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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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Study was performed between 2002-05-09 and 2002-05-29. Study report signed off 2002-12-23.
- 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.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- 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
- Details on test material:
- Nature of substance: crystalline solid
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues 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 twenty 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 17 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.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye remained untreated and was used for control purposes
- Amount / concentration applied:
- A volume of 0.1ml of the test substance which was found to weigh approx. 88mg.
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 7 days (observations at 1, 24, 48, 72 hours and 7 days)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used.
Initially, a single rabbit was treated. A volume of 0.1 ml of the test item, was placed into the conjunctival sac of the right eye, formed by gently pulling the lower lid away from the eyeball. The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of the test item, and then released. The left eye remained untreated and was used for control purposes. Immediately after administration of the test item, an assessment of the initial pain reaction was made according to a six point scale.
After consideration of the ocular responses produced in the first treated animal, two additional animals were treated.
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the numerical evaluation given in (from Draize J H (1977) "Dermal and Eye Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC p.48 to 49). Any other ocular effects were also noted. Examination of the eye was facilitated by the use of a light source from a standard ophthalmoscope.
An additional observation was made on day 7 to assess the reversibility of the ocular effects.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: (redness)
- Basis:
- animal: 140 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Pink staining prevented evaluation of conjunctival redness at 1h
- Irritation parameter:
- other: (redness)
- Basis:
- animal: 60 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Pink staining prevented evaluation of conjunctival redness at 1h and 24h.
- Irritation parameter:
- other: (redness)
- Basis:
- animal: 79 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Pink staining prevented evaluation of conjunctival redness at 1h and 24h.
- Irritation parameter:
- chemosis score
- Basis:
- animal: 140 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 60 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 79 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: Male 140
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Pink staining prevented evaluation of cornea at 1h and 24h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 60 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Pink staining prevented evaluation of cornea at 1h and 24h
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 79 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Pink staining prevented evaluation of the cornea at 1h and 24h.
- Irritation parameter:
- iris score
- Basis:
- animal: 140 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Pink staining prevented evaluation of the iris at 1h and 24h
- Irritation parameter:
- iris score
- Basis:
- animal: 60 Male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Pink staining prevented evaluation of the iris at 1h and 24h.
- Irritation parameter:
- iris score
- Basis:
- animal: 79 male
- Time point:
- other: highest score at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: Pink staining prevented evaluation of the iris at 1h and 24h.
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 7 days
- Other effects:
- Pink-coloured staining was noted in all treated eyes at the
1, 24 and 48 hour observations and persisted in two treated
eyes at the 72 hour observation.
Staining prevented evaluation of corneal and iridial effects in all treated eyes at the 1 and 24h observations and the evaluation of conjunctival redness in all treated eyes at the 1h observation and in two treated eyes at the 24h observation.
Slight to moderate conjunctival chemosis and severe discharge were noted in all treated eyes at the 1h observation period. Minimal chemosis and discharge were noted in two treated eyes at the 24h observation. Moderate conjunctival irritation was apparent in one treated eye at the 24h observation. Mininal conjunctival irritation was apparent in all treated eyes at the 48 and 72h observations.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
- Conclusions:
- The test substance produced a maximum group mean score in the range of 10.7 to 106.7 and was considered to be at least a mild irritant (class 4 on a 1 to 8 scale) to the rabbit eye according to the modified Kay and Calandra classification system. Staining of the eyes was reversible within 7 days. The test substance does not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC and Regulation (EC) No. 1272/2008.
The test substance did not meet the criteria for classification as an irritant according to EU labelling regulations (Regulation EC No. 1272/2008 and Directive 2001/59/EC) - Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test substance to the eye of the New Zealand white rabbit. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' (adopted 24 February 1987)
Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 92/69/EEC
Result & Conclusion
The test material produced a maximum group mean score in the range of 10.7 to 106.7 and was considered to be at least a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC and Regualtion (EC) No. 1272/2008.
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