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Toxicological information

Genetic toxicity: in vitro

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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:
1994
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

Constituent 1
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
IUPAC Name:
2,2-bis(hydroxymethyl)propane-1,3-diol; 3-(prop-2-en-1-yloxy)prop-1-ene
Test material form:
liquid

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.