Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 413-330-9 | CAS number: 134724-55-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Based on the results of these experiments and on standard evaluation criteria, it is concluded that FAT 40554 did not induce genetic toxicity.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- other: EEC B.14 (Ames test)
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- None
- Target gene:
- None
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- E. coli WP2uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat-liver post mitochondrial supernatant (S9 fraction)
- Test concentrations with justification for top dose:
- 0.05, 0.5, 5, 50, 500, 5000 μg/plate for pretest0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate for TA100 without S9 activation on main test I & II0.5, 1.5, 5, 15, 50, 150 μg/plate for TA100 with S9 activation on main test I & II156, 313 ,625, 1250, 2500, 5000 μg/plate for TA 1535, TA 1537, TA 98 and WP2uvrA on main test I & II
- Vehicle / solvent:
- Solvent:DMSO
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- benzo(a)pyrene
- Details on test system and experimental conditions:
- None
- Rationale for test conditions:
- None
- Evaluation criteria:
- Does not use statistical approach for data analysis. A number of revertant colonies treated with test sample solution shows twice or more as many as a number of revertant colonies treated with solvent. And it increase concentration-dependent.Th result is judged as "Positive" for mutagenicity
- Statistics:
- Does not use statistical approach for data analysis.
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
- Executive summary:
With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent.
Pretest organized with 0.05, 0.5, 5, 50, 500, 5000 μg/plate.
With or without S9 mix, fatal effect was not observed. Without S9 mix, precipitation was observed on the concentration of 50μg/plate and more. With S9 mix, precipitation was observed on the concentration of 500μg/plate and more. With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent.
Based on pretest result, TA100 without S9mix takes 0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate and TA100 with S9mix takes 0.5, 1.5, 5, 15, 50, 150 μg/plate for main test I and II. (Table 2 and 4) Other species with or without S9 mix takes 156, 313 ,625, 1250, 2500, 5000 μg/plate. (Table 3 and 5) Based on main test result, with or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent. And without S9 mix, the number of revertant colonies treated with test sample solution for TA98 shows almost twice as many as the one treated with solvent. Based on above result, the test substance is judged as "Positive" for mutagenicity.
In conclusion, FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- None
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
- Specific details on test material used for the study:
- None
- Target gene:
- Not applicable
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Additional strain / cell type characteristics:
- not specified
- Remarks:
- Not reported within the SNIF file
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat-liver post mitochondrial supernatant (S9 fraction)
- Test concentrations with justification for top dose:
- '0, 20, 39, 78, 156, 313, 625, 1250, 2500, 5000 μg/ml
- Vehicle / solvent:
- - Solvent used: CMC -Na (carboxymethyl cellulose)-1%
- Untreated negative controls:
- yes
- Remarks:
- CMC -Na (carboxymethyl cellulose)-1%
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- mitomycin C
- Remarks:
- with and without metabolic activation
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 6 hours
- Rationale for test conditions:
- None
- Evaluation criteria:
- In each concentration, frequency of number of cells which has structural abnormality and polyploid excluding number of GAP is used to judge.In case the frequency is below 5%, the result is judged as "Negative".In case the frequency is 5% to 10%, exclusive 10%giyousei , the result is judged as "Pseudo-positive".In case the frequency is 10% or more, the result is judged as "Positive".In case frequency of cells which has structural abnormality is clearly increased compare to solvent control. And the function has repeatability or dose-response, it is judged the test substance has clastogenicity.
- Statistics:
- None
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article FAT 40554 did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line).
- Executive summary:
An in vitro screening assay was performed to assess the potential of FAT 40554 to induce structural chromosome aberrations.
The test substance does not induce frequency of cells which has structural abnormality and polyploid cells, even if metabolic activation method or direct methods .
Based on inhibition test result of cell proliferation, test substance has weak inhibition for Direct methods (without metavolic activation) 1250, 2500, 5000 μg/ml is selected for chromosomal aberration test with and without metabolic activation. In all concentration, test substance in medium is suspended.
In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article FAT 40554 did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line).
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods with acceptable restrictions
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- yes
- Remarks:
- The incubation period of all cultures for cytotoxicity was5 days instead of 6 days.
- Principles of method if other than guideline:
- None
- GLP compliance:
- not specified
- Type of assay:
- mammalian cell gene mutation assay
- Specific details on test material used for the study:
- None
- Target gene:
- V79 Chinese hamster cells were obtained. Rat liver S9 was prepared.
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Not reported within the SNIF file
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S9 mix of induced rats
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 625 ... 5000 µg/mlConcentration range in the main test (without metabolic activation): 625 ... 5000 µg/ml
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: CMC (carboxymethyl cellulose)
- Details on test system and experimental conditions:
- Exposure period (with metabolic activation): 5 hExposure period (without metabolic activation): 5 hcell cutlure: 7 d
- Rationale for test conditions:
- None
- Evaluation criteria:
- The chemical was judged to be mutagenic when all the following requirements are fulfilled:1. The mutation frequencies of the chemical-treated cultures are higher than threefold of that of the corresponding vehicle control.2. The mutation frequencies of the chemical-treated culture are higher than the highest historical background data.3. The mutation frequency inctreases dose-dependently. to examine the dose-relationship, linear regression analysis is performed.4. Above 3 responses are reproduced in the two independent assays.
- Statistics:
- The plating efficiency and the mutation frequency were calculated.
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 5000 µg/ml)
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- None
- Remarks on result:
- other: other: Chinese hamster lung fibroblasts (V79)
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Negative with and without metabolic activation.
- Executive summary:
The test substance FAT 40554 was examined for its mutagenecity activity by assayinh the induction of 6- thioguanine resistant mutants of cultured V79 Chinese hamster cells in the presence and absence of metabolic activation (S9 mix) according to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test).
The cells were exposed to the test compound for 5 hr at doses of 625, 1250, 2500 and 5000 µg/ml both with and without metabolic activation. The test compound did not induce any increase in the mutation frequency as compared with those of the vehicle controls either in the presence or absence of metabolic activation. On the other hand, positive control chemicals, ethyl methanesulfonate (EMS, 200 µg/ml, without metabolic activation) and 9, 10 -dimethyl-1,2 -benzanthracene (DMBA, 5 µg/ml, with metabolic activation), induced marked increase in the mutation frequency.
Based on the above findings, it is concluded that the substance is not mutagenic under the conditions tested.
Referenceopen allclose all
None
| Cell reproductive rate. | ||||
| Direct methods (w/o metabolic activity) | Conc (mg/ml) | Reproductive rate (%) | ||
| 24hr treatment | 48hr treatment | |||
| 0 | (solvent) | 100.0 | 100.0 | |
| 0.020 | * | 96.7 | 90.5 | |
| 0.039 | * | 97.4 | 94.5 | |
| 0.078 | * | 93.2 | 94.1 | |
| 0.156 | * | 92.6 | 89.0 | |
| 0.313 | * | 84.4 | 96.1 | |
| 0.625 | * | 77.4 | 85.9 | |
| 1.250 | * | 71.0 | 67.8 | |
| 2.500 | * | 72.4 | 65.1 | |
| 5.000 | * | 66.3 | 60.8 | |
| Direct methods (w/o metabolic activity) | Conc (μg/ml) | Reproductive rate (%) | ||
| 6hr treatment +S9 | 6hr treatment -S9 | |||
| 0 | (solvent) | 100.0 | 100.0 | |
| 20 | * | 96.6 | 95.7 | |
| 39 | * | 94.0 | 97.9 | |
| 78 | * | 91.7 | 96.5 | |
| 156 | * | 90.0 | 96.8 | |
| 313 | * | 97.2 | 96.4 | |
| 625 | * | 90.8 | 92.5 | |
| 1250 | * | 91.6 | 93.1 | |
| 2500 | * | 89.2 | 90.6 | |
| 5000 | * | 88.6 | 88.2 | |
| * test substnce is a suspension in medium | ||||
None
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
Based on the results of micronucleus assay and on standard evaluation criteria, it is concluded that FAT 40554 did not induce genetic toxicity.
Link to relevant study records
- Endpoint:
- in vivo mammalian germ cell study: gene mutation
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- None
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Industrial Safety and Health Law guideline
- Principles of method if other than guideline:
- None
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Specific details on test material used for the study:
- None
- Species:
- mouse
- Strain:
- not specified
- Details on species / strain selection:
- None
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Specific Pathogen Free(SPF) male mice of BDF1(C57BL/6xDBA/2) strain Pilot study Main Study a) Receipt of animals Feb. 15, 1990 March 15, 1990 (age) (8 weeks old) (8 weeks old)b) Number ordered Male: 50 Male: 45c) Date of administration Feb. 26, 1990 March 26, 1990 (age) (9 weeks old) (9 weeks old)d) Body weight at 25.7-27.9g 24.3-28.7g administration period
- Route of administration:
- intraperitoneal
- Vehicle:
- Corn oil
- Details on exposure:
- None
- Duration of treatment / exposure:
- None
- Frequency of treatment:
- None
- Post exposure period:
- None
- No. of animals per sex per dose:
- Female: 1250 mg/kg; No. of animals: ; Sacrifice times: hoursFemale: 2500 mg/kg; No. of animals: ; Sacrifice times: hoursFemale: 5000 mg/kg; No. of animals: ; Sacrifice times: hours
- Positive control(s):
- Mitomycin C with saline
- Tissues and cell types examined:
- None
- Details of tissue and slide preparation:
- None
- Evaluation criteria:
- None
- Statistics:
- None
- Key result
- Sex:
- female
- Toxicity:
- yes
- Remarks:
- Doses producing toxicity:>= 2500 mg/kg
- Additional information on results:
- Observations:The test substance induced significant cytotoxicity in mouse bone marrow cells at 5000 mg/kg (p<0.005). However, the incidence of MNPCE at any of the dose levels was comparable to that in the control group and there was no statistically significant increase.Mitomycin C-treated (2mg/kg) mice, the positive control, caused a statistically significant increase in the frequency of MNPCE. clinical symptoms: no lethal effects.
- Conclusions:
- Negative is the in vivo chromosome aberration test.
- Executive summary:
The in-vivo mouse micronucleus test was conducted using BDF (C57BL/6xDBA/2) hybrid to assess the potential of D-523 to induce micronucleated erythrocyte. Dose levels of 1250, 2500 and 5000 mg/kg were selected on the basis of a erythrocytes (MNPCE) and polychromatic erythrocytes (PCE) were counted 24 hours after a single intraperitoneal injection of FAT 40554.
The test substance, FAT 40554, induced significant cytotoxicity in mouse bone marrow cells at 5000 mg/kg (p<0.05). However, the incidence of MNPCE at any of the dose levels and comparable to that in the solvent control group and there was no statisticakky significant increase.
Reference
None
Additional information
In-vitro:
An in vitro screening assay was performed to assess the potential of FAT 40554 to induce structural chromosome aberrations.
The test substance does not induce frequency of cells which has structural abnormality and polyploid cells, even if metabolic activation method or direct methods .
Based on inhibition test result of cell proliferation, test substance has weak inhibition for Direct methods (without metabolic activation) 1250, 2500, 5000 μg/ml is selected for chromosomal aberration test with and without metabolic activation. In all concentration, test substance in medium is suspended.
In conclusion, it can be stated that in the study described and under the experimental conditions reported, the test article FAT 40554 did not induce structural chromosome aberrations in V79 cells (Chinese hamster cell line).
An in vitro screening assay was performed to assess the potential of FAT 40554 using Ames test. With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent. Pretest organized with 0.05, 0.5, 5, 50, 500, 5000 μg/plate.
With or without S9 mix, fatal effect was not observed. Without S9 mix, precipitation was observed on the concentration of 50μg/plate and more. With S9 mix, precipitation was observed on the concentration of 500μg/plate and more. With or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent.
Based on pretest result, TA100 without S9mix takes 0.015, 0.05, 0.15, 0.5, 1.5, 5 μg/plate and TA100 with S9mix takes 0.5, 1.5, 5, 15, 50, 150 μg/plate for main test I and II. (Table 2 and 4) Other species with or without S9 mix takes 156, 313 ,625, 1250, 2500, 5000 μg/plate. (Table 3 and 5) Based on main test result, with or without S9 mix, the number of revertant colonies treated with test sample solution for TA100 shows more than twice as many as the one treated with solvent. And it increased concentration-dependent. And without S9 mix, the number of revertant colonies treated with test sample solution for TA98 shows almost twice as many as the one treated with solvent. Based on above result, the test substance is judged as "Positive" for mutagenicity. In conclusion, FAT 40554 is considered to be mutagenic in this Salmonella typhimurium reverse mutation assay.
The test substance FAT 40554 was examined for its mutagenecity activity by assaying the induction of 6- thioguanine resistant mutants of cultured V79 Chinese hamster cells in the presence and absence of metabolic activation (S9 mix) according to OECD Guideline 476 (In vitro Mammalian Cell Gene Mutation Test).
The cells were exposed to the test compound for 5 hr at doses of 625, 1250, 2500 and 5000µg/ml both with and without metabolic activation. The test compound did not induce any increase in the mutation frequency as compared with those of the vehicle controls either in the presence or absence of metabolic activation. On the other hand, positive control chemicals, ethyl methanesulfonate (EMS, 200µg/ml, without metabolic activation) and 9, 10 -dimethyl-1,2 -benzanthracene (DMBA, 5µg/ml, with metabolic activation), induced marked increase in the mutation frequency. Based on the above findings, it is concluded that the substance is not mutagenic under the conditions tested.
In-vivo:
The in vivo mouse micronucleus test was conducted using BDF (C57BL/6xDBA/2) hybrid to assess the potential of D-523 to induce micronucleated erythrocyte. Dose levels of 1250, 2500 and 5000 mg/kg were selected on the basis of a erythrocytes (MNPCE) and polychromatic erythrocytes (PCE) were counted 24 hours after a single intraperitoneal injection of FAT 40554.
The test substance, FAT 40554, induced significant cytotoxicity in mouse bone marrow cells at 5000 mg/kg (p<0.05). However, the incidence of MNPCE at any of the dose levels and comparable to that in the solvent control group and there was no statisticakky significant increase.
Based on the available in vitro (positive - Ames test, negative - in vitro mammalian cell gene mutation test and negative - in vitro mammalian chromosome aberration test)
and in vivo (negative - chromosome aberration test in mouse) studies, FAT 40554 can be deemed as non genotoxic.Justification for classification or non-classification
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.
