Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 236-283-4 | CAS number: 13280-60-9
- 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
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Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic and germ cell study: gene mutation
- Type of information:
- experimental study planned
- Study period:
- 2021-2022 // The study will be conducted after a decision on the requirement to carry out the proposed test has been taken according to the procedure laid down in Regulation (EC) 1907/2006, and a deadline to submit the information required has been set.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
A testing proposal for an in vivo Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay according to OECD TG 488 has been submitted by the registrant in order to meet the information required of Section 8.4 of Annex IX of the REACH Regulation.
An Ames test in accordance with OECD Guideline 471 was performed using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli strain WP2 uvrA with and with metabolic activation. The study showed positive results in Salmonella typhimurium strain TA98 without metabolic activation. Therefore, the Ames test was concluded to be positive and further in vivo testing is deemed required in accordance with column 2 of Annex IX of the REACH Regulation. On this basis, the registrant considers the testing proposal for an in vivo Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay justified.
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: 5-Amino-2-Nitrobenzoic Acid
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 to cover this endpoint
- Available non-GLP studies: no non-GLP studies available to cover this endpoint
- Historical human/control data: no historical human data available to cover this endpoint
- (Q)SAR: (Q)SAR methods are not appropriate to cover this endpoint
- In vitro methods: The in vitro testing gave positive results, therefore further in vivo testing is required
- Weight of evidence: no appropriate weight of evidence information is available to cover this endpoint
- Grouping and read-across: read-across was considered; however it has been concluded that no appropriate information from related or appropriate source substances is available to cover this endpoint
- Substance-tailored exposure driven testing [if applicable]: not applicable
- Approaches in addition to above [if applicable]: not applicable
- Other reasons [if applicable]: not applicable
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:
- There are no adequate specific adaptation possibilities that allow to generate the necessary information.
FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: the proposed testing will be run according to OECD Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assay)
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 488 (Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- transgenic rodent mutagenicity assay
Test material
- Reference substance name:
- 5-amino-2-nitrobenzoic acid
- EC Number:
- 236-283-4
- EC Name:
- 5-amino-2-nitrobenzoic acid
- Cas Number:
- 13280-60-9
- Molecular formula:
- C7H6N2O4
- IUPAC Name:
- 5-amino-2-nitrobenzoic acid
Constituent 1
Test animals
- Species:
- rat
Administration / exposure
- Route of administration:
- oral: gavage
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.
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