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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
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Effects on fertility
Description of key information
Reproductive toxicity study
Based on the data available from different studies, NOAEL for test material was considered to be 1000mg/kg /day for reproductive toxicity, when male and female rats were treated with test material orally. Thus, comparing this value with the criteria of CLP regulation test material is not likely to classify as reproductive toxicant.
Link to relevant study records
- Endpoint:
- multi-generation reproductive 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:
- Experimental data from study report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- A multigeneration reproduction study was conducted in rats administered the dye in their diets at concentrations based on multiples of lx, 10x, 30x, and 100x the ADI (acceptable daily intake).
- GLP compliance:
- not specified
- Limit test:
- no
- Justification for study design:
- No data available
- Specific details on test material used for the study:
- - Name of test material (IUPAC name): 1,4-Bis(p-tolylamino)anthraquinone
- Common name: C.I. Solvent Green 3
- Molecular formula: C28H22N2O2
- Molecular weight: 418.4938 g/mol
- Smiles notation: c12c(c(Nc3ccc(cc3)C)ccc1Nc1ccc(cc1)C)C(=O)c1c(C2=O)cccc1
- InChl: 1S/C28H22N2O2/c1-17-7-11-19(12-8-17)29-23-15-16-24(30-20-13-9-18(2)10-14-20)26-25(23)27(31)21-5-3-4-6-22(21)28(26)32/h3-16,29-30H,1-2H3
- Substance type: Organic - Species:
- rat
- Strain:
- not specified
- Details on species / strain selection:
- No data available
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:Test chemical were administrated in a diet based on acceptable daily intake.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Diet
- Concentration in vehicle: 1x, 10x, 30x and 100x the ADI (acceptable daily intake) - Details on mating procedure:
- No data available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- up to 3 generation
- Frequency of treatment:
- Daily
- Details on study schedule:
- No data available
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Positive control:
- No data available
- Parental animals: Observations and examinations:
- No data available
- Oestrous cyclicity (parental animals):
- No data available
- Sperm parameters (parental animals):
- No data available
- Litter observations:
- No data available
- Postmortem examinations (parental animals):
- No data available
- Postmortem examinations (offspring):
- No data available
- Statistics:
- No data available
- Reproductive indices:
- No data available
- Offspring viability indices:
- No data available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- 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
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- not specified
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: No adverse effects on reproduction were observed.
- Remarks on result:
- other: Generation: multigeneration
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- not specified
- Mortality / viability:
- 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
- Sexual maturation:
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings:
- not specified
- Other effects:
- not specified
- Behaviour (functional findings):
- not specified
- Developmental immunotoxicity:
- not specified
- Dose descriptor:
- other: not specified
- Generation:
- F1
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- other: not specified
- Remarks on result:
- other: not specified
- Critical effects observed:
- not specified
- System:
- other: not specified
- Organ:
- not specified
- Reproductive effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- In a multigeneration reproduction study the NOAEL was considered to be 1,000 mg/kg when rats were treated with test chemical orally.
- Executive summary:
A multigeneration reproduction study was conducted in rats administered the test chemical in their diets at concentrations based on multiples of lx, 10x, 30x, and 100x the ADI (acceptable daily intake); the doses, however, did not exceed 1,000 mg/kg (Pierce et al. 1974). No adverse effects on reproduction were observed.Therefore, NOAEL was considered to be 1,000 mg/kg when rats were treated with test chemical orally.
Reference
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is Klimicsh 2 and from authoritative database
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Reproductive toxicity study
Data available from different studies were reviewed to determine the reproductive toxicity of testchemical.The studies are as mentioned below:
Study 1
A multigeneration reproduction study was conducted in rats administered the test chemical in their diets at concentrations based on multiples of lx, 10x, 30x, and 100x the ADI (acceptable daily intake); the doses, however, did not exceed 1,000 mg/kg (Pierce et al. 1974). No adverse effects on reproduction were observed.Therefore, NOAEL was considered to be 1,000 mg/kg when rats were treated with test chemical orally.
Study 2
Reproductive toxicity study was observed for test material in P0 female Wistar rats, when they were exposed at the concentration of 0, 94, 282 or 940mg /kg bw/day through 6-17of gestation period by oral (gavage).The test substance (in1%carboxymethylcellulose in water) was given daily at dose volumes of 10 ml/kg bw by oral gavage. Dams were observed daily for clinical signs, body weight and food intake recorded at designated intervals. The females were killed on gestation day 21, subjected to macroscopic examination, and foetuses were removed by Caesarean section. Common litter parameters were recorded and foetuses were sexed, weighed and submitted to external examination. About one half of the foetuses were also examined for soft tissue anomalies where as remaining foetuses were examined for skeletal anomalies following alizarin red staining. At the does group of 94 mg /kg bw/day one female had only embryonic resorptions.
At the dose group of 282 and 940 mg /kg bw/day two Females were not pregnant, one female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. These findings were considered by the study authors to be incidental as a dose relation was missing.No mortality was observed. Discoloured faeces were observed at 940mg/kg bw/day. No significant changes were observed on litter parameters and fetal weight. No significant changes were observed on external soft tissue and skeletal anomalies in treated group compare to control. Therefore NOAEL was considered to be 940 mg /kg bw/day for test material in P0 female Wistar rats.
Study 3
Reproductive and development toxicity study of test materialwas performed on female HanBrl:WIST (SPF) rats.22 mated females rats were divided into per dose group . The test substance in bi-distilled water containing 1% carboxymethylcellulose was given daily at dose volumes of 10 ml/kg bw by oral gavagein dose0, 100, 300 and 1000 mg/kg bw/day (0, 86, 258, and 861 mg active dye/kg bw/day) from day 6 (implantation) through to day 20post coitum. Mortality, morbidity, signs of abortion, and clinical signs and/or symptoms was checked at least twice daily. Food consumption was recorded on 3-day intervals and body weights were recorded daily. The females were sacrificed on gestation day 21, subjected to macroscopic examination. The foetuses were removed by Caesarean section, sexed, weighed, examined for gross external abnormalities, killed, and allocated to either visceral or skeletal (about one half of the foetuses for each examination).
No mortalities occurred. Clinical signs included darker faeces (all treated groups, from day 7-21 post coitum), and discolouration of skin, eyes and bedding (generally only in the high dose group). The mean body weight gain was slightly decreased and the corrected body weight gain (corrected for gravid uterus weight) was marginally lower in high-dose females compared to control females. Food consumption was similar in treated and control groups. One low-dose female was not pregnant. The incidence of pre-implantation loss was slightly higher (statistically significant) in the high-dose group; this difference was considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Hence No Observed Adverse Effect Level (NOAEL) for maternal toxicity is 300 mg/kg bw/day (258 mg active dye/kg bw/day) and the NOAEL for reproductive and developmental toxicity is 1000 mg/kg bw/day (861 mg active dye/kg bw/day).When femaleHanBrl:WIST (SPF)rats were treated with test material orally.
Based on the data available from different studies, NOAEL for test material was considered to be 1000mg/kg /day for reproductive toxicity, when male and female rats were treated with test material orally. Thus, comparing this value with the criteria of CLP regulation test material is not likely to classify as reproductive toxicant.
Effects on developmental toxicity
Description of key information
Developmental toxicity study
Based on the various studies available for the test chemical were reviewed to determine the developmental toxicity, NOAELfor test chemical was considered to be 1000 mg /kg bw/day .When rats were treated with test chemical orally. Thus, comparing this value with the criteria of CLP regulation test chemical is not likely to classify as reproductive and developmental toxicant.
Link to relevant study records
- Endpoint:
- 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:
- Experimental data from study report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Test chemical was tested for teratogenic effects in rats.
- GLP compliance:
- not specified
- Limit test:
- no
- Specific details on test material used for the study:
- - Name of test material (as cited in study report):Solvent Green 3 (D 6 C Green No.6)
- Molecular formula:C28H22N2O2
- Molecular weight :418.4938 g/mole
- Substance type:Organic
- Physical state:No data available
- Impurities (identity and concentrations):No data available - Species:
- rat
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data available
- Route of administration:
- oral: feed
- Type of inhalation exposure (if applicable):
- not specified
- Vehicle:
- not specified
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Test chemical were administrated in a diet based on acceptable daily intake.
VEHICLE
- Justification for use and choice of vehicle (if other than water): Diet
- Concentration in vehicle: 1x, 10x, 30x and 100x the ADI (acceptable daily intake) - Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Any other deviations from standard protocol: Animals were dosed during the critical stage of organogenesis.
- Duration of treatment / exposure:
- No data available
- Frequency of treatment:
- Daily
- Duration of test:
- Long term
- Dose / conc.:
- 1 000 other: mg/kg/day
- No. of animals per sex per dose:
- No data available
- Control animals:
- not specified
- Details on study design:
- No data available
- Maternal examinations:
- Reproductive effects were examined.
- Ovaries and uterine content:
- No data
- Fetal examinations:
- - Soft tissue examinations: Yes
- Skeletal examinations: Yes - Statistics:
- No data available
- Indices:
- No data available
- Historical control data:
- No data available
- Clinical signs:
- not specified
- Dermal irritation (if dermal study):
- 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:
- not specified
- Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Number of abortions:
- not specified
- Pre- and post-implantation loss:
- not specified
- Total litter losses by resorption:
- not specified
- Early or late resorptions:
- not specified
- Dead fetuses:
- not specified
- Changes in pregnancy duration:
- not specified
- Changes in number of pregnant:
- not specified
- Other effects:
- no effects observed
- Description (incidence and severity):
- No effects were observed on reproduction of treated rats.
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Details on maternal toxic effects:
No effects were observed on reproduction of treated rats. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Remarks on result:
- other: No effects were observed on reproduction of treated rats.
- Abnormalities:
- not specified
- Localisation:
- not specified
- Fetal body weight changes:
- not specified
- Reduction in number of live offspring:
- not specified
- Changes in sex ratio:
- not specified
- Changes in litter size and weights:
- not specified
- Changes in postnatal survival:
- not specified
- External malformations:
- no effects observed
- Skeletal malformations:
- no effects observed
- Visceral malformations:
- no effects observed
- Other effects:
- not specified
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
No effect were observed on skeleton or soft tissues of treated pups. - Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- not specified
- Basis for effect level:
- external malformations
- skeletal malformations
- visceral malformations
- Remarks on result:
- other: No effect were observed on skeleton or soft tissues of treated pups.
- Abnormalities:
- not specified
- Developmental effects observed:
- not specified
- Treatment related:
- not specified
- Conclusions:
- The NOAEL was considered to be 1000 mg/kg/day when rats were treated with test chemical orally.
- Executive summary:
In a multigeneration reproduction toxicity study, rats were treated with test chemical in the concentration based on multiples of 1x, 10x, 30x and 100x the ADI (acceptable daily intake) which did not exceed 1,000 mg/kg in diet. No effects were observed on reprodution of F0 genration in treated rats. In addition, no effects were observed on skeleton or soft tissues of treated pups. Therefore, NOAEL was considered to be 1000 mg/kg/day when rats were treated with test chemical orally for long term.
Reference
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is Klimicsh 2 and from authoritative database
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Developmental toxicity study
Data available from different studies for test chemicals were reviewed to determine the developmental toxicity of test chemical. The studies are as mentioned below:
Study 1
In a multigeneration reproduction toxicity study, rats were treated with test chemical in the concentration based on multiples of 1x, 10x, 30x and 100x the ADI (acceptable daily intake) which did not exceed 1,000 mg/kg in diet. No effects were observed on reprodution of F0 genration in treated rats. In addition, no effects were observed on skeleton or soft tissues of treated pups. Therefore, NOAEL was considered to be 1000 mg/kg/day when rats were treated with test chemical orally for long term.
Study 2
The development toxicity study of test chemicalwas performed on female HanBrl:WIST (SPF) rats.22 mated females rats were divided into per dose group . The test chemical in bi-distilled water containing 1% carboxymethylcellulose was given daily at dose volumes of 10 ml/kg bw by oral gavagein dose0, 100, 300 and 1000 mg/kg bw/day (0, 86, 258, and 861 mg active dye/kg bw/day) from day 6 (implantation) through to day 20post coitum. Mortality, morbidity, signs of abortion, and clinical signs and/or symptoms was checked at least twice daily. Food consumption was recorded on 3-day intervals and body weights were recorded daily. The females were sacrificed on gestation day 21, subjected to macroscopic examination. The foetuses were removed by Caesarean section, sexed, weighed, examined for gross external abnormalities, killed, and allocated to either visceral or skeletal (about one half of the foetuses for each examination).
No mortalities occurred. Clinical signs included darker faeces (all treated groups, from day 7-21 post coitum), and discolouration of skin, eyes and bedding (generally only in the high dose group). The mean body weight gain was slightly decreased and the corrected body weight gain (corrected for gravid uterus weight) was marginally lower in high-dose females compared to control females. Food consumption was similar in treated and control groups. One low-dose female was not pregnant. The incidence of pre-implantation loss was slightly higher (statistically significant) in the high-dose group; this difference was considered as being incidental by the study authors because pre-implantation loss mainly occurred prior to onset of treatment. Post-implantation loss and number of foetuses per dam was not affected. At necropsy discolouration of intestinal contents, kidneys, fatty tissues, intrauterine fluids and foetuses was noted in all high-dose dams. No effects on litter parameters or foetal weight were observed. Incidences of external, visceral and skeletal findings were similar for control and treated groups. Hence the No Observed Adverse Effect Level (NOAEL) for developmental toxicity was considered to be 1000 mg/kg bw/day (861 mg active dye/kg bw/day).When femaleHanBrl:WIST (SPF)rats were treated with test chemicalorally.
Study 3
Developmental toxicity study was observed for test chemical in P0 female Wistar rats ,they were were exposed at the concentration of 0, 94, 282 or 940mg /kg bw/day through 6-17of gestation period by oral (gavage).The test substance (in1%carboxymethylcellulose in water) was given daily at dose volumes of 10 ml/kg bw by oral gavage.Dams were observed daily for clinical signs ,body weight and food intake recorded at designated intervals. The females were killed on gestation day 21, subjected to macroscopic examination, and foetuses were removed by Caesarean section. Common litter parameters were recorded and foetuses weresexed, weighed and submitted to external examination. About one half of the foetuses werealso examined for soft tissue anomalies whereas remaining foetuses were examined forskeletal anomalies following alizarin red staining.At the does group of 94 mg /kg bw/day one female had only embryonic resorptions.
At the dose group of 282 and 940 mg /kg bw/day twoFemales were not pregnant, one female had only empty implantation sites and a further one only embryonic resorptions at Caesarean section. No mortality was observed. Discoloured faeces were observed at 940mg/kg bw/day. No significant changes were observed on litter parameters and fetal weight. No significant changes were observed on external soft tissue and skeletal anomalies in treated group compare to control. Therefore NOAEL for developmental toxicity was considered to be 1000(940)mg /kg bw/day . When femaleWistar ratswere treated with test chemicalthrough6-17of gestation period by oral (gavage).
Based on the various studies available for the test chemical were reviewed to determine the developmental toxicity, NOAELfor test chemical was considered to be 1000 mg /kg bw/day .When rats were treated with test chemical orally. Thus, comparing this value with the criteria ofCLP regulation testchemical isnot likelyto classify as reproductive and developmental toxicant.
Justification for classification or non-classification
Thus, comparing this value with the criteria of CLP regulation test chemical isnot likelyt o classify as reproductive and developmental toxicant.
Additional information
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.