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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 220-509-3 | CAS number: 2786-76-7
- 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:
- key study
- Study period:
- From03 JUN 1992 to 01 JUL 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD TG 407), GLP compliant
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)
- Deviations:
- no
- GLP compliance:
- yes
- 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: bulk
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Hoe: WISKf (SPF71)
- Source: Hoechst AG, Kastengrund, SPF breeding colony, Germany
- Age at study initiation: 6 weeks
- Housing: in groups of 5 in fully air-conditioned rooms in wire-mesh cages (type 4)
- Diet: Altromin1321 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: approx. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 50 +-20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
- dose formulations were prepared once before beginning of the study.
- 1 kg of Premix with 8-fold concentration and 7 kg of Altromin 1321 were mixed for 30 minutes using a Lödoge Plugscharmischer.
VEHICLE
-none - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- After preparation the mixture was analysed for homogenicity and compound content. (no further details provided)
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 500, 2500, 12500 mg/kg food
Basis:
nominal in diet
- No. of animals per sex per dose:
- - 5 male and 5 female in each dose group
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- - Dose selection rationale: Based on the results of a preliminary study (3 males/3 females, treated for 14 days with 12500 mg/kg food). Animals showed normal body weight development, no deaths or symptoms occurred, no macroscopically visible changes observed at the end of the study.
- Positive control:
- - none
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
BODY WEIGHT: Yes,
- Time schedule: twice weekly
FOOD CONSUMPTION: yes
- Time schedule: twice weekly
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
WATER CONSUMPTION: yes
- Time schedule: once weekly over a period of 16 h
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: weeky
- Endpoint investigated: opacity of the refracting media of the eyes
- Dose groups that were examined: all
HAEMATOLOGY: Yes
- Time schedule: after 4 weeks
- Parameters checked see below in Hematology
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: after 4 weeks
- Animals fasted: No
- How many animals: all animals
- Parameters checked see below
URINALYSIS: Yes
- Time schedule for collection of urine: a few days before termination of the study
- Metabolism cages used for collection of urine: Yes
- Animals fasted: no data
- Parameters checked see below
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: weekly
- Dose groups that were examined: all
- Battery of functions tested: neurological disturbances
OTHER:
- weekly investigation of damage to the oral mucosa, impairment of dental growth - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (parameters checked see below)
HISTOPATHOLOGY: Yes (parameters checked see below) - Statistics:
- The following parameters were compared statistically with the control group values at the level of significance p = 0.05:
- Body weight at the designated measurement times
- Hematological data
- Clinical chemistry parameters
- Clinical chemistry parameters
- Urine data (volume, pH-value, specific weight)
- Absolute organ weights and organ to body weight ratios.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- 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:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
- no deaths occurred during the test
- red feces were noted in all animals treated with the test item
- red discoloured fur was observed in the animals of the high dose group
- overall no clinical observations of toxicological relevance were found
BODY WEIGHT AND WEIGHT GAIN
The body weight gains were not impaired by the administration of the test substance
FOOD AND WATER CONSUMPTION:
- The absolute and relative food consumption remained unaffected by the treatment during the whole study.
- Water consumption was comparable in all groups
CLINICAL LABORATORY INVESTIGATOIONS
- HAEMATOLOGY
- Some changes in haematological parameters were noted in male animals of the highest dosing group: Reticulocyte count was significantly decreased. However the change was only small, and remained within the range considered normal for rats of this age and strain. Furthermore there were no signs indicative for anemia. Therefore, this change is considered not to be treatment related.
- CLINICAL CHEMISTRY
Several clinical biochemistry parameters were changed at a intermediate and highest dose level. These changes were slight and were not accompanied with any alteration indicative for a toxic effect. Therefore a compound-related effect is not evident. In other cases there was no dose-dependency .
- URINANALYSIS
No treatment-related changes were detected by urine analysis. The sediments were normal.
ORGAN WEIGHTS
Some changes were noted in liver, ovary, thymus and adrenal weight of animals treated with the intermediate and highest concentration. As there was no dose-dependency these changes are considered not to be treatment-related. Regarding the increase in relative thymus weight no histpathological visible alterations were found.
GROSS PATHOLOGY
- test compound could be detected 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.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 172 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: no clinical signs; no mortality; body weight development was not impaired; food consumption was not affected; no findings in haematology; urinalysis, gross pathology and histopathology up to highest dose tested
- Dose descriptor:
- NOAEL
- Effect level:
- 1 193 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: no clinical signs; no mortality; body weight development was not impaired; food consumption was not affected; no findings in haematology; urinalysis, gross pathology and histopathology up to highest dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no changes in clinical appearance, functional observations, body weights, food consumption, clinical laboratory investigations, macroscopic examination, organ weights and microscopic examination that were considered to be an effect of treatment.
From the results presented in this report a definitive No Adverse Observed Effect Level (NOAEL) of 12500 mg/kg food was established, This is equivalent to a mean daily compound intake of 1172 mg/kg bw in males and 1193 mg/kg bw in females. - Executive summary:
A 28-day repeated dose toxicity study with the test item administered orally via the food to Wistar rats (SPF-bred; 5/sex/dose) was performed according to OECD TG 407. The dose levels for this study were 500, 2500 and 12500 mg/kg food. A control group was treated similarly without the test item. The dosing lasted for 28 days. The test item revealed no treatment-related findings. From the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for the test item of 1172 mg/kg bw and day for male rats and 1193 mg/kg bw and day for female rats was established.
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.