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EC number: 210-765-4 | CAS number: 623-03-0
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicity to microorganisms
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The mutagenic potential of 4-Chlorobenzonitrile was assessed according to OECD 471 ("Bacterial Reverse Mutation Test").
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:
- 07.01.2014 - 06.05.2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Gene involved in histidine synthesis
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Details on mammalian cell type (if applicable):
- n. a.
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Mammalian Microsomal Fraction S9 Mix
- Test concentrations with justification for top dose:
- Experiment I: 15, 50, 150, 500 and 1500 µg/plate
Experiment II: 94, 188, 375, 750 and 1500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:The test item was dissolved in DMSO and diluted prior to treatment. The solvent was compatible with the survival of the bacteria and the S9 activity. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene diamine; 2-Aminoanthracene
- Details on test system and experimental conditions:
- see "any other information om materials and methods incl. tables"
- Evaluation criteria:
- The colonies were counted visually and, the numbers were recorded. A spreadsheet soft-ware (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The increase factor f(I) of revertant induction (mean revertants divided by mean spontane-ous revertants) and the absolute number of revertants (“Rev. abs.”, mean revertants less mean spontaneous revertants) were also calculated.
A test item is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor >= 2) in at least one strain can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity. - Statistics:
- no data
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 97
- Remarks:
- TA 97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Executive summary:
In a study according to OECD 471 and EU Method B.13/14 two valid experiments were performed.
First Experiment:
Five concentrations of the test item, dissolved in DMSO were used. Five genetically manipulated strains of Salmonella typhimurium(TA97a, TA98, TA100, TA102 and TA1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (S9) for 48 hours, using the plate incorporation method.
None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item didn’t show any mutagenic effects in the first experiment. No signs of toxicity towards the bacteria could be observed. The sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Second Experiment:
To verify the results of the first experiment, a second experiment was performed, using five concentrations of the test item and a modification in study performance (pre-incubation method).
The test item didn’t show mutagenic effects in the second experiment, either. No signs of toxicity towards the bacteria could be observed. The sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Under the conditions of the test, the test item didn’t show mutagenic effects towards Salmonella typhimurium strainsTA97a, TA98, TA100, TA102 and TA1535. Therefore, no concentration-effect relationship could be determined.
The test item 4-Chlorobenzonitrile is considered as “not mutagenic under the conditions of the test”.
Reference
1 Results
1. 1 First Experiment
1.1.1 Confirmation of the Criteria and Validity
The treatments for the sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.
1.1.2 Solubility and Toxicity
The test item was dissolved in DMSO. No signs of toxicity towards the tested strains could be observed. The background lawn was visible and the number of revertant colonies was not reduced.
1.1.3 Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
In the treatment with metabolic activation in the highest concentration (1500 µg/plate) the mean value of the revertants of the strain TA97a is higher than the mean value of the spontaneous revertants of the solvent control DMSO. But it lies below the threshold of the increase factor for mutagenicity. Furthermore, in the second experiment, the respective value clearly shows no evidence of mutageniticty. Bacteria strains are living biological systems, therefore variations in behaviour are not unusual.
The mean revertant values of the four replicates are presented in table 1.
Table 1: Mean Revertants of the First Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
166 |
101 |
25 |
30 |
93 |
93 |
329 |
169 |
15 |
13 |
sd |
8.5 |
21.2 |
9.3 |
4.9 |
27.1 |
11.4 |
18.6 |
30.0 |
1.7 |
1.4 |
|
DMSO |
Mean |
150 |
97 |
23 |
24 |
167 |
134 |
173 |
331 |
12 |
15 |
sd |
7.6 |
10.8 |
2.6 |
9.6 |
9.1 |
52.8 |
25.6 |
78.6 |
1.3 |
1.4 |
|
Positive |
Mean |
511 |
225 |
194 |
248 |
290 |
307 |
417 |
1148 |
180 |
195 |
sd |
71 |
40 |
29 |
47 |
53 |
30 |
52 |
45 |
29 |
48 |
|
f(I) |
3.41 |
2.32 |
8.43 |
10.33 |
3.12 |
2.29 |
2.41 |
3.47 |
12.00 |
13.00 |
|
1500 µg/plate |
Mean |
138 |
189 |
15 |
24 |
162 |
149 |
280 |
198 |
14 |
12 |
sd |
23 |
23 |
4 |
5 |
20 |
37 |
61 |
5 |
3 |
2 |
|
f(I) |
0.92 |
1.95 |
0.65 |
1.00 |
0.97 |
1.11 |
1.62 |
0.60 |
1.17 |
0.80 |
|
500 µg/plate |
Mean |
140 |
140 |
22 |
25 |
144 |
102 |
266 |
270 |
15 |
16 |
sd |
29 |
19 |
4 |
10 |
32 |
22 |
32 |
10 |
3 |
3 |
|
f(I) |
0.93 |
1.44 |
0.96 |
1.04 |
0.86 |
0.76 |
1.54 |
0.82 |
1.25 |
1.07 |
|
150 µg/plate |
Mean |
110 |
133 |
23 |
24 |
158 |
97 |
245 |
216 |
15 |
17 |
sd |
13 |
39 |
7 |
8 |
13 |
11 |
40 |
18 |
3 |
2 |
|
f(I) |
0.73 |
1.37 |
1.00 |
1.00 |
0.95 |
0.72 |
1.42 |
0.65 |
1.25 |
1.13 |
|
50 µg/plate |
Mean |
125 |
151 |
23 |
23 |
170 |
160 |
281 |
253 |
16 |
17 |
sd |
27 |
33 |
4 |
5 |
7 |
29 |
32 |
39 |
5 |
5 |
|
f(I) |
0.83 |
1.56 |
1.00 |
0.96 |
1.02 |
1.19 |
1.62 |
0.76 |
1.33 |
1.13 |
|
15 µg/plate |
Mean |
121 |
137 |
17 |
22 |
130 |
117 |
249 |
230 |
14 |
17 |
sd |
35 |
18 |
2 |
6 |
37 |
27 |
38 |
29 |
4 |
1 |
|
f(I) |
0.81 |
1.41 |
0.74 |
0.92 |
0.78 |
0.87 |
1.44 |
0.69 |
1.17 |
1.13 |
sd = standard deviation; f(I) = increase factor; * = Different positive controls were used
1.2 Second Experiment
1.2.1 Confirmation of the Criteria and Validity
The treatments for the sterility control and the determination of the titre didn’t show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls showed mutagenic effects with and without metabolic activation.
1.2.2 Solubility and Toxicity
The test item was dissolved in DMSO. No signs of toxicity towards the tested strains could be observed. The background lawn was visible and the number of revertant colonies was not significantly reduced.
1.2.3 Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation was observed. No concentration-related increase over the tested range was found. Therefore, the test item is stated as not mutagenic under the test conditions.
The mean revertant values of the four replicates are presented in table 2.
Table 2: Mean Revertants of the Second Experiment
Strain |
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
||||||
Induction |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
H2O |
Mean |
107 |
117 |
25 |
25 |
85 |
125 |
306 |
291 |
15 |
15 |
sd |
4.3 |
4.7 |
3.8 |
2.5 |
11.7 |
12.8 |
39.0 |
16.5 |
4.9 |
2.4 |
|
DMSO |
Mean |
119 |
125 |
27 |
24 |
99 |
105 |
317 |
284 |
14 |
17 |
sd |
6.7 |
11.2 |
4.7 |
3.8 |
20.6 |
5.3 |
45.8 |
16.7 |
1.6 |
1.7 |
|
Positive |
Mean |
440 |
418 |
412 |
212 |
587 |
413 |
1046 |
820 |
162 |
121 |
sd |
13 |
27 |
8 |
28 |
99 |
13 |
182 |
45 |
35 |
20 |
|
f(I) |
3.70 |
3.34 |
15.26 |
8.83 |
6.91 |
3.93 |
3.30 |
2.89 |
10.80 |
7.12 |
|
1500 µg/plate |
Mean |
122 |
122 |
14 |
24 |
156 |
90 |
254 |
266 |
16 |
13 |
sd |
2 |
16 |
9 |
3 |
13 |
13 |
24 |
10 |
4 |
2 |
|
f(I) |
1.03 |
0.98 |
0.52 |
1.00 |
1.58 |
0.86 |
0.80 |
0.94 |
1.14 |
0.76 |
|
750 µg/plate |
Mean |
120 |
134 |
21 |
32 |
171 |
98 |
266 |
312 |
16 |
15 |
sd |
3 |
11 |
4 |
10 |
16 |
12 |
11 |
80 |
4 |
3 |
|
f(I) |
1.01 |
1.07 |
0.78 |
1.33 |
1.73 |
0.93 |
0.84 |
1.10 |
1.14 |
0.88 |
|
375 µg/plate |
Mean |
121 |
123 |
23 |
27 |
123 |
137 |
304 |
278 |
16 |
17 |
sd |
3 |
40 |
5 |
2 |
29 |
16 |
39 |
14 |
3 |
3 |
|
f(I) |
1.02 |
0.98 |
0.85 |
1.13 |
1.24 |
1.30 |
0.96 |
0.98 |
1.14 |
1.00 |
|
188 µg/plate |
Mean |
141 |
109 |
22 |
24 |
98 |
135 |
298 |
297 |
15 |
17 |
sd |
29 |
37 |
4 |
5 |
11 |
6 |
26 |
25 |
4 |
4 |
|
f(I) |
1.18 |
0.87 |
0.81 |
1.00 |
0.99 |
1.29 |
0.94 |
1.05 |
1.07 |
1.00 |
|
94 µg/plate |
Mean |
114 |
134 |
21 |
26 |
105 |
140 |
303 |
294 |
13 |
22 |
sd |
8 |
35 |
5 |
5 |
14 |
10 |
14 |
26 |
3 |
2 |
|
f(I) |
0.96 |
1.07 |
0.78 |
1.08 |
1.06 |
1.33 |
0.96 |
1.04 |
0.93 |
1.29 |
sd = standard deviation; f(I) = increase factor; * = Different positive controls were used
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Additional information from genetic toxicity in vitro:
4-Chlorobenzonitrile was tested for genotoxic effects in a GLP guideline study according to OECD 471 ("Bacterial Reverse Mutation Test"). Concentrations up to 1500 µg/plate were tested. No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, eighter with or without metabolic activation. The test material was considered to be non-mutagenic under the conditions of the test.
Justification for classification or non-classification
The mutagenic potential of 4-Chlorobenzonitrile was assessed according to OECD 471 ("Bacterial Reverse Mutation Test"). The test material was considered to be non-mutagenic under the conditions of the test. Therefore the 4-Chlorobenzonitrile does not need to be classified as mutagenic.
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