Registration Dossier
Registration Dossier
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EC number: 701-428-7 | CAS number: -
Toxicological information
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Three samples of mixed chlorinated and brominated copper phthalocyanine pigments were tested for mutegenicity in five bacteria strains (OECD 471, GLP). In all studies, precipitation of the green pigment, but no toxicity to bacteria up to the limit dose of 5 mg per plate were observed. All three studies showed absence of mutagenicity in the Ames test. Vehicle and positve control experiments confirmed the validity of the assays.
For the endpoints of gene mutation and clastogenicity in mammalian cells, read-across is applied. Justifications are attached to the robust study summaries.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Specific details on test material used for the study:
- Lot 029008P050
Green powder
Storage Room temperature
Year of manufacture: 2003 - Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from liver of Aroclor 1254-induced rats
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500 and 5000 microgramm/plate
- Vehicle / solvent:
- DMSO
- 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
- other: 2-Aminoanthracene, N-methyl-N`-nitro-N-nitrosoguanidine, 4-nitro-phenylendiamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation) for the first experiment and preincubation for the repeat experiment
- Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
*A dose-related and reproducible increase in the number of revertant colonies, i.e. about
doubling of the spontaneous mutation rate in at least one tester strain either without
S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
*The number of revertants for all tester strains were within the historical negative control
range under all experimental conditions in two experiments carried out independently of
each other.
Acceptance criteria
Generally, the experiment is considered valid if the following criteria are met:
" The number of revertant colonies in the negative controls was within the normal range of
the historical control data for each tester strain (see Appendix 5).
" The sterility controls revealed no indication of bacterial contamination.
" The positive control articles both with and without S-9 mix induced a significant increase in
the number of revertant colonies within the range of the historical control data or above
(see Appendix 6).
" The titer of viable bacteria was > 108/mI. - 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
- 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
- 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
- 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
- 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
- Additional information on results:
- No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed.
Test substance precipitation was found from about 100 microgramm/plate onward.
The test substance did not Iead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay). - Conclusions:
- The substance is not mutagenic in the Ames test.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Specific details on test material used for the study:
- Lot 020032P050
Green powder
Storage Room temperature
Year of manufacture: 2003 - Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from liver of Aroclor 1254-induced rats
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500 and 5000 microgramm/plate
- Vehicle / solvent:
- DMSO
- 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
- other: 2-Aminoanthracene, N-methyl-N`-nitro-N-nitrosoguanidine, 4-nitro-phenylendiamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation) for the first experiment and preincubation for the repeat experiment
- Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
*A dose-related and reproducible increase in the number of revertant colonies, i.e. about
doubling of the spontaneous mutation rate in at least one tester strain either without
S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
*The number of revertants for all tester strains were within the historical negative control
range under all experimental conditions in two experiments carried out independently of
each other.
Acceptance criteria
Generally, the experiment is considered valid if the following criteria are met:
" The number of revertant colonies in the negative controls was within the normal range of
the historical control data for each tester strain (see Appendix 5).
" The sterility controls revealed no indication of bacterial contamination.
" The positive control articles both with and without S-9 mix induced a significant increase in
the number of revertant colonies within the range of the historical control data or above
(see Appendix 6).
" The titer of viable bacteria was > 108/mI. - 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
- 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
- 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
- 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
- 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
- Additional information on results:
- No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed.
Test substance precipitation was found from about 100 microgramm/plate onward.
The test substance did not Iead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay). - Conclusions:
- The substance is not mutagenic in the Ames test.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Specific details on test material used for the study:
- Lot 020036P050
Green powder
Storage Room temperature
Year of manufacture: 2003 - Target gene:
- his operon
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from liver of Aroclor 1254-induced rats
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500 and 5000 microgramm/plate
- Vehicle / solvent:
- DMSO
- 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
- other: 2-Aminoanthracene, N-methyl-N`-nitro-N-nitrosoguanidine, 4-nitro-phenylendiamine
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation) for the first experiment and preincubation for the repeat experiment
- Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
*A dose-related and reproducible increase in the number of revertant colonies, i.e. about
doubling of the spontaneous mutation rate in at least one tester strain either without
S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
*The number of revertants for all tester strains were within the historical negative control
range under all experimental conditions in two experiments carried out independently of
each other.
Acceptance criteria
Generally, the experiment is considered valid if the following criteria are met:
" The number of revertant colonies in the negative controls was within the normal range of
the historical control data for each tester strain (see Appendix 5).
" The sterility controls revealed no indication of bacterial contamination.
" The positive control articles both with and without S-9 mix induced a significant increase in
the number of revertant colonies within the range of the historical control data or above
(see Appendix 6).
" The titer of viable bacteria was > 108/mI. - 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
- 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
- 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
- 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
- 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
- Additional information on results:
- No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants, reduction in the titer) was observed.
Test substance precipitation was found from about 100 microgramm/plate onward.
The test substance did not Iead to an increase in the number of revertant colonies either without S-9 mix or after adding a metabolizing system in two experiments carried out independently of each other (standard plate test and preincubation assay). - Conclusions:
- The substance is not mutagenic in the Ames test.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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 examined
- Positive controls validity:
- valid
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- 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 examined
- Positive controls validity:
- valid
Referenceopen allclose all
| E.coli. WP2 uvrA | without S9 | with S9 | |||||||
| Dose/Plate | Revertants | Number | SD | Factor | Revertants | Mean | SD | Factor | Titre |
| DMSO | 28 | 31 | 3 | 1.0 | 30 | 34 | 5 | 1.0 | 26 |
| 31 | 39 | 30 | |||||||
| 34 | 34 | 30 | |||||||
| 20 ug | 30 | 34 | 4 | 1.1 | 31 | 34 | 3 | 1.0 | |
| 34 | 36 | ||||||||
| 37 | 35 | ||||||||
| 100 ug | 30P 27P |
32 | 7 | 1.0 | 35P 33P |
32 | 4 | 0.9 | |
| 40P | 27P | ||||||||
| 500 ug | 28P 29P |
29 | 1 | 0.9 | 33P 36P |
35 | 2 | 1.0 | |
| 30P | 36P | ||||||||
| 2500 ug | 29P | 29 | 2 | 0.9 | 32P | 32 | 3 | 0.9 | 21 |
| 27P | 35P | 33 | |||||||
| 30P | 30P | 25 | |||||||
| 5000 ug | 28P | 26 | 5 | 0.8 | 36P | 32 | 3 | 0.9 | 27 |
| 29P | 31P | 30 | |||||||
| 20P | 30P | 25 | |||||||
| 4-NQO 5.0 ug | 705 | 673 | 28 | 21.7 | |||||
| 661 | |||||||||
| 653 | |||||||||
| 2-AA 60 ug | 250 | 226 | 22 | 6 | |||||
| 207 | |||||||||
| 222 |
Tables from the plate incorporation test are provided in the attachment.
Tables are provided in the attachment.
Tables with results of the plate incorporation and preincubation assay are provided in the attachment.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. No adverse findings on genotoxicity was observed in in-vitro or in-vivo studies either for the substance itself or for structural analogues. As a result the substance is not considered to be classified for mutagenicity under Regulation (EC) No. 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.
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.
