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Diss Factsheets
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EC number: 204-576-6 | CAS number: 122-80-5
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro genotoxicity of para-phenylenediamine and its N-monoacetyl or N,N'-diacetyl metabolites
- Author:
- J-L. Garrigue, M. Ballantyne, T. Kumaravel, M. Lloyd, G. J. Nohyneka, D. Kirkland, H. Toutain
- Year:
- 2 006
- Bibliographic source:
- Mutation Research 608 (2006) 58–71
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Remarks:
- GLP compliance according to the author
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4'-aminoacetanilide
- EC Number:
- 204-576-6
- EC Name:
- 4'-aminoacetanilide
- Cas Number:
- 122-80-5
- Molecular formula:
- C8H10N2O
- IUPAC Name:
- 4'-aminoacetanilide
- Test material form:
- solid
- Details on test material:
- Name: 4'-aminoacetanilide
Constituent 1
- Specific details on test material used for the study:
- N-monacetylpara-phenylenediamine (MAPPD; CAS 122-80-5) was obtained from Lancaster Synthesis Ltd., Strasbourg, France. MAPPD was at least 95% pure according to the specifications of the manufacturer.
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: histidine-requiring strains
- Metabolic activation:
- without
- Metabolic activation system:
- S9 mammalian liver post-mitochondrial fraction
- Test concentrations with justification for top dose:
- 1st experiment: 1.6 to 5000 µg/plate
2nd experimzent: 156.3-5000 µg/plate - Vehicle / solvent:
- The vehicle control was sterile water for injection (purified water).
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- vehicle control (quintuplicate)
- True negative controls:
- not specified
- Positive controls:
- yes
- Remarks:
- as appropriate per strain (triplicate)
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- Details on test system and experimental conditions:
- N-monoacetyl-para-phenylenediamine (MAPPD) was tested in Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102. Two independent mutation experiments were performed with all five bacterial strains, using appropriate vehicle and positive controls. MAPPD was assayed only in the absence of S-9. Triplicate platings were performed for each bacterial strain at each dose level, and for positive controls. Quintuplicate platings were performed for vehicle controls in each strain. For the mutation experiments using a plate-incorporation method, molten soft agar (comprising 0.9% Difco Bacto agar and 0.5% sodium chloride, 2.5mLper tube) was dispensed into sterile tubes and held at 46±1°C. Bacterial culture (0.1 mL), control or test solution (0.1 mL) and buffer solution (0.5 mL) were added to each tube, the contents homogenised by rapid mixing, and poured onto Vogel-Bonner E agar plates (25 mL) supplied by Biotrace Fred Baker Ltd., UK. When the soft agar had set, all plates were inverted and incubated at 37±1°C for 3 days. Plating of these mixtures and incubation then proceeded as for the plate incorporation procedure. Plates were scored for revertant colony numbers using a Seescan Colony Counter (Seescan plc, UK) and the data processed using Colony2 software (York Electronic Research Ltd., York, UK).
- Statistics:
- Dunnett’s t-test was used to compare the colony counts at each dose with the vehicle control. The presence or otherwise of a dose response was checked by linear regression analysis. A positive result was indicated by a dose-related and reproducible response that was statistically significant at the 1% level.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535; 1537; 98; 100; 102
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Untreated negative controls validity:
- valid
- Remarks:
- The mean numbers of revertant colonies on negative control plates were all within acceptable ranges.
- Positive controls validity:
- valid
- Remarks:
- The mean number of revertant colonies in positive controls were significantly higher from the negative control.
Any other information on results incl. tables
Strain | First test (−S-9) | Second test (−S-9) | ||
Concentration (µg/plate) | Mean±S.D. | Concentration (µg/plate) | Mean±S.D. | |
TA 1535 | Vehicle | 17 ± 4 | Vehicle | 16 ± 2 |
200 | 16 ± 3 | 1250 | 16 ± 7 | |
1000 | 23 ± 5 | 2500 | 10 ± 6 | |
5000 | 18 ± 6 | 5000 | 16 ± 3 | |
NaN3 | 604 ± 21 | NaN3 | 612 ± 17 | |
TA 1537 | Vehicle | 23 ± 2 | Vehicle | 21 ± 3 |
200 | 22 ± 4 | 1250 | 23 ± 6 | |
1000 | 24 ± 4 | 2500 | 17 ± 3 | |
5000 | 17 ± 3 | 5000 | 21 ± 5 | |
9-AA | 173 ± 9 | 9-AA | 154 ± 57 | |
TA 98 | Vehicle | 28 ± 3 | Vehicle | 25 ± 6 |
200 | 28 ± 9 | 1250 | 37 ± 8 | |
1000 | 30 ± 2 | 2500 | 31 ± 6 | |
5000 | 25 ± 7 | 5000 | 22 ± 8 | |
2-NF | 1027 ± 123 | 2-NF | 928 ± 61 | |
TA 100 | Vehicle | 109 ± 5 | Vehicle | 102 ± 12 |
200 | 108 ± 12 | 1250 | 92 ± 6 | |
1000 | 115 ± 5 | 2500 | 86 ± 13 | |
5000 | 86 ± 6 | 5000 | 80 ± 4 | |
NaN3 | 590 ± 32 | NaN3 | 520 ± 41 | |
TA 102 | Vehicle | 248 ± 20 | Vehicle | 211 ± 15 |
200 | 248 ± 17 | 1250 | 188 ± 14 | |
1000 | 243 ± 6 | 2500 | 187 ± 22 | |
5000 | 217 ± 29 | 5000 | 186 ± 36 | |
MMC | 685 ± 22 | MMC | 401 ± 32 |
Applicant's summary and conclusion
- Conclusions:
- 4’-aminoacetanilide did not induce mutation in five histidine requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of S. typhimurium when tested at concentrations up to 5000 µg/plate in the absence of any exogenous metabolic activation.
- Executive summary:
Genotoxic properties of N-monoacetyl-para-phenylenediamine (MAPPD) were investigated in the Ames test. Given that MAPPD is an actual human skin and hepatic metabolite of PPD (para-Phenylenediamine) and represents the substance to which humans are systemically exposed, it was tested in the absence of metabolic activation. No increases in revertant numbers were observed for MAPPD treatments that were statistically or biologically significant. It was concluded that MAPPD did not induce mutation in the five histidine-requiring strains (TA98, TA100, TA1535, TA1537 and TA102) of S. typhimurium when tested at concentrations up to 5000µg/plate in the absence of any exogenous metabolic activation.
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