Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Diss Factsheets
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: 260-976-0 | CAS number: 57834-33-0
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian cell study: DNA damage and/or repair
- Type of information:
- experimental study planned
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
-Name of the substance on which testing is proposed to be carried out:
Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
-EC: 260-976-0
-CAS: 57834-33-0
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies: No GLP studies available for this substance for the end point ‘genetic toxicity in vivo’.
- Available non-GLP studies: No non-GLP study available for this substance for the end point ‘genetic toxicity in vivo’.
- Grouping and read-across: it has been attempted to look at similar substances, and although such substances exist, there is limited data on most of these. Several similar substances give negative results from in-vitro data and weight of evidence is that the substance for further examination will be negative.
Unfortunately, this has not been considered sufficient evidence to avoid further work, although if ECHA are aware of sufficient existing information on this class of substance to avoid this animal study, it would be good to be informed. Everlight are willing to use alternative sources of data to avoid new animal studies if such data exists.
- Historical human data: There is no historical human data available for this substance on ‘genetic toxicity in vivo’. Hence no evidence of human adverse effect.
- (Q)SAR: not available and not appropriate for this endpoint
- In vitro methods: The in vitro bacterial reverse mutation assay (OECD 471), in vitro mammalian chromosome aberration (OECD 473) and in vitro Mammalian Cell Gene Mutation Tests (OECD 490) were conducted. The present dossier contains positive results for the in vitro bacterial mutation assay OECD 471 which raises the concern for gene mutation. Therefore, in vivo mutagenicity test is inevitable.
- Weight of evidence: there is no alternative data available for weight of evidence approach using similar testing endpoints
- Substance-tailored exposure driven testing [if applicable]: this approach is not applicable for this substance. Exposure to human is unavoidable (still exist) during process.
CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
As indicated above, adaptation in accordance with Annex XI does not seem possible, but Everlight are willing to act on any proposals by ECHA to avoid the need for further animal testing.
CONSIDERATIONS ON THE IN VIVO STUDIES INSERTED IN THE DOSSIER:
-OECD 489 allows to measure DNA strand breaks, that may result from direct interactions with DNA, alkali labile sites or as a consequence of incomplete excision repair. Therefore, the alkaline comet assay recognises primary DNA damage that would lead to gene mutations and/or chromosome aberrations, but will also detect DNA damage that may be effectively repaired or lead to cell death. The comet assay can be applied to almost every tissue of an animal from which single cell or nuclei suspensions can be made, including specific site of contact tissues.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 489 (In vivo Mammalian Alkaline Comet Assay)
Test material
- Reference substance name:
- Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- EC Number:
- 260-976-0
- EC Name:
- Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- Cas Number:
- 57834-33-0
- Molecular formula:
- C17H18N2O2
- IUPAC Name:
- ethyl 4-[[(methylphenylamino)methylene]amino]benzoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Eversorb EP4
- Substance type: Liquid
- Composition of test material, percentage of components: 98.94%
- Lot/batch No.: 4023
- Storage condition of test material: Ambient
Constituent 1
Test animals
- Species:
- mouse
Results and discussion
Applicant's summary and conclusion
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.