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EC number: 277-753-9 | CAS number: 74186-17-7
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenicity was investigated in an Ames reverse mutation assay. No mutagenic effects were detected. The test item did not show mutagenic potential.
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
- Study period:
- 2016 -01-19 till 2016-02-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline-conform study under GLP without deviations
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9 (experiment I) and non-induced hamster liver S9 (experiment II)
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I
1; 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / experiment II - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: deionized water
- Justification for choice of solvent/vehicle: best suitable solvent - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene; Congo red
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 30 minutes
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
- Key result
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: soluble
- Precipitation: The test item precipitated in the overlay agar in the test tubes from 10 to 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 100 to 5000 µg/plate. The undissolved particles had no influence on the data recording.
- Other confounding effects: none
COMPARISON WITH HISTORICAL CONTROL DATA: In experiment II, the data in solvent controls of strain TA 100 without S9 and strain 1535 with S9 mix and the untreated controls of strains TA 1537 and TA 100 with S9mix were slightly above our historical control range. Since this deviation is rather small, this effect is considered to be based upon biologically irrelevant fluctuations in the number of colonies and had no detrimental impact on the outcome of the study.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without metabol¬ic activation. Only in experiment II minor toxic effects were observed in strain TA 1535 with S9 mix at 5000 µg/plate. - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with and without rat- and hamster S9
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. - Executive summary:
This study was performed to investigate the potential of the test substance to induce gene mutations according to the plate incorporation test (experiment I) with and without rat S9 mix and the pre-incubation test (experiment II) with and without hamster S9 mix using theSalmonella typhimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia colistrain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II: 1; 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 10 to 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 100 to 5000 µg/plate. The undissolved particles had no influence on the data recording. The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in all strains with and without metabolic activation. Only in experiment II minor toxic effects were observed in strain TA 1535 with S9 mix at 5000 µg/plate. No substantial increase in revertant colony numbers of any of the fivetester strains was observed following treatment with Aluminium-Braun 1134 p at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
Reference
Summary Tabellen
Table1 Summary of Experiment I
Study Name: 1743802 |
Study Code: Envigo 1743802 |
Experiment: 1743802 VV Plate |
Date Plated: 19/01/2016 |
Assay Conditions: |
Date Counted: 22/01/2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
Deionised water |
|
|
11 ± 5 |
9 ± 4 |
25 ± 8 |
181 ± 30 |
45 ± 9 |
Untreated |
|
|
8 ± 1 |
13 ± 4 |
26 ± 10 |
199 ± 7 |
49 ± 5 |
|
Aluminium- |
3 µg |
|
11 ± 5 |
10 ± 4 |
29 ± 5 |
185 ± 22 |
45 ± 10 |
|
Braun 1134 p |
10 µg |
|
12 ± 4 |
10 ± 4 |
21 ± 1 |
172 ± 12 |
50 ± 17 |
|
|
33 µg |
|
10 ± 3 |
10 ± 4 |
25 ± 5 |
179 ± 5 |
51 ± 7 |
|
|
100 µg |
|
10 ± 2P |
9 ± 2P |
26 ± 6P |
174 ± 13P |
48 ± 5P |
|
|
333 µg |
|
10 ± 4P |
8 ± 2P |
28 ± 2P |
196 ± 19P |
44 ± 12P |
|
|
1000 µg |
|
9 ± 4P |
6 ± 1P |
27 ± 8P |
194 ± 18P |
40 ± 6P |
|
|
2500 µg |
|
12 ± 2P |
7 ± 2P |
34 ± 6P |
185 ± 18P |
40 ± 6P |
|
|
5000 µg |
|
9 ± 4P |
8 ± 2P |
27 ± 4P |
172 ± 11P |
31 ± 3P |
|
NaN3 |
10 µg |
|
1171 ± 88 |
|
|
2083 ± 137 |
|
|
4-NOPD |
10 µg |
|
|
|
302 ± 36 |
|
|
|
4-NOPD |
50 µg |
|
|
63 ± 5 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
|
999 ± 76 |
|
|
|
|
|
|
|
|
|
|
With Activation |
Deionised water |
|
|
13 ± 3 |
12 ± 2 |
30 ± 5 |
185 ± 17 |
45 ± 4 |
Untreated |
|
|
10 ± 3 |
10 ± 3 |
28 ± 6 |
195 ± 29 |
59 ± 8 |
|
Aluminium- |
3 µg |
|
13 ± 5 |
10 ± 5 |
28 ± 2 |
189 ± 15 |
51 ± 8 |
|
Braun 1134 p |
10 µg |
|
12 ± 5 |
7 ± 2 |
25 ± 13 |
173 ± 25 |
52 ± 6 |
|
|
33 µg |
|
13 ± 3 |
8 ± 2 |
27 ± 6 |
186 ± 21 |
52 ± 10 |
|
|
100 µg |
|
10 ± 4P |
9 ± 3P |
24 ± 5P |
191 ± 5P |
62 ± 8P |
|
|
333 µg |
|
11 ± 4P |
11 ± 5P |
31 ± 5P |
202 ± 17P |
50 ± 3P |
|
|
1000 µg |
|
7 ± 1P |
7 ± 3P |
27 ± 4P |
200 ± 23P |
58 ± 9P |
|
|
2500 µg |
|
9 ± 1P |
10 ± 5P |
30 ± 4P |
176 ± 27P |
43 ± 3P |
|
|
5000 µg |
|
10 ± 5P |
10 ± 3P |
26 ± 6P |
147 ± 25P |
31 ± 7P |
|
2-AA |
2.5 µg |
|
510 ± 32 |
107 ± 11 |
4431 ± 85 |
4790 ± 229 |
|
|
2-AA |
10.0 µg |
|
|
|
|
|
359 ± 14 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
P |
Precipitate |
Table2 Summary of Experiment II
Study Name: 1743802 |
Study Code: Envigo 1743802 |
Experiment: 1743802 HV2 Pre |
Date Plated: 12/02/2016 |
Assay Conditions: |
Date Counted: 18/02/2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
|
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
|
Without Activation |
Deionised water |
|
|
14 ± 5 |
8 ± 1 |
33 ± 8 |
197 ± 5 |
52 ± 10 |
Untreated |
|
|
16 ± 5 |
7 ± 1 |
30 ± 4 |
206 ± 6 |
55 ± 5 |
|
Aluminium- |
1 µg |
|
14 ± 2 |
8 ± 1 |
33 ± 9 |
247 ± 6 |
55 ± 7 |
|
Braun 1134 p |
3 µg |
|
15 ± 5 |
9 ± 2 |
32 ± 3 |
259 ± 7 |
59 ± 7 |
|
|
10 µg |
|
13 ± 2 |
9 ± 3 |
29 ± 7 |
263 ± 24 |
49 ± 10 |
|
|
33 µg |
|
13 ± 4 |
9 ± 1 |
34 ± 10 |
267 ± 14 |
50 ± 8 |
|
|
100 µg |
|
14 ± 5P |
9 ± 1P |
33 ± 4P |
253 ± 35P |
51 ± 8P |
|
|
333 µg |
|
13 ± 3P |
8 ± 3P |
29 ± 7P |
271 ± 25P |
47 ± 2P |
|
|
1000 µg |
|
16 ± 4P |
15 ± 1P |
29 ± 2P |
249 ± 25P |
50 ± 7P |
|
|
2500 µg |
|
12 ± 4P |
8 ± 1P |
36 ± 6P |
252 ± 22P |
56 ± 2P |
|
|
5000 µg |
|
9 ± 4P |
8 ± 1P |
49 ± 6P |
246 ± 9P |
39 ± 11P |
|
NaN3 |
10 µg |
|
1421 ± 64 |
|
|
2394 ± 58 |
|
|
4-NOPD |
10 µg |
|
|
|
371 ± 10 |
|
|
|
4-NOPD |
50 µg |
|
|
72 ± 13 |
|
|
|
|
MMS |
2 µL |
|
|
|
|
|
1169 ± 126 |
|
|
|
|
|
|
|
|
|
|
With Activation |
Deionised water |
|
|
22 ± 3 |
27 ± 4 |
49 ± 3 |
204 ± 4 |
55 ± 11 |
Untreated |
|
|
25 ± 4 |
27 ± 4 |
55 ± 1 |
216 ± 16 |
61 ± 2 |
|
Aluminium- |
1 µg |
|
26 ± 3 |
26 ± 3 |
51 ± 2 |
225 ± 18 |
60 ± 12 |
|
Braun 1134 p |
3 µg |
|
28 ± 2 |
32 ± 3 |
53 ± 2 |
230 ± 23 |
54 ± 11 |
|
|
10 µg |
|
28 ± 2 |
32 ± 1 |
56 ± 1 |
235 ± 25 |
56 ± 6 |
|
|
33 µg |
|
27 ± 5 |
30 ± 3 |
58 ± 11 |
242 ± 3 |
55 ± 1 |
|
|
100 µg |
|
25 ± 6P |
31 ± 3P |
54 ± 2P |
233 ± 5P |
64 ± 9P |
|
|
333 µg |
|
21 ± 3P |
32 ± 4P |
51 ± 10P |
240 ± 9P |
63 ± 6P |
|
|
1000 µg |
|
22 ± 1P |
25 ± 3P |
59 ± 11P |
250 ± 7P |
53 ± 4P |
|
|
2500 µg |
|
14 ± 4P |
20 ± 3P |
81 ± 7P |
231 ± 19P |
47 ± 2P |
|
|
5000 µg |
|
9 ± 1P |
20 ± 4P |
82 ± 6P |
242 ± 48P |
49 ± 13P |
|
2-AA |
2.5 µg |
|
|
|
|
2251 ± 49 |
|
|
2-AA |
2.5 µg |
|
395 ± 21 |
119 ± 12 |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
|
832 ± 103 |
|
Congo red |
500 µg |
|
|
|
328 ± 11 |
|
|
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD Congo red MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine Congo red methyl methane sulfonate |
P |
Precipitate |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
no mutagenic effects
Additional information
Justification for classification or non-classification
No classification; no mutagenic effects were detected.
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