Registration Dossier
Registration Dossier
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EC number: 203-860-7 | CAS number: 111-34-2
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No mutagenic activity was detected in bacteria with BVE.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with minor restrictions (no data about historical negative control [but number of revertants within literature range])
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- (BASF AG, Department of Toxicology)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- His- and Trp-
- Species / strain / cell type:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix; S9-fraction from Aroclor 1254-induced (i.p. 500 mg/kg bw 5 days prior to sacrifice) male Sprague-Dawley rat liver
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500 and 5000 µg/plate in 1) the standard plate test and 2) in the preincubation assay
- Vehicle / solvent:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- plus sterility control
- Positive controls:
- yes
- Positive control substance:
- other: With S9: 2.5 µg/plate 2-aminoanthracene (all tester strains of S.typhimurium) and 60 µg/plate of this substance for E. coli. Without metabolic activation (MA) see remarks
- Remarks:
- Without MA: 5 µg/plate N-methyl-N'-nitro-N-nitrosoguanidine in TA 100 and TA 1535; 10 µg/plate 4-nitro-o-phenylendiamine in TA 98; 100 µg/plate 9-aminoacridine in TA 1537; 10 µg/plate N-ethyl-N'-nitro-N-nitrosoguanidin in E. coli WP2uvrA
- Details on test system and experimental conditions:
- Standard plate test (1st experiment) and preincubation assay (2nd experiment) with and without metabolic activation (MA), triplicate plates.
- Evaluation criteria:
- (i) doubling of the spontaneous mutation rate, (ii) dose-response relationship, (iii) reproducibility of results
- Statistics:
- means +- standard deviation of 3 test plates per dose or per control
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2uvrA
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100 and E. coli WP2uvrA
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (at >= 2500 µg/plate; details in remarks on results)
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
BVE gave negative results in the standard plate test and the preincubation assay according to OECD Guideline 471 in S. typhimurium TA1535, TA100, TA1537, TA98 and E. coli WP2uvrA both in the absence and in the presence of a metabolic activation system at concentrations up to 5000 µg/plate.
Reference
Only in strains tested with MA in the preincubation assay cytotoxic effects were detected, however, authors tested up to the limit dose recommended in OECD TG471 (5 mg/plate).
Ames
test with BVE
Standard plate test
Dose level in µg/plate |
TA1535 |
TA100 |
TA1537 |
TA98 |
E. coli WP2uvrA |
- |
Without metabolic activation |
||||
Vehicle control |
19+-1 |
126+-11 |
9+-2 |
33+-6 |
33+-4 |
20 |
21+-6 |
121+-14 |
9+-2 |
36+-3 |
33+-4 |
100 |
20+-4 |
128+-9 |
8+-5 |
32+-3 |
25+-4 |
500 |
13+-2 |
115+-10 |
7+-1 |
31+-7 |
26+-4 |
2500 |
15+-2 |
105+-8 |
4+-1 |
33+-4 |
29+-4 |
5000 |
19+-6 |
100+-10 |
4+-2 |
32+-4 |
33+-4 |
Positive control |
760+-106 |
1252+-141 |
715+-22 |
958+-27 |
651+-46 |
- |
With metabolic activation |
||||
Vehicle control |
19+-2 |
136+-21 |
11+-3 |
40+-4 |
43+-4 |
20 |
17+-2 |
112+-17 |
11+-2 |
34+-5 |
38+-3 |
100 |
16+-3 |
105+-7 |
11+-1 |
48+-2 |
35+-2 |
500 |
19+-1 |
102+-11 |
10+-3 |
44+-3 |
32+-7 |
2500 |
11+-3 |
96+-3 |
5+-1 |
46+-5 |
23+-6 |
5000 |
5+-2 |
83+-6 |
4+-3 |
25+-5 |
13+-2 |
Positive control |
114+-11 |
905+-77 |
114+-6 |
1182+-76 |
206+-13 |
Mean revertants +- standard deviation of 3 plates
Ames
test with BVE
Preincubation assay
Dose level in µg/plate |
TA1535 |
TA100 |
TA1537 |
TA98 |
E. coli WP2uvrA |
- |
Without metabolic activation |
||||
Vehicle control |
19+-2 |
106+-8 |
9+-2 |
26+-3 |
42+-10 |
20 |
18+-2 |
117+-6 |
8+-2 |
26+-6 |
42+-8 |
100 |
18+-2 |
104+-9 |
12+-4 |
22+-1 |
41+-10 |
500 |
16+-1 |
97+-9 |
9+-2 |
24+-4 |
34+-7 |
2500 |
15+-1 |
83+-8 |
11+-4 |
25+-3 |
37+-10 |
5000 |
15+-3 |
87+-12 |
10+-2 |
26+-4 |
41+-5 |
Positive control |
1296+-74 |
943+-33 |
746+-71 |
1305+-30 |
825+-50 |
- |
With metabolic activation |
||||
Vehicle control |
19+-1 |
108+-12 |
10+-2 |
32+-3 |
33+-4 |
20 |
19+-1 |
118+-4 |
8+-4 |
28+-3 |
27+-5 |
100 |
17+-5 |
104+-7 |
9+-4 |
25+-3 |
28+-6 |
500 |
14+-2 |
110+-3 |
5+-3 |
21+-3 |
26+-7 |
2500 |
10+-1 |
102+-18 |
6+-1T |
25+-5 |
25+-4T |
5000 |
7+-2 |
86+-2T |
6+-0T |
22+-3T |
23+-3T |
Positive control |
129+-6 |
1360+-62 |
124+-3 |
1002+-9 |
177+-5 |
Mean revertants +- standard deviation of 3 plates
T: reduced background lawn
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Additional information from genetic toxicity in vitro:
Key Ames Test (Butylvinylether)
BVE gave negative results in the standard plate test and the preincubation assay according to OECD Guideline 471 in S. typhimurium TA1535, TA100, TA1537, TA98 and E. coli WP2uvrA both in the absence and in the presence of a metabolic activation system at concentrations up to 5000 µg/plate (BASF 1998).
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available study is considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is considered not to be classified under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation No 605/2014.
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