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EC number: 224-244-4 | CAS number: 4263-52-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
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- Oxidation reduction potential
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- Endpoint summary
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- Environmental data
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In an in vitro bacterial reverse mutagenicity assay (AMES) according to OECD Guideline 471, the test item did not show a mutagenic potential (reference 7.6.1-1).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 September 2016 - 08 November 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- 1993
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his/trp
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Aroclor 1254 induced male Wistar rat liver
- Test concentrations with justification for top dose:
- The test material concentrations used were selected according to the EEC, OECD and Japanese guidelines for this test system. A maximum concentration of 5000 µg/plate was selected, in order that initial treatments were performed up to the maximum recommended concentration according to current regulatory guidelines (OECD, 1997).
1st series: 5.0, 15.8, 50, 158, 500, 1580, 5000 µg/plate, with or without 10% S9 mix
2nd series: 50, 500, 1580, 2810, 5000 µg/plate, with or without 30% S9 mix - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: Solubility properties of the test item, non-toxicity to bacteria. - 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
- sodium azide
- other: Daunomycin DAUN, 1 µg/plate; 2-Aminoanthracene 2-AA, 2.0, 5.0, 10.0 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2 -3 days
SELECTION AGENT: via medium
NUMBER OF REPLICATIONS: 2, 3 parallel plates were used for each concentration step of the lest material and the positive controls. Twice as many solvent control plates were used for each bacterial strain.
DETERMINATION OF CYTOTOXICITY
- Method: The presence of a background lawn of non-reverlant cells was checked for each plate. - Evaluation criteria:
- The assessment of test material-induced effects is dependent on the number of spontaneous revertants of each bacterial strain (solvent controls) and the increase in the number of revertants at the test material concentration which shows the highest number of colonies. The following criteria, based upon the historical controls of the laboratory and statistical considerations, are established. All further results, ranging between "no" and "clear", are assessed as "weak increases".
Interpretations:
A test material was to be defined as negative or non-mutagenic in this assay if
• the assay was to be considered valid, and
• "no" or "weak increases" occurred in the test series performed ("weak increases" randomly occur due to experimental variation)
For valid data, the test material was considered to be positive or mutagenic if:
• a dose dependent (over at least two test material concentrations) increase in the number of revertants was induced, the maximal effect was a "clear increase", and the effects were reproduced at similar concentration levels in the same test system, or
• "clear increases" occurred at least at one test material concentration, higher concentrations showed strong precipitation or cytotoxicity, and the effects were reproduced at the same concentration level in the same test system.
In general two series of experiments must be performed. However, there was no requirement for verification of a clear positive response.
Results which only partially satisfied the above criteria were dealt with on a case-by-case basis. Biological relevance was taken into account, for example consistency of response within and between concentrations and (where applicable) between experiments. - Key result
- 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
- Key result
- 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
- Key result
- 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
- Key result
- 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
- Key result
- 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
- Conclusions:
- In an in vitro bacterial reverse mutagenicity assay (AMES) according to OECD Guideline 471, the test item did not show a mutagenic potential.
- Executive summary:
In an in vitro bacterial reverse mutagenicity assay (AMES) according to OECD Guideline 471, the mutagenic potential of the test item was determined. The assay was performed in Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated male Wistar rats was used. In this study, two experimental series were performed. In the two series with S9 mix, 10% S9 mix were used in the 1st (test item: 5.0, 15.8, 50, 158, 500, 1580, 5000 µg/plate), and 30% S9 in the 2nd series (test item: 50, 500, 1580, 2810, 5000 µg/plate), respectively.
Vehicle and positive control treatments were included for all strains. The mean numbers of revertant colonies all fell within acceptable ranges for vehicle control treatments, and were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. Following test substance treatments of all the tester strains in the absence and presence of S9 mix, no relevant increases in revertanl numbers were observed. It is concluded that with and without addition of S9 mix the test substance was not mutagenic under the experimental conditions.
Reference
Results 1st series:
Metabolic Activation |
Test Material |
Conc. [µg/plate] |
Revertants per plate (mean ± SD) |
||||
TA98 |
TA100 |
TA1535 |
TA1537 |
E.coli |
|||
Without Activation |
H2O |
|
34 ± 4 |
117 ± 11 |
29 ± 3 |
31 ± 8 |
37 ± 7 |
Test substance |
5.0 |
36 ± 10 |
119 ± 23 |
26 ± 7 |
28 ± 6 |
39 ± 3 |
|
15.8 |
28 ± 7 |
114 ± 11 |
28 ± 5 |
29 ± 6 |
31 ± 7 |
||
50.0 |
36 ± 6 |
121 ± 17 |
27 ± 10 |
31 ± 1 |
43 ± 16 |
||
158 |
31 ± 6 |
112 ± 11 |
29 ± 8 |
32 ± 4 |
38 ± 6 |
||
500 |
23 ± 2 |
126 ± 9 |
26 ± 7 |
30 ± 6 |
31 ± 5 |
||
1580 |
26 ± 6 |
120 ± 11 |
26 ± 3 |
35 ± 7 |
37 ± 8 |
||
5000 |
31 ± 3 |
106 ± 8 |
31 ± 4 |
30 ± 4 |
38 ± 9 |
||
DAUN |
1.0 |
360 ± 9 |
|
|
|
|
|
NaN3 |
2.0 |
|
1505 ± 132 |
974 ± 36 |
|
|
|
9-AA |
50.0 |
|
|
|
783 ± 317 |
|
|
NQO |
2.0 |
|
|
|
|
1769 ± 101 |
|
With Activation |
H2O |
|
34 ± 8 |
148 ± 12 |
28 ± 7 |
35 ± 1 |
45 ± 5 |
Test Substance |
5.0 |
30 ± 2 |
137 ± 4 |
20 ± 3 |
35 ± 6 |
56 ± 4 |
|
15.8 |
39 ± 3 |
144 ± 15 |
21 ± 1 |
30 ± 5 |
39 ± 12 |
||
50.0 |
34 ± 10 |
136 ± 7 |
29 ± 12 |
27 ± 1 |
44 ± 1 |
||
158 |
35 ± 4 |
134 ± 11 |
32 ± 6 |
28 ± 8 |
41 ± 4 |
||
500 |
37 ± 1 |
141 ± 14 |
33 ± 11 |
29 ± 6 |
46 ± 7 |
||
1580 |
29 ± 3 |
134 ± 14 |
37 ± 3 |
34 ± 1 |
41 ± 2 |
||
5000 |
34 ± 13 |
148 ± 6 |
25 ± 3 |
29 ± 4 |
38 ± 4 |
||
2-AA |
2.0 |
340 ± 10 |
1178 ± 103 |
|
|
|
|
5.0 |
|
|
245 ± 20 |
415 ± 33 |
|
||
10.0 |
|
|
|
|
378 ± 15 |
Results 2nd series:
Metabolic Activation |
Test Material |
Conc. [µg/plate] |
Revertants per plate (mean ± SD) |
||||
TA98 |
TA100 |
TA1535 |
TA1537 |
E.coli |
|||
Without Activation |
H2O |
|
24 ± 6 |
132 ± 8 |
26 ± 8 |
28 ± 4 |
35 ± 11 |
Test substance |
50.0 |
27 ± 4 |
122 ± 10 |
34 ± 9 |
30 ± 6 |
32 ± 10 |
|
500 |
30 ± 8 |
120 ± 22 |
29 ± 8 |
26 ± 5 |
33 ± 4 |
||
1580 |
28 ± 6 |
122 ± 14 |
28 ± 6 |
28 ± 2 |
40 ± 3 |
||
2810 |
34 ± 5 |
136 ± 11 |
28 ± 4 |
28 ± 7 |
28 ± 4 |
||
5000 |
23 ± 5 |
115 ± 5 |
32 ± 5 |
26 ± 10 |
32 ± 5 |
||
DAUN |
1.0 |
159 ± 36 |
|
|
|
|
|
NaN3 |
2.0 |
|
1537 ± 76 |
927 ± 41 |
|
|
|
9-AA |
50.0 |
|
|
|
1482 ± 257 |
|
|
NQO |
2.0 |
|
|
|
|
1741 ± 112 |
|
With Activation |
H2O |
|
31 ± 5 |
137 ± 16 |
28 ± 7 |
32 ± 8 |
40 ± 9 |
Test Substance |
50.0 |
27 ± 7 |
135 ± 11 |
21 ± 3 |
35 ± 1 |
45 ± 17 |
|
500 |
22 ± 2 |
149 ± 6 |
29 ± 5 |
37 ± 8 |
36 ± 12 |
||
1580 |
28 ± 9 |
125 ± 22 |
24 ± 4 |
36 ± 3 |
42 ± 3 |
||
2810 |
29 ± 6 |
131 ± 21 |
31 ± 2 |
39 ± 4 |
42 ± 3 |
||
5000 |
22 ± 6 |
131 ± 2 |
23 ± 2 |
33 ± 6 |
37 ± 2 |
||
2-AA |
2.0 |
176 ± 8 |
|
|
|
|
|
5.0 |
|
19970 ± 61 |
|
|
|
||
10.0 |
|
|
164 ± 5 |
390 ± 13 |
181 ± 9 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In an in vitro bacterial reverse mutagenicity assay (AMES) according to OECD Guideline 471 (reference 7.6.1 -1), the mutagenic potential of the test item was determined. The assay was performed in Salmonella typhimurium tester strains TA 98, TA 100, TA 1535 and TA 1537, and Escherichia coli WP2 uvrA. The plate incorporation test with and without addition of liver S9 mix from Aroclor 1254-pretreated male Wistar rats was used. In this study, two experimental series were performed. In the two series with S9 mix, 10% S9 mix were used in the 1st (test item: 5.0, 15.8, 50, 158, 500, 1580, 5000 µg/plate), and 30% S9 in the 2nd series (test item: 50, 500, 1580, 2810, 5000 µg/plate), respectively. Vehicle and positive control treatments were included for all strains. The mean numbers of revertant colonies all fell within acceptable ranges for vehicle control treatments, and were clearly elevated by positive control treatments, thus, showing the expected reversion properties of all strains and good metabolic activity of the S9 mix used. Following test item treatments of all the tester strains in the absence and presence of S9 mix, no relevant increases in revertant numbers were observed. It is concluded that with and without addition of S9 mix the test item was not mutagenic under the experimental conditions.
Justification for classification or non-classification
Classification, Labeling, 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 test item is not considered to be classified for genetic toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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