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EC number: 243-478-8 | CAS number: 20039-37-6
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- Ecotoxicological Summary
- Aquatic toxicity
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The test item is mutagenic in the Ames test with the strains TA97a, TA98, TA100 and TA102 with and without an external metabolising system (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:
- 29 July to 16 September 2010
- 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:
- 21 July 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his- (S. typhimurium)
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : A lyophilised post-mitochondrial supernatant of homogenised livers of male Sprague Dawley rats, induced with Aroclor 1254 and obtained from Fa. Moltox (11-01L, Lot No. 2465), was used as metabolic system (S9-Mix).
- concentration or volume of S9 mix and S9 in the final culture medium: 0.5 mL of S9-mix
- quality controls of S9: The metabolic activity of the microsomes was verified by the positive control substances of each study. - Test concentrations with justification for top dose:
- 0.8, 2.5, 7.4, 22, 67 and 200 µg per plate without external metabolisation, and
0.8, 2.5, 7.4, 22, 67 and 200 µg per plate with S9-mix from Aroclor 1254 induced microsomes of rat liver as an external metabolising system
The concentrations for the first experiment were set according to a preliminary toxicity test. The test substance was toxic at 5000 and 1667 µg/plate At 556 and 185 µg/plate only microcolonies were visible instead of a bacterial background lawn Therefore 200 µg/plate was chosen as highest concentration which could be in the toxic range, and a total of 6 concentrations was tested. The number and intervals of the concentrations are in accordance with the guidelines. - Vehicle / solvent:
- deionised water
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-o-phenylenediamine
- Remarks:
- 10 µg, TA97a, without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 2 µg, TA98, without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA100 (2 µg), TA1535 (1 µg), without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: t-Butyl-hydroperoxide
- Remarks:
- 50 µg, TA102, without S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- Remarks:
- 10 µg, TA97a, with S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- TA98 (1 µg), TA100 (2 µg), TA 1535 (2 µg), with S9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1,8-Dihydroxy-anthraquinone
- Remarks:
- 50 µg, TA102, with S9 mix
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
Triplicate repetitions were run for each dose group, for the control groups six-fold repetitions were run. Due to the clear positive result of this test only one experiment was performed.
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in agar (plate incorporation)
TREATMENT AND HARVEST SCHEDULE:
- Exposure duration/duration of treatment: After the top agar had solidified, the plates were incubated at 37 °C until the colonies were visible (2 days).
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: relative total growth - Evaluation criteria:
- Determination of the toxicity
Additionally to the counting of colonies the bacterial background of the plates was inspected visually. The following signs of toxicity, if present, were recorded:
• A reduced bacterial background lawn (mottled instead of homogeneous).
• Microcolonies of bacteria instead of a homogeneous background lawn.
• No background lawn.
• Clearly reduced numbers of revertant colonies.
Calculations, criteria for a positive result:
Means and standard deviations were calculated for the number of mutants in every concentration group.
The criteria for a positive result are:
A reproducible increase of the number of revertants to more than the following threshold values for at least one of the concentrations:
• For the strains with a low spontaneous revertant rate i.e. TA98 and TA1535: The 2½ fold of the amount of the spontaneous revertants.
• For the strains with a high spontaneous revertant rate i.e. TA97a, TA100 and TA102: The 1 2/3 fold of the amount of the spontaneous revertants.
These threshold values were derived from the variations in the control samples of our historic data of the Ames test. - Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- at 67 µg/plate
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- at 67 and 22 µg/plate
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- at 67 and 22 µg/plate
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Remarks:
- at 67 and 22 µg/plate
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 200 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: No precipitation of the test substance was seen in any of the concentration groups.
Ames test:
- Signs of toxicity
In the preliminary test the test substance was toxic to the bacteria at 185 µg/plate and above. In the main test the test substance was again toxic to the bacteria at 200 and 67 µg/plate, resulting in the occurrence of microcolonies instead of a bacterial background or a reduced bacterial background lawn. At 22 µg/plate and beneath the bacterial background was normal.
- Genotoxicity results:
In the plates of strain TA97a, TA98, TA100 and TA102 a significant increase of the revertant colonies was observed in the higher concentrations.
In the strain TA1535 no significant increase of the revertant counts was obtained. - Conclusions:
- According to these results, the substance is mutagenic in the Ames test with the strains of Salmonella typhimurium TA97a, TA98, TA100 and TA102 with and without an external metabolising system.
- Executive summary:
A study according OECD TG 471 was performed to determine a possible mutagenic action of the test substance with the Salmonella typhimurium reverse mutation test (Ames test). This test is sensitive to frameshift mutations as well as to base pair mutations. The performance of the test with and without an external metabolising system enables the detection of the mutagenic action of the test substance itself as well as of its metabolites.
The test substance was dissolved in deionised water. The following concentrations were tested:
0.8, 2.5, 7.4, 22, 67 and 200 µg per plate without external metabolisation, and
0.8, 2.5, 7.4, 22, 67 and 200 µg per plate with S9-mix from Aroclor 1254 induced microsomes of rat liver as an external metabolising system.
The test was performed according to the plate incorporation method. As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. Due to the clear positive result of this test only one experiment was performed.
Toxicity of the test substance to the bacteria was observed at 200 and 67 µg/plate, resulting in the occurrence of micro-colonies instead of a bacterial background or a reduced bacterial background lawn. At 22 µg/plate and beneath the bacterial background was normal.
No precipitation of the test substance was seen in any of the concentration groups.
In the plates of the strains TA97a, TA98, TA100 and TA102 an increase of the mutation frequency to more than the threshold values (250 % of the controls for strains TA98 and TA1535, 167 % of the controls for strains TA97a, TA100 and TA102) was obtained. In the strain TA1535 no significant increase of the revertant counts was obtained.
According to the results obtained in this study, the test item is mutagenic in the Ames test with the strains TA97a, TA98, TA100 and TA102 with and without an external metabolising system.
Reference
Table 1: Mean number of revertants per plate for strain TA97a
Without metabolisation |
Metabolisation with S9-mix |
||||||
conc. |
revertants / plate |
conc. |
revertants / plate |
||||
µg/plate |
mean |
SD |
N |
µg/plate |
mean |
SD |
N |
200 |
0.0 |
0.0 |
3 |
200 |
39.7 |
1.5 |
3 |
67 |
119.5 |
57.3 |
2 |
67 |
344.3 |
26.7 |
3 |
22 |
177.3 |
26.4 |
3 |
22 |
182.0 |
22.5 |
3 |
7.4 |
117.3 |
17.9 |
3 |
7.4 |
136.3 |
0.6 |
3 |
2.5 |
101.0 |
9.9 |
2 |
2.5 |
123.7 |
14.6 |
3 |
0.8 |
104.7 |
8.5 |
3 |
0.8 |
124.7 |
27.0 |
3 |
solvent |
102.5 |
2.1 |
2 |
solvent |
162.7 |
7.9 |
6 |
positive |
327.0 |
26.9 |
2 |
positive |
417.7 |
21.1 |
3 |
solvent: deionised water
positive: without metabolisation: 4-Nitro-o-phenylene-diamine, 10 µg / plate
with metabolisation: 7,12-Dimethylbenz[a]anthracene, 10 µg / plate
reverse: |
exceeding the threshold for mutagenicity:>167 % of the solvent controls |
Table 2: Mean number of revertants per plate for strain TA1535
Without metabolisation |
Metabolisation with S9-mix |
||||||
conc. |
revertants / plate |
conc. |
revertants / plate |
||||
µg/plate |
mean |
SD |
N |
µg/plate |
mean |
SD |
N |
200 |
0.0 |
0.0 |
0 |
200 |
0.0 |
0.0 |
0 |
67 |
4.0 |
1.0 |
3 |
67 |
16.0 |
1.0 |
3 |
22 |
10.7 |
3.8 |
3 |
22 |
9.3 |
4.0 |
3 |
7.4 |
11.0 |
1.0 |
3 |
7.4 |
8.3 |
1.5 |
3 |
2.5 |
8.0 |
2.0 |
3 |
2.5 |
10.0 |
1.7 |
3 |
0.8 |
7.7 |
3.1 |
3 |
0.8 |
10.0 |
2.6 |
3 |
solvent |
7.2 |
3.1 |
6 |
solvent |
10.0 |
4.1 |
6 |
positive |
163.3 |
25.8 |
3 |
positive |
217.0 |
9.2 |
3 |
solvent: deionised water
positive: without metabolisation: Sodium azide, 1 µg / plate
with metabolisation: 2-Amino-anthracene, 2 µg / plate
reverse: |
exceeding the threshold for mutagenicity:>250 % of the solvent controls |
Table 3: Mean number of revertants per plate for strain TA98
Without metabolisation |
Metabolisation with S9-mix |
||||||
conc. |
revertants / plate |
conc. |
revertants / plate |
||||
µg/plate |
mean |
SD |
N |
µg/plate |
mean |
SD |
N |
200 |
0.0 |
0.0 |
3 |
200 |
0.0 |
0.0 |
3 |
67 |
6.0 |
3.5 |
3 |
67 |
48.7 |
2.5 |
3 |
22 |
29.3 |
5.1 |
3 |
22 |
22.7 |
1.5 |
3 |
7.4 |
16.3 |
1.5 |
3 |
7.4 |
12.7 |
2.5 |
3 |
2.5 |
12.3 |
3.2 |
3 |
2.5 |
15.0 |
1.7 |
3 |
0.8 |
9.0 |
1.7 |
3 |
0.8 |
11.0 |
1.0 |
3 |
solvent |
12.7 |
1.4 |
6 |
solvent |
15.2 |
2.2 |
6 |
positive |
199.7 |
3.8 |
3 |
positive |
403.0 |
22.3 |
3 |
solvent: deionised water
positive: without metabolisation: 2-Nitrofluorene, 2 µg / plate
with metabolisation: 2-Amino-anthracene, 1 µg / plate
reverse: |
exceeding the threshold for mutagenicity:>250 % of the solvent controls |
Table 4: Mean number of revertants per plate for strain TA100
Without metabolisation |
Metabolisation with S9-mix |
||||||
conc. |
revertants / plate |
conc. |
revertants / plate |
||||
µg/plate |
mean |
SD |
N |
µg/plate |
mean |
SD |
N |
200 |
0.0 |
0.0 |
3 |
200 |
0.0 |
0.0 |
3 |
67 |
175.3 |
29.7 |
3 |
67 |
403.0 |
23.8 |
3 |
22 |
150.3 |
35.3 |
3 |
22 |
122.0 |
8.0 |
3 |
7.4 |
75.7 |
3.5 |
3 |
7.4 |
78.7 |
7.4 |
3 |
2.5 |
82.7 |
10.6 |
3 |
2.5 |
82.7 |
17.6 |
3 |
0.8 |
71.7 |
3.8 |
3 |
0.8 |
93.3 |
14.0 |
3 |
solvent |
74.3 |
14.7 |
6 |
solvent |
90.2 |
12.4 |
6 |
positive |
303.7 |
9.1 |
3 |
positive |
1165.3 |
137.7 |
3 |
solvent: deionised water
positive: without metabolisation: Sodium azide, 2 µg / plate
with metabolisation: 2-Amino-anthracene, 2 µg / plate
reverse: |
exceeding the threshold for mutagenicity:>167 % of the solvent controls |
Table 5: Mean number of revertants per plate for strain TA102
Without metabolisation |
Metabolisation with S9-mix |
||||||
conc. |
revertants / plate |
conc. |
revertants / plate |
||||
µg/plate |
mean |
SD |
N |
µg/plate |
mean |
SD |
N |
200 |
0.0 |
0.0 |
3 |
200 |
174.7 |
94.6 |
3 |
67 |
413.7 |
79.5 |
3 |
67 |
554.3 |
43.4 |
3 |
22 |
296.0 |
39.4 |
3 |
22 |
272.0 |
13.5 |
3 |
7.4 |
177.7 |
17.7 |
3 |
7.4 |
177.7 |
30.2 |
3 |
2.5 |
165.0 |
9.5 |
3 |
2.5 |
179.0 |
17.4 |
3 |
0.8 |
144.7 |
5.1 |
3 |
0.8 |
205.3 |
26.6 |
3 |
solvent |
146.8 |
13.0 |
6 |
solvent |
150.5 |
20.3 |
6 |
positive |
397.0 |
14.7 |
3 |
positive |
366.0 |
57.3 |
3 |
solvent: deionised water
positive: without metabolisation: t-Butyl-hydroperoxide, 50 µg / plate
with metabolisation: 1,8-Dihydroxy-anthraquinone, 50 µg / plate
reverse: |
exceeding the threshold for mutagenicity:>167 % of the solvent controls |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (positive)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Ames Test
A study according OECD TG 471 was performed to determine a possible mutagenic action of the test substance with the Salmonella typhimurium reverse mutation test (Ames test). This test is sensitive to frameshift mutations as well as to base pair mutations. The performance of the test with and without an external metabolising system enables the detection of the mutagenic action of the test substance itself as well as of its metabolites.
The test substance was dissolved in deionised water. The following concentrations were tested:
0.8, 2.5, 7.4, 22, 67 and 200 µg per plate without external metabolisation, and
0.8, 2.5, 7.4, 22, 67 and 200 µg per plate with S9-mix from Aroclor 1254 induced microsomes of rat liver as an external metabolising system.
The test was performed according to the plate incorporation method. As test system the bacterial strains Salmonella typhimurium TA97a, TA98, TA100, TA102 and TA1535 were used. Negative and positive controls were included. Due to the clear positive result of this test only one experiment was performed.
Toxicity of the test substance to the bacteria was observed at 200 and 67 µg/plate, resulting in the occurrence of micro-colonies instead of a bacterial background or a reduced bacterial background lawn. At 22 µg/plate and beneath the bacterial background was normal.
No precipitation of the test substance was seen in any of the concentration groups.
In the plates of the strains TA97a, TA98, TA100 and TA102 an increase of the mutation frequency to more than the threshold values (250 % of the controls for strains TA98 and TA1535, 167 % of the controls for strains TA97a, TA100 and TA102) was obtained. In the strain TA1535 no significant increase of the revertant counts was obtained.
According to the results obtained in this study, the test item is mutagenic in the Ames test with the strains TA97a, TA98, TA100 and TA102 with and without an external metabolising system.
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
According to Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) Chromium (VI) compounds (Index Number 024-017-00-8) are harmonised classified for carcinogenicity Cat 1B (H350). Therefore, a separate classification for mutagenicity was not conducted.
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