Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 204-933-6 | CAS number: 129-16-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from experimental reports
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:
- other: OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- To assess the toxicological profile of the test chemical on application as a single semi-occlusive dermal application to rats
- GLP compliance:
- 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
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Eosine
- Molecular formula (if other than submission substance): C20H8Br4O5.2Na
- Molecular weight (if other than submission substance): 691.858 g/mol
- Smiles notation (if other than submission substance): c1(c2c(oc3c1cc(Br)c(c3Br)[O-])c(c(=O)c(c2)Br)Br)c1c(cccc1)C(=O)[O-].[Na+].[Na+]
- InChl (if other than submission substance): 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
- Substance type: Organic
- Physical state: Solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- - 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
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: Milli-Q water
- Controls:
- not specified
- Amount / concentration applied:
- DRF = 200, 100, 2000 mg/kgbw
Main = 2000 mg/kg - Duration of treatment / exposure:
- 24 hourd
- Observation period:
- treatment site was observed 24, 48 and 72 hours after removal of test chemical using the Draize criteria
- Number of animals:
- G1 – DRF - 1
G2 – DRF - 1
G3 – DRF and G3-Main – 3 - Details on study design:
- TEST SITE
- Area of exposure: clipped skin of the torso
- % coverage: 10% of the body surface of the animal (semi-occlusive).
- Type of wrap if used: The area of application was covered with cotton gauze (size: Females: 8 x 5 cm of 6 ply) and it was secured in position by adhesive tape wound around the torso
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 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
OBSERVATION TIME POINTS
(indicate if minutes, hours or days) : All the rats were observed for clinical signs of toxicity and mortality
for 14 days post application. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria
SCORING SYSTEM:
- Method of calculation: Draize method
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- There were no skin reactions at the site of application at 24, 48 and 72 hours after test patch removal (as per Draize method).
- Other effects:
- There were no clinical signs and pre-terminal deaths (mortality) observed during the study
Any other information on results incl. tables
Dose Range Finding Study -DRF
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
Sex |
Initial Bwt (g) |
Quantity (mg) applied |
Observation and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1h |
2h |
3h |
4h |
5h |
6h |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
|||||||
G1 and 200 |
28 JUNE 2018 10:23 to 10: 24 AM |
Rw223 |
F |
238.66 |
221.66 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
Sex |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G1 and 200 |
Rw223 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
Sex |
Initial Bwt (g) |
Quantity (mg) applied |
Observation and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1h |
2h |
3h |
4h |
5h |
6h |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
|||||||
G2 and 1000 |
03 July 2018 and 11.24 AM |
Rw224 |
F |
217.20 |
217 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
Sex |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G2 and 1000 |
Rw224 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
Sex |
Initial Bwt (g) |
Quantity (mg) applied |
Observation and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1h |
2h |
3h |
4h |
5h |
6h |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
|||||||
G3 and 2000 |
05 July 2018 and 11.30 AM |
Rw225 |
F |
221.40 |
442 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
Sex |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G3 and 2000 |
Rw225 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Main study
Group & Dose (mg/kg body weight) |
Date and time of application |
Rat Number |
Sex |
Initial Bwt (g) |
Quantity (mg) applied |
Observation and skin reaction |
||||||||||||||||
Days |
||||||||||||||||||||||
1 |
2 |
3 |
4 |
5 |
||||||||||||||||||
30 min |
1h |
2h |
3h |
4h |
5h |
6h |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
* |
Er@ |
Ed@ |
|||||||
G3 and 2000 |
07 July 2018 and 11:32 AM and 11:33 AM |
Rw226 |
F |
219.14 |
438 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Rw227 |
F |
222.36 |
444 |
N |
N |
N |
N |
N |
N |
N |
N |
N |
0 |
0 |
N |
0 |
0 |
N |
0 |
0 |
Group & Dose (mg/kg body weight) |
Animal Number |
Sex |
Observation |
Necropsy findings |
|||||||||
Days |
|||||||||||||
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G3 and 2000 |
Rw226 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rw227 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
N: Normal
h: hour
min: minutes
NAD: No abnormality detected
Er: Erythema
Ed: Edema Score
0: No Erythema / Edema
*: Clinical signs; @: Skin scoring as per Draize method (approximately 24, 48 and 72 hours) after test patch removal
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
- Conclusions:
- There were no skin reactions at the site of application at 24, 48 and 72 hours after test patch removal (as per Draize method). The mean erythema and edema scores were 0.0 at all observation times. Hence, it was concluded that the test chemical was "Not Irritating" to the skin of Wistar rats under the experimental conditions tested and classified as “Category-Not Classified” as per CLP Classification.
- Executive summary:
A study designed and conducted to determine the dermal reaction profile of the test chemical in Wistar rats. The study was performed as per OECD Guidelines 402 and complying to the GLP procedures.Wistar rats were 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. 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. In addition, the treatment site was observed at 24, 48 and 72 hours after removal of test item using the Draize criteria.
There were no clinical signs of toxicity and mortality. There were no skin reactions at the site of application at 24, 48 and 72 hours after test patch removal (as per Draize method). The mean erythema and edema scores were 0.0 at all observation times. Hence, it was concluded that the test chemical was "Not Irritating" to the skin of Wistar rats under the experimental conditions tested and classified as “Category-Not Classified” as per CLP Classification.
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.