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EC number: 228-783-6 | CAS number: 6358-69-6
- 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
90 days toxicity study was conducted in rats with test substance fed at dietary levels of 50,500 and 5000mg/kg/day. (100, 1000, 10000 ppm) Therefore No Observed Adverse Effect Level (NOAEL) for repeated oral administration of test substance in rats was considered to be 500mg/kg bw for 90 days by oral feed.
Repeated dose toxicity: inhalation
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Solvent Green 7 also known as Pyranine; trisodium 8-hydroxypyrene-1,3,6-trisulfonate (6358-69-6 ) which is reported as 0.0001860153mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical trisodium 8-hydroxypyrene-1,3,6-trisulfonate is highly unlikely. Therefore this study is considered for waiver.
Repeated dose toxicity: dermal
In a two year study 60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance in 60 mice for 2 years is 3.5 mg (0.05 ml of a 7% solution)
Key value for chemical safety assessment
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- data from secondary literature
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- To determine the repeated dose – oral toxicity of the test chemical .
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- oral: feed
- Vehicle:
- other: feed
- 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
- Remarks:
- Doses / Concentrations:
50, 500, 5000 mg/kgb.w - No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: : Yes
Time schedule: No data
BODY WEIGHT: Yes
Time schedule for examinations: No data
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Yes
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
OPHTHALMOSCOPIC EXAMINATION: Yes
Time schedule for examinations: No data
Dose groups that were examined: No data
HAEMATOLOGY: Yes
Time schedule for collection of blood: No data
Anesthetic 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. : No data
URINALYSIS: Yes / No / No data: Yes
Time schedule for collection of urine: No data
Metabolism cages used for collection of urine: No data
Animals fasted: Yes / No / No data: No data
Parameters checked in table [No.?] were examined.: No data
NEUROBEHAVIOURAL EXAMINATION: No data
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
OTHER: No data - Sacrifice and pathology:
- Sacrifice and pathology
GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Other examinations:
- no data
- Statistics:
- no data
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Growth was slightly retarded in males of 5000 mg/kg/day group compare to control
- 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:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Dose descriptor:
- NOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No toxic effects observed at thos dose level.
- Remarks on result:
- other: No toxic effect were observed
- Critical effects observed:
- not specified
- Conclusions:
- 90 days toxicity study was conducted in rats with test substance fed at dietary levels of 100, 1000, 10000 ppm. The No Observed Adverse Effect Level (NOAEL) for repeated oral administration of test substance is considered to be 500mg/kg bw.
- Executive summary:
Sub chronic toxicity study was conducted for test substance for its possible toxic effects. The test substance was exposed to male and female rats by oral feed at the dose concentration of 50,500 and 5000 mg/kg/day(100, 1000, 10000 ppm) for 90 days . The animals were observed for clinical sign, mortality, food consumption, body weight, hematology, clinical chemistry, urine analysis, organ weight histopathology and gross pathology. Growth was slightly retarded in males of the 5000 mg/kg/day. No significant effect were observed in clinical sign, mortality, food consumption, body weight, hematology, clinical chemistry, urine analysis, organ weight histopathology and gross pathology of 50 and 500 mg/kg/day group. Therefore No Observed Adverse Effect Level (NOAEL) for repeated oral administration of test substance in rats was considered to be 500mg/kg bw for 90 days by oral feed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 500 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from publication
Repeated dose toxicity: inhalation - systemic effects
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:
- repeated dose toxicity: dermal
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- The study was performed to determine the repeated dose – dermal toxicity of the test chemical.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- other: topical application
- Vehicle:
- water
- Details on exposure:
- TEST MATERIAL
Amount(s) applied (volume or weight with unit): 3.5 mg
substance
Concentration (if solution): (0.05 ml of a 7% solution)
Constant volume or concentration used: yes/no: Yes - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- no data
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- applied once a week
- Remarks:
- Doses / Concentrations:
3.5 mg substance (0.05 ml of a 7% solution)
Basis:
no data - No. of animals per sex per dose:
- 60 mice (sex not specified)
- Control animals:
- not specified
- Details on study design:
- no data
- Positive control:
- no data
- Observations and examinations performed and frequency:
- no data
- Sacrifice and pathology:
- no data
- Other examinations:
- Animals were observed for skin tumours and systemic toxicity
- Statistics:
- no data
- Clinical signs:
- not specified
- Dermal irritation:
- no effects observed
- 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
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Animals were observed for skin tumours and systemic toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 3.5 other: mg (0.05 ml of 7% solution)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: No signs of toxicity observed after 2 years
- Remarks on result:
- other: No toxic effects were observed
- Critical effects observed:
- not specified
- Conclusions:
- In a two year study 60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance in 60 mice for 2 years is 3.5 mg (0.05 ml of a 7% solution)
- Executive summary:
Two year toxicity study was performed to determine the repeated dose – dermal toxicity of the test chemical .60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. No toxicity was observed after 2 years. One mouse out of 60 developed a benign skin tumour (fibroma) near the application site. No control group was used in this study. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance in 50 male mice for 2 years is 3.5 mg (0.05 ml of a 7% solution)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 3.5 mg/kg bw/day
- Study duration:
- chronic
- Species:
- mouse
- Quality of whole database:
- Data is from publication
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Various data available for the test chemical was reviewed to determine the toxic nature of Solvent Green 7 also known as Pyranine; trisodium 8-hydroxypyrene-1,3,6-trisulfonate (6358-69-6 ) upon repeated exposure by oral route. The studies are as summarized below:
Repeated dose toxicity: Oral
Sub chronic toxicity study was conducted for test substance for its possible toxic effects. The test substance was exposed to male and female rats by oral feed at the dose concentration of 50,500 and 5000 mg/kg/day(100, 1000, 10000 ppm) for 90 days . The animals were observed for clinical sign, mortality, food consumption, body weight, hematology, clinical chemistry, urine analysis, organ weight histopathology and gross pathology. Growth was slightly retarded in males of the 5000 mg/kg/day. No significant effect were observed in clinical sign, mortality, food consumption, body weight, hematology, clinical chemistry, urine analysis, organ weight histopathology and gross pathology of 50 and 500 mg/kg/day group. Therefore No Observed Adverse Effect Level (NOAEL) for repeated oral administration of test substance in rats was considered to be 500mg/kg bw for 90 days by oral feed.
Repeated dose toxicity test were performed for test chemical on mice with different concentrations from 0.1, 0.25,0.5 or 1.0% (130,325,650,1300 mg/kg bw/d) for 80 wk. 30 males and 30 females was used for the treatment and group of 60 mice of each sex as control. The general condition and behaviour of the animals were observed frequently and any mouse that showed signs of ill-health was isolated, to be returned to its cage on recovery or to be killed if its condition deteriorated. The mice were weighed at the start of the experiment, at wk 3 and then at intervals of 2 wk until wk 73 of the experiment. Blood sample were taken at week 28 and 55.At 80 wk, blood samples were collected from the aorta of all surviving mice during the autopsy. For haematology blood samples were collected and for urine sample from 6-hr period from three groups of five mice of each sex from the controls and the groups on the two highest dietary levels of test substance. Histopathology was also conducted. There were no dose-related effects on body-weight gain, haematology or organ weights. The incidence of histopathological findings, including tumours, was not altered by the feeding of test substance. Therefore, the endpoint for the repeated dose toxicity was found to be NOAEL at 1 % (1300 mg/kg/day) concentration of test substance to mice.
In the subchronic study that was conducted to determine the adverse effects, groups of 10 males and 10 females B6C3F1 mouse was fed diets containing 0, 6,000, 12,500, 25,000, 50,000, or 100,000 mg/kg test substance or 12 weeks and then given control diets for 1 week. The animals were observed twice per day and weighed weekly. Necropsies were performed on all animals. Gross and histopathological examinations were performed on all animals. Mean body weight gain was decreased compared to controls among male mice receiving the 100,000 mg/kg diet intake level. Decreases in body weight gain were also reported for female mice at all intake levels, and was dose related from 12,500 mg/kg diet to 100,000 mg/kg diet. Gross and histopathological examinations revealed no treatment related lesions in male or female mice at any intake level. Thus, on the basis of study results the NOAEL (No observed adverse effect level) was observed to be less than 6000 ppm and 50000 ppm.
Repeated dose toxicity: inhalation
According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Solvent Green 7 also known as Pyranine; trisodium 8-hydroxypyrene-1,3,6-trisulfonate (6358-69-6 ) which is reported as 0.0001860153mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical trisodium 8-hydroxypyrene-1,3,6-trisulfonate is highly unlikely. Therefore this study is considered for waiver.
Repeated dose toxicity: dermal
Two year toxicity study was performed to determine the repeated dose – dermal toxicity of the test chemical .60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. No toxicity was observed after 2 years. One mouse out of 60 developed a benign skin tumour (fibroma) near the application site. No control group was used in this study. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance in 50 male mice for 2 years is 3.5 mg (0.05 ml of a 7% solution).
Repeated dermal dose toxicity test was performed on Swiss Webster mice for 19.5 months. 50 animals per sex were used and the distilled water was the vehicle.100 female and 100 male mice were used in each control group. First the hair was removed and to the depilated area dosage was applied. Each mouse was observed daily for behavior, survival and visible or palable growth. No abnormalities were observed in treated group as compare with control group and no significant change was observed in gross or histopathology. Therefore, from the study it was found that the end point for the dermal repeated dose toxicity study was found to be No Observed Adverse effect level (NOAEL) at 1428.5 mg/kg of test substance treated to mice.
In a Subcutaneous repeated dose toxicity study, Shell or Carworth Farm E SPF male and female rats were treated with test substance in the concentration of 2000 mg/kg Twice-weekly. Skin and subcutaneous tissue were examined histopathologically. Type ll tissue reactions were observed i.e. insufficient progressive lesions in treated rats. In addition, test substance shows weak physicochemical properties which indicate a self-limiting reaction (type II). Therefore, NOAEL was considered to be 2000 mg/kg when Shell or Carworth Farm E SPF male and female rats were treated with test substance Subcutaneous for 10 weeks.
Based on the data available from the test chemical, olvent Green 7 also known as Pyranine; trisodium 8-hydroxypyrene-1,3,6-trisulfonate (6358-69-6 )not likely to exhibit repeated dose oral,dermal and inhalation toxicity. Hence the test chemical is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available from the test chemical, olvent Green 7 also known as Pyranine; trisodium 8-hydroxypyrene-1,3,6-trisulfonate (6358-69-6 )not likely to exhibit repeated dose oral,dermal and inhalation toxicity. Hence the test chemical is not likely to classify as per the criteria mentioned in CLP regulation.
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