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EC number: 443-510-2 | CAS number: 738587-10-5
- 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:
- The study was performed between 2002-11-25 and 2002-12-09. Report signed off 2003-01-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 443-510-2
- EC Name:
- -
- Cas Number:
- 738587-10-5
- Molecular formula:
- C26H14N10Ni2O18S4 as free acid
- IUPAC Name:
- dinickel(2+) sodium 3-carboxy-5-[(1E)-2-(7-oxido-2,6-disulfonaphthalen-1-yl)diazen-1-yl]-1H-1,2,4-triazol-1-ide 3-carboxy-5-[(1E)-2-(7-oxido-2-sulfo-6-sulfonatonaphthalen-1-yl)diazen-1-yl]-1H-1,2,4-triazol-1-ide
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Five male and five female Sprague-Dawley CD (Cd: CD® (SD) IGS BR) strain rats were supplied by Charles River (UK) Ltd, Margate, Kent, UK. On receipt the animals were randomly allocated to cages. The females were nulliparous and non-pregnant. After an acclimatisation period of at least five days the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the study the animals weighed at least 200g, and were eight to twelve weeks of age. The animals were housed in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were housed individually during the 24-hour exposure period and in groups of five, by sex, for the remainder of the study. Free access to mains drinking water and food was allowed throughout the study. The diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that could reasonably be expected to affect the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70% respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The rate of air exchange was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
The animals were provided with environmental enrichment items which were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- The test concentration was 2000 mg/kg bodyweight of test substance. The appropriate amount of test material, moistened with distilled water, was applied as evenly as possible to an area of shorn skin (approximately 10% of the total body surface area). A piece of surgical gauze was placed over the treatment area and semi-occluded with a piece of self-adhesive. Any other skin reactions, if present were also recorded. The animals were caged individually for the 24-hour exposure period. Shortly after dosing the dressings were examined to ensure that they were securely in place. After the 24-hour contact period the bandage was carefully removed and the treated skin and surrounding hair wiped with moistened cotton wool to remove any residual test material. The animals were returned to group housing for the remainder of the study period.
- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg/bodyweight
- No. of animals per sex per dose:
- 5 male, 5 female
- Control animals:
- not required
- Details on study design:
- A group of ten animals (five males and five females) was given a single, 24-hour, semi-occluded dermal application of test material to intact skin at a dose level of 2000 mg/kg bodyweight. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
The animals were observed for deaths or overt signs of toxicity at 0.5, 1, 2 and 4h after dosing and susequently once daily for fourteen days.
After removal of the dressings and subsequently once daily for fourteen days the test sites were examined for evidence of primary irritation. - Statistics:
- None used.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: Signs of toxicity related to dose levels: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- Dermal reactions: Red coloured staining which prevented evaluation of erythema was noted at the treatment sites of all animals up to six days after treatment.
There were no signs of dermal irritation.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- After a single application of the test substance the acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. There were no deaths during the study, no signs of systemic toxicity, no signs of dermal irritation, all animals showed expected gains in bodyweight and there were no abnormalities noted at necropsy.
The test substance does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commision Directive 93/21/EEC for classification and labelling of dangerous substances and preparations and in accordance with Regulation (EC) No. 1272/2008. - Executive summary:
Introduction
The study was performed to assess the acute dermal toxicity of the test material in the Sprague Dawley CD strain rat. The method was designed to be compatible with:
OECD Guidelines for the Testing of Chemicals No. 42 'Acute Dermal Toxicity' (adopted 24 February 1987)
Method B3 Acute Toxicity (Dermal) of Commision Directive 92/69/EEC
Result
After a single application of the test substance the acute dermal median lethal dose (LD50) of the test substance in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. There were no deaths during the study, no signs of systemic toxicity, no signs of dermal irritation, all animals showed expected gains in bodyweight and there were no abnormalities noted at necropsy.
The test substance does not meet the criteria for classification and will not require labelling for dermal toxicity in accordance with EU labelling regulations Commision Directive 93/21/EEC for classification and labelling of dangerous substances and preparations and in accordance with Regulation (EC) No. 1272/2008.
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