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EC number: 225-691-8 | CAS number: 5012-29-3
- 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:
- 1992-06-03 - 1992-07-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
- EC Number:
- 220-509-3
- EC Name:
- 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide
- Cas Number:
- 2786-76-7
- Molecular formula:
- C26H22N4O4
- IUPAC Name:
- 4-[(4-carbamoylphenyl)diazenyl]-N-(2-ethoxyphenyl)-3-hydroxy-2-naphthamide
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HOE: Wisk (SPF71)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoechst AG Frankfurt, Germany
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: not specified
- Weight at study initiation: Male: 134-137 g; female: 114 -117 g
- Fasting period before study: no
- Housing: groups of 5 in wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 C
- Humidity (%):50 +/- 20%
- Air changes (per hr): not specified
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- admixture in food
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg diet
- Remarks:
- Control
- Dose / conc.:
- 500 mg/kg diet
- Dose / conc.:
- 2 500 mg/kg diet
- Dose / conc.:
- 12 500 mg/kg diet
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, plain diet
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations included: general behaviour & health, neurological abservations, teeht, eyes.
DETAILED CLINICAL OBSERVATIONS: Not specified
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: 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: Yes, twice weekly
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Not specified
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
- Time schedule for examinations: weekly
OPHTHALMOSCOPIC EXAMINATION: Not specified
HAEMATOLOGY: Yes
- Time schedule for collection of blood: end of study
- Anaesthetic used for blood collection: Not specified
- Animals fasted: No
- How many animals: all
- Parameters were examined: RBC. Hb, Hematocrit, MCV, MCH, MCHC, Leuco, Platelets, Diff. Leuco, Rei, Heinzbodies, coagulation time
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: end of study
- Animals fasted: No
- How many animals: all
- Parameters examined: Na, K, PO4, Uric acid, Bilirubin, Creatinine, Glucose, Ca, Cl, ASAT, ALAT, AP, gamma GT, Cholesterol, triglycerides, Tot. protein, tot. Lipids, Albumen, urea nitrogen
URINALYSIS: Yes
- Time schedule for collection of urine: shortly before end of study
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Not specified
- Parameters examined: Appearance, colour, Volume, pH, Hb, Protein, Glucose, Ketone bodies, Bilirubin, Urobiinogen, density, sediment,
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations:daily,
- Dose groups that were examined: all
- Battery of functions tested: sensory activity , other: general observations
IMMUNOLOGY: No
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Organweights: Heart lung, liver, kidneys, spleen
Histopathology: Heart lung, liver, kidneys, spleen, stomach, jejunum,colon, urinary bladder, testes,epididymides, prostate, seminal vesicles, ovaries, uterus, adrenals, thymus, brain, nstrachea, bone marrow (femur), skeletal muscle, nervus ischiadicus, spinal cord (3 locations), lymphnodes (2 locations)
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The red colouration of feces and fur is considered a non-adverse effect of the coloured test item.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Decreased number of reticulocytes in high dose males without signs of anemia and within normal range of the strain used.
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Several, non dose related statistical variations were seen in differnt groups
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- red coloured content of digestive tract was considered not adverse.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not examined
- Details on results:
- According to food consumption, mean substance intakes were as follows:
Males
low dose group 47 mg/kg bodyweight per day
intermediate dose group 227 mg/kg bodyweight per day
high dose group 1172 mg/kg bodyweight per day
Females
low dose group 46 mg/kg bodyweight per day
intermediate dose group 236 mg/kg bodyweight per day
high dose group 1193 mg/kg bodyweight per day
Behaviour and general health condition remained unaffected by the administration of the test compound in all groups. Body weight development, food and water consumption were comparable in all groups.
No signs of neurological disturbances, opacity of the refracting media of the eyes, damage to the oral mucosa or impairment of dental growth were observed in the control or treatment groups.
Hematological and clinical chemistry examinations revealed no abnormalities.
No treatment-related changes were observed by urine analysis.
Organ weights were not affected by the administration of the test compound.
No compound-related effect was observed at necropsy.
The histopathological examinations revealed test compound in the lumen of the alimentary tract, adherent to the surface of the mucous membrane and/or the food. The mucous membranes themselves were uninjured.
In conclusion, Pigment Red 170 caused no detectable adverse effects in male and female Wistar rats when administered via food at the concentration of 12500 mg/kg food for 28 days.
With regard to the present study the 'No Observed Effect Level' is 12500 mg Pigment Red 170 /kg food. This is equivalent to a mean daily compound intake of
1172 mg/kg bodyweight in males and 1193 mg/kg bodyweight in females.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Remarks on result:
- not determinable due to adverse toxic effects at highest dose / concentration tested
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- The test item caused no adverse effects after oral exposure for 28 days at doses up to more than 1000 mg/kg bw per day.
- Executive summary:
Groups of male and female Wistar rats received Pigment Red 170 at concentrations of 0, 500, 2500 or 12500 mg/kg food for a period of 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 and water consumption once weekly.
Hematological examinations, clinical chemistry and urine analysis were carried out at the termination of the study.
During necropsy the animals were examined for macroscopically visible abnormalities, the main organs weighed and the organ to bodyweight ratios calculated.
Many organs and tissues were processed for histopathological examination and checked for microscopically visible changes.
Body weights, hematological and clinical chemistry data, urine data (volume, pH value and specific weight), absolute and relative organ weights were analysed with the aid of a statistical program to show differences compared with the controls.
According to food consumption, mean substance intakes were as follows:
Males - low dose group 47 mg/kg bodyweight per day
intermediate dose group 227 mg/kg bodyweight per day
high dose group 1172 mg/kg bodyweight per day
Females - low dose group 46 mg/kg bodyweight per day
intermediate dose group 236 mg/kg bodyweight per day
high dose group 1193 mg/kg bodyweight per day
Behaviour and general health condition remained unaffected by the administration of the test compound in all groups. Body weight development, food and water consumption were comparable in all groups.
No signs of neurological disturbances, opacity of the refracting media of the eyes, damage to the oral mucosa or impairment of dental growth were observed in the control or treatment groups.
Hematological and clinical chemistry examinations revealed no abnormalities. No treatment-related changes were observed by urine analysis.
Organ weights were not affected by the administration of the test compound.
No compound-related effect was observed at necropsy.
The histopathological examinations revealed test compound in the lumen of the alimentary tract, adherent to the surface of the mucous membrane and/or the
food. The mucous membranes itself were uninjured.
In conclusion, Pigment Red 170 caused no detectable adverse effects in male and female Wistar rats when administered via food at the concentration of 12500 mg/kg food for 28 days.
With regard to the present study the 'No Observed Effect Level' is 12500 mg test item / kg food. This is equivalent to a mean daily compound intake of
1172 mg/kg bodyweight in males and 1193 mg/kg bodyweight in females.
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