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EC number: 940-433-0 | CAS number: -
- 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
- Remarks:
- existing study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-04-21 to 2010-05-12
- 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:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- lithium hydrogen 7-{(E)-[2-amino-4-(2-naphthyl)-1,3-thiazol-5-yl]diazenyl}naphthalene-1,3,5-trisulfonate (2:1:1)
- EC Number:
- 940-433-0
- Molecular formula:
- C23H14Li2N4O9S4
- IUPAC Name:
- lithium hydrogen 7-{(E)-[2-amino-4-(2-naphthyl)-1,3-thiazol-5-yl]diazenyl}naphthalene-1,3,5-trisulfonate (2:1:1)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Loughborough, UK
- Age at study initiation: 12 - 20 weeks old
- Weight at study initiation: 2.28 or 2.30 kg
- Housing: suspended cages
- Diet : free access to food throughout the study (2030 Teklad Global Rabbit diet supplied by Harlan Laboratories UK Ltd, Oxon, UK)
- Water : free access to water throughout the study
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye remained untreated for use as control
- Amount / concentration applied:
- A volume of 0.1ml of test material, which was found to weigh 68mg (as measured by gently compacting the required volume into an adapted syringe) was placed into the conjunctival sac of the right eye.
- Duration of treatment / exposure:
- The upper and lower eyelids were held together for about one second immediately after treatment, to prevent loss of test material, and then released. The left eye remained untreated and was used for control purposes.
- Observation period (in vivo):
- Immediately after administration of the test material an assessment of initial pain reaction was made according to a six point scale. Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment according to the Draize Scale for Scoring Ocular Irritation (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. Any clinical signs of toxicity, if present, were also noted. An additional observation was made in one treated eye on day 7 to assess the reversibility of the ocular staining.
Individual bodyweights were recorded on day 0 (the day of dosing) and at the end of the observation period. - Number of animals or in vitro replicates:
- Initially a single rabbit was treated. After consideration of the ocular responses produced in the first treated animal, a second animal was treated.
- Details on study design:
- TOOL USED TO ASSESS SCORE: light source from standard opthalmoscope
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 69133
- Time point:
- other: highest score at 24,48 & 72h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 69176
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: pale red coloured staining on lower part of cornea
- Irritation parameter:
- iris score
- Basis:
- animal: 69133
- Time point:
- other: highest score at 24,48 & 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal: 69176
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal: 69133
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 69176
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Irritation parameter:
- other: redness
- Basis:
- other: 69133
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- other: redness
- Basis:
- animal: 69176
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72h
- Irritation parameter:
- other: discharge
- Basis:
- other: 69133
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: staining of fur around treated eye
- Irritation parameter:
- other: discharge
- Basis:
- other: 69176
- Time point:
- other: highest score at 24, 48 & 72h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- other: staining of fur around treated eye
- Irritant / corrosive response data:
- Staining of the fur around the treated eyes was noted throughout the study. Pale red coloured staining on the lower part of the cornea was noted in one treated eye at the 48 and 72h observations. The staining did not affect evaluation of the cornea.
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one and 24h after treatment with minimal conjunctival irritation noted at the 48h observation.
No adverse ocular effects were noted in both treated eyes at the 72h observation. - Other effects:
- Both animals showed expected gain in bodyweight during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a maximum group mean score of 12.0 and was classified as 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. - Executive summary:
Introduction
The study was performed to assess the irritancy potential of the test material following a single application to the eye. The method was designed to meet the requirements of:
OECD Guidelines for the testing of Chemicals No. 405 'Acute Eye Irritation/Corrosion' (adopted 24 April 2002)
Method B5 Acute Toxicity (Eye Irritation) of Commission Regulation (EC) No. 440/2008
Results & Conclusion
The test material produced a maximum group mean score of 12.0 and was classified as 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.
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