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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The study was performed between 2002-05-02 and 2002-05-05. Report signed off 202-12-23.
- 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:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Three New Zealand White rabbits were supplied by David Percival Ltd, Moston, Sandbach, Cheshire, UK. At the start of the study the animals were in the weight range of 2.0 to 3.5 kg and were twelve to sixteen weeks old. After an acclimatisation period of at least five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label. The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
The temperature and relative humidity were set to achieve limits of I7 to 23°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.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped with veterinary clippers
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- 500 mg (moistened with 0.5ml distilled water).
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- Test sites examined for primary irritation 1, 24, 48 and 72h after removal of the patches
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: A 2.5cm x 2.5cm cotton gauze patch was placed in position on the shorn skin and secured with a strip of surgical tape. Tp prevent the animals interfering with the patches the trunk of each rabbit was wrapped in an elasticated corset and the animals were returned to their cages for the duration of the exposure period.
REMOVAL OF TEST SUBSTANCE
- Washing: The patches were removed and any residual test substance was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: Four hours
SCORING SYSTEM:
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema/Eschar formation
- Basis:
- animal: 115Male
- Time point:
- other: Score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- other: No evidence of skin irritation
- Remarks on result:
- other: Pink/red coloured staining present
- Irritation parameter:
- other: Erythema/Eschar formation
- Basis:
- animal: 137 Male
- Time point:
- other: Score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- other: No evidence of skin irritation
- Remarks on result:
- other: Pink/red coloured staining
- Irritation parameter:
- other: Erythema/Eschar formation
- Basis:
- animal: 139 Male
- Time point:
- other: Score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- other: No evidence of skin irritation
- Remarks on result:
- other: Pink/red coloured staining
- Irritation parameter:
- other: Oedema formation
- Basis:
- animal: 115 Male
- Time point:
- other: Score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 5
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Oedema formation
- Basis:
- animal: 137 Male
- Time point:
- other: Score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Oedema formation
- Basis:
- animal: 139 male
- Time point:
- other: Score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 6
- Reversibility:
- other: No evidence of skin irritation
- Irritant / corrosive response data:
- No evidence of skin irritation or corrosivity were noted during the study.
- Other effects:
- Pink/red coloured staining was noted at all treated skin sites throughout the study. The staining did not affect evaluation of skin responses.
Any other information on results incl. tables
Interpretation of Results
Calculation of Primary Irritation Index and Grading of Irritancy Potential Using the Draize Scheme
The scores for erythema and oedema at the 24 and 72 - Hour readings were totalled for the three test rabbits (12 values) and this total was divided by six to give the primary irritation index of the test item. The test item was classified according to the following scheme devised by Draize J H (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.47:
Primary Irritation Index |
Classification of Irritancy |
0 |
Non-irritant |
> 0 to 2 |
Mild irritant |
> 2 to 5 |
Moderate irritant |
> 5 to 8 |
Severe irritant |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test substance did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Directive 2001/59/EC and Regulation (EC) No. 1272/2008 - Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test item to the skin of the New Zealand White Rabbit. The method was designed to be compatible with the following guidelines:
OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 17 July 1992)
Commision Directive 92/69/EEC Method B4 Acute Toxicity (Skin Irritation)
Results
A single 4h semi-occluded application of the test substance to the intact skin of 3 rabbits produced no evidence of skin irritation. Pink/red coloured staining was noted at all treated skin sites throughout the study.
Conclusion
The test substance produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test substance did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Directive 2001/59/EC and Regulation (EC) No. 1272/2008
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)