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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 284-395-7 | CAS number: 84870-65-5
- 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:
- key study
- Study period:
- 7 January 1988 - 4 February 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile
- EC Number:
- 284-395-7
- EC Name:
- 2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile
- Cas Number:
- 84870-65-5
- Molecular formula:
- C19H18N6O2
- IUPAC Name:
- 2-[[4-(diethylamino)-2-methylphenyl]azo]-5-nitrobenzene-1,3-dicarbonitrile
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- No further details specified on the study report.
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on species / strain selection:
- Specification: Sprague Dawley CFY rats obtained from Interfauna UK Limited, Wyton, Huntingdon, Cambridgeshire.
Justification: Preferred species of choice as historically used for safety evaluation studies and specified by appropriate regulatory authorities. - Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Specification: At the start of the main study the animals were aged 5 to 8 weeks. The weight variation did not exceed 20% of the mean weight.
Environment:
Temperature: 19 – 25 °C
Humidity: 45 – 75%
Lighting: 12 hours of artificial light in each 24-hour period
Ventilation: at least 15 air changes per hour.
Housing: Groups of five by sex in polypropylene cages with stainless steel lids suspended over trays containing absorbent paper.
Diet and Water: Rat and Mouse SQC. Expanded Diet No. 1 (Special Diet Services Limited, Witham, Essex, U.K.), and tap water ad libitum.
Acclimatisation period: Minimum 5 days.
Allocation: Animals will be allocated to dose groups using total randomisation procedure.
Identification: Each animal, selected at random, identified by ear-punch. Colour-coded cage card prepared with details of test material, project number, dose level, sex, numbers of animals, route of administration and Home Office licensee responsible for the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- Gavage using a stomach tube attached to a graduated syringe.
- Vehicle:
- arachis oil
- Details on oral exposure:
- Preparation: The test material was dissolved in arachis oil B.P. weekly.
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Analysis: No analysis of the test material formulations will be carried out.
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- Four groups of 10 animals (5 male/5 female per group).
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Dose levels have been selected on the basis of the results from the 14-day Range Finding Test (Project Number: 10/207). Control animals received the vehicle alone in the amount received by the high dose group.
- Positive control:
- No.
Examinations
- Observations and examinations performed and frequency:
- Morbidity/Mortality Inspection: Twice daily during normal working week. Once daily at weekends.
Clinical Observations: Immediately before dosing and one hour after dosing. An additional observation was made five hours after dosing during the normal working week, not at weekends.
Bodyweights: Individual bodyweights are recorded on the day before the start of dosing and at weekly intervals.
Food Consumption: Diet intake recorded weekly for each cage group.
Laboratory Investigations: Haematological and blood chemical investigations were performed on all test and control group animals at termination (day 28). Blood samples were withdrawn under light ether anaesthesia from the orbital sinus.
Haematology;
Haemoglobin (Hb)
Haematocrit (HCT)
Red blood cell count (RBC)
Total white blood cell count (WBC)
Differential white blood cell count
Red blood cell indices
-mean cell haemoglobin (MCH)
-mean cell volume (MCV)
-mean cell haemoglobin concentration (MCHC)
Thrombotest Time (TT)
Blood Chemistry:
Blood urea Nitrogen
Total Protein
Albumin
Albumin/Globulin ratio (by calculation)
Sodium
Potassium
Chloride
Calcium
Inorganic Phosphorus
Creatinine
Total bilirubin
Alkaline phosphatase (AP)
Alkaline aminotransferase (ALAT)
Aspartate aminotransferase (ASAT)
Glucose - Sacrifice and pathology:
- Post Mortem Studies: Carried out on all surviving animals (killed by intravenous sodium pentobarbitone) at termination and on animals that died or become moribund and killed during the study.
Gross Examination: Full external and internal examination of all animals.
Organ Weights;
Adrenals; Kidneys; Brain; Pituitary; Liver; Gonads; Spleen; Heart
Carried out on all survivors at termination.
Histopathology: Samples of the following tissues will be preserved from all animals in buffered formalin.
Adrenals Gross lesions
Aorta (thoracic) Muscle (skeletal)
Bone & Bone Marrow Pancreas
(sternum) Pituitary
Brain Rectum
Caecum Sciatic nerve
Colon Skin (hind limb)
Duodenum Spleen
Eyes Stomach
Heart Testes
Ileum Thymus
Jejunum Thyroid/parathyroid
Kidneys Trachea
Liver Urinary bladder
Lungs Oesophagus
Lymph nodes Ovaries
Initially the following tissues from control and high dose groups (Groups 1 and 4) will be examined microscopically.
Adrenals Liver
Gross lesions Spleen
Heart Target Organs
Kidneys - Other examinations:
- No further examinations specified in the study report.
- Statistics:
- All data will be summarised in tabular form and analysed by appropriate statistical methods to assess the significance.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No clinically observable signs of toxicity were noted during the study.
- Mortality:
- no mortality observed
- Description (incidence):
- There were no deaths.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Animals in all dose groups made expected bodyweight gains over the study period. Bodyweight gains in test animals were comparable to those seen in controls.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Food consumption in test animals was comparable with that seen in controls.
- Food efficiency:
- no effects observed
- Description (incidence and severity):
- Calculation of food efficiency showed no appreciable differences between groups.
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No intergroup differences were detected.
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were demonstrated on any of the parameters measured.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related effects were demonstrated on any of the parameters measured
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- Several statisically significant differences were noted between organ weights for high dose males and those for control males.
Testes weights were reduced whilst heart and liver weights were increased. In all cases the differences were slight and there was no histopathological evidence of abnormalities in liver or heart.
All other organ weights, including kidney weights, were comparable between test and control animals. - Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Macroscopic examination revealed kidney abnormalities in two males and two females treated with 1000 mg/kg/day. The females showed pallor of the kidneys whilst the males showed enlargement of the right kidney. All kidneys appeared normal in intermediate and low dose group animals.
No further treatment-related macroscopic abnormalities were noted. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Treatment-related changes were observed in the kidneys of rats treated with 1000 mg/kg/day, but not at any other dose level.
Changes were characterised by basophilia and degeneration of the proximal tubular epithelium.
No further treatment-related changes were noted. - Histopathological findings: neoplastic:
- not examined
- Other effects:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- System:
- urinary
- Organ:
- kidney
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAEL in the 28-d study (repeated dose, oral) for Dispersionsblau F 60 768 is 250 mg/kg bw in rats.
- Executive summary:
The test material, Dispersionsblau F-60 768, was administered by gavage to three groups, each of five male and five female Sprague-Dawley (CFV) rats, for twenty-eight consecutive days, at dose levels of 50, 250 and 1000 mg/kg/day. A control group of five males and five females was dosed with vehicle alone (arachis oil B.P.).
Results
Mortality: There were no deaths.
Clinical Observations: No clinically observable signs of toxicity were noted during the study
Bodyweight: Animals in all dose groups made expected bodyweight gains over the study period.
Bodyweight gains in test animals were comparable to those seen in controls.
Food consumption: Food consumption in test animals was comparable with that seen in controls.
Calculation of food efficiency showed no appreciable differences between groups.
Water consumption: No intergroup differences were detected.
Haematology: No treatment-related effects were demonstrated on any of the parameters measured.
Blood chemistry: No treatment-related effects were demonstrated on any of the parameters measured.
Necropsy: Macroscopic examination revealed kidney abnormalities in two males and two females treated with 1000 mg/kg/day. The females showed pallor of the kidneys whilst the males showed enlargement of the right kidney. All kidneys appeared normal in intermediate and low dose group animals.
No further treatment-related macroscopic abnormalities were noted.
Organ weights: Several statistically significant differences were noted between organ weights for high dose males and those for control males.
Testes weights were reduced whilst heart and liver weights were increased. In all cases the differences were slight and there was no histopathological evidence of abnormalities in liver or heart.
All other organ weights, including kidney weights, were comparable between test and control animals.
Histopathology: Treatment-related changes were observed in the kidneys of rats treated with 1000 mg/kg/day, but not at any other dose level.
Changes were characterised by basophilia and degeneration of the proximal tubular epithelium.
No further treatment-related changes were noted.
Conclusion
The NOAEL for Dispersionsblau F-60 768 is 250 mg/kg.
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.