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EC number: 612-028-6 | CAS number: 607724-47-0
- 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
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- The study will be conducted according to the following guideline:
Acute Oral Toxicity-Acute Toxic Class Method, OECD Guideline for the Testing of Chemicals No 423, Adopted: 17th December 2001
Guidance Document on Acute Oral Toxicity Testing, OECD Series on Testing and Assessment No 24, 2001
Guidance Document on the Recognition, Assessment and Use of Clinical Signs as Humane Endpoints for Experimental Animals Used in Safety Evaluation. Environmental Health and Safety Publications Series on Testing and Assessment No 19, 2000 - Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, trisodium salt
- EC Number:
- 612-028-6
- Cas Number:
- 607724-47-0
- Molecular formula:
- C26H22N5Na3O16S5
- IUPAC Name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, trisodium salt
- Test material form:
- solid: particulate/powder
- Details on test material:
- 1 MATERIALS AND METHODS
1.2 Test Item
Designation in Test Facility: 17031402G
Date of Receipt: 14. Mar. 2017
Condition at Receipt Room temperature, in proper conditions
1.2.1 Specification.
Name Blendazol Red Blendwell
Batch no. E 328
Appearance Dark Red Powder
Composition 2-Naphtalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, triso dium salt
Purity 95 % by HPLC
Homogeneity homogeneous
Expiry date 17. Feb. 2019
Storage Room Temperature: (20 ± 5°C); Keep away from humidity
CAS No. 607724-47-0
EINECS-No. 612-028-6
Chemical Class not stated
Stability H2O: 96h; EtOH: unknown; acetone: unknown CH3CN: unknown; DMSO: unknown
Solubility H2O: to be determined*; EtOH: unknown; acetone: unknown CH3CN: unknown; DMSO: unknown
* Will be determined in another GLP-study at LAUS GmbH and will be stated in the final report, this
This information is not provided by the sponsor but determined at LAUS GmbH.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Test Animals
8-12 weeks; 6 females Wistar rats from Dobrá Voda, Slovak Republic were used for test, they were non-pregnant and nulliparous
Health condition of animals was examined by a veterinarian before initiation of the study.
The animals were acclimated under the conditions identical to the conditions during the experiment 5 days prior to the start of treatment. The acclimation was according to the standard operation procedure.
The animals were housed in plastic cages suspended on stainless steel racks, up to 3 animals per cage in a room equipped with central air-conditioning. The average room temperature was maintained within the range of 22.9 ± 0.4° C, relative humidity within 53.8 ± 2 %. The light regimen was set to a 12-hour light /12-hour dark cycle. Sanitation was performed according to the standard operation procedures.
The laboratory food ssniff (Spezialdiäten GmbH, Germany) was offered at recommended doses each day approximately at the same time. The certificate of analysis is included in the raw data.
The animals received tap water for human consumption. Supply of drinking was unlimited. The quality of drinking water is periodical analysed and recorded; certificate of analysis is included in the raw data.
Bedding: Lignocel S3/4, Lufa - ITL GmbH, Germany
The animals in the cage were marked by a line (I-III) on the tail with a waterproof marker. Each cage was marked with the study code, ID of animals and date of administration of the test item.
Females were used for testing according to OECD TG 423 because females are typically the more sensitive gender.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- Aqua pro injection, lot number 0125K16, Expiry date: 10/2019 Manufacturer: Imuna Pharm a.s., Slovakia Aqua pro injectione is a standard vehicle according to OECD TG 423
- Details on oral exposure:
- The required amount of the test item (according to the body weight and dose) was mixed with vehicle (aqua pro injectione) shortly before administration.
The test item was administered in a single dose by gavage using a metal stomach tube. Animals were fasted prior to dosing (food but not water were withheld over-night). Following a period of fasting, animals were weighed and the test item administered. After test item administration, food was withheld for further 3-4 hours - Doses:
- The starting dose could be selected from the fixed dose levels of 5, 50, 300, and 2000 mg/kg body weight. Available information
indicated that the test item is likely to be non-toxic with regard to acute toxicity. A limit dose of 2000 mg/kg body weight was used as a starting dose. - No. of animals per sex per dose:
- One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a second step another 3 females were treated at the same dose
- Control animals:
- no
- Details on study design:
- Clinical Observation:
Animals were observed individually immediately after administration of the test item and 0.5, 1, 2, and 4 hours later. Each animal was inspected daily for the next 14 days.
Observations included: changes in skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous systems, somatomotor activity, and behavioural pattern. Particular attention was given to potential neurologic endpoints such as tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight:
Individual weights of animals were measured immediately prior to administration of the test item and weekly thereafter. Weight differences after first and second weeks after administration were calculated and recorded.
Necropsy
All test animals were subjected to gross necropsy and the results were recorded for each animal. - Statistics:
- All (6/6 females) animals survived the limit dose of 2000 mg/kg body weight.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- >= 5 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No mortality was observed during the study. During the follow up period, no animals displayed signs of intoxication, change of health, nor any other adverse reaction
- Clinical signs:
- No observed signs
- Body weight:
- Stagnation of body weight in rats No 1, 2, 4, and 6 were observed between first and second week after administration.
- Gross pathology:
- All animals were necropsied. During necropsy, no macroscopic findings were observed.
Any other information on results incl. tables
Stagnation of body weight in rats No 1, 2, 4, and 6 were observed between first and second week after administration. Summary results of body weights are presented inTable3.
Table3 Body Weight
Sex |
Dose |
ID |
Body Weight (g) |
Body Weight Difference (g) |
||||
Initial |
Week 1 |
Week 2 |
Week 1 - Initial |
Week 2 - Initial |
Week 2 - Week 1 |
|||
♀ |
2000 mg/kg |
1 |
205 |
220 |
220 |
15 |
15 |
0 |
2 |
210 |
220 |
220 |
10 |
10 |
0 |
||
3 |
195 |
205 |
210 |
10 |
15 |
5 |
||
4 |
200 |
220 |
220 |
20 |
20 |
0 |
||
5 |
200 |
210 |
220 |
10 |
20 |
10 |
||
6 |
210 |
230 |
230 |
20 |
20 |
0 |
Table4Necropsy Results
Sex |
Dose |
ID |
Result |
Sex |
Dose |
ID |
Result |
♀ |
2000 mg/kg |
1 |
no finding |
♀ |
2000 mg/kg |
4 |
no finding |
2 |
no finding |
5 |
no finding |
||||
3 |
no finding |
6 |
no finding |
1.1 Summary Results
The test item Blendazol Red Blendwellwas administeredto 6 females at a limit dose of 2000 mg/kg. Stagnation of body weight in 4 animals were observed between one and two weeks after administration of the test item.
Nosigns of toxicity were observed at the dosage of 2000 mg/kg during the first 4 hours in females or the 14-day observation period thereafter.During necropsy, no macroscopic findings were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- The test item Blendazol Red Blendwell was administered to 6 females at a limit dose of 2000 mg/kg. Stagnation of body weight in 4 animals were observed between one and two weeks after administration of the test item.
No signs of toxicity were observed at the dosage of 2000 mg/kg during the first 4 hours in females or the 14-day observation period thereafter. During necropsy, no macroscopic findings were observed. - Executive summary:
The oral acuste toxicity of Blendazol Red Blendwell was determined following OECD Guideline 423 Acute Toxic Class Method after a single oral administration dose of 2000 mg/kg body weight in 6 femalles rats and observed for 14 days, obtaining that :
The LD50of the test item Blendazol Red Blendwell is greater than 2000 mg/kg body weight after single oral administration to Wistar rats.
Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item Blendazol Red Blendwell is classified in Category 5/Unclassified with a LD50cutoff value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats.
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