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EC number: 470-130-4 | CAS number: 697235-49-7
- 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:
- 2004-04-20 to 2004-05-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001-12-17
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- , 2004
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 470-130-4
- EC Name:
- -
- Cas Number:
- 697235-49-7
- Molecular formula:
- Hill formula: C16H15NO4 CAS formula: C16H15NO4
- IUPAC Name:
- 2-((3-(4-Hydroxyphenyl)propanoylamino)benzoic acid
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Physical state: white powder
- Molecular formula: C16H15NO4
- Molecular weight: 285.3 g/mole
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS - stock Shoe:WIST
- Source: DIMED Schönwalde GmbH, Schönwald, Germany
- Weight at study initiation: test group: 133 g - 144 g; vehicle control group 131 g - 140 g
- Fasting period before study: rats fasted overnight prior to dosing. After dosing diet was withheld for 4 more hours.
- Housing: rats were kept in transparent polycarbonate cages (Macrolone type III, floor area 810 cm2) with two or three in each cage. Bedding was pinewood sawdust "Lignocel-Fasern" (Altromin, Lage, Lippe, Germany).
- Diet (ad libitum): a pelleted complete rodent diet "Altromin 1314" (Altromin GmbH, Lage, Lippe, Germany)
- Water (ad libitum): domestic quality drinking water acidified with hydrochloric acid to pH 2.5 in order to prevent microbial growth
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C ± 3°C
- Relative humidity: 55% ± 15%
- Air changes: 10 times/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- propylene glycol
- Details on oral exposure:
- VEHICLE
Propylenglycol was used as the vehicle and its toxicological harmlessness was shown with an additional control group.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw
DOSAGE PREPARATION: for the preparation of the test item a dispersion tool (Ultra-Turrax T25) was used.
The study was carried out with two groups consisting of three female animals each given a dose of 2000 mg/kg bw. An additional control group consisting of three female animals was given the vehicle only. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- Test group: 6 female rats
Vehicle control group: 3 female rats - Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: each rat was observed 30 minutes, 2, 4 and 6 hours after the administration and thereafter daily for a period of 14 consecutive days. Body weight was recorded on days 0, 7 and 14.
- Necropsy of survivors performed: yes, all rats were killed by inhalation of CO2 an day 14 and subjected to a gross necropsy examination. - Statistics:
- none
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Neither animals of the control group nor of the two test groups died on account of the treatment nor did they show severe signs of toxicosis.
- Clinical signs:
- other: Vehicle control group : The 3 female rats showed a hunched posture and piloerection 30 minutes after the application of the vehicle. After 2 and 4 hours piloerection was still observed, whereas the three rats showed normal behaviour after 6 hours. From d
- Gross pathology:
- The gross necropsy revealed no pathological abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- LD50 (female rats) > 2000 mg/kg bw
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as acute toxic via the oral route.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.
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