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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 421-880-6 | CAS number: 201792-73-6
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 12 October 1995-26 October 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 421-880-6
- EC Name:
- -
- Cas Number:
- 201792-73-6
- Molecular formula:
- C34H25N11Na2O11S3
- IUPAC Name:
- disodium 4-amino-6-{2-[4-({4-[2-(2,4-diaminophenyl)diazen-1-yl]phenyl}sulfamoyl)phenyl]diazen-1-yl}-5-hydroxy-3-[2-(4-nitrophenyl)diazen-1-yl]naphthalene-2,7-disulfonate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Alpk: APfSD (Wistar)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Species: Rat
strain: Alpk: APfSD (Wistar)
source: Barriered Animal Breeding Unit, zeneca Pharmaceuticals, Alderley Park
Sex: female and male
specification: young adults. Males weighed 247-273g and the females weighed 178-210g at the beginning of the study
The rats were housed individually, in multiple rat racks suitable for animlas of this strain and the weight range expected during the course of the study.
The rats were transferred to clean cages and racks, as necessary, during the study.
The animal room was designed to give the environmental conditions shown below:
temperature: 21±2°C
relative humidity: 40-70%
Air: approximately 25-30 changes/hour
light cycle: artificial giving 12 hours light, 12 hours dark.
Both temperature and relative humidity were monitored continuosly using an automated system which triggers an alarm if values are outside specified ranges. In general, the recorded values were within the specified ranges and any deviations that were observed are considered not to have affected the integrity of the study.
Diet (PCD) supplied by Special diet Services Limited, Witham, Essex, UK and mains water, supplied by an automatic system were available ad libitum.
Each batch of diet is routinely analysed for composition and for presence of contaminants. Water is also periodically analysed for the presence of contaminants. No contaminants were found to be present in the diet or water at levels considered to be capable of interfering with the purpose or outcome of the study.
The animals were housed under the experimental conditions for at least 6 days, prior to the start of the study.
Five male and five female rats were allocated to the study. Animals were individually identified with a number, unique within the study, by ear punching.
On the front of each cage of animals was a card identifying the contained animals by procedure code, test substance, date of dministration, dose level, individual number, sex and study.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: deionised water
- Duration of exposure:
- 24 h
- Doses:
- single limit dose level of 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- As no deaths were noted in the speculative study, a single, limit dose level of 2000 mg/kg was administered.
The appropriate amount of the test sample was weighed onto a plastic weighing boat and made into a paste by adding a small amount (0.5-0-6ml) of deionised water. The amount applied was calculated for each animal according to its weight at the time of dosing. The test sample covered approximately two-thirds of the application site and the estimated amount applied per unit area of skin was 14.8-16.4mg/cm2 for males and 10.7-12-6mg/cm2 for females. The paste, covered by a 4 ply gauze patch (approximately 7cmx7cm) was applied to the shorn back of each animals and was kept in contact for 24 hours using an occlusive dressing. The gauze patch was covered by a patch of plastic film (7cmx7cm) and was held in position using adhesive bandage (25cmx7.5cm) which was secured by two pieced of PVC tape (approximately 2.5cmx20cm).
At the end of the 24-hour contact period, the dressing were carefully cut, using blunt tipped scissors, removed and discarded. the skin, at the site of application, was cleansed free of any residual test sample using clean swabs of absorbent cotton wool soaked in clean warm water and was then dried with clean tissue paper.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none of the animals died
- Clinical signs:
- other: no sign of toxicity. The skin of all the animlas was stained black or purple by the test sample and in some animals the application site was obscured, preventing the full assessment of irritation. there were pratically no signs of skin irritation (one mal
- Other findings:
- Apart from staining of the hair/skin by the test sample, there were no abnormalities in any animal.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritant
- Conclusions:
- LD50 > 2000 mg/kg to male and female rats.
- Executive summary:
A group of five male and five female Alpk: APfSD (Wistar) rats received a single dermal application of substance.
The animals were assessed daily for the following 14 days for any signs of systemic toxicity and their bodyweights were recorded at intervals throughout the study. At the end of the study all the animals were killed and subjected to a macroscopic examination post mortem.
Following a single dermal application of 2000 mg/kg, none of the animals died. There were no signs of toxicity and practically no signs of skin irritation.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)