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EC number: 606-440-5 | CAS number: 201214-53-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Protocol approval date: 18 January 2001 - Report approval date: 10 May 2001
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study report did not contain a reference to an international guideline. Further, the study was performed according to SOP in a laboratory that conforms to GLP, but the report was not audited by the QAU.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- This type of study is no longer part of the OECD guidelines for the Testing of Chemicals
- Principles of method if other than guideline:
- A single-dose oral toxicity study (limit study) was performed by gavage in 20 rats, including a treatment group of 10 rats exposed to the test material and a control group of 10 rats treated with the vehicle. The dosing was followed by an observation period of 15 days.
- GLP compliance:
- no
- Remarks:
- Study performed according to SOP in a laboratory that conforms to GLP, but report not audited by the QAU
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- IODOMESAC
- IUPAC Name:
- IODOMESAC
- Reference substance name:
- Methyl 4-(acetylamino)-5-iodo-2-methoxybenzoate
- IUPAC Name:
- Methyl 4-(acetylamino)-5-iodo-2-methoxybenzoate
- Reference substance name:
- methyl 4-acetamido-5-iodo-2-methoxybenzoate
- EC Number:
- 606-440-5
- Cas Number:
- 201214-53-1
- Molecular formula:
- C11H12INO4
- IUPAC Name:
- methyl 4-acetamido-5-iodo-2-methoxybenzoate
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of test material (as cited in study report): Iodomesac
- Physical state: solid, powder
- Impurities (identity and concentrations): no data available
- Lot/batch No.: 204386
- Expiration date of the lot/batch: 15/05/2001
- A certificate of analysis is included in the report.
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Crédo, Domaine des Oncins, 69210 L’Arbresle, France
- Age at initiation of treatment: 5 weeks
- Weight at initiation of treatment: Male: 114 to 126 g; Female: 113 to 124 g
- Fasting period before study: Food was withdrawn 18 hours before treatment and redistributed approximately 4 hours after gavage
- Housing: housed in wire mesh bottomed, stainless steel cages. Space allocated: 891cm² x 18 cm (2 or 3 rats per cage).
- Diet (e.g. ad libitum): controlled pelleted rodent diet (re. AO4C.10, U.A.R.) ad libitum
- Water (e.g. ad libitum): free access to controlled tap water through automatic waterers
- Acclimation period: 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature: 22 +/– 2 ° C
- Humidity: 40-70%
- Air flow: 10-12 changes/hour without recirculation
- Photoperiod: 12/24 hours
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.6% methylcellulose aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: Suspension in a 0.6% methylcellulose aqueous solution
- Administration volume: 10 mL/kg - Doses:
- 0 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 rats/sex/dose
- Control animals:
- yes
- Details on study design:
- - Treatment frequency: Once, a single administration on day 1 (D1)
- Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
= Clinical signs: daily observations
= Body weight (D1, 3, 8, 15)
- Necropsy of survivors performed: yes at D15 - Statistics:
- no data
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 2 000 mg/kg bw
- Based on:
- other: suspended
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- other: suspended
- Mortality:
- No mortality observed at any dose
- Clinical signs:
- other: No treatment-related changes.
- Gross pathology:
- No treatment-related changes.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The maximal non-lethal dose determined experimentally was 2000 mg/kg in male and female rats (with LD50 > 2000 mg/kg). This dose did not induce any adverse effects.
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