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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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 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 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- The objective of this acute dermal toxicity study was to assess the toxicological profile of the test item on application as a single semi-occlusive dermal application to rats.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
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
- Test material form:
- solid: particulate/powder
- 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: Females: 217.20 to 222.36 g
- Identification:By rat accession number. Identification of individual rats is by cage card and crystal violet colour body markings. The temporary body marking during acclimatization period was done with crystal violet. The rat accession numbers were allotted during the course of the study and was included in raw data and reported.
- Housing: Animals were housed individually in standard polysulfone cages (Size: L 425 x B 266 x H 185 mm), with stainless steel top grill. Additionally, polycarbonate rat huts were placed inside the cage as enrichment objects and were changed along with the cage once a week. Bedding: Steam sterilized corn cob was used and changed once a week along with the cage.
- 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, ad libitum
- Acclimation period: The animals were acclimatized six days for G1-DRF, eleven days for G2-DRF, thirteen days G3-DRF and fifteen days for G3-Main 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
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Milli-Q water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the hair on the dorsolateral thoracic surface of the skin was clipped (approximately 10 x 8 cm) with an electric clipper.
- % coverage: about 10% of body surface of the rat.
- Type of wrap if used: The cotton gauze was secured in position by adhesive tape wound around the torso.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the applied area was washed with deionized water and wiped dry using clean towel.
- Time after start of exposure:24 hours
TEST MATERIAL
- For solids, paste formed: yes, the test item at dose of 200 (G1-DRF), 1000 (G2-DRF) and 2000 (G3-DRF and Main) mg/kg body weight, was weighed on an aluminium foil and made into a paste by adding sufficient volume (about 0.1 mL, 0.2 mL, 0.3 mL and 0.4 mL) of Milli-Q water. - Duration of exposure:
- 24 hours
- Doses:
- Three treatment group
G1 – DRF
G2 – DRF
G3 – DRF and G3-Main - No. of animals per sex per dose:
- G1 – DRF - 1
G2 – DRF - 1
G3 – DRF and G3-Main - 3 - Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical examination and pre-terminal deaths - The animals were observed for clinical signs and pre-terminal deaths (mortality) once during first 30 minutes after application, and at hourly intervals for 6 hours after application on the day of treatment (day 1) and once daily during Days 2 to 15. In addition, treatment site at was observed 24, 48 and 72 hours after removal of test item using the Draize criteria (Refer Annexure 4 of this report). All rats were observed for 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 observations of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
- Body weights - Individual body weights of animals were recorded on test days 1 (Pre-application), 8 (7 days post application), and 15 (14 days post application).
- Necropsy of survivors performed: yes, at the end of the observation period, all rats were euthanised and exsanguinated under isoflurane anesthesia and subjected to detailed necropsy by an experienced prosector and the findings were recorded. Microscopic examination was not carried out as no gross pathological changes were observed. - Statistics:
- not specified
Results and discussion
- Preliminary study:
- Dose range finding study - As there was no acute dermal toxicity data available, an initial dose of 200 mg/kg body weight was tested in 1 female rat (dose range finding study) followed by 1000 mg/kg and 2000 mg/kg (dose range finding study). Based on the outcome of these dose range-finding studies, the main study was conducted with 2 further animals to confirm the classification. There was no test item-related mortality. The subsequent dosing was done approximately 2-4 days after the previous dosing.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no pre-terminal deaths (mortality) observed during the study.
- Clinical signs:
- other: There were no clinical signs observed during the study.
- Gross pathology:
- No abnormality was detected at necropsy.
- Other findings:
- not specified
Any other information on results incl. tables
TABLE 1. |
Individual body weight, body weight changes and pre-terminal deaths |
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Group and |
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S |
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Body weight (g) |
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Pre-terminal |
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Dose |
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Rat |
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deaths |
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Initial |
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e |
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8th |
Weight change |
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15th |
Weight change |
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(mg/kg body weight) |
No. |
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x |
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(Day 1 - at |
day |
(day 8 – Initial) |
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day |
(day 15 – Initial) |
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treatment) |
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G1 |
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Rw223 |
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200 |
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F |
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221.66 |
223.87 |
2.21 |
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225.29 |
3.63 |
0 |
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DRF |
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G2 |
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Rw224 |
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1000 |
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F |
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217.20 |
220.14 |
2.94 |
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222.61 |
5.41 |
0 |
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DRF |
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G3 |
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Rw225 |
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2000 |
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F |
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221.00 |
223.12 |
2.12 |
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226.92 |
5.92 |
0 |
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DRF |
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G3 |
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Rw226 |
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F |
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219.14 |
220.89 |
1.75 |
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224.83 |
5.69 |
0 |
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2000 |
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Main study |
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Rw227 |
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F |
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222.36 |
225.16 |
2.8 |
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230.45 |
8.09 |
0 |
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DRF: Dose Range |
Finding |
F: Female |
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Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Conclusions:
- Based on the present study results, the acute dermal LD50 of the given test chemical is >2000 mg/kg body weight in female Wistar rats. The test item does not classified for acute dermal toxicity.
CLP classification "Not classified”. - Executive summary:
The acute dermal toxicity study was conducted as per OECD Guideline 402 (Acute Dermal Toxicity) for the given test chemical tested with 200 mg/kg, 1000 mg/kg and 2000 mg/kg with 1 female for the dose range finding study, followed by additional 2 females for main study at the dose of 2000 mg/kg body weight in Wistar rats.
Based on the individual body weight, the test item at the dose of 200 mg/kg, 1000 mg/kg and 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding sufficient volume of the Milli-Q water and completely transferred on to the cotton gauze (size: Females: 8 x 5 cm of 6 ply) and applied directly (semi-occlusive) to the clipped skin of the rat to cover about 10% of body surface of the rat. It was secured in position by adhesive tape wound around the torso. The test item contact period with the skin was for 24 hours.
After the 24 hours contact period, the dressing was removed and the applied area was washed with deionized water and wiped dry using clean towels.
All the rats were observed for clinical signs of toxicity and mortality for 14 days post application. There were no clinical signs of toxicity and mortality. There was no skin reaction observed at test item applied area. Body weight was measured on days 1, 8 and 15 and all rats gained weight during experimental period. At the end of observation period, all surviving animals were euthanized and subjected to necropsy. There were no abnormalities detected at the necropsy.
Based on the present study results, the acute dermal LD50 of the given test chemical is >2000 mg/kg body weight in female Wistar rats. The test item does not classified for acute dermal toxicity. CLP classification "Not classified”.
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