Registration Dossier
Registration Dossier
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EC number: 900-501-2 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- strain with AT base pair as primary mutation site missing, only 4 test concentrations up to 4000 µg/plate tested
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 6-O-α-D-glucopyranosyl-D-fructose
- EC Number:
- 237-282-1
- EC Name:
- 6-O-α-D-glucopyranosyl-D-fructose
- Cas Number:
- 13718-94-0
- Molecular formula:
- C12H22O11
- IUPAC Name:
- 6-O-alpha-D-glucopyranosyl-D-fructose
- Details on test material:
- - Name of test material (as cited in study report): isomaltulose
- Physical state: white, crystalline powder
- Analytical purity: no data
- Reference No.: 571/271105/UK
- Storage condition of test material: stored in a cool, dry place
Constituent 1
Method
- Target gene:
- his operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (10% S9 in S9 mix), prepared from the livers of Fischer 344 rats treated with Aroclor 1254 (500 mg/kg bw for 5 days)
- Test concentrations with justification for top dose:
- 100, 500, 1000 and 4000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide (SA; 1 µg/plate, -S9, TA 100 and TA 1535); 9-aminoacridine (9AA; 50 µg/plate, -S9, TA 1537); 2-nitrofluorene (2NF; 0.5 µg/plate, -S9, TA 1538 and TA 98); 2-aminoanthracene (2AA; 2µg/plate, +S9, all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
DETERMINATION OF CYTOTOXICITY
- Method: other: reduction in the background lawn on the plates
Number of replications: triplicates each in one (TA 1535, TA 98, TA 100) or two (TA 1537, TA 1538) independent experiments - Statistics:
- Mean values and standard deviations were calculated for each treatment. Analysis of variance were performed on each set of data to give the F-statistic. As no F-statistic was biologically significant, no further analysis were carried out.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results for Isomaltulose (experiment I)
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 |
|||||
TA100 |
TA1535 |
TA98 |
TA1537 |
TA1538 |
||
– |
water |
159.3 ± 3.8 |
18 ± 2.6 |
18.7 ± 8.7 |
7.7 ± 4.7 |
22.7 ± 4.0 |
– |
100 |
173.7 ± 8.1 |
15.7 ± 5.0 |
20.0 ± 5.2 |
6.0 ± 4.4 |
19.0 ± 10.5 |
– |
500 |
150.3 ± 12.5 |
23.3 ± 9.6 |
19.0 ± 2.0 |
4.0 ± 0.0 |
21.0 ± 2.6 |
– |
1000 |
165.7 ± 13.9 |
16.0 ± 3.0 |
20.7 ± 3.2 |
6.0 ± 2.6 |
11.7 ± 5.5 |
– |
4000 |
139.3 ± 4.0 |
20.7 ± 9.1 |
19.7 ± 1.5 |
7.0 ± 6.2 |
14.0 ± 6.0 |
– |
Positive controls (concentrations (µg/plate)) |
SA (1) |
SA (1) |
2NF (0.5) |
9AA (50) |
2NF (0.5) |
Mean No. of colonies/plate (average of 3 plates) ± SD |
909.3 ± 112.0 |
626.7 ± 68.5 |
104.5 ± 7.5a |
343.0 ± 16.1 |
241.7 ± 17.2 |
|
+ |
water |
144.0 ± 24.6 |
15.7 ± 5.5 |
37.7 ± 2.3 |
15.7 ± 4.7 |
29.7 ± 8.0 |
+ |
100 |
130.0 ± 10.6 |
21.0 ± 3.6 |
36.3 ± 6.7 |
12.3 ± 1.2 |
30.7 ± 3.5 |
+ |
500 |
116.0 ± 18.7 |
20.0 ± 4.6 |
33.0 ± 8.9 |
14.7 ± 4.0 |
26.3 ± 3.2 |
+ |
1000 |
135.7 ± 5.8 |
18.0 ± 3.6 |
29.7 ± 8.1 |
14.0 ± 2.6 |
21.0 ± 7.0 |
+ |
4000 |
112.0 ± 3.6 |
17.7 ± 2.5 |
32.0 ± 4.4 |
11.3 ± 0.6 |
31.7 ± 1.2 |
+ |
Positive controls (concentrations (µg/plate)) |
2AA (2) |
2AA (2) |
2AA (2) |
2AA (2) |
2AA (2) |
Mean No. of colonies/plate (average of 3 plates) ± SD |
490.3 ± 84.7 |
62.3 ± 13.0 |
375.5 ± 117.5a |
58.3 ± 8.3 |
330 ± 22.6 |
|
a: The mean was calculated based on two plates (one plate lost)
SA = sodium azide
9AA = 9-aminoacridine
2NF = 2-nitrofluorene
2AA = 2-aminoanthracene
SD = standard deviation
Table 2. Test results for Isomaltulose (experiment II)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) ± standard deviation |
|
Frameshift type |
|||
TA1537 |
TA1538 |
||
– |
water |
5.3 ± 1.2 |
6.0 ± 2.6 |
– |
100 |
6.7 ± 1.5 |
7.0 ± 1.0 |
– |
500 |
4.7 ± 1.5 |
6.7 ± 2.1 |
– |
1000 |
4.0 ± 2.0 |
9.0 ± 4.6 |
– |
4000 |
5.3 ± 1.5 |
10.7 ± 3.8 |
– |
Positive controls (concentrations (µg/plate)) |
9AA (50) |
2NF (0.5) |
Mean No. of colonies/plate (average of 3 plates) ± SD |
100.0 ± 37.5 |
333.7 ± 35.3 |
|
+ |
water |
7.3 ± 0.6 |
20.0 ± 3.5 |
+ |
100 |
6.7 ± 2.3 |
24.0 ± 4.6 |
+ |
500 |
12.3 ± 1.5 |
22.0 ± 2.6 |
+ |
1000 |
5.3 ± 1.5 |
16.3 ± 6.1 |
+ |
4000 |
6.3 ± 1.5 |
21.3 ± 2.3 |
+ |
Positive controls (concentrations (µg/plate)) |
2AA (2) |
2AA (2) |
Mean No. of colonies/plate (average of 3 plates) ± SD |
72.3 ± 25.4 |
602.7 ± 99.9 |
|
9AA = 9-aminoacridine
2NF = 2-nitrofluorene
2AA = 2-aminoanthracene
SD = standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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