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EC number: 277-874-7 | CAS number: 74441-06-8
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed GLP and OECD guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 4-amino-N-[4-(aminocarbonyl)phenyl]benzamide
- EC Number:
- 277-874-7
- EC Name:
- 4-amino-N-[4-(aminocarbonyl)phenyl]benzamide
- Cas Number:
- 74441-06-8
- Molecular formula:
- C14H13N3O2
- IUPAC Name:
- 4-amino-N-(4-carbamoylphenyl)benzamide
- Details on test material:
- - Name of test material (as cited in study report): p-Aminobenzoylaminobenzamid TF
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test Animals:
Animals: Rat, RccHan: WIST(SPF)
Rationale: Recognized by international guidelines as a recommended test system.
Breeder: Harlan Laboratories B.V., Kreuzelweg 53, 5961 NM Horst / The Netherlands, Postbus 6174, 5960 AD Horst / The Netherlands
Age (when treated): 10 weeks
Body Weight Range (when treated): 176.3 g – 199.7 g
Randomization: Selected by hand at time of delivery. No computer generated randomization program.
Acclimatization: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
Environmental Conditions:
room temperature: 22 ± 3 °C
relative humidity: 30-70%,
light cycle: 12 hours light and 12 hours dark, music during the daytime light period.
Accommodation: In groups of three in Makrolon type-4 cages with wire mesh tops and standard softwood bedding
Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintenance diet, batch no. 15/09 ad libitum
Water: Community tap water from Füllinsdorf ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- The animals received a single dose of the test item by oral gavage administration at 2000 mg/kg body weight after being fasted for approximately 17 to 19 hours (access to water was permitted). Food was provided again approximately 3 hours after dosing.
The dosing volume was 10 mL/kg body weight. - Doses:
- 2000 mg/kg body weight
- No. of animals per sex per dose:
- 2 dose groups, 3 females per dose group
- Control animals:
- no
- Details on study design:
- Preparation of Dose Formulations:
Dose levels are in terms of the test item as supplied by the Sponsor. The dose formulations were prepared shortly before each dosing occasion using a magnetic stirrer and a spatula as homogenizers. The test item was weighed into a tared glass beaker on a suitable precision balance and the
vehicle added (weight:volume). Homogeneity of the test item in the vehicle was maintained during administration using a magnetic stirrer.
Vehicle:
Purified water was found to be a suitable vehicle. The vehicle was chosen after a non-GLP solubility trial which was performed before the study initiation date. This formulation trial is excluded from the statement of compliance.
Observations:
Viability / Mortality: Daily during the acclimatization period, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1 (in common with the clinical signs) and twice daily during days 2-15.
Clinical Signs: Daily during the acclimatization period, within the first 30 minutes and at approximately 1, 2, 3 and 5 hours after administration on test day 1, depending on the occurrence of clinical signs of toxicity. Once daily during days 2-15.
Body Weights: On test days 1 (prior to administration), 8 and 15.
Necropsy:
All animals were killed at the end of the observation period by carbon dioxide asphyxiation and discarded after macroscopic examinations were performed. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: All animals showed slightly ruffled fur and hunched posture immediately after treatment. Hunched posture persisted one to several hours following the treatment and ruffled fur was noted in all animals until week two. No clinical signs were observed in any
- Gross pathology:
- No macroscopic findings were recorded at necropsy.
Any other information on results incl. tables
LD50 cut-off (mg/kg b.w.): ∞, unclassified
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The median lethal dose of p-Aminobenzoylaminobenzamid TF after single oral administration to female rats, observed over a period of 14 days, is:
LD50 (female rat): greater than 2000 mg/kg body weight
LD50 cut-off (mg/kg b.w.): ∞, unclassified - Executive summary:
Two groups, each of three female RccHan: WIST (SPF) rats, were treated with p-Aminobenzoylaminobenzamid TF by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was formulated in purified water at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg.
The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on test day 1 and once daily during test days 2-15. Mortality/viability was recorded within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during test days 2-15. Body weights were recorded on test day 1 (prior to administration) and on test days 8 and 15. All animals were necropsied and examined macroscopically.
All animals survived until the end of the observation period.
All animals showed slightly ruffled fur and hunched posture immediately after treatment. Hunched posture persisted one to several hours following the treatment and ruffled fur was noted in all animals until week two. No clinical signs were observed in any animal from test day 11 onward until the end of the observation period.
The body weight of the animals was within the range commonly recorded for this strain and age.
No macroscopic findings were recorded at necropsy.
The median lethal dose of p-Aminobenzoylaminobenzamid TF after single oral administration to female rats, observed over a period of 14 days, is:
LD50 (female rat): greater than 2000 mg/kg body weight
LD50 cut-off (mg/kg b.w.): ∞, unclassified
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