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EC number: 267-636-0 | CAS number: 67905-17-3
- 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:
- repeated dose toxicity: oral, other
- Remarks:
- Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from authoritative database
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Repeated dose oral toxicity study of the test chemical
- Author:
- National Institute of Technology and Evaluation
- Year:
- 2 019
- Bibliographic source:
- J-check
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Principles of method if other than guideline:
- According to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- 9,10-Anthracenedione, 1,8-dihydroxy-4-nitro-5-(phenylamino)-
- Cas Number:
- 20241-76-3
- Molecular formula:
- C20-H12-N2-O6
- IUPAC Name:
- 9,10-Anthracenedione, 1,8-dihydroxy-4-nitro-5-(phenylamino)-
- Test material form:
- solid
- Remarks:
- Powder
- Details on test material:
- - name of the test chemical: 1,8-Dihydroxy-4-nitro-5-(phenylamino)anthracene-9,10-dione
- molecular formula: C20H12N2O6
- molecular weight: 376.32 g/mol
- substance type: Organic
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Age at study initiation of dosing: 10 weeks old
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 0.5 % Methylcellulose aqueous solution
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
The test chemical was dissolved in 0.5 % Methylcellulose aqueous solution to give dose level of 0, 40, 200 or 1000 mg/Kg/day.
VEHICLE
- Justification for use and choice of vehicle (if other than water): 0.5 % Methylcellulose aqueous solution
- Concentration in vehicle: 0, 40, 200 or 1000 mg/Kg/day - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The prepared solution was confirmed by UV-visible absorbance method.
- Duration of treatment / exposure:
- - Male: 42 days
- Female: 41 - 45 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- 0, 40, 200 or 1000 mg/Kg/day
- No. of animals per sex per dose:
- Test group:
0 mg/Kg/day: 7 males and 12 females
40 mg/Kg/day: 12 males and 12 females
200 mg/Kg/day: 12 males and 12 females
1000 mg/Kg/day: 7 males and 12 females
Recovery group:
0 mg/Kg/day: 5 males and 5 females
1000 mg/Kg/day: 5 males and 5 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Rationale for selecting satellite groups:
5 females
- Post-exposure recovery period in satellite groups: Females, 14 days - Positive control:
- No data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No data
- Cage side observations checked in table [No.?] were included. No data
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: No data
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: No data
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: No data
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 data
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No data
- Time schedule for examinations: No data
OPHTHALMOSCOPIC EXAMINATION: No data
- Time schedule for examinations: No data
- Dose groups that were examined: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: No data
- Anaesthetic used for blood collection: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. No data
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: No data
- Animals fasted: No data
- How many animals: No data
- Parameters checked in table [No.?] were examined. TP, Alb, 2-Glob
URINALYSIS: Yes
- Time schedule for collection of urine: No data
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters checked in table [No.?] were examined. No data
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: No data
- Dose groups that were examined: No data
- Battery of functions tested: sensory activity / grip strength / motor activity / other: No data
IMMUNOLOGY: No data
- Time schedule for examinations: No data
- How many animals: No data
- Dose groups that were examined: No data
- Parameters checked in table [No.?] were examined. No data
OTHER: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes, no detailed data available
HISTOPATHOLOGY: Yes, no detailed data available - Other examinations:
- No data
- Statistics:
- No data
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Colored feces were noted in male and female rats treated with 40, 200 or 1000 mg/Kg/day
- 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 specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Decrease in the TP, decrease in the Alb and increase in the percentage of alpha 2-Glob (Male) in 1000 mg/Kg day treated animals. Though albumin level (mg/dL) was significantly decreased in males of the high dose group, A/G ratio was not affected.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Abnormal color of urine was observed in males and females treated with 200 or 1000 mg/Kg/day
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Colored aqueous content in the alimentary tract in 40 mg/Kg/day treated male animals.
Colored aqueous content in the alimentary tract (Male/Female), Mucosal discoloration of alimentary tract (Male) in 200 mg/Kg/day treated animals.
Colored aqueous content in the alimentary tract (Male/Female), Mucosal discoloration of alimentary tract (Male/Female) in 1000 mg/Kg/day treated animals. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- urinalysis
- Remarks on result:
- other: No significant effects were observed at 1000 mg/Kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The no observed adverse effect level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day when male and female rats were exposed to the test chemical in combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422).
- Executive summary:
Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422) was performed to determine the toxic nature of the test chemical. The study was performed using Crl:CD (SD) male and female rats. Recovery group was also included in the study. The test chemical was dissolved in 0.5 % methylcellulose aqueous solution and used at dose level of 0, 40, 200 or 1000 mg/Kg/day. The treated animals were observed for mortality, clinical signs, changes in body weight, food consumption, urinalysis, hemotology, clinical chemistry and were subjected to gross and histopathology. No mortality was noted and no effects were observed in clinical signs, functional battery observations, body weight and food consumption changes, hematology, organ weights and histopathology. Colored feces (40, 200 and 1000 mg/Kg/day) and abnormal urine color (200 and 1000 mg/Kg/day) was noted in the treated animals. Decrease in the TP, decrease in the Alb and increase in the percentage of alpha 2-Glob (Male) in treated animals of 1000 mg/Kg/day. Though albumin level (mg/dL) was significantly decreased in males of the high dose group, A/G ratio was not affected. Colored aqueous content in the alimentary tract in 40 mg/Kgday treated male animals. Colored aqueous content in the alimentary tract (Male/Female), Mucosal discoloration of alimentary tract (Male) in 200 mg/Kg/day treated animals. Colored aqueous content in the alimentary tract (Male/Female), Mucosal discoloration of alimentary tract (Male/Female) in 1000 mg/Kg/day treated animals. Based on the observations of the study, the no observed adverse effect level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day when male and female rats were exposed to the test chemical in combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (OECD TG422).
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