Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 276-911-4 | CAS number: 72829-25-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Mutagenic potential of FAT 40034 was evaluated in two different bacterial reverse mutation assays.
In a key study conducted by Haroz et al. (1978), Salmonella typhimurium strains TA 1535, TA1537, TA 98 and
TA 100 were exposed to the test substance with and without metabolic activation. Under the conditions
employed and using the doubling of the spontaneous reversion rate as a criterion of mutagenicity, FAT 40034/A
did not induce significant reverse mutations with and without metabolic activation. Hence, based on the findings
of the study, it can be concluded that FAT 40034 was not mutagenic in the bacterial reverse mutation assay.
In a supporting study conducted by Arni, P. (1979), FAT 40034/B was tested for mutagenic effects on
histidine-auxotrophic mutants of Salmonella typhimurium which included TA 98, TA 100, TA 1535, TA 15 37
and TA 1538. The investigations were performed with the following concentrations of the trial substance with
and without microsomal activation: 15, 45, 135, 405 and 1215 microg/0.1 ml. A repetition of the experiments
was performed with the concentrations of 25, 75, 225, 675 and 2025 microg/0.1 ml. In these experiments tests
on Strain TA 1538 were included. In the experiments performed with and without microsomal activation,
comparison of the number of back-mutant colonies in the controls and the cultures treated with the various
concentrations of FAT 40034/B revealed no marked deviations. Based on the findings of the study, no evidence
of the induction of point mutations by FAT 40034/B or by the metabolites of the substance formed as a result of
microsomal activation was detectable in the strains of S. typhimurium used in these experiments. Hence, FAT
40034/B was determined to be non-mutagenic in the bacterial reverse mutation assay.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- February 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer chapter 13 for the detailed analogue justification.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 tester strains tested which was in line with OECD technical guideline 471 as available in 1978.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- see Table 1 (any other information on material and methods)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I: 0.2, 2.0, 20, 200 and 2000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
Deionised water. The solvent was chosen because of its solubility properties. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Thio tepa
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
plate incorporation
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Statistics:
- not applicable (no toxicity)
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Vehicle controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- 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
- 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
- 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
- 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:
- Optimization of Concentration of Liver Activating Enzymes
In a preliminary trial with known mutagens, twenty-five microliters was selected as the concentration of liver homogenate yielding maximum numbers of revertants.
Assay
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- FAT 400034/A did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test material is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- only 4 tester strains tested which was in line with OECD technical guideline 471 as available in 1978.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- see Table 1 (any other information on material and methods)
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Experiment I: 0.2, 2.0, 20, 200 and 2000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:
Deionised water. The solvent was chosen because of its solubility properties. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other:
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: Thio tepa
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
plate incorporation
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Statistics:
- not applicable (no toxicity)
- Species / strain:
- E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- not examined
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- not examined
- 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
- 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
- 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
- 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:
- Optimization of Concentration of Liver Activating Enzymes
In a preliminary trial with known mutagens, twenty-five microliters was selected as the concentration of liver homogenate yielding maximum numbers of revertants.
Assay
The product was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 and TA 100 at five dose levels : 0.2, 2.0, 20, 200 and 2000,ug per Petri dish. Simultaneously, positive controls were assayed. - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- FAT 400034/A did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test material is considered to be non-mutagenic in this Salmonella typhimurium reverse mutation assay.
Referenceopen allclose all
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate as a criterion of mutagenicity, product FAT 40034/A was not mutagenic for Salmonella ty-phimurium strains TA 1535, TA1537, TA 98 and TA 100.
The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S9-mix) from male rats pretreated vith Aroclor 1251 and over a concentration range of 0.2 to 2000 µg of product per Petri dish.
Under the experimental conditions defined in the protocol, and employing a doubling of the spontaneous reversion rate as a criterion of mutagenicity, product FAT 40034/A was not mutagenic for Salmonella ty-phimurium strains TA 1535, TA1537, TA 98 and TA 100.
The lack of evidence for mutagenicity existed both in the absence and presence of a liver microsomal enzyme preparation (S9-mix) from male rats pretreated vith Aroclor 1251 and over a concentration range of 0.2 to 2000 µg of product per Petri dish.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Currently no further data are available for FAT 40034 to evaluate genotoxic potential of the test substance in mammalian cells.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Based on the available data, classification for Reactive Red 024:1 is not considered necessary for genotoxicity in accordance to the EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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.
