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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 255-473-8 | CAS number: 41642-51-7
- 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
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:
- 1973-10-24 to 1974-09-11
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Purity not specified, liquid containing other chemicals that might influence results
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No specific guideline followed, but testing procedure in alignment with national standard methods.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- EC Number:
- 255-473-8
- EC Name:
- N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- Cas Number:
- 41642-51-7
- Molecular formula:
- C20H19N7O3
- IUPAC Name:
- N-[2-[(2,6-dicyano-4-nitrophenyl)azo]-5-(diethylamino)phenyl]acetamide
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: males: 80 - 88 g, females: 80 - 86 g
- Housing: 5 animals/sex were kept in plastic cages on wooden chips
- Diet (e.g. ad libitum): Altromin 1324; ad libitum
- Water (e.g. ad libitum): tap water; ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test item was formulated in water at a concentration of 5% (50 mg/mL).
VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- once daily for 14 consecutive days.
Doses / concentrations
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes, concurrent vehicle
- Positive control:
- not applicable
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes, body weight gain was monitored
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at the beginning and at the end of the study
- Anaesthetic used for blood collection: Not specified
- Animals fasted: Not specified
- Parameters checked: Haemoglobin content, erythrocytes, leukocytes, haematocrit, differential blood count and occurrence of Heinz bodies)
URINALYSIS: Yes
- Time schedule for collection of urine: at the beginning and at the end of the study
- Metabolism cages used for collection of urine: No
- Animals fasted: not specified
- Parameters checked: appearance, colour, glucose, bilirubin, protein, pH, haemoglobin, sediment - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
Within 24 hours after the last application the animals were sacrificed and the organs of all animals were checked macroscopically.
HISTOPATHOLOGY: Yes,
The following organs were checked microscopically after HE- staining, PAS-and iron reaction: heart, liver, kidney, adrenal gland, lung and spleen
ORGAN WEIGHTS: yes
The following organs were weighed after sacrification: heart, lung, both kidneys, liver, spleen and adrenal glands - Statistics:
- no data
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No adverse signs of toxicity were observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- The body weight gain during the entire treatment period was not affected.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- The results were comparable to the control group.
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- The results were comparable to the control group.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- The organ weights were within the normal standard deviation range.
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No adverse findings were recorded.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, non-treatment-related
- Description (incidence and severity):
- 4 treated and untreated females had calcifications at the border between the renal cortex and renal medulla. Sections of the liver showed different sizes and numbers of Kupfer cells in test animals and controls.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not examined
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to absence of adverse toxic effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The toxicity of the test item at the dosage of 500 mg/kg bw/day was investigated, when given orally to male and female Wistar rats for 14 days. Based on the results, the NOAEL can be considered to be 500 mg/kg bw/day.
- Executive summary:
In a short-term repeated dose toxicity study, the test item diluted in water was administered to young adult Wistar rats (10/sex) at a dose level of 500 mg/kg bw/day. No clinical signs were observed during the study. Blood and urine analysis did not show any adverse effects. No gross pathological effects were observed. Only minor histopathological findings were recorded, which were considered to be not related to the test item treatment. Due to the absence of toxic effects, the NOAEL can be considered to be 500 mg/kg bw/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.