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EC number: 307-276-4 | CAS number: 97592-79-5
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
- Study period:
- 1998-01-15 to 1998-06-23
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UKEMS Guidelines
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.
- EC Number:
- 307-276-4
- EC Name:
- 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.
- Cas Number:
- 97592-79-5
- Molecular formula:
- No molecular formula
- IUPAC Name:
- 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.
- Details on test material:
- - Lot/batch No.: 6108
- clear colourless liquid
- Purity : 100%
- Expiration date of the lot/batch: march 1999
- Storage condition of test material: at room temperature in the dark
Constituent 1
Method
- Target gene:
- histidine gene
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 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- A mammalian liver post-mitochondrial fraction (S-9) was prepared from male Sprague Dawley rats induced with Aroclor 1254 and obtained from Molecular Toxicilogy Incorporated, USA.
- Test concentrations with justification for top dose:
- -Mutation experiment 1 :
without S-9 : Final concentration : (µg/plate) : 0.032 ; 0.16 ; 0.8 ; 4 ; 20
with S9 : Final concentration : (µg/plate) : 0.16 ; 0.8 ; 4 ; 20 ; 100
- Mutation experiment 2 :
without S-9 (except TA1535) : 0.01953 ; 0.078125 ; 0.3125 ; 1.25 ; 5 ; 20
All strains with S-9 and strain TA1535 without S-9 : 0.078125 ; 0.3125 ; 1.25 ; 5 ; 5 ; 20 ; 80 - Vehicle / solvent:
- solvent used: DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO for 2NF, AAC and AAN // water for NaN3 and GLU
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-nitrofluorene (2NF), sodium azide (NaN3), 9-aminoacridine (AAC), glutaraldéhyde (GLU) and 2-aminoanthracene (AAN)
- Evaluation criteria:
- The test article was considered to be mutagenic if :
- the assay was valid
- a dose related and reproductible increase in the number of revertants is observed, or a signifiant* and reproductible increase in the number of revertants was induced at one or more test concentration.
* an increase in revertant numbers was considered to be signifiant if the number of revertant colonies was at least two times the mean negative control counts in strains TA98, TA100 and TA102, or three times in strains TA1535 and TA1537.
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:
- 40 ug/plate wo/metabolic activation (-S9) and 200 ug/plate w/metabolic activation (+S9)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'. Remarks: TA102 was also tested
Any other information on results incl. tables
Table 1 Summary of mean revertant colonies (no metabolic activation) Experiment 1
| Test type | |||||
| Dose | TA98 | TA100 | TA1535 | TA1537 | TA102 |
| Vehicle only | 25 +/-4 | 110 +/-11 | 13 +/- 2 | 15 +/-3 | 410 +/- 58 |
| 0.032 ug/plate | 32 +/- 3 | 110 +/-8 | 14 +/- 6 | 15 +/-2 | 462 +/- 37 |
| 0.16 ug/plate | 22 +/-5 | 113 +/-10 | 13 +/-2 | 12 +/-3 | 429 +/-9 |
| 0.8 ug/plate | 26 +/-12 | 106 +/-8 | 10 +/-2 | 15 +/-7 | 428 +/-31 |
| 4 ug/plate | 25 +/-2 | 104 +/-4 | 17 +/-5 | 12 +/-3 | 376 +/-51 |
| 20 ug/plate | 21 +/-2 | 63 +/-5 | 13 +/-2 | 12 +/-2 | 176 +/-27 |
T toxic, S slightly thinning
Table 2 Summary of mean revertant colonies (with metabolic activation) Experiment 1
| Test type | |||||
| Dose | TA98 | TA100 | TA1535 | TA1537 | TA102 |
| Vehicle | 33 +/-6 | 131 +/-9 | 23 +/-3 | 13 +/-3 | 500 +/-34 |
| 0.16 ug/plate | 31 +/-1 | 140 +/-15 | 14 +/-2 | 17 +/-3 | 519 +/-26 |
| 0.8 ug/plate | 37 +/-9 | 127 +/- | 20 +/-4 | 15 +/-2 | 463 +/-10 |
| 4 ug/plate | 31 +/-8 | 130 +/-8 | 20 +/-9 | 9 +/-4 | 436 +/-39 |
| 20 ug/plate | 31 +/-5 | 153 +/-7 | 15 +/-5 | 13 +/-7 | 496 +/-11 |
| 100 ug/plate | 17 +/-4 (S) | T | 16 +/-3 (S) | T | T |
T toxic, S slightly thinning
Table 3 Summary of mean revertant colonies (no metabolic activation) Experiment 2
| Test type | |||||
| Dose | TA98 | TA100 | TA1535 | TA1537 | TA102 |
| Vehicle | 34+/-6 | 111 +/-12 | 17 +/-6 | 15 +/-5 | 482 +/-22 |
| 0.01953 ug/plate | 39 +/-3 | 114 +/-6 | 13 +/-2 | 500 +/-15 | |
| 0.078125 ug/plate | 34 +/-1 | 131 +/-14 | 12 +/-8 | 15 +/-5 | 428 +/-20 |
| 0.3125 ug/plate | 35 +/-4 | 119 +/-6 | 14 +/-4 | 12 +/-3 | 419 +/-32 |
| 1.25 ug/plate | 36 +/-1 | 122 +/-6 | 14 +/-2 | 13 +/-3 | 460 +/-14 |
| 5 ug/plate | 39 +/-2 | 134 +/-7 | 11+/-1 | 17 +/-5 | 452 +/-25 |
| 20 ug/plate | 20 +/-4 | 83 +/-2 (M+V) | 13 +/-3 | 11 +/-3 (S) | 191 +/-28 (M+V) |
| 80 ug/plate | 4 +/-2 (M+A) | ||||
M manual count, V very thin background lawn, A absence of background lawn, S slight thinning
Table 4 Summar of mean revertant colonies (with metabolic activation) Experiment 2
| Test type | |||||
| Dose | TA98 | TA100 | TA1535 | TA1537 | TA102 |
| Vehicle | 44 +/-10 | 169 +/-15 | 18 +/-2 | 17 +/-5 | 552 +/-50 |
| 0.078125 ug/plate | 40 +/-8 | 170 +/-9 | 18 +/-7 | 19 +/-5 | 613 +/-5 |
| 0.3125 ug/plate | 44 +/-8 | 168 +/-16 | 21 +/-7 | 17 +/-3 | 555 +/-16 |
| 1.25 ug/plate | 50 +/-7 | 155 +/-9 | 20+/-3 | 16 +/-3 | 519 +/-8 |
| 5 ug/plate | 44 +/-7 | 157 +/-14 | 14 +/-2 | 14+/-1 | 585 +/-22 |
| 20 ug/plate | 55 +/-6 | 160 +/-5 | 22 +/-2 | 17 +/-5 | 591 +/-35 |
| 80 ug/plate | 32 +/-11 (S) | 150 +/-5 (S) | 16 +/-2 | 19 +/-3 (S) | 416 +/-51 (S) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
ambiguous without metabolic activation
It was concluded that 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. did not induce mutation in five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1537 and TA102), when tested under the conditions employed for this study, which included treatments approaching, or extending into, the toxic range, both in the absence and in the presence of a rat liver metabolic activation system (S-9). - Executive summary:
The potential of 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. inducing mutations was assayed in 5 bacterial models; TA98 (frameshift), TA100 (basepair substitution), TA102 (basepair substitution), TA1535 (basepair substitution), and TA1537 (frameshift). The test item was diluted in anhydrous DMSO immediately before added to test plates. Negative control (vehicle only) and positive controls (2 -nitrofluorene, Sodium Azide, 9 -aminoacridine, Glutaraldehyde and 2 -aminoanthracene) were included. The tests were carried out with/without metabolic activation (S9 fraction from Aroclor 1254 treated rats). Colonies were counted electronically.
In an initial rangefinder assay, the test item was added to plates at a concentration of 8, 40, 200, 1000, and 2000 ug/plate. Significant toxicity was observed at 40 ug/plate (-S9) and 200 ug (+S9). Based on these studies the upper dose limits were set at 20 ug/plate (-S9) and 100 ug/plate (+S9) for the mutagenicity assessment. Polyram SL was fully soluble at the concentrations tested.
2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. did not induce mutations in any of the five strains tested and at the dose conditions listed. The positive controls performed with satisfaction.
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