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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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:
- other: authoritative database
- Title:
- Repeated Dose Toxicity Study of the given test chemical.
- Author:
- J Check
- Year:
- 2 010
- 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:
- Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test was conducted by using the given test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data
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: pressed powder
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): 1,8-Dihydroxy-4-nitro-5-(phenylamino)anthracene-9,10-dione
- Molecular formula (if other than submission substance): C20H12N2O6
- Molecular weight (if other than submission substance): 376.32 g/mol
- Substance type: Organic
- Physical state: Solid: Powder
- Impurities (identity and concentrations): Unknown
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- No Data Available
Administration / exposure
- Route of administration:
- oral: gavage
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5% w/v Methylcellulose aqueous solution (suspended)
- Details on exposure:
- VEHICLE
- Justification for use and choice of vehicle (if other than water): 0.5 % Methylcellulose solution was used because the test chemical was insoluble in water.
- Concentration in vehicle: 5 mL/kg - Details on mating procedure:
- .- M/F ratio per cage: 12 pairs/dose
- Length of cohabitation: Male and female were allowed to live in a male cage one to one.
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as [day 0 / day 1] of pregnancy - 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:
- Males: 42 Days
Females: 41-45 days(from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily
- Details on study schedule:
- No Data Available
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Control Group
- Dose / conc.:
- 0 mg/kg bw/day
- Remarks:
- Control Group (Recovery)
- Dose / conc.:
- 40 mg/kg bw/day
- Remarks:
- Low Dose Group
- Dose / conc.:
- 200 mg/kg bw/day
- Remarks:
- Mid-Dose Group
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- High Dose Group
- Dose / conc.:
- 1 000 mg/kg bw/day
- Remarks:
- High Dose (Recovery) Group
- No. of animals per sex per dose:
- Males: 12 animals/group/sex (5 animals for recovery group)
Females: 12 animals/group/sex (5 animals for recovery group) - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No Data Available
- Positive control:
- No Data Available
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: No Data Available
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: No Data Available
BODY WEIGHT: Yes
- Time schedule for examinations: No Data Available
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
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes
OTHER: No Data Available - Oestrous cyclicity (parental animals):
- Yes, Oestrus cycle was examined.
- Sperm parameters (parental animals):
- Parameters examined in [P] male parental generations: testis weight, epididymis weight
- Litter observations:
- Yes, The effect of the test chemical was observed on the litter parameters.
- Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals.
- Maternal animals: All surviving animals
GROSS NECROPSY
- Yes, gross necropsy was performed on all the organs in abdomen, viscera and reproductive organs.
HISTOPATHOLOGY / ORGAN WEIGHTS: Yes, Organs weights and Histopathology was performed. - Postmortem examinations (offspring):
- No Data Available
- Statistics:
- No Data Available
- Reproductive indices:
- Gestational Index, estrous cycle examination, Copulation Index, Copulation interval, fertility index, gestation period, no of corpora lutea, number of implantations, implantation index, delivery index, nursing behaviour.
- Offspring viability indices:
- Pup Viability Index
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Test item coloured fecal matter in both male and female animals was observed in both the dose groups.
- Dermal irritation (if dermal study):
- not specified
- Mortality:
- no mortality observed
- Description (incidence):
- No Mortality was observed in all animals in either of the dose groups.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No abnormal effects were observed in body weight changes in males or females due to the test chemical administration.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No abnormal effects were observed in feed consumption patterns in males or females due to the test chemical administration.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No abnormal effects were observed in hematological parameters in males or females due to the test chemical administration.
- Clinical biochemistry findings:
- effects observed, non-treatment-related
- Description (incidence and severity):
- Significant decrease in Albumin content, Total Protein, and significant increase in α2-Globulin (%) in males of 1000 mg/kg bw was observed. No effects in females were observed. However, these effects were considered to be toxicolgically insignificant since, therse effects were observed to be reversed in the recovery group.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Abnormal coloration in the urine was observed in males and females at 200 mg/kg bw and 1000 mg/kg bw dose groups. This coloration was attributed to the test chemical or a metabolite of the test chemical.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No effect of the test chemical was observed on the grip strength, locomotor activity and other functional observation battery parameters in either sex at all the dose groups.
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histopathological abnormalities were observed in any animals of either sex and at all the dose levels, including the high dose recovery groups.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- No effects on the estrous cyclicity due to the test chemical was observed at any dose groups.
- Reproductive function: sperm measures:
- no effects observed
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- No effects on the reproductive performance due to the test chemical was observed at any dose groups.
Details on results (P0)
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- body weight and weight gain
- food consumption and compound intake
- haematology
- clinical biochemistry
- urinalysis
- organ weights and organ / body weight ratios
- gross pathology
- histopathology: non-neoplastic
- reproductive function (oestrous cycle)
- reproductive performance
- Remarks on result:
- other: No effects observed
Target system / organ toxicity (P0)
- Critical effects observed:
- not specified
- System:
- other: Not Specified
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Sexual maturation:
- no effects observed
- Anogenital distance (AGD):
- not specified
- Nipple retention in male pups:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- no effects observed
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effects were observed on number of pups delivered, number of live pups, live birth index, viability index and sex ratio on day 0 and day 4 at any dose groups.
Developmental neurotoxicity (F1)
- Behaviour (functional findings):
- not specified
Developmental immunotoxicity (F1)
- Developmental immunotoxicity:
- not specified
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- viability
- sexual maturation
- clinical signs
- mortality
- body weight and weight gain
- gross pathology
- histopathology: non-neoplastic
- other: number of pups delivered, number of live pups, live birth index, viability index and sex ratio on day 0 and day 4
- Remarks on result:
- other: No effects observed
Target system / organ toxicity (F1)
- Critical effects observed:
- not specified
- System:
- other: Not Specified
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Based on all the observations and results it was concluded that the NOAEL for the test chemical was considered to be 1000 mg/kg bw.
- Executive summary:
In a combined repeated and reproductive toxicity studies according to OECD 422 guideline, the test chemical was administered to Crl:CD (SD) male and female rats, aged 10 weeks old at the initiation of dosing. The rats were dosed at concentrations of 0, 40, 200, 1000 mg/kg/day with two revesal groups of 0 and 1000 mg/kg bw/day as control and high dose group recovery group, respectively. The vehicle used in the study was 0.5% w/v Methylcellulose aqueous suspended solution. Male animals were dosed for 42 Days, while females were dosed for 41-45 days.
After the administration of the test chemical, test item coloured fecal matter in both male and female animals was observed in both the dose groups. However, no mortality was observed in all animals in either of the dose groups. No abnormal effects were observed in body weight changes and feed consumption in males or females due to the test chemical administration. In hematological parameters, no abnormal effects were observed in hematological parameters in males or females due to the test chemical administration. In blood chemistry parameters, significant decrease in Albumin content, Total Protein, and significant increase in α2-Globulin (%) in males of 1000 mg/kg bw was observed. No effects in females were observed. However, these effects were considered to be toxicolgically insignificant since, therse effects were observed to be reversed in the recovery group. Also, abnormal coloration in the urine was observed in males and females at 200 mg/kg bw and 1000 mg/kg bw dose groups. This coloration was attributed to the test chemical or a metabolite of the test chemical. No effect of the test chemical was observed on the grip strength, locomotor activity and other functional observation battery parameters in either sex at all the dose groups. No adverse effects were observed on any abdominal, visceral or reproductive organs / 100 grams of body weight due to the test chemical in either of the sex at any dose groups. In gross necropsy, colored aqueous content in the alimentary tract was observed in males, and in males and females both 40 mg/kg bw dose group and 200 mg/kg bw dose group, respectively. Also, mucosal discoloration of alimentary tract in males of 200 mg/kg bw was also observed. Colored aqueous content in the alimentary tract and mucosal discoloration of alimentary tract in both males and females were observed in 1000 mg/kg bw dose group. However, these effects were reversed in the recovery group doses and thus were not considered to be of toxicological significance. No histopathological abnormalities were observed in any animals of either sex and at all the dose levels, including the high dose recovery groups. No effects on the estrous cyclicity due to the test chemical was observed at any dose groups. No effects on the reproductive performance due to the test chemical was observed at any dose groups. No effects were observed on number of pups delivered, number of live pups, live birth index, viability index and sex ratio on day 0 and day 4 at any dose groups. Also, no test chemical changes were noted in the number of pups delivered, number of live pups, live birth index,viability index or sex ratio on day 0 and 4, clinical signs, body weights, external examinations, body weights or necropsy. Thus, based on all the observations and results it was concluded that the NOAEL for the test chemical was considered to be 1000 mg/kg bw.
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