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EC number: 293-883-9 | CAS number: 91648-24-7
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 16 June 1993 to 21 October 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
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:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: US EPA (TSCA)
- Version / remarks:
- Guideline number not specified
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
- EC Number:
- 293-883-9
- EC Name:
- 1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether
- Cas Number:
- 91648-24-7
- Molecular formula:
- C14H24O4
- IUPAC Name:
- 2,2-bis(hydroxymethyl)propane-1,3-diol; 3-(prop-2-en-1-yloxy)prop-1-ene
- Test material form:
- liquid
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced S-9
- Test concentrations with justification for top dose:
- 312.5, 625, 1250, 2500 and 5000 µg/plate in the preliminary test
8, 40, 200, 1000 and 5000 µg/plate in the first main experiment
312.5, 625, 1250, 2500 and 5000 µg/plate in the second main experiment
The highest concentration was the maximum concentration in the OECD guideline. - Vehicle / solvent:
- Dimethyl sulphoxide (DMSO)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- A preliminary study was conducted in strains TA100 and WP2 uvrA in the absence of S-9. The two main experiments were conducted with all tester strains in the absence and in the presence of S-9. The bacteria were grown overnight for 10 hours at 37 °C. Aliquots of the bacterial culture (0.1 mL) were added to 0.1 test solution (vehicle control, positive control or test article), 0.5 mL of buffer (treatments in the absence of S-9) or S-9 (for treatments in the presence of S-9) and 2 mL of agar (containing trace amounts of histidine for salmonella strains or tryptophan for the E. coli strain), mixed and poured onto Vogel Bonner plates. The plates were incubated at 38 °C for 48 hours. The plates were then scored for revertant colonies. The preliminary test was plated in duplicate; the main experiments were plated in triplicate.
- Evaluation criteria:
- For a test substance to be considered positive, a concentration-related and statistically significant increase in the the number of revertants of at least twice the concurrent control should have been observed in at least one strain in either the absence or presence of S-9 in both experiments. Where the results of experiments gave conflicting results, an additional test would be required.
- Statistics:
- Not stated
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- None
Any other information on results incl. tables
Results: Experiment 1 in the absence of S-9
Concentration of test material |
Mean number of revertants |
||||
TA98 |
TA00 |
TA1535 |
TA1537 |
WP2 uvrA |
|
0 |
22.7 |
143.3 |
17.7 |
4.7 |
29.0 |
8 |
20.7 |
129.3 |
23.3 |
4.3 |
25.7 |
40 |
29.3 |
118.0 |
22.3 |
5.3 |
23.3 |
200 |
26.0 |
136.0 |
17.7 |
4.7 |
21.3 |
1000 |
37.1 |
125.0 |
19.0 |
4.7 |
220 |
5000 |
31.0 |
154.3 |
14.3 |
4.7 |
20.0 |
Positive control |
161.3 |
523.7 |
249.7 |
347.7 |
280.0 |
Results: Experiment 1 in the presence of S-9
Concentration of test material |
Mean number of revertants |
||||
TA98 |
TA00 |
TA1535 |
TA1537 |
WP2 uvrA |
|
0 |
25.7 |
139.0 |
25.3 |
12.7 |
26.3 |
312.5 |
23.7 |
130.7 |
22.7 |
10.7 |
23.3 |
625 |
24.0 |
146.0 |
25.3 |
8.0 |
20.0 |
1250 |
15.0 |
142.7 |
19.3 |
10.7 |
23.7 |
2500 |
27.3 |
142.0 |
18.0 |
9.3 |
24.3 |
5000 |
24.3 |
133.0 |
13.7 |
7.7 |
23.0 |
Positive control |
165.3 |
407.7 |
161.0 |
108.0 |
242.0 |
Results: Experiment 2 in the absence of S-9
Concentration of test material |
Mean number of revertants |
||||
TA98 |
TA00 |
TA1535 |
TA1537 |
WP2 uvrA |
|
0 |
20.3 |
110.0 |
17.0 |
14.0 |
28.7 |
312.5 |
15.3 |
118.3 |
16.0 |
11.3 |
22.0 |
625 |
15.7 |
103.7 |
15.3 |
10.0 |
23.0 |
1250 |
20.7 |
99.7 |
17.3 |
9.7 |
19.0 |
2500 |
17.3 |
114.7 |
16.7 |
10.3 |
23.3 |
5000 |
14.7 |
101.3 |
22.3 |
8.7 |
20.0 |
Positive control |
143.0 |
533.3 |
152.3 |
591.0 |
321.7 |
Results: Experiment 2 in the presence of S-9
Concentration of test material |
Mean number of revertants |
||||
TA98 |
TA00 |
TA1535 |
TA1537 |
WP2 uvrA |
|
0 |
26.0 |
148.0 |
28.7 |
9.0 |
27.7 |
8 |
23.3 |
111.7 |
26.0 |
10.0 |
27.3 |
40 |
24.7 |
95.3 |
22.3 |
7.7 |
22.3 |
200 |
20.0 |
94.3 |
27.3 |
10.0 |
24.0 |
1000 |
19.0 |
100.3 |
22.3 |
8.3 |
25.7 |
5000 |
23.7 |
93.7 |
18.3 |
9.7 |
27.0 |
Positive control |
154.7 |
407.7 |
169.7 |
134.0 |
259.3 |
Applicant's summary and conclusion
- Conclusions:
- 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether showed no evidence of mutagenicity in the absence and in the presence of metabolic activation when tested up to 5000 µg/plate in strains TA98, TA100, TA535, TA1537 and WP2 uvrA.
- Executive summary:
An Ames test was conducted with 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether according to OECD guideline 471. Testing was conducted in Salmonella typhmurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2 uvrA in the absence and presence of metabolic activation. Two independent tests were conducted up to 5000 µg/plate. There was no evidence of toxicity, precipitation or increases in the number of revertants which were 2 -fold the concurrent controls. The overall conclusion of the study is that the test material has shown no evidence of mutagenicity when tested up to the maximum concentration of 5000 µg/plate.
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