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EC number: 241-409-6 | CAS number: 17372-87-1
- 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
The No Observed adverse effect level (NOAEL) for test chemical is considered to be in a dose range of 1000mg/kg bw in rats for subchronic study
Repeated dose study: Inalation
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 Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1)which is reported as 8.62571e-13 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron -10 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate is highly unlikely. Therefore this study is considered for waiver.
Repeated dose study: Dermal
The acute toxicity value for Disodium 2-(2, 4, 5, 7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Disodium 2-(2, 4, 5, 7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl) benzoate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
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:
- read-across from supporting substance (structural analogue or surrogate)
- 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 from handbook or collection of data
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Weight of evidence prepared based on the data from various publication
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: 1,Charles River CD Sprague-Dawley 2,Crl:CD (SD)
- Details on species / strain selection:
- No data
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- 1,TEST ANIMALS
- Source:
Female rats: Charles River Breeding Laboratories, Portage, Michigan.
Male rats: Langshaw Farms, Augusta, Michigan
- Age at study initiation: 18 weeks
- Weight at study initiation: No data
- Fasting period before study: No data
- Housing: The animals were housed in wire bottomed cages
- Diet (e.g. ad libitum): Purina Certified Rodent Chow No. 5002 ad libitum
- Water (e.g. ad libitum): Water ad libitum
- Acclimation period: 4 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.2 ± -15.5 ˚C
- Humidity (%): 50 ± 15%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hrs light/dark cycle
IN-LIFE DATES: From: To: No data
2,Details on test animal
TEST ANIMALS
- Source: No data
- Age at study initiation: 9 weeks
- Weight at study initiation: No data - Route of administration:
- oral: gavage
- Details on route of administration:
- No data
- Vehicle:
- water
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test chemical was mixed with water as vehicle at dose levels of 0, 100, 500 or 1500 mg/kg body weight and prepared daily
DIET PREPARATION
- Rate of preparation of diet (frequency): No data
- Mixing appropriate amounts with (Type of food): No data
- Storage temperature of food: No data
VEHICLE
- Justification for use and choice of vehicle (if other than water): No data
- Concentration in vehicle: 0, 100, 500 or 1500 mg/kg bw
- Amount of vehicle (if gavage): 10 mL/Kg
- Lot/batch no. (if required): No data
- Purity: No data - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- No data
- Duration of treatment / exposure:
- 1,14 days
2,Male: 42 days / - Female: 41 - 47 days (from 14 days before mating to day 4 of lactation) - Frequency of treatment:
- Daily from 6-15 days of gestation
- Remarks:
- 0, 100, 500 or 1500 mg/kg bw
- Remarks:
- Test group: 0, 40, 200 or 1000 mg/Kg/day
Recovery group: 0, 1000 mg/kg/day - No. of animals per sex per dose:
- 1,Total: 100 females
0 mg/Kg bw: 25 females
100 mg/Kg bw: 25 females
500 mg/Kg bw: 25 females
1500 mg/Kg bw: 25 females - Control animals:
- yes, concurrent vehicle
- Details on study design:
- No data
- Positive control:
- No data
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: During the study period
- Cage side observations checked in table [No.?] were included. Mortality
DETAILED CLINICAL OBSERVATIONS: No data
- Time schedule: No data
BODY WEIGHT: Yes
- Time schedule for examinations: body weights were recorded on days 6, 9, 12 and 16 of gestation
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): No data
- 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: No data
- 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: No data
- 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
- 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: 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:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: No data - Other examinations:
- No data
- Statistics:
- No data
- Clinical signs:
- not specified
- Description (incidence and severity):
- No data
- Mortality:
- mortality observed, non-treatment-related
- Description (incidence):
- 1,Survival was 100% in the controls and the groups receiving 100 and 500 mg/kg of dye. Six rats in the high-dose group (1500 mg/kg) died during the dosing period.
2, No mortality were observed at dose level of 0, 40, 200 or 1000 mg/Kg/day of treated group compare to control. - Body weight and weight changes:
- effects observed, non-treatment-related
- Description (incidence and severity):
- There were slight reductions in body-weight gains in 1500 mg/Kg bw group, compared with controls, throughout the dosing period
- 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:
- effects observed, treatment-related
- Description (incidence and severity):
- Orange discoloration of the urine was noted in all treated rats during the treatment period.
- 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):
- 1,At autopsy, green discoloration of the amniotic fluid was noted in 1, 10 and 16 rats in the 100, 500 and 1500 mg/kg/day groups, respectively, and the small intestines were green in colour in many rats in the 500 mg/Kg group.
2,No effects were observed at dose level of 0, 40, 200 or 1000 mg/Kg/day of treated group compare to control. - Neuropathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Other effects:
- not specified
- Dose descriptor:
- NOAEL
- Effect level:
- 1 500 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- female
- Basis for effect level:
- other: No significant effects were noted at the mentioned dose level
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 other: mg/Kg/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No significant effect were observed at this dose
- Remarks on result:
- other: No toxic effect were observed
- Critical effects observed:
- not specified
- Conclusions:
- The No Observed adverse effect level (NOAEL) for test chemical is considered to be in a dose range of 1000mg/kg bw in rats for subchronic study
- Executive summary:
Data available for the test chemicals was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:
In another combined repeated dose repro-devp. Screen was performed to determine the toxic nature of test chemical upon repeated exposure by oral route.An aqueous solution of the dye was administered by garage to groups of 25 Charles River Sprague-Dawley rats at doses of 100, 500 and 1500 mg/kg on days 6- 19 of gestation. A control group received water on a comparable basis. Individual doses were determined on the basis of body weights recorded on days 6, 9, 12 and 16 of gestation.Survival was 100% in the controls and the groups receiving 100 and 500 mg/kg of dye. Six rats in the high-dose group (1500 mg/kg) died during the dosing period. There were slight reductions in body-weight gains in 1500 mg/Kg bw group, compared with controls, throughout the dosing period.Orange discoloration of the urine was noted in all treated rats during the treatment period.At autopsy, green discoloration of the amniotic fluid was noted in 1, 10 and 16 rats in the 100, 500 and 1500 mg/kg/day groups, respectively, and the small intestines were green in colour in many rats in the 500 mg/Kg group. Based on the above observations made, the No Observed adverse effect level (NOAEL) for test chemical is considered to be 1500 mg/kg bw.
In yet another combined repeated dose and reproduction / developmental screening, study was performed to evaluate the toxic nature of Pigment Orange 13. Male and female Crl:CD (SD) rats were used in the study. The test compound was dissolved in water and used at dose levels of 0, 40, 200 or 1000 mg/Kg/day. The male rats were treated for 42 days and female rats were treated for 41-47 days. Recovery group of 0 and 1000 mg/Kg/day was also included in the study. The treated animals were noted for clinical signs, functional battery observations, body weight, food consumption, urinanalysis, hematology, blood chemistry, organ weight changes and histopathology. No adverse effects were noted in the various parameters studied. Based on the observations made, The No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day when male and female Crl: CD (SD) rats were exposed for subchronic toxicity study duration .
Based on the data available, the No Observed adverse effect level (NOAEL) for test chemical is considered to be in a dose range of 1000mg/kg bw in rats for subchronic study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Weight of evidence prepared from various qualified 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
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The data available for the test chemicals Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1) was reviewed to determine the toxic nature upon repeated exposure by oral, dermal and inhalation route. The studies are as mentioned below:
Repeated dose toxicity: Oral
In another combined repeated dose repro-devp. Screen was performed to determine the toxic nature of test chemical upon repeated exposure by oral route.An aqueous solution of the dye was administered by garage to groups of 25 Charles River Sprague-Dawley rats at doses of 100, 500 and 1500 mg/kg on days 6- 19 of gestation. A control group received water on a comparable basis. Individual doses were determined on the basis of body weights recorded on days 6, 9, 12 and 16 of gestation.Survival was 100% in the controls and the groups receiving 100 and 500 mg/kg of dye. Six rats in the high-dose group (1500 mg/kg) died during the dosing period. There were slight reductions in body-weight gains in 1500 mg/Kg bw group, compared with controls, throughout the dosing period.Orange discoloration of the urine was noted in all treated rats during the treatment period.At autopsy, green discoloration of the amniotic fluid was noted in 1, 10 and 16 rats in the 100, 500 and 1500 mg/kg/day groups, respectively, and the small intestines were green in colour in many rats in the 500 mg/Kg group. Based on the above observations made, the No Observed adverse effect level (NOAEL) for test chemical is considered to be 1500 mg/kg bw.
In yet another combined repeated dose and reproduction / developmental screening, study was performed to evaluate the toxic nature of Pigment Orange 13. Male and female Crl:CD (SD) rats were used in the study. The test compound was dissolved in water and used at dose levels of 0, 40, 200 or 1000 mg/Kg/day. The male rats were treated for 42 days and female rats were treated for 41-47 days. Recovery group of 0 and 1000 mg/Kg/day was also included in the study. The treated animals were noted for clinical signs, functional battery observations, body weight, food consumption, urinanalysis, hematology, blood chemistry, organ weight changes and histopathology. No adverse effects were noted in the various parameters studied. Based on the observations made, The No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day when male and female Crl: CD (SD) rats were exposed for subchronic toxicity study duration .
Based on the data available, the No Observed adverse effect level (NOAEL) for test chemical is considered to be in a dose range of 1000mg/kg bw in rats for subchronic study.
Repeated dose study: 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 Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1)which is reported as 8.62571e-13 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron -10 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate is highly unlikely. Therefore this study is considered for waiver.
Repeated dose study: Dermal
The acute toxicity value for Disodium 2-(2, 4, 5, 7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Disodium 2-(2, 4, 5, 7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl) benzoate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.
Based on the data available and applying the weight of evidence approach, the test chemical not likely to exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available and applying the weight of evidence approach, the test chemical not likely to exhibit toxic nature upon repeated exposure by oral, inhalation and dermal route of exposure and hence is not likely to classify as per the criteria mentioned in CLP regulation.
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