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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from experimental study report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- The objective of this acute oral toxicity study was to assess the toxicological profile of the test item when administered to rats by a single oral gavage.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- EC Number:
- 241-409-6
- EC Name:
- Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
- Cas Number:
- 17372-87-1
- Molecular formula:
- C20H6Br4Na2O5
- IUPAC Name:
- disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate
- Details on test material:
- - IUPAC Name: Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate
- InChI: 1S/C20H8Br4O5.2Na/c21-11-5-9-13(7-3-1-2-4-8(7)20(27)28)10-6-12(22)17(26)15(24)19(10)29-18(9)14(23)16(11)25;;/h1-6,25H,(H,27,28);;/q;2*+1/p-2
- Smiles: c1(c2c(oc3c1cc(Br)c(c3Br)[O-])c(c(=O)c(c2)Br)Br)c1c(cccc1)C(=O)[O-].[Na+].[Na+]
- Molecular formula :C20H6Br4Na2O5
- Molecular weight :691.858 g/mol
- Substance type:Organic
- Physical state:Brownish powder
- Purity as per Certificate of Analysis:95.022 %
- Lot No.:L168831601
- Manufactured date:JAN-2016
- Retest date:DEC-2020
- pH:6.55 at 26 °C
- Density:Pour density :0.781 g/cm3 @ 27.05 °C; Tap density :0.97 g/cm3 @ 27.05 °C
- Storage conditions:Ambient (+15 to +25 °C )
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Geniron Biolabs Pvt. Ltd, Bengaluru
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 11 to 12 Weeks
- Weight at study initiation: 169.70 g to 189.74 g
- Identification:By rat accession number. Identification of individual rats was by cage card and turmeric colour body markings. The rat accession number was allotted during the course of the study. The temporary body marking during acclimatization period was done with crystal violet.
- Fasting period before study: rats were fasted for approximately 17 hours.
- Housing:Rats were housed individually in standard polysulfone cages (Size: L 425 x B 266 x H 185 mm), with stainless steel top grill
- Diet (e.g. ad libitum): Rat & Mice pellet feed, ad libitum
- Water (e.g. ad libitum): Deep bore-well water passed through activated charcoal filter and exposed to UV rays in Aquaguard on-line water filter-cum-purifier, Mumbai, ad libitum
- Acclimation period: The animals were acclimatized six days for G1-FTS and eleven days for G1-STS before treatment. Animals were observed once daily during acclimatization period.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 24°C
- Humidity (%): 56 to 67%
- Air changes (per hr): air conditioned with adequate fresh air supply (12.9 air changes/hour)
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle.
IN-LIFE DATES: From: 22 June 2018 To: 31 August 2018
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Milli-Q water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2000 mg/kg body weight (G1 First and second treatment steps)
- Amount of vehicle (if gavage):10 mL/kg
DOSAGE PREPARATION (if unusual): A required quantity of test item was weighed in beaker and small volume of the Milli-Q water was added and mixed by using glass rod and transferred to a measuring cylinder. The beaker was rinsed with vehicle and all the rinsing was quantitatively transferred into the measuring cylinder. The final volume was made up to the mark with Milli-Q water to get the desired test item concentration of 200 mg/mL. The prepared dose formulation was transferred to the dedicated labeled beaker. Preparations were made prior to dosing. - Doses:
- G1 (FTS) - 2000 mg/kg
G1 (STS) - 2000 mg/kg - No. of animals per sex per dose:
- G1 (FTS) - 2000 mg/kg - 3
G1 (STS) - 2000 mg/kg - 3 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical signs and pre-terminal deaths - At each step, the animals were observed five times on test day 1 (day of administration) i.e. at 30 minutes and four times at hourly intervals and once daily during days 2 to 15 post administration. Observations included changes in skin and fur, eyes and mucous membranes, and also respiratory, circulatory, autonomic and central nervous systems and somatomotor activity and behaviour pattern. Attention was directed to the observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma and all observed clinical signs were recorded.
- Body weights - The body weights were recorded on test day 1 (pre-administration), day 8 (7 days post administration) and day 15 (14 days post administration).
- Necropsy of survivors performed: yes, the rats surviving to the end of the observation period were euthanised by using isoflurane anaesthesia and subjected to detailed necropsy. Gross
pathological findings were recorded and reported. Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- not specified
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- G1 - [2000 mg/kg body weight - Treatment (FTS and STS)]: There were no pre-terminal deaths were observed.
- Clinical signs:
- other: G1 - [2000 mg/kg body weight - Treatment (FTS and STS)]: There were no clinical signs observed in any of the rats, except reddish brown faeces on days 2 and 3 of the observation period which is due to the colour of the test item.
- Gross pathology:
- There were no gross pathological changes at necropsy.
- Other findings:
- not specified
Any other information on results incl. tables
TABLE 1. Body weight, body weight change and pre-terminal deaths
Group and |
|
|
|
|
Body weight (g) |
|
|
|
No. dead/ |
Pre- |
||
|
|
|
|
|
|
|
|
|
|
|||
Dose |
Rat |
|
|
|
Weight |
|
|
Weight |
|
Day of Death |
terminal |
|
(mg/kg |
No. |
Sex |
Initial |
th |
change |
th |
|
change |
At |
(Time of Death) |
No. |
deaths |
body weight) |
|
|
(Day 1) |
8 day |
(day 8 – |
15 day |
|
(day 15 |
Death |
|
tested |
(%) |
|
|
|
|
|
Initial) |
|
|
– Initial) |
|
|
|
|
G1 |
Rw211 |
F |
176.39 |
181.69 |
5.3 |
186.17 |
|
9.78 |
NA |
NA |
|
|
(FTS) |
|
|
|
|
|
|
|
|
|
|
|
|
Rw212 |
F |
178.59 |
181.85 |
3.26 |
187.22 |
|
8.63 |
NA |
NA |
0/3 |
0 |
|
2000 |
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rw213 |
F |
183.89 |
195.05 |
11.16 |
199.81 |
|
15.92 |
NA |
NA |
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
G1 |
Rw214 |
F |
176.99 |
184.00 |
7.01 |
187.32 |
|
10.33 |
NA |
NA |
|
|
|
|
|
|
|||||||||
(STS) |
|
|
|
|
|
|
|
|
|
|
|
|
Rw215 |
F |
169.70 |
171.39 |
1.69 |
180.53 |
|
10.83 |
NA |
NA |
0/3 |
0 |
|
2000 |
|
|
||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rw216 |
F |
189.74 |
196.18 |
6.44 |
197.84 |
|
8.1 |
NA |
NA |
|
|
|
|
|
|
|
||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
F: Female |
FTS: First Treatment Step |
STS: Second Treatment Step |
|
NA: Not Applicable 0: No deaths |
|
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based on the results of the present study, the LD50 value of the given test chemical is >2000 mg/kg bw. Thus, the test item is not classified for acute oral toxicity. CLP criteria "Not Classified".
- Executive summary:
The acute oral toxicity study was conducted to assess the toxicological profile of the test item as per OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) in Wistar rats.
The dose formulation was prepared by using Milli-Q water and administered as a single oral gavage to overnight fasted (approximately 17 hours) three female rats (G1-FTS) at the dose of 2000 mg/kg body weight. There were no clinical signs of toxicity and pre-terminal deaths.
Hence, a confirmatory test was done at 2000 mg/kg body weight (G1-STS) with three additional female rats as per Annex 2d of the guideline OECD 423. There were no clinical signs of toxicity and pre-terminal deaths. Based on the scheme - Annex 2d of the guideline OECD 423, the dose was stopped.
The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and on days 8 and 15. Necropsy was performed for all the rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy.
Based on the results of the present study, the LD50 value of the given test chemical is >2000 mg/kg bw. Thus, the test item is not classified for acute oral toxicity. CLP criteria "Not Classified".
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