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EC number: 255-235-3 | CAS number: 41131-65-1
- 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
Genetic toxicity: in vitro
Administrative data
- 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:
- 1996-11-22 to 1997-01-17
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study documented and performed according to GLP standards and in compliance with OECD Guideline 471.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N,N'-(2-chloro-5-methyl-1,4-phenylene)bis[3-oxobutyramide]
- EC Number:
- 255-235-3
- EC Name:
- N,N'-(2-chloro-5-methyl-1,4-phenylene)bis[3-oxobutyramide]
- Cas Number:
- 41131-65-1
- Molecular formula:
- C15H17ClN2O4
- IUPAC Name:
- N-[5-chloro-2-methyl-4-(3-oxobutanamido)phenyl]-3-oxobutanamide
- Details on test material:
- Identity: P0045
Batch No.: 1130
Storage: RT
Purity: 99.4%
Expiry date: May 18, 1998
Appearance: Brown powder
Constituent 1
Method
- Target gene:
- Not applicable.
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- liver S9 fraction from rats pre-treated with phenobarbitone and betanaphthoflavone.
- Test concentrations with justification for top dose:
- Dose range finding test (Toxicity test): 5000, 1580, 500, 158 and 50 microg/plate.
Mutation tests: 5000, 2500, 1250, 625, 313 microg/plate. - Vehicle / solvent:
- Dimethylsulphoxide
Controls
- Untreated negative controls:
- yes
- Remarks:
- dimethylsulphoxide
- Negative solvent / vehicle controls:
- yes
- Remarks:
- dimethylsulphoxide
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Sodium azide, 2-Aminoanthracene, 9-Aminoacridine, 2-Nitrofluorene, Cumene hydroperoxide, Sterile distilled water
- Details on test system and experimental conditions:
- For use in tests sub-cultures were grown in Nutrient Broth No. 2 (Oxoid) at 37°C for 10 hours. This culture provided approximately 2 x 10x9
organisms per ml which was assessed photometrically.
Preparation of liver homogenate S—9 fraction:
Species: Rat.
Strain: Sprague—Dawley derived.
Source: Bantin and Kingman Ltd., The Field
Station, Grimston, Aldbrough, Hull,
North Humberside, HU11 4QE.
Age range: 7 — 8 weeks.
Weight range: <300 g.
Diet: Labsure Rodent Diet LAD 1.
Stimulation of rat liver enzymes:
Mixed—function oxidase systems in the rat liver were stimulated following a single i/p injection of Aroclor 1254 (diluted in Arachis oil to 200 mg/ml) at a dosage of 500 mg/kg. On the fifth day of induction, following an overnight starvation, the rats were killed and their livers aseptically removed. - Evaluation criteria:
- The mean number of revertant colonies for all treatment groups is compared with those obtained for solvent control groups. The mutagenic activity
of a test material is assessed by applying different criteria.
Revertant colonies were counted using a Biotran Automatic Colony Counter. Any toxic effects of the test substance can be detected by a substantial
reduction in revertant colony counts or by the absence of a complete background bacterial lawn. - Statistics:
- Not applicable.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- In the preliminary toxicity test P0005 was not toxic towards the tester strains.
Therefore, 5000 microg/plate was chosen as the top dose level in the mutation tests.
The mean number of revertant colonies, together with the individual plate counts for P0005 obtained in the first and second mutation test with the
tester strains are shown in the Table below.
No substantial increases in revertant colony numbers of any of the tester strains were observed following treatment with P0005 at any dose level,
either in the presence or absence of S-9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Strain |
Dose level (microg/plate) |
Metabolic activation -/+ |
Mean revertant colony counts |
TA 1535 |
5000 2500 1250 625 313 0 Untreated |
- / + - / + - / + - / + - / + - / + - / + |
20 / 17 22 / 15 20 / 20 21 / 18 21 / 18 20 / 19 20 / 17 |
TA 1537 |
5000 2500 1250 625 313 0 Untreated |
- / + - / + - / + - / + - / + - / + - / + |
18 / 23 20 / 26 20 / 24 20 / 24 20 / 24 19 / 26 19 / 23 |
TA 102 |
5000 2500 1250 625 313 0 Untreated |
- / + - / + - / + - / + - / + - / + - / + |
298 / 404 314 / 441 318 / 448 311 / 449 316 / 448 312 / 454 310 / 444 |
TA 98 |
5000 2500 1250 625 313 0 Untreated |
- / + - / + - / + - / + - / + - / + - / + |
27 / 35 28 / 37 28 / 34 29 / 36 28 / 36 28 / 37 27 / 36 |
TA 100 |
5000 2500 1250 625 313 0 Untreated |
- / + - / + - / + - / + - / + - / + - / + |
148 / 160 149 / 158 151 / 164 150 / 159 149 / 161 147 / 164 153 / 168 |
- Absence
+ Presence
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
lt is concluded that P0045 does not induce reverse mutation in Salmonella typhimurium under the reported experimental conditions. - Executive summary:
The genetic toxicity study in vivo (Ames) was performed in year 1996/1997 according to GLP standards and in compliance with OECD Guideline 471.
In the toxicity test, the test substance was assayed at a maximum dose-level of 5000 microgram/plate and four lower dose-levels spaced at approximately half-long intervals. No toxicity was observed in any tester strain even at the highest dose-level tested. The same maximum dose-level was selected for the principal assay.
The test substance did not induce two-fold increases in the number of revertant colonies in the plate incorporation or pre-incubation assay, at any dose-level, in any tester strain, in the absence or presence of S9 metabolism.
Therefore, it is concluded that P0045 is not mutagenic in this bacterial system.
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