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EC number: 282-438-4 | CAS number: 84204-70-6
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- points 8.1 and 8.2 of Annex VIII of REACH have been amended. Nevertheless, adequate information from existing in vivo skin irritation or eye irritation studies can still be used to fulfil the information requirement at any tonnage level.
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From the 13th to the 20th of April, 1990
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted according to internationally accepted guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)
- EC Number:
- 282-438-4
- EC Name:
- Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)
- Cas Number:
- 84204-70-6
- Molecular formula:
- C32H20CoN10Na3O14S2
- IUPAC Name:
- trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Environmental fate/Ecotoxicological/Toxicological studies:
Storage: Room temperature, 20-24 °C, in the dark
Stability: pure, for 5 years; in solvent > 24 hours in water, DMSO, DMF, stable for at least 2 hours in aqueous medium.
Evidence of chemical instability at pH 6: none
Safety precaution: routine hygienic procedures were sufficient to assure personnel health and safety.
Toxicological studies:
Preparation: On the day of the experiment, the test article was suspended in Carboxymethylcellulose (1 %).
The vehicle was chosen to its nontoxicity for the animals. All animals received a single standard dose volume of 10 mL/kg body weight orally.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Source: BRL, Biological Research Laboratories Ltd. Wolferstrasse 4, CH-4414 Fullinsdorf
Number of animals: 1 male, 2 females
Age at start of treatment: male, 15 weeks, females 16 weeks
Body weight at start of or treatment: male, 3.0 kg, females: 3.2 kg
Identification: by unique cage number and corresponding ear tags.
Acclimatization: four days under test conditions after veterinary examination.
Allocation: Animal Numbers, Male no, 1 Female nos. 2, 3
HUSBANDRY
Room No,: 138
Standard Laboratory Conditions.
Air-onditioned with 10-15 air changes per hour and hourly monitored environment with temperature 20±3 °C, relative humidity 40-70%, 12 hours
artificial fluorescent light/12 hours dark, music/light period.
Accommodation: individually in stainless steel cages equipped with an automatic cleaning and drinking system.
Diet: pelleted standard Kliba 341, Batch 52/90 rabbit maintenance diet (“Kliba”, Klingentalmuehle AG, CH-4303 Kaiseraugst), ad libitum,
Analysis for contaminants performed.
Water: community tap water from Itingen, ad libitum
Analysis for contaminants performed.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Controls:
- no
- Amount / concentration applied:
- 0.5 g of the test article
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Viability, mortality: daily
Body weight: Start of acclimatization, day 1 of test (application day) and at termination of observation.
The skin reaction was assessed at 1, 24, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test article. - Number of animals:
- 1 male
2 females - Details on study design:
- Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). The skin of the animals was observed 1 day prior to test article administration.
On test day 1, 0.5 g of the test article was applied to approx. 6 cm^2 of the intact skin of the shaved area. It was covered with a 3.0 cm x 3.0 cm patch of surgical gauze. The gauze was covered with a semi—occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.
Four hours after the application, the dressing was removed and the skin was flushed with lukewarm tap water. The skin reaction was assessed according to the following numerical scoring system.
The observation was terminated 72 hours after application of the test article.
All rabbits were killed by an intravenous injection of T61 (Hoechst AG) into the ear vein and discarded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- The substance showed a primary irritation score of 0.00 when applied to intact rabbit skin. Local signs (mean 1 hour to 72 hours/day) consisted or grade 0.00 erythema and grade 0.00 edema.
No destructions or irreversible alterations or the treated skin were observed. No corrosive effect was evident on the skin.
In the area of application yellowish staining of the treated skin by pigment or coloring of the test article was observed in all animals between 1 to 72 hours
(termination or the study). - Other effects:
- The body weight gain of all rabbits was similar.
No acute clinical symptoms were observed in the animals during the test period, and no mortality occurred.
No necropsy was performed. All animals were killed and discarded.
Any other information on results incl. tables
Data are summarized in tabular form, showing for each individual animal the irritation scores for erythema and edema at 60 minutes, 24, 48 and 72 hours after patch removal, any lesions, a description or the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed. The dermal irritation scores were evaluated in conjunction with the nature and reversibility or otherwise of the responses observed. The individual scores do not represent an absolute standard for the irritant properties of a material, and they are viewed as reference values. The use of a semi-occlusive dressing is a severe test and the results are not directly comparable to human exposure conditions.
Mean values and standard deviations were calculated whenever possible.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Classification criteria according to the CLP Regulation 1272/2008 and its amendments
- Conclusions:
- Non irritant/corrosive for the skin
- Executive summary:
Materials and methods
The irritation/corrosion property was tested on the substance according to the OECD Guideline 404 (Acute Dermal Irritation/Corrosion) and the EU Method B.4 (Acute Toxicity: Dermal Irritation/Corrosion), in GLP.
Under the conditions of the experiment, the tested substance was found to cause a primary irritation score of 0.00 when applied to intact rabbit skin. No corrosive effect had occurred on the skin at any measuring interval.
Local signs (mean 1 hour to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema.
In the area of application, yellowish staining of the treated skin by pigment or coloring of the test article was observed in all animals until termination.
Observations
According to EEC Council Directive, 83/467/EEC, the mean value of the scores for each type of lesion, calculated for each animal separately, is the following:
Mean 24-72 hours 0.00 (Erythema, Edema), all the animals (1 male, 2 females).
Conclusions
Due to the results described above, the substance is considered non irritant to the skin of rabbits.
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