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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-612-3 | CAS number: 2835-68-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- 1993
- 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:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- p-aminobenzamide
- EC Number:
- 220-612-3
- EC Name:
- p-aminobenzamide
- Cas Number:
- 2835-68-9
- Molecular formula:
- C7H8N2O
- IUPAC Name:
- 4-aminobenzamide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- WISKf (SPF71)
- Source: Hoechst AG, breeding colony
- Age at study initiation: Approximately 6 weeks
- Weight at study initiation: 110 - 123 g (male); 99 - 125 g (female)
- Fasting period before study: none
- Housing: group housing of 5 animals per sex in Macrolon cages type 4 on soft wood granulate
- Diet (e.g. ad libitum): rat diet Altromin 1324, ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: approx. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.0 ± 3.0°C
- Humidity (%):30-70%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: sesame oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Formulations (w/v) 0.48, 2.4 and 12.0 % were prepared daily immediately before treatment; the test item was suspended homogenously in the vehicle by means of magnetic stirrer. 5 mL/kg bw were administered.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Test substance formulations in sesame oil were noted as stable for at least 4 hours and formed a homogeneous suspension at the concentrations tested. Analysis of the accuracy of dose preparations revealed mean values within the range of about 84-103 % of nominal, which was considered to represent an acceptable level of accuracy for formulations of this type.
- Duration of treatment / exposure:
- 28 days treatment
- Frequency of treatment:
- 28 applications within 29 days, 7 days/week; application between 7.00 and 12.00 a.m.. Animals were dosed up to the day prior to necropsy.
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
24 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
120 mg/kg bw/day
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
600 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 5 (with 5 additional animals/sex in the control group)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: in a preliminary study groups of 3 male and 3 female rats received the test item by oral gavage at dose levels of 500 or 1000 mg/kg bw per day over a period of 14 days. in the high dose group, the animals showed unspecific symptoms, impairments of motility and breathing, pale skin and closed palpebral fissures. Development of body weight was impaired. Dark discoloration of the spleen was observed at necropsy.
One animal treted with 500 mg/kg bw per day showed unspecific symptoms, impairment of motility and breathing after 14 days as well as impaired body weight development. The caecum was filled with gas at necropsy. Neither symptoms nor macroscopically visible changes were observed in the other animals.
Based on these results the test substance was tested at the dose levels of 0, 24, 120 and 600 mg/kg bw per day. - Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
- Cage side observations included: mortality, viability
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: at the start of the study and then twice weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: twice weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study):
- Time schedule for examinations: once weekly over a period of 16 h, results given as water consumption/animal/16 h
OPHTHALMOSCOPIC EXAMINATION: opacity of the refracting media of the eyes
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of treatment
- Anaesthetic used for blood collection: Yes (Ketanest (R))
- Animals fasted: No
- How many animals: 40 (end of treatment)
- Parameters examined: Erythrocyte count, Hemoglobin, Hematocrit, mean cellular volume (MCV), mean cellular hemoglobin (MCH), mean cellular hemoglobin conc. (MCHC), Leucocyte count, Thrombocyte count, differential leucocyte count and red cell morphology, Reticulocyte count, Heinz bodies, coagulation time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of treatment
- Animals fasted: No
- How many animals: 40 (end of treatment)
- Parameters examined: Alanine aminotransferase, Aspartate aminotransferase, Alkaline phosphatase, Total Protein, Albumin, Total Bilirubin, Urea nitrogen, Creatinine, Glucose, Cholesterol, Triglyderides, Sodium, Potassium, Chloride, Calcium, Inorganic Phosphorus, Uric acid, Bilirubin total, Bilirubin direct
URINALYSIS: Yes
- Time schedule for collection of blood: end of treatment
- Animals fasted: Yes
- How many animals: 40 (urine collected overnight from day 26 to 27)
- Parameters examined: Appearance, Volume, Colour, Specific gravity, pH, Protein, Hemoglobin, Glucose, Ketone, Bilirubin, Urobilinogen, Sediment
NEUROBEHAVIOURAL EXAMINATION: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. All animals were necropsied and descriptions of all macroscopic abnormalities recorded.
The following organ weights (and terminal body weight) were recorded from the animals on the scheduled day of necropsy: Heart, lung, liver, kidneys, spleen, ovaries, testes, epididymides, adrenals, brain, thymus
HISTOPATHOLOGY: the following tissues or organs (or pieces of them) were preserved in a suitable fixative and processed for histopathological investigations: heart, liver, kidneys, adrenals, spleen, lung, brain, thymus, ovaries, testes, epididymides, trachea, stomach, jejunum, colon, urinary bladder, uterus, prostata, seminal vesicles, skeletal muscle, N. ischiadicus, femur with bone marrow, spinal cord, lymph nodes, throid glands (high dose group) - Other examinations:
- None
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- both sexes in high dose group
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- both sexes in high dose group
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- >= 120 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No test item related effects were observed in male and female rats after repeated application of 120 mg/kg bw per day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Groups of 5 male and 5 female Wistar rats received the test item by oral gavage at dose levels of 0, 24, 120 and 600 mg/kg bw per day for 28 days and were necropsied at day 29.
Behaviour and state of health were observed daily in all groups. Body weights and food consumption were recorded twice weekly, water consumption once weekly.
Hematological examinations and clinical chemistry were carried out at the termination of the study. Urine analysis was also performed at the end of the study.
No compound-related effects were observed in male and female Wistar rats after repeated application of 120 mg/kg bw. With regard to the present study the no observed effect level is 120 mg/kg bw per day.
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.