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EC number: 211-089-2 | CAS number: 629-40-3
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, GLP study (only TA 98, TA 100, TA 1535 and TA 1537 tested)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1983)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- (adopted 1997)
- Deviations:
- yes
- Remarks:
- (only 4 strains; only 2-aminoanthracene as positive control with metabolic activation)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Suberonitrile
- EC Number:
- 211-089-2
- EC Name:
- Suberonitrile
- Cas Number:
- 629-40-3
- Molecular formula:
- C8H12N2
- IUPAC Name:
- octanedinitrile
- Details on test material:
- - Name of test substance (as cited in study report): Korksaeuredinitril
- Analytical purity: 99.18%
- Substance No.: 91/319
- Batch No.: KW 7376 107-5 P 5
- Physical state: yellowish liquid
- Storage: room temperature
Constituent 1
Method
- Target gene:
- His-operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- 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:
- 20, 100, 500, 2500, 5000 µg/plate
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: (+ S9): 2-aminoanthracene (2AA; all strains); (- S9): N-methyl-N'-nitro-N-nitrosoguanidine (MNNG; TA 100 and TA 1535), 4-nitro-o-phenylendiamine (NOPD; TA 98), 9-aminoacridine chloride monohydrate (AAC; TA 1537)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation): experiment 1
DURATION
- Exposure duration: 48 h (37 °C in the dark)
METHOD OF APPLICATION: preincubation: experiment 2
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h (37 °C in the dark)
NUMBER OF REPLICATIONS: 3 plates per dose per experiment
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the number of revertant colonies; clearing or diminution of the background lawn; degree of survival of treated cultures - Evaluation criteria:
- In general, a substance has to fulfill the follwoing requirements to be characterized as positvie in the Ames test:
- doubling of the spontaneous mutation rate
- dose-response relationship
- reproducibility of the results.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (TA 1537 and TA 100 (5000 µg/plate, (-S9); TA 100 (2500 µg/plate, (+S9))
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation occurred up to a concentration of 5000 µg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Standard plate test
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
|||
Base-pair substitution type |
Frameshift type |
||||
TA 100 |
TA1535 |
TA98 |
TA1537 |
||
– |
DMSO |
133 ± 5 |
16 ± 6 |
35 ± 4 |
12 ± 2 |
– |
20 |
125 ± 17 |
16 ± 1 |
28 ± 2 |
9 ± 3 |
– |
100 |
123 ± 15 |
13 ± 3 |
20 ± 3 |
8 ± 1 |
– |
500 |
139 ± 15 |
11 ± 2 |
23 ± 5 |
7 ± 3 |
– |
2500 |
102 ± 1 |
14 ± 2 |
29 ± 8 |
9 ± 6 |
– |
5000 |
83 ± 6 |
12 ± 2 |
29 ± 2 |
5 ± 3 |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
NOPD |
AAC |
Concentrations (μg/plate) |
5 |
5 |
10 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1187 ± 49 |
1220 ± 69 |
890 ± 200 |
683 ± 137 |
|
+ |
DMSO |
142 ± 6 |
17 ± 3 |
38 ± 5 |
15 ± 3 |
+ |
20 |
126 ± 15 |
18 ± 2 |
48 ± 4 |
12 ± 3 |
+ |
100 |
130 ± 12 |
15 ± 5 |
42 ± 8 |
6 ± 1 |
+ |
500 |
95 ± 18 |
18 ± 4 |
37 ± 9 |
9 ± 2 |
+ |
2500 |
77 ± 7 |
15 ± 4 |
31 ± 2 |
12 ± 6 |
+ |
5000 |
96 ± 16 |
16 ± 3 |
27 ± 7 |
9 ± 2 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1393 ± 29 |
185 ± 69 |
680 ± 34 |
106 ± 8 |
|
MNNG = N-methyl-N'-nitro-N-nitrosoguanidine
NOPD = 4-nitro-o-phenylenediamine
AAC = 9-aminoacridine
2AA = 2-aminoanthracene
Table 2: Preincubation test
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
|||
Base-pair substitution type |
Frameshift type |
||||
TA 100 |
TA1535 |
TA98 |
TA1537 |
||
– |
DMSO |
140 ± 9 |
22 ± 2 |
27 ± 2 |
10 ± 4 |
– |
20 |
139 ± 12 |
24 ± 5 |
28 ± 5 |
12 ± 1 |
– |
100 |
151 ± 5 |
22 ± 3 |
28 ± 6 |
11 ± 1 |
– |
500 |
129 ± 16 |
23 ± 4 |
27 ± 3 |
8 ± 1 |
– |
2500 |
131 ± 15 |
20 ± 4 |
27 ± 7 |
11 ± 3 |
– |
5000 |
122 ± 6 |
21 ± 6 |
28 ± 4 |
9 ± 1 |
Positive controls, –S9 |
Name |
MNNG |
MNNG |
NOPD |
AAC |
Concentrations (μg/plate) |
5 |
5 |
10 |
100 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
915 ± 75 |
601 ± 67 |
1247 ± 6 |
982 ± 227 |
|
+ |
DMSO |
130 ± 7 |
20 ± 3 |
40 ± 6 |
13 ± 3 |
+ |
20 |
131 ± 20 |
23 ± 5 |
38 ± 4 |
13 ± 5 |
+ |
100 |
143 ± 20 |
20 ± 4 |
35 ± 3 |
12 ± 3 |
+ |
500 |
120 ± 11 |
22 ± 4 |
42 ± 2 |
13 ± 1 |
+ |
2500 |
103 ± 2 |
21 ± 3 |
44 ± 3 |
12 ± 2 |
+ |
5000 |
120 ± 18 |
21 ± 1 |
34 ± 4 |
9 ± 2 |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
877 ± 36 |
163 ± 20 |
536 ± 8 |
149 ± 13 |
|
MNNG = N-methyl-N'-nitro-N-nitrosoguanidine
NOPD = 4-nitro-o-phenylenediamine
AAC = 9-aminoacridine
2AA = 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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