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reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-6-[(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
EC number: 445-280-9 | CAS number: 371921-40-3
- 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:
- other: read across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- From February 10 to March 08, 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The reliability of the source study is 1
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- July 31, 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance
- IUPAC Name:
- Similar Substance
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne
- Age at study initiation: 15 weeks
- Housing: Individually in stainless steel cages equipped with feed hoppers, drinking water bowls, with wood and haysticks for gnawing.
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum
- Water (e.g. ad libitum): Community tap water from Itingen, qd libitum, in water bowls
- Acclimation period: Under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70 %
- Air changes (per hr): 10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): fluorescent light on a 12 hour light/dark cycle
:
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 g (per animal) of the test article
- Duration of treatment / exposure:
- The substance was places into the conjunctival sac on the left eye and the eye was not rinsed
- Observation period (in vivo):
- 1, 24, 48 and 72 hours, as well as 7, 14 and 21 days after administration
- Number of animals or in vitro replicates:
- 1 male and 2 females
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal:
- Remarks:
- all
- Time point:
- 24/48/72 h
- Score:
- 0
- Other effects:
- COLORATION
Blue staining of the nictitating membrane and the sclera by the test article was observed in all animals. Scleral staining persisted in two animals until 14 days after treatment and in one animal until 21 days. Light Staining of the nictitating membrane was evident in all animals until the end of the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 1 (irreversible effects on the eyes) based on GHS criteria
- Conclusions:
- Irreversible effects on the eye due to persistent staining
- Executive summary:
The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to the OECD guideline 405. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary irritation score was 0.00 (max. 13). No signs of irritation were observed.
Blue staining of the nictitating membrane and the sclera by the test article was observed in all animals. Scleral staining persisted in two animals until 14 days after treatment and in one animal until 21 days. Light staining of the nictitating membrane was evident in all animals until the end of the observation period.
No corrosion was observed at any of the measuring intervals.
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