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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 276-538-7 | CAS number: 72252-58-5
- 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
- Study period:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-)
- EC Number:
- 276-538-7
- EC Name:
- Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-)
- Cas Number:
- 72252-58-5
- Molecular formula:
- C23H8Cr2N6O16S3.4Na
- IUPAC Name:
- tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Geniron Biolabs Pvt. Ltd., No.93, Solur, Thally Road, Anekal, Bengaluru - 562106, India
- Age at study initiation: 11 to 12 weeks
- Weight at study initiation: Males : 229.4 to 234.3 g; Females: 215.3 to 225.8 g
- Housing: Animals were housed individually in standard polysulfone cages (Size: approximately L 425 x B 266 x H 185 mm), with stainless steel top grill having facilities for pelleted food and drinking water in polycarbonate bottle. Additionally, polycarbonate rat huts were placed inside the cage as an enrichment object and were changed along with the cage at once a week.
Bedding: Steam sterilized corn cob was used and changed once a week along with the cage.
- Diet (e.g. ad libitum): Hypro rat & mice pellet feed, manufactured by Pranav Agro Industries Ltd., Pune 411 030, Maharashtra, India, was provided to animals
- 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 manufactured by Eureka Forbes Ltd, Mumbai 400 001, India, was provided to animals in polycarbonate bottles with stainless steel sipper tubes.
- Acclimation period: After physical examination for good health and suitability for experiment, the rats were acclimatized for six days before treatment under standard laboratory conditions. Animals were observed once daily during acclimatization period. Females were nulliparous and non-pregnant
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 to 23°C
- Humidity (%): 65 to 67 %
- Air changes (per hr): 14.1 to 14.3 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light and 12 hours dark cycle
IN-LIFE DATES: From : 29 September 2016 To : 19 October 2016
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: milli-Q water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 24 hours before treatment, the hair on the dorsolateral thoracic surface of the skin was clipped (approximately 10 x 8 cm) with an electric clipper (Aesculap- Germany).
Based on the individual body weight, the finely ground test item at the dose of 2000 mg/kg body weight was weighed on an aluminium foil and made into a paste by adding sufficient volume of Milli-Q water (approximately 1.4 mL) and completely transferred on to the cotton gauze (size: Males: 9 x 6 cm; Females: 8 x 5 cm of 6 ply) and applied (semi-occlusive) directly to the clipped skin of the rat to cover about 10% of body surface of the rat. Then the cotton was secured in position by adhesive tape wound around the torso. The test item contact period with the skin was for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): After the 24 hour contact period, the dressing was removed and the applied area was washed with water and wiped dry using a clean towel.
- Time after start of exposure:10:27 AM to 10:34 AM
TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
Refer Appendix 1
- Constant volume or concentration used: no
- For solids, paste formed: yes
VEHICLE
- Amount(s) applied (volume or weight with unit): Approxmately 1.4 mL - Duration of exposure:
- 24 hours
- Doses:
- limit dose: 2000 mg/kg
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for clinical signs and pre-terminal deaths (mortality) four times (at hourly intervals after application) during day 1 and twice daily on day 2 and 3 and once daily during Days 4 to 15. 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
- Other examinations performed: clinical signs, body weight, gross pathology. - Statistics:
- The statistical analysis was not performed as the test was completed with the limit dose.
Results and discussion
- Preliminary study:
- No priliminary study
Effect levels
- Sex:
- male/female
- Dose descriptor:
- approximate LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality
- Clinical signs:
- other: There were no clinical signs observed during the study. However, black colour stain was observed on test item applied area in all rats on day 2 and 3 post dose observation
- Gross pathology:
- No abnormality was detected at necropsy
Any other information on results incl. tables
Table 1. Individual body weight, body weight changes and pre-terminal deaths
Group and Dose (mg/kg body weight) |
Rat No. |
S e x |
Body weight (g) |
No.dead / No.tested |
Pre- terminal deaths (%) |
||||
Initial (at treatment) |
8th day |
Weight change (day 8 – Initial) |
15th day |
Weight change (day 15 – Initial) |
|||||
G1 and 2000 Limit test
|
Rm5211 |
M |
234.3 |
251.6 |
17.3 |
264.6 |
30.3 |
0/10 |
0 |
Rm5212 |
M |
230.8 |
246.8 |
16.0 |
258.9 |
28.1 |
|||
Rm5213 |
M |
231.4 |
242.9 |
11.5 |
255.6 |
24.2 |
|||
Rm5214 |
M |
229.4 |
245.1 |
15.7 |
257.3 |
27.9 |
|||
Rm5215 |
M |
232.9 |
250.0 |
17.1 |
262.2 |
29.3 |
|||
Rm5216 |
F |
220.8 |
232.6 |
11.8 |
245.6 |
24.8 |
|||
Rm5217 |
F |
215.3 |
227.2 |
11.9 |
229.8 |
14.5 |
|||
Rm5218 |
F |
223.8 |
234.8 |
11.0 |
245.1 |
21.3 |
|||
Rm5219 |
F |
225.8 |
238.7 |
12.9 |
251.6 |
25.8 |
|||
Rm5220 |
F |
218.9 |
231.3 |
12.4 |
243.4 |
24.5 |
F: Female M: Male
Table 2. Individual test item application, clinical signs and necropsy findings
Group and Dose (mg/kg body weight) |
Date & Time of Application |
Rat No. |
Sex |
Body weight initial (g) |
Quantity applied (mg)
|
Day of Observations |
|||||||
Day 1 |
2 |
3 |
|||||||||||
1 hour |
2 hours |
3 hours |
4 hours |
|
|
||||||||
AM |
PM |
AM |
PM |
||||||||||
G1 and 2000 Limit test |
05 October 2016 and 10:27 AM to 10:34 AM |
Rm5211 |
M |
234.3 |
469 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
Rm5212 |
M |
230.8 |
462 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5213 |
M |
231.4 |
463 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5214 |
M |
229.4 |
459 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5215 |
M |
232.9 |
466 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5216 |
F |
220.8 |
442 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5217 |
F |
215.3 |
431 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5218 |
F |
223.8 |
448 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5219 |
F |
225.8 |
452 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
||
Rm5220 |
F |
218.9 |
438 |
N |
N |
N |
N |
N* |
N* |
N* |
N* |
F: Female M: Male N: AM: Ante Meridian PM: Post *:Black colour stain on test item applied area.
Table 2 contd. Individual test item application, clinical signs and necropsy findings
Group and Dose (mg/kg body weight) |
Rat No. |
Sex |
Day of Observations |
Necropsy Findings |
|||||||||||
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
15 |
||||
G1 and 2000 Limit test |
Rm5211 |
M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
Rm5212 |
M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5213 |
M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5214 |
M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5215 |
M |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5216 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5217 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5218 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5219 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
|
Rm5220 |
F |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
N |
NAD |
F: Female M: Male NAD: No Abnormality Detected N: AM: Ante Meridian PM: Post
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: not specified
- Conclusions:
- The acute dermal LD50 of the test item is more than 2000 mg/kg body weight in male and female Wistar rats.
- Executive summary:
The acute dermal toxicity of the test item was tested in 5 male and 5 female Wistar rats with the limit dose of 2000 mg/kg body weight.
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. However, black colour stain was observed on test item applied area in all rats on day 2 and 3 post dose observation. 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 LD50of the test item is more than 2000 mg/kg body weight in male and female Wistar rats.
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.