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EC number: 204-909-5 | CAS number: 128-80-3
- 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 230 mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation.
Repeated dose toxicity: inhalation
This end point was considered for waiver since according to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. The test chemical has very low vapor pressure of 9.40E-11 Pa (7.05E-013 mmHg). Also, the test chemical has a particle size distribution of 25-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.
Repeated dose toxicity: dermal
Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 500 mg/Kg bw using rabbits. Hence the test chemical is not likely to be toxic upon repeated exposure by dermal route as per the criteria mentioned in CLP regulation.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Experimental data from study report
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- The 90 days subchronic repeated dose oral toxicity study was designed to evaluate the toxic effects of test chemical in dogs.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test chemical: D and C green 6
- IUPAC name: 1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Substance type: Organic - Species:
- dog
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
- Route of administration:
- oral: feed
- Details on route of administration:
- No data
- Vehicle:
- other: diet
- Details on oral exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- daily
- Dose / conc.:
- 290 other: mg/kg/day
- Remarks:
- Basis: nominal in diet
- Dose / conc.:
- 570 other: mg/kg/day
- Remarks:
- Basis: nominal in diet
- Dose / conc.:
- 500 other: mg/kg/day
- Remarks:
- Basis: nominal in diet
- No. of animals per sex per dose:
- At 290 mg/kg/day: 2 dogs
- Control animals:
- not specified
- Details on study design:
- In a 90 day subchronic study, two dogs were fed a diet containing 1 percent test chemical during week 1 (290 mg/kg/day); the concentration was increased to 2 percent during week 3 (570 and 500 mg/kg/day) and 3 percent during week 5. The weight normalized doses fluctuated between 610 and 1400 mg/kg/day during the remainder of the experiment.
- Positive control:
- No data
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
BODY WEIGHT: Yes - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- There were no gross signs of toxicity was observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No significant changes in body weight was observed in treated dogs.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Only an accumulation of dye in the pelvis of the kidney, in the mucosa of the small and large intestines, in adipose tissue, and in the gall bladder were observed.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No histopathological alterations were observed in treated dogs.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No data
- Dose descriptor:
- NOAEL
- Effect level:
- 570 other: mg/kg/day
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No effect on body weight, gross pathology and histopathology
- Remarks on result:
- other: No toxic effects were observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Conclusions:
- The No observed Adeverse Effect Level (NOAEL) for test chemical in dogs by the oral route is considered to be 570 mg/kg body weight upon repeated exposure by oral route for 90 days.
- Executive summary:
The 90 days subchronic toxicity study was designed to evaluate the toxic effects of test chemical in dogs. Two dogs were fed a diet containing 1 percent test chemical 3 during week 1 (290 mg/kg/day); the concentration was increased to 2 percent during week 3 (570 and 500 mg/kg/day) and 3 percent during week 5. The weight normalized doses fluctuated between 610 and 1400 mg/kg/day during the remainder of the experiment. There were no gross signs of toxicity, and no significant changes in body weight. Necropsy revealed only an accumulation of dye in the pelvis of the kidney, in the mucosa of the small and large intestines, in adipose tissue, and in the gall bladder. No histopathological alterations were observed; therefore, test chemical was not found to be toxic under the conditions of this test. Based on the observations made, The No observed Adeverse Effect Level (NOAEL) for test chemical in dogs by the oral route is considered to be 570 mg/kg body weight upon repeated exposure by oral route for 90 days.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 230 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- The data is from K2 article
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation, other
- Data waiving:
- exposure considerations
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Experimental data from study report
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- 95 weeks chronic repeated dose toxicity study of test chemical in mouse was conducted to evaluate the adverse effects by dermal route.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of the test chemical: D and C green 6
- IUPAc name: 1,4-bis[(4-methylphenyl)amino]-9,10-anthraquinone
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Substance type: Organic - Species:
- mouse
- Strain:
- not specified
- Details on species / strain selection:
- No data
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data
- Type of coverage:
- not specified
- Vehicle:
- other: Benzene
- Details on exposure:
- No data
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 95 weeks
- Frequency of treatment:
- Weekly
- Dose / conc.:
- 1 other: mg
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- Single weekly applications of 1 mg of Solvent Green 3 in 0.1 mL of benzene to the skin of mice for 95 weeks.
- Positive control:
- No data
- Observations and examinations performed and frequency:
- No data
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Dermal irritation:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- 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
- Behaviour (functional findings):
- not specified
- Immunological findings:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The thyroid glands in the male mice were enlarged.
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- Histopathological examination did not show any effect.
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Details on results:
- No significant local or systemic effects were observed in treated mice.
- Dose descriptor:
- NOAEL
- Effect level:
- 1 other: mg
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No significant local or systemic effects. The thyroid glands in the male mice were enlarged, but histopathological examination did not show an effect.
- Remarks on result:
- other: No toxic effects were observed
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Conclusions:
- The No observed adverse effect level (NOAEL) was considered to be 1 mg when mice were treated with test chemical for 95 weeks.
- Executive summary:
In a repeated dose dermal toxicity study, mice were treated with test chemical A single weekly application of 1 mg of test chemical in 0.1 mL of benzene to the skin of mice for 95 weeks did not cause significant local or systemic effects. The thyroid glands in the male mice were enlarged, but histopathological examination did not show an effect. Therefore, the No observed adverse effect level (NOAEL) was considered to be 1 mg when mice were treated with test chemical for 95 weeks.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rabbit
- Quality of whole database:
- The data is from K2 article
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Data available for the target chemical was reviewed to determine the toxic nature of upon repeated exposure. The studies are as mentioned below:
Repeated dose toxicity: Oral
Study 1
In a 6-week dose range-finding study in rats, test chemical was administered in the diet at concentrations of 0.1, 0.23, 0.55, 1.29, or 3,0 percent (100, 230, 550, 1290 or 3000 mg/kg bw). There were no deaths or gross signs of toxicity. Food consumption and body weights were within normal range. The thyroid gland was small in animals fed the 0.55 (550 mg/kg bw/day) and the 3.0 (3000 mg/kg bw/day) percent diets, but histopathological evaluation did not reveal abnormalities in the thyroid gland. Gross degenerative changes in the liver were observed and confirme the by histopathological examination, which showed an increase in vacuolated cells around the hepatic central vein. No other effects were observed. Therefore, the No observed adverse effect level (NOAEL) was considered to be 230 mg/kg bw/day when rats were treated with test chemical orally in feed for 6 weeks.
Study 2
The 90 days subchronic toxicity study was designed to evaluate the toxic effects of test chemical in dogs. Two dogs were fed a diet containing 1 percent test chemical 3 during week 1 (290 mg/kg/day); the concentration was increased to 2 percent during week 3 (570 and 500 mg/kg/day) and 3 percent during week 5. The weight normalized doses fluctuated between 610 and 1400 mg/kg/day during the remainder of the experiment. There were no gross signs of toxicity, and no significant changes in body weight. Necropsy revealed only an accumulation of dye in the pelvis of the kidney, in the mucosa of the small and large intestines, in adipose tissue, and in the gall bladder. No histopathological alterations were observed; therefore, test chemical was not found to be toxic under the conditions of this test. Based on the observations made, The No observed Adeverse Effect Level (NOAEL) for test chemical in dogs by the oral route is considered to be 570 mg/kg body weight upon repeated exposure by oral route for 90 days.
Repeated dose toxicity: inhalation
This end point was considered for waiver since according to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. The test chemical has very low vapor pressure of 9.40E-11 Pa (7.05E-013 mmHg). Also, the test chemical has a particle size distribution of 25-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.
Repeated dose toxicity: Dermal
Study1
Repeated dose dermal toxicity were evaluated in rabbit by using test chemical.The test chemical was applied at a dose of 500 mg for 13 weeks. No local toxic and no systemic toxic effects were observed in treated rabbits. Therefore, the No observed Adeverse Effect Level (NOAEL) was considered to be 500 mg/kg when rabbits were treated with test chemical for 13 weeks.
Study 2
In a repeated dose dermal toxicity study, mice were treated with test chemical A single weekly application of 1 mg of test chemical in 0.1 mL of benzene to the skin of mice for 95 weeks did not cause significant local or systemic effects. The thyroid glands in the male mice were enlarged, but histopathological examination did not show an effect. Therefore, the No observed adverse effect level (NOAEL) was considered to be 1 mg when mice were treated with test chemical for 95 weeks.
Based on the above mentioned subchronic and chronic repeated-dose study conducted in experimental animals, no significant toxic effects were seen to occur upon repeated exposure by oral route. Hence, based on the above studies summarized with dermal routes it can be observed that the test chemical is not likely to be toxic as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the target chemical, is not likely to be toxic upon repeated exposure by oral, dermal and inhalation route of exposure as per the criteria mentioned in CLP regulation.
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.
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