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EC number: 923-201-3 | CAS number: 1192143-92-2
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, Landesinstitut für Arbeitsschutz und Produktsicherheit, München, Germany)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- UMA121
- IUPAC Name:
- UMA121
- Reference substance name:
- Propanol, oxybis-, oligomeric reaction products with 1,1'-methylenebis[isocyanatobenzene], propylene glycol monomethacrylate-blocked
- EC Number:
- 923-201-3
- Cas Number:
- 1192143-92-2
- Molecular formula:
- C29H34N2O8 C50H58N4O13 C71H82N6O18 C92H106N8O23 C113H130N10O28
- IUPAC Name:
- Propanol, oxybis-, oligomeric reaction products with 1,1'-methylenebis[isocyanatobenzene], propylene glycol monomethacrylate-blocked
Constituent 1
Constituent 2
Method
- Target gene:
- his operon
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:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male Wistar rats treated with phenobarbital (80 mg/kg bw) and β-naphtoflavone (100 mg/kg bw) for three consecutive days
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- Aqua dest.
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (10 µg/pl.; TA 100, TA 1535); 4-nitro-o-phenylene-diamine (10 µg/pl. for TA 98 and 40 µg/pl. for TA 1537); methylmethanesulfonate (1 µL/pl.; TA 102); +S9: 2-aminoanthracene (10 µg/pl. for TA 102; 2.5 µg/pl. for all other strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: in agar (plate incorporation)
Experiment II: preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: clearing of the background lawn or reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control - Evaluation criteria:
- A substance is considered to be mutagenic if a clear and dose-related increase in the number of revertants occurs and/or a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation. A biologically relevant positive response will be assumed if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high than the reversion rate of the solvent control and/or if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
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
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation was observed in Experiment I in all tester strains at 1000 µg/plate and higher without metabolic activation and at 5000 µg/plate with metabolic activation. In Experiment II, precipitation of the test substance was noticed in all tester strains at 2500 and 5000 µg/plate with and without metabolic activation.
COMPARISON WITH HISTORICAL CONTROL DATA: The positive and negative control data of both experiments were in the range of the historical control data.
ADDITIONAL INFORMATION ON CYTOTOXICITY: A reduction of the background lawn was only observed in tester strain TA1537 in Experiment II at concentrations of 2500 and 5000 µg/plate without metabolic activation. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Experiment I: Plate-incorporation Test
Bacterial Reverse Mutation Assay, mean revertants colonies/plate (mutation factor) |
|||||
EXPERIMENT I (Plate incorporation test) |
|||||
S9-Mix |
Without
|
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
18 ± 2.0 (1.0) |
87 ± 11.0 (1.1) |
7 ± 2.1 (1.0) |
8 ± 1.7 (1.6) |
178 ± 5.6 (1.2) |
VC |
18 ± 4.4 (1.0) |
76 ± 9.0 (1.0) |
7 ± 4.0 (1.0) |
5 ± 0.0 (1.0) |
153 ± 9.0 (1.0) |
31.6 |
16 ± 3.5 (0.9) |
80 ± 14.7 (1.0) |
5 ± 1.0 (0.8) |
8 ± 2.0 (1.6) |
172 ± 5.5 (1.1) |
100 |
19 ± 3.8 (1.1) |
87 ± 15.5 (1.1) |
6 ± 3.5 (1.0) |
9 ± 3.2 (1.9) |
165 ± 15.0 (1.1) |
316 |
23 ± 4.0 (1.3) |
74 ± 6.6 (1.0) |
6 ± 3.5 (0.9) |
10 ± 3.6 (2.0) |
167 ± 3.0 (1.1) |
1000 |
15 ± 2.3 P (0.9) |
86 ± 12.3 P (1.1) |
5 ± 0.6 P (0.8) |
13 ± 7.1 P (2.5) |
166 ± 9.0 P (1.1) |
2500 |
13 ± 2.5 P (0.7) |
70 ± 6.0 P (0.9) |
4 ± 3.1 P (0.7) |
8 ± 1.0 P (1.6) |
189 ± 12.3 P (1.2) |
5000 |
18 ± 1.0 P (1.0) |
82 ± 6.2 P (1.1) |
6 ± 2.9 P (0.9) |
8 ± 3.5 P (1.5) |
176 ± 7.5 P (1.1) |
4-NOPD |
425 ± 56.3 (23.6) |
--- |
--- |
86 ± 4.7 (17.1) |
--- |
NaN3 |
--- |
318 ± 102.2 (3.7) |
612 ± 193.7 (91.9) |
--- |
--- |
MMS |
--- |
--- |
--- |
--- |
1454 ± 246.3 (8.2) |
S9-Mix
|
With |
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
23 ± 4.7 (0.8) |
118 ± 15.0 (1.0) |
6 ± 1.5 (1.4) |
8 ± 3.2 (1.4) |
216 ± 40.0 (1.3) |
VC |
28 ± 4.7 (1.0) |
115 ± 15.6 (1.0) |
5 ± 2.1 (1.0) |
6 ± 3.2 (1.0) |
169 ± 19.7 (1.0) |
31.6 |
24 ± 5.5 (0.9) |
123 ± 14.9 (1.1) |
4 ± 2.5 (0.9) |
9 ± 6.4 (1.6) |
206 ± 18.1 (1.2) |
100 |
32 ± 8.1 (1.1) |
116 ± 10.7 (1.0) |
5 ± 2.0 (1.1) |
8 ± 5.5 (1.5) |
209 ± 15.3 (1.2) |
316 |
29 ± 4.0 (1.0) |
116 ± 10.0 (1.0) |
5 ± 2.1 (1.1) |
9 ± 1.5 (1.5) |
172 ± 13.1 (1.0) |
1000 |
31 ± 10.0 (1.1) |
107 ± 5.0 (0.9) |
5 ± 1.7 (1.1) |
5 ± 3.5 (0.9) |
176 ± 15.5 (1.0) |
2500 |
29 ± 2.1 (1.0) |
123 ± 8.1 (1.1) |
8 ± 3.2 (1.6) |
8 ± 2.1 (1.4) |
187 ± 12.1 (1.1) |
5000 |
25 ± 4.6 P (0.9) |
119 ± 18.0 P (1.0) |
6 ± 2.1 P (1.2) |
6 ± 1.0 P (1.1) |
214 ± 1.7 P (1.3) |
2-AA |
2278 ± 372.4 (82.3) |
1805 ± 347.6 (15.7) |
74 ± 18.6 (15.9) |
276 ± 38.6 (48.7) |
389 ± 30.8 (2.3) |
NC = Negative Control (Aqua dest.) VC = Vehicle Control (DMSO) 4-NOPD = 4-nitro-o-phenylene-diamine NaN3= sodium azide MMS = methylmethanesulfonate 2-AA = 2-aminoanthracene P = Precipitation |
|||||
Table 2. Experiment II: Preincubation Test
Bacterial Reverse Mutation Assay, mean revertants colonies/plate (mutation factor) |
|||||
EXPERIMENT II (Preincubation test) |
|||||
S9-Mix |
Without
|
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
23 ± 3.8 (1.2) |
87 ± 8.2 (1.4) |
6 ± 1.0 (1.1) |
8 ± 0.0 (1.7) |
178 ± 17.8 (1.0) |
VC |
18 ± 6.5 (1.0) |
61 ± 9.5 (1.0) |
5 ± 0.6 (1.0) |
5 ± 2.3 (1.0) |
175 ± 13.8 (1.0) |
31.6 |
21 ± 7.0 (1.1) |
69 ± 6.7 (1.1) |
6 ± 1.0 (1.1) |
6 ± 1.5 (1.4) |
173 ± 16.1 (1.0) |
100 |
22 ± 8.3 (1.2) |
81 ± 2.1 (1.3) |
3 ± 3.5 (0.6) |
7 ± 4.0 (1.6) |
161 ± 13.4 (0.9) |
316 |
25 ± 4.6 (1.4) |
77 ± 7.6 (1.3) |
4 ± 2.1 (0.7) |
4 ± 1.2 (0.9) |
162 ± 8.6 (0.9) |
1000 |
20 ± 4.4 (1.1) |
72 ± 4.6 (1.2) |
3 ± 1.5 (0.5) |
6 ± 1.0 (1.3) |
155 ± 2.9 (0.9) |
2500 |
12 ± 2.6 P (0.7) |
77 ± 5.9 P (1.3) |
5 ± 2.1 P (0.9) |
8 ± 2.1 BP (1.6) |
160 ± 14.9 P (0.9) |
5000 |
27 ± 9.3 P (1.5) |
79 ± 7.6 P (1.3) |
4 ± 2.1 P (0.8) |
6 ± 1.5 BP (1.2) |
171 ± 25.0 P (1.0) |
4-NOPD |
266 ± 37.5 (14.5) |
--- |
--- |
78 ± 7.0 (16.7) |
--- |
NaN3 |
--- |
894 ± 219.3 (10.3) |
417 ± 4.4 (69.5) |
--- |
--- |
MMS |
--- |
--- |
--- |
--- |
1430 ± 407.6 (8.0) |
S9-Mix
|
With |
||||
Test item (µg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
NC |
28 ± 5.8 (1.2) |
97 ± 19.1 (1.1) |
5 ± 1.0 (1.0) |
5 ± 2.5 (0.8) |
263 ± 36.5 (1.1) |
VC |
23 ± 4.0 (1.0) |
88 ± 9.0 (1.0) |
5 ± 2.0 (1.0) |
6 ± 0.6 (1.0) |
235 ± 9.5 (1.0) |
31.6 |
27 ± 2.1 (1.2) |
89 ± 5.1 (1.0) |
6 ± 2.1 (1.1) |
6 ± 1.2 (1.0) |
257 ± 36.8 (1.1) |
100 |
28 ± 1.2 (1.2) |
100 ± 13.3 (1.1) |
5 ± 1.0 (1.0) |
6 ± 1.5 (1.0) |
259 ± 2.5 (1.1) |
316 |
21 ± 5.3 (0.9) |
84 ± 27.3 (1.0) |
4 ± 0.6 (0.7) |
8 ± 0.0 (1.3) |
255 ± 6.4 (1.1) |
1000 |
26 ± 8.5 (1.1) |
88 ± 22.1 (1.0) |
6 ± 2.1 (1.3) |
9 ± 4.4 (1.4) |
259 ± 5.3 (1.1) |
2500 |
26 ± 7.6 P (1.1) |
97 ± 6.7 P (1.1) |
8 ± 4.0 P (1.5) |
10 ± 4.0 P (1.6) |
223 ± 6.8 P (0.9) |
5000 |
29 ± 4.5 P (1.3) |
155 ± 27.4 P (1.8) |
4 ± 2.1 P (0.7) |
6 ± 3.2 P (1.0) |
333 ± 31.5 P (1.4) |
2-AA |
2005 ± 694.8 (85.9) |
1443 ± 57.5 (16.5) |
53 ± 2.0 (10.6) |
209 ± 26.9 (33.0) |
696 ± 69.9 (3.0) |
NC = Negative Control (Aqua dest.) VC = Vehicle Control (DMSO) 4-NOPD = 4-nitro-o-phenylene-diamine NaN3= sodium azide MMS = methylmethanesulfonate 2-AA = 2-aminoanthracene P = Precipitation B = Background lawn reduced |
|||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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