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EC number: 292-222-1 | CAS number: 90583-23-6
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:
- 16 Sept - 25 Sept 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No E. coli strain and/or S. typhimurium TA 102 tested
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 26 May 1983
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- yes
- Remarks:
- No E. coli strain and/or S. typhimurium TA 102 tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts
- EC Number:
- 292-222-1
- EC Name:
- Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts
- Cas Number:
- 90583-23-6
- Molecular formula:
- Not applicable, UVCB substance
- IUPAC Name:
- Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment: 8, 40, 200, 1000, and 5000 µg/plate with and without metabolic activation
Second experiment: 1.6, 8, 40, 200, and 1000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Remarks:
- water
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 4-Nitro-o-phenylen diamine (NPD; 40 µg/plate; - and +S9; TA 1538 and TA 98) 2-Amino anthracene (AA; - and +S9, all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, both experiments)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replications each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met: For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels.
All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537, and TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- refer to detailed tables in section "Any other information on results incl. tables"
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Test Results of Experiment 1
EXPERIMENT 1 (Standard Plate Test, SPT) |
|||||
S9-Mix |
Without |
||||
Test item (µg/plate) |
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
NC |
14.8 ± 2.5 |
165.8 ± 8.6 |
8.3 ± 1.6 |
19.6 ± 3.3 |
19.6 ± 3.7 |
5000 |
## |
## |
## |
## |
8.6 ± 2.0 |
1000 |
## |
51.3 ± 11.2 |
## |
## |
16.6 ± 3.5 |
200 |
10.3 ± 3.0 |
98.6 ± 10.7 |
## |
17.3 ± 3.5 |
20.3 ± 2.0 |
40 |
15.3 ± 5.1 |
137.6 ± 17.9 |
8.3 ± 1.1 |
21.6 ± 1.1 |
20.6 ± 6.4 |
8 |
15.3 ± 2.8 |
164.6 ± 8.3 |
10.3 ± 2.0 |
21.0 ± 1.7 |
23.3 ± 5.6 |
sodium azide |
1012.0 ± 83.5 |
916.0 ± 51.5 |
-- |
-- |
-- |
2-Amino anthracene |
17.0 ± 4.0 |
188.3 ± 3.0 |
11.0 ± 2.0 |
36.0 ± 4.5 |
27.3 ± 5.1 |
9-Amino acridine |
-- |
-- |
1613.6 ± 193.9 |
-- |
-- |
4-Nitro-o-phenylen diamine |
-- |
-- |
-- |
1556.6 ± 202.5 |
1313.3 ± 36.2 |
S9-Mix |
With |
||||
|
|
|
|
|
|
Test item (µg/plate) |
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
NC |
13.8 ± 2.9 |
106.3 ± 16.8 |
8.3 ± 2.4 |
20.8 ± 4.4 |
24.1 ± 4.0 |
5000 |
## |
## |
## |
## |
12.6 ± 2.5 |
1000 |
10.0 ± 2.8 |
54.6 ± 14.1 |
## |
12.0 ± 1.4 |
24.0 ± 1.7 |
200 |
9.6 ± 0.57 |
93.6 ± 15.0 |
7.0 ± 1.7 |
21.3 ± 2.0 |
22.3 ± 3.2 |
40 |
13.3 ± 2.5 |
136.3 ± 21.5 |
10.6 ± 1.5 |
21.0 ± 1.0 |
30.3 ± 9.8 |
8 |
15.3 ± 1.5 |
156.6 ± 26.8 |
11.3 ± 2.0 |
25.6 ± 8.5 |
27.3 ± 6.5 |
sodium azide |
293.6 ± 19.2 |
372.3 ± 50.0 |
-- |
-- |
-- |
2-Amino anthracene |
245.6 ± 25.1 |
1025.3 ± 58.2 |
143.0 ± 41.7 |
1494.6 ± 45.3 |
1011.3 ± 127.9 |
9-Amino acridine |
-- |
-- |
590.0 ± 46.8 |
-- |
-- |
4-Nitro-o-phenylen diamine |
-- |
-- |
-- |
800.3 ± 138.2 |
735.3 ± 121.5 |
NC = Negative/Vehicle Control ##: Complete inhibition of bacterial growth --: Not tested |
|||||
Table 2: Test Results of Experiment 2
EXPERIMENT 2 (Standard Plate Test, SPT) |
|||||
S9-Mix |
Without |
||||
Test item (µg/plate) |
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
NC |
13.6 ± 1.2 |
158.3 ± 20.3 |
11.3 ± 2.3 |
20.6 ± 1.0 |
33.5 ± 3.4 |
1000 |
## |
48.0 ± 9.8 |
## |
## |
27.0 ± 3.0 |
200 |
9.6 ± 1.5 |
115.6 ± 20.4 |
## |
19.0 ± 1.0 |
28.0 ± 4.3 |
40 |
12.6 ± 3.2 |
120.0 ± 18.5 |
11.0 ± 2.0 |
21.0 ± 2.0 |
33.3 ± 5.5 |
8 |
15.6 ± 2.3 |
149.3 ± 17.6 |
13.6 ± 2.3 |
21.6 ± 1.5 |
36.0 ± 2.6 |
1.6 |
15.3 ± 0.57 |
159.0 ± 13.1 |
13.0 ± 2.6 |
24.3 ± 1.5 |
31.6 ± 3.7 |
sodium azide |
1037.0 ± 77.1 |
1017.6 ± 20.1 |
-- |
-- |
-- |
2-Amino anthracene |
18.0 ± 2.6 |
197.3 ± 12.0 |
16.6 ± 1.5 |
41.0 ± 8.7 |
39.6 ± 9.6 |
9-Amino acridine |
-- |
-- |
1250.3 ± 341.0 |
-- |
-- |
4-Nitro-o-phenylen diamine |
-- |
-- |
-- |
1753.3 ± 323.4 |
1284.3 ± 72.7 |
S9-Mix |
With |
||||
|
|
|
|
|
|
Test item (µg/plate) |
TA 1535 |
TA 100 |
TA 1537 |
TA 1538 |
TA 98 |
NC |
19.5 ± 4.0 |
191.0 ± 16.9 |
12.1 ± 1.7 |
29.5 ± 3.8 |
33.5 ± 7.3 |
1000 |
13.3 ± 2.0 |
83.6 ± 10.1 |
## |
## |
29.3 ± 3.2 |
200 |
17.6 ± 3.0 |
159.0 ± 12.0 |
8.6 ± 3.5 |
25.6 ± 4.1 |
33.3 ± 7.7 |
40 |
21.3 ± 3.7 |
196.6 ± 8.7 |
13.0 ± 1.7 |
29.3 ± 3.5 |
31.0 ± 6.0 |
8 |
20.6 ± 1.5 |
206.3 ± 11.0 |
14.6 ± 2.0 |
29.3 ± 2.0 |
36.6 ± 6.1 |
1.6 |
24.6 ± 2.5 |
200.6 ± 8.0 |
14.3 ± 2.5 |
31.3 ± 4.5 |
34.0 ± 2.6 |
sodium azide |
1095.0 ± 74.8 |
1059.0 ± 119.4 |
-- |
-- |
-- |
2-Amino anthracene |
203.6 ± 18.5 |
1669.3 ± 389.4 |
541.3 ± 56.4 |
1297.6 ± 109.9 |
1509.3 ± 36.6 |
9-Amino acridine |
-- |
-- |
1583.3 ± 134.9 |
-- |
-- |
4-Nitro-o-phenylen diamine |
-- |
-- |
-- |
1437.0 ± 44.0 |
957.3 ± 49.5 |
NC = Negative/Vehicle Control ##: Complete inhibition of bacterial growth --: Not tested |
|||||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
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