Registration Dossier
Registration Dossier
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EC number: 229-494-8 | CAS number: 6574-99-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
There is no data available on the genetic toxicity of 3,4-Dichlorobenzonitrile. In order to classify the substance according to GHS relevant endpoint data available for 2-Chlorobenzonitrile and 2,6-Dichlorobenzonitrile was read-acrossed to 3,4-Dichlorobenzonitrile based on structural and physico chemical similarities.
2,6-Dichlorobenzonitrile, as well as 3,4 -Dichlorobenzonitrile is a disubstituted Benzonitrile. Both substances only differ in the position of the chloro substituents. 2-Chlorobenzonitile is a next lower homologon of 2,6-Dichlorobenzonitrile. Furthermore all three substances are solid, practically insoluble in water and have a water octanol partition coefficient between 2.2 and 2.8. This might perhaps also lead to a similiar toxicological behavior. The Read-Across approach assumes that if a Monochlorobenzonitrile and a Dichlorobenzonitril show similiar toxicological behavior, it is likely that a second Dichlorobenzonitril also shows this similar behavior, particularly if it has the same physico chemical properties (solid, practically insoluble in water and logKow between 2.2 and 2.8)
In order to classify the substance 3,4 -Dichlorobenzonitrile (without any unneccessary animal testing) the negative results of the AMES tests with 2-Chlorobenzonitrile and 2,6-Dichlorbenzonitrile are read acrossed and lead to a non-classification of 3,4-Dichlorobenzonitrile in genetic toxicity (according to GHS).
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 21 September 1983 to 3 October 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- There is no data available on the genetic toxicity of 3,4-Dichlorobenzonitrile. In order to classify the substance according to GHS relevant endpoint data available for 2-Chlorobenzonitrile was read-acrossed to 3,4-Dichlorobenzonitrile based on structural and physico chemical similarities. 2-Chlorobenzonitrile, as well as 3,4 -Dichlorobenzonitrile is a Chloro substituted Benzonitrile. Although 2-Chlorobenzonitrile is only monosubstituted both substances are solid, practically insoluble in water and have similar water octanol partition coefficients (2.2 and 2.8). This might perhaps also lead to a similiar toxicological behavior.
For justification of reaacross see section 13.2 - Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- Histidine dependence
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 0, 40, 200, 1000 and 5000 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- other: 4-nitro-o-phenylene diamine, 2-amino-anthracene, Neutral Red,
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: five at each dose level and ten for the solvent controls - Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The top concentration of 5,000 µg/plate precipitated in the top agar. The revertant colony counts per plate are summarised in Table 1. No increases in revertant colony numbers were observed after treatment of any of the five tested strains with the test material, either in the presence or absence of rat liver microsomal fraction.
- Conclusions:
- Under the conditions of the test, the test material was determined to be negative in a bacterial gene mutation assay.
- Executive summary:
A non-GLP compliant bacterial gene mutation assay was conducted in line with sound scientific principles similar to OECD 471 and EU Method B13/14.
No increases in revertant colony numbers were observed after treatment of any of the five tested strains with the test material, either in the presence or absence of rat liver microsomal fraction.
Under the conditions of the test, the test material was determined to be negative in a bacterial gene mutation assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- There is no data available on the genetic toxicity of 3,4-Dichlorobenzonitrile. In order to classify the substance according to GHS relevant endpoint data available for 2-Chlorobenzonitrile was read-acrossed to 3,4-Dichlorobenzonitrile based on structural and physico chemical similarities. 2-Chlorobenzonitrile, as well as 3,4 -Dichlorobenzonitrile is a Chloro substituted Benzonitrile. Although 2-Chlorobenzonitrile is only monosubstituted both substances are solid, practically insoluble in water and have similar water octanol partition coefficients (2.2 and 2.8). This might perhaps also lead to a similiar toxicological behavior.
For justification of reaacross see section 13.2 - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- initial range-finder: 0, 8, 40, 200, 1000, 5000 µg/plate
main experiment: TA98: 0, 500, 1000, 1500, 2000, 2500 (without S9)
main experiment: all other strains: 0, 1000, 1500, 2000, 2500, 3000 (without S9)
main experiment: all strains: 0, 1000, 2000, 3000, 4000, 5000 (with S9) - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 9-aminoacridine, sodium azide, 2-nitrofluorene
- Statistics:
- F-test
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at highes concentration
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Initial range-finder treatment of strain TA100 was carried out 8, 40, 200, 100 and 5000 µg/plate. The treatment resulted in complete toxicity at 5000 µg/plate in the absence of S9, and a reduction in revertant numbers on plates treated with S9. In the main study concentrations were reduced to 2500 µg/plate (TA 98) and 3000 µg/plate (all other strains) in the absence of S9. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results
negative
2-chlorobenzonitrile did not induce mutation in five strains of Samonella typhimurim, when tested up the cytotoxicity limit, both in the absence and presence of metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 of S. typhimurium were exposed to 2-chlorobenzonitrile dissolved in dimethyl sulphoxide (DMSO) at concentrations of up to 5000 µg/plate in the presence and absence of mammalian liver post-mitochondrial fraction (S-9) as metabolic activation. There was no evidence of induced mutant colonies over background. This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation).
As there is no data available on genetic toxicity testing with 3,4 -Dichlorobenzonitrile relevant endpoint data available for 2 -Chlorobenzonitrile was read-acrossed to 3,4 -Dichlorobenzonitrile in order to classify the substance (without any unnecesssary animal testing) according to GHS. The Read-Across approach was based on structural and physico chemical similarities (see rational for reliability).
In the AMES test 2 -Chlorobenzonitrile was tested to be non mutagenic. Therefore and because of the also negative AMES test with 2,6 -Dichlorobenzonitrile (see second study record) 3,4 -Dichlorobenzonitrile does not need to be classified as mutagenic.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 21 September 1983 to 3 October 1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- There is no data available on the genetic toxicity of 3,4-Dichlorobenzonitrile. In order to classify the substance according to GHS relevant endpoint data available for 2-Chlorobenzonitrile was read-acrossed to 3,4-Dichlorobenzonitrile based on structural and physico chemical similarities. 2-Chlorobenzonitrile, as well as 3,4 -Dichlorobenzonitrile is a Chloro substituted Benzonitrile. Although 2-Chlorobenzonitrile is only monosubstituted both substances are solid, practically insoluble in water and have similar water octanol partition coefficients (2.2 and 2.8). This might perhaps also lead to a similiar toxicological behavior.
For justification of reaacross see section 13.2 - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial gene mutation assay
- Target gene:
- Histidine dependence
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- 0, 40, 200, 1000 and 5000 µg/plate.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- other: 4-nitro-o-phenylene diamine, 2-amino-anthracene, Neutral Red,
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: five at each dose level and ten for the solvent controls - Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- The top concentration of 5,000 µg/plate precipitated in the top agar. The revertant colony counts per plate are summarised in Table 1. No increases in revertant colony numbers were observed after treatment of any of the five tested strains with the test material, either in the presence or absence of rat liver microsomal fraction.
- Conclusions:
- Under the conditions of the test, the test material was determined to be negative in a bacterial gene mutation assay.
- Executive summary:
A non-GLP compliant bacterial gene mutation assay was conducted in line with sound scientific principles similar to OECD 471 and EU Method B13/14.
No increases in revertant colony numbers were observed after treatment of any of the five tested strains with the test material, either in the presence or absence of rat liver microsomal fraction.
Under the conditions of the test, the test material was determined to be negative in a bacterial gene mutation assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- There is no data available on the genetic toxicity of 3,4-Dichlorobenzonitrile. In order to classify the substance according to GHS relevant endpoint data available for 2-Chlorobenzonitrile was read-acrossed to 3,4-Dichlorobenzonitrile based on structural and physico chemical similarities. 2-Chlorobenzonitrile, as well as 3,4 -Dichlorobenzonitrile is a Chloro substituted Benzonitrile. Although 2-Chlorobenzonitrile is only monosubstituted both substances are solid, practically insoluble in water and have similar water octanol partition coefficients (2.2 and 2.8). This might perhaps also lead to a similiar toxicological behavior.
For justification of reaacross see section 13.2 - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- rat liver post-mitochondrial fraction (S-9)
- Test concentrations with justification for top dose:
- initial range-finder: 0, 8, 40, 200, 1000, 5000 µg/plate
main experiment: TA98: 0, 500, 1000, 1500, 2000, 2500 (without S9)
main experiment: all other strains: 0, 1000, 1500, 2000, 2500, 3000 (without S9)
main experiment: all strains: 0, 1000, 2000, 3000, 4000, 5000 (with S9) - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 9-aminoacridine, sodium azide, 2-nitrofluorene
- Statistics:
- F-test
- Key result
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at highes concentration
- 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
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES:
Initial range-finder treatment of strain TA100 was carried out 8, 40, 200, 100 and 5000 µg/plate. The treatment resulted in complete toxicity at 5000 µg/plate in the absence of S9, and a reduction in revertant numbers on plates treated with S9. In the main study concentrations were reduced to 2500 µg/plate (TA 98) and 3000 µg/plate (all other strains) in the absence of S9. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results
negative
2-chlorobenzonitrile did not induce mutation in five strains of Samonella typhimurim, when tested up the cytotoxicity limit, both in the absence and presence of metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria, strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 of S. typhimurium were exposed to 2-chlorobenzonitrile dissolved in dimethyl sulphoxide (DMSO) at concentrations of up to 5000 µg/plate in the presence and absence of mammalian liver post-mitochondrial fraction (S-9) as metabolic activation. There was no evidence of induced mutant colonies over background. This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation).
As there is no data available on genetic toxicity testing with 3,4 -Dichlorobenzonitrile relevant endpoint data available for 2 -Chlorobenzonitrile was read-acrossed to 3,4 -Dichlorobenzonitrile in order to classify the substance (without any unnecesssary animal testing) according to GHS. The Read-Across approach was based on structural and physico chemical similarities (see rational for reliability).
In the AMES test 2 -Chlorobenzonitrile was tested to be non mutagenic. Therefore and because of the also negative AMES test with 2,6 -Dichlorobenzonitrile (see second study record) 3,4 -Dichlorobenzonitrile does not need to be classified as mutagenic.
Referenceopen allclose all
Table 1: Mean revertant colony counts per plate
| Strain of Salmonella typhimurium | ||||||
| Concentration (µg/plate) | Metabolic activation | TA1535 | TA1537 | TA1538 | TA98 | TA100 |
| 5000 | - | ** | ** | ** | ** | ** |
| 1000 | - | 20 | 5 | 12 | 13 | 63 |
| 200 | - | 14 | 4 | 9 | 13 | 81 |
| 40 | - | 14 | 7 | 11 | 14 | 77 |
| 0 | - | 13 | 6 | 13 | 16 | 84 |
| 5000 | + | ** | ** | ** | ** | ** |
| 1000 | + | 13 | 3 | 9 | 13 | 50 |
| 200 | + | 14 | 5 | 12 | 13 | 69 |
| 40 | + | 6 | 6 | 14 | 23 | 72 |
| 0 | + | 11 | 8 | 17 | 20 | 76 |
- absence of metabolic activation
+ presence of metabolic activation
** test material precipitated in top agar
Table 1: Mean revertant colony counts per plate
| Strain of Salmonella typhimurium | ||||||
| Concentration (µg/plate) | Metabolic activation | TA1535 | TA1537 | TA1538 | TA98 | TA100 |
| 5000 | - | ** | ** | ** | ** | ** |
| 1000 | - | 20 | 5 | 12 | 13 | 63 |
| 200 | - | 14 | 4 | 9 | 13 | 81 |
| 40 | - | 14 | 7 | 11 | 14 | 77 |
| 0 | - | 13 | 6 | 13 | 16 | 84 |
| 5000 | + | ** | ** | ** | ** | ** |
| 1000 | + | 13 | 3 | 9 | 13 | 50 |
| 200 | + | 14 | 5 | 12 | 13 | 69 |
| 40 | + | 6 | 6 | 14 | 23 | 72 |
| 0 | + | 11 | 8 | 17 | 20 | 76 |
- absence of metabolic activation
+ presence of metabolic activation
** test material precipitated in top agar
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
There is no data available on the genetic toxicity of 3,4-Dichlorobenzonitrile. In order to classify the substance according to GHS relevant endpoint data available for 2-Chlorobenzonitrile and 2,6-Dichlorobenzonitrile was read-acrossed to 3,4-Dichlorobenzonitrile based on structural and physico chemical similarities.
2,6-Dichlorobenzonitrile, as well as 3,4 -Dichlorobenzonitrile is a disubstituted Benzonitrile. Both substances only differ in the position of the chloro substituents. 2-Chlorobenzonitile is a next lower homologon of 2,6-Dichlorobenzonitrile. Furthermore all three substances are solid, practically insoluble in water and have a water octanol partition coefficient between 2.2 and 2.8. This might perhaps also lead to a similiar toxicological behavior. The Read-Across approach assumes that if a Monochlorobenzonitrile and a Dichlorobenzonitril show similiar toxicological behavior, it is likely that a second Dichlorobenzonitril also shows this similar behavior, particularly if it has the same physico chemical properties (solid, practically insoluble in water and logKow between 2.2 and 2.8)
In order to classify the substance 3,4 -Dichlorobenzonitrile (without any unneccessary animal testing) the negative results of the AMES tests with 2-Chlorobenzonitrile and 2,6-Dichlorbenzonitrile are read acrossed and lead to a non-classification of 3,4-Dichlorobenzonitrile in genetic toxicity (according to GHS).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
