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Diss Factsheets

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:
2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
3,5-dimethylhex-1-yn-3-ol
EC Number:
203-500-9
EC Name:
3,5-dimethylhex-1-yn-3-ol
Cas Number:
107-54-0
Molecular formula:
C8H14O
IUPAC Name:
3,5-dimethylhex-1-yn-3-ol
Test material form:
other: liquid
Details on test material:
Batch#: 1602145
Purity: 99.7 %

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
Details on mammalian cell type (if applicable):
Salmonella typhimurium
Strains Genotype Type of mutations indicated
TA1537 his C 3076; rfa-; uvrB-: frame shift mutation
TA98 his D3052; rfa-; uvrB-; R-factor frame shift mutation
TA1535 his G 46; rfa-; uvrB-: base pair substitution
TA1535 his G 46; rfa-; uvrB-; R-factor base pair substitution

Escherichia coli
Strain Genotype Type of mutations indicated
WP2uvrA trp-; uvrA-: base pair substitution
Metabolic activation:
with and without
Metabolic activation system:
S9-mix
Test concentrations with justification for top dose:
1.5, 5, 15, 50, 150, 1500, 5000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
9-aminoacridine
N-ethyl-N-nitro-N-nitrosoguanidine
benzo(a)pyrene
other: 2-Aminoanthracene

Results and discussion

Any other information on results incl. tables

Test Results: Main Test - Without Metabolic Activation
Test Period From: 27. October 2014 31. October 2014* To: 30. October 2014 // 03. November 2014*
S9-Mix Dose Level per Plate Number of Revertants (Mean) +/- SD
Base-Pair Substitution Strains Frameshift Strains
TA100 TA1535* WP2uvrA TA98* TA1537*
Solvent Control (DMSO) 82 (88) 
4.9#		 15 (13)4.9 7 (12)4.2 25 (22)6.4 8 (10)2.1
91 7 15 15 12
90 16 13 27 11
5µg 103 (96)6.1 11 (11)0.6 20 **(20)0.6 8 (17)10.1 8 (15)3.2
91 11 20 15 12
95 12 19 28 11
15µg 79 (89)0.5 15 (11)3.8 16 (14)2.1 17 (15)5.7 8 (15)2.3
100 8 12 20 12
88 9 15 9 11
50µg 118 (95)20.6 9 (11)3.5 12 (13)2.1 13 (18)6.4 8 (14)8.7
87 9 11 25 12
79 15 15 15 11
150µg 80 (102)19.5 24 (19)6.8 17 (17)2.5 31 (22)8.1 8 (8)4.0
116 11 15 17 12
111 21 20 17 11
500µg 116 (101)28.3 17 (14)3.1 17 (16)5.0 20 (16)3.5 8 (8)4.2
118 15 11 13 12
68 11 21 16 11
1500µg 64 S (51)6.4 19 S (13)5.1 12 S (16)4.0 19 (15)4.0 8 (5)1.7
69 S 12 S 17 S 11 12
21 S 9 S 20 S 16 11
5000µg 0 V (0)0.0 0 T (0)0.0 0 T (0)0.0 0 T (0)0.0 0 T (0)0.0
0 V 0 T 0 T 0 T 0 T
0 V 0 T 0 T 0 T 0 T
PositiveControlsS9-Mix(-) Name Dose LevelNo. of Revertants ENNG ENNG ENNG 4NQO 9AA
3 µg 5 µg 2 µg 0.2 µg 80 µg
282 (283)10.0 731 (649)72.4 768 (716)45.4 186 (203)22.9 275 (420)127.0
293 624 684 229 476
273 563 696 194 510
Test Results: Main Test - With Metabolic Activation
Test Period From: 27. October 2014 31. October 2014* To: 30. October 2014 03. November 2014*
S9-Mix Dose Level per Plate Number of Revertants (Mean) +/- SD
Base-pair substitution Strains Frameshift Strains
TA100 TA1535* WP2uvrA TA98* TA1537*
Solvent Control (DMSO) 82 (88)5.2# 19 (18)2.1 24 (19)4.0 29 (27)3.5 23 (18)4.0
91 16 17 23 16
91 20 17 29 16
5µg 111 (103)21.7 19 (18)1.2 16 (19)12.2 24 (24)0.6 19 (16)6.7
119 19 32 24 20
78 17 8 23 8
15µg 79 (91)11.5 15 (14)1.2 13 (12)3.1 25 (26)1.7 13 (14)2.3
102 13 15 25 17
91 13 9 28 13
50µg 102 (105)6.4 9 (12)3.1 11 (10)1.2 25 (26)1.2 11 (15)4.7
112 15 11 25 20
100 13 9 27 13
150µg 107 (105)8.2 11 (14)3.1 27 (23)3.5 15 (20)7.0 13 (13)1.5
112 17 23 28 15
96 15 20 17 12
500µg 86 (104) 16.1 13 (16)3.6 11 (15)4.0 21 (22)1.2 8 (8)1.0
116 20 16 21 9
111 15 19 23 7
1500µg 74 S (86)15.9 0 V (0)0.0 15 (16)1.2 16 (20)7.2 8 (10)4.0
80 S 0 V 17 28 8
104S 0 V 15 15 15
5000µg 0 V (0)0.0 0 V (0)0.0 15 S (9)5.3 0 T (0)0.0 6 S (4)1.5
0 V 0 V 5 S 0 T 4 S
0 V 0 V 7 S 0 T 3 S

Positive

controls

S9-Mix

(-)

Name 

Dose Level

No. of

Revertants

2AA

2AA

2AA

BP

2AA

1 µg

2 µg

10 µg

5 µg

2 µg

417

(330)

80.6

290

(268)

20.4

164

(162)

29.6

128

(131)

9.5

517

(515)

2.1

315

263

131

142

513

258

250

190

124

516

* Experimental procedure repeated at a later date due to contamination in the original test.

 

** p≤0.05

 

 

 

 

 

 

 

ENNG N-ethyl-N´-nitro-N-nitrosoguanidine

 

 

 

 

 

4NQO 4-Nitroquinoline-1-oxide

 

 

 

 

 

 

9AA 9-Aminoacridine

 

 

 

 

 

 

BP Benzo(a)pyrene

 

 

 

 

 

 

2AA 2-Aminoanthracene

 

 

 

 

 

 

S Sparse bacterial background lawn

 

 

 

 

 

T Toxic, no bacterial background lawn

 

 

 

 

 

V Very weak bacterial background lawn

 

 

 

 

 

# Standard deviation

 

 

 

 

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

This substance was considered to be non-mutagenic under the conditions of this test according to OECD Guideline 471.
Executive summary:

This substance was considered to be non-mutagenic under the conditions of this test according to OECD Guideline 471.