ( 40 37 ) |
50 |
100 |
58 |
61 |
61 |
100 ( 26 72 ) |
100 |
91 |
93 |
99 |
90 |
80 ( 24 53 ) |
125 |
103 |
69 |
74 |
76 |
91 ( 12 78 ) |
175(1) |
98 |
93 |
99 |
97 |
68 ( 11 56 ) |
CP |
68 |
64 |
68 |
46 |
602 ( 134 424 ) |
Note: all calculations were made without rounding off
RSG = Relative Suspension Growth; CE = Cloning Efficiency; RCE = Relative Cloning Efficiency; RTG = Relative Total Growth;
SC = Solvent control = DMSO; MMS = Methylmethanesulfonate; CP = Cyclophosphamide
(1) = the test item precipitated in the exposure medium
Table 4
Experiment 2: Cytotoxic and Mutagenic Response of Eversorb EP4 in the Mouse Lymphoma L5178Y Test System
dose
(μg/ml) |
RSG
(%) |
CE day2
(%) |
RCE
(%) |
RTG
(%) |
mutation frequency per 106survivors total ( small large ) |
without metabolic activation 24 hour treatment |
|||||
SC1 |
100 |
93 |
100 |
100 |
132 ( 61 63 ) |
SC2 |
76 |
161 ( 73 79 ) |
|||
3.1 |
101 |
97 |
115 |
116 |
128 ( 50 70 ) |
6.3 |
89 |
88 |
104 |
92 |
129 ( 50 72 ) |
12.5 |
93 |
94 |
112 |
104 |
140 ( 60 71 ) |
25 |
88 |
95 |
113 |
100 |
104 ( 33 66 ) |
50 |
70 |
76 |
90 |
63 |
199 ( 140 47 ) |
100 |
38 |
83 |
98 |
37 |
214 ( 116 79 ) |
125 |
19 |
72 |
86 |
17 |
176 ( 92 73 ) |
175(1) |
9 |
86 |
102 |
9 |
180 ( 98 68 ) |
MMS |
88 |
60 |
72 |
63 |
938 ( 321 491 ) |
Note: all calculations were made without rounding off
RSG = Relative Suspension Growth; CE = Cloning Efficiency; RCE = Relative Cloning Efficiency; RTG = Relative Total Growth;
SC = Solvent control = DMSO; MMS = Methylmethanesulfonate
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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