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EC number: 235-628-6 | CAS number: 12392-64-2
- 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, other
- Remarks:
- in vivo test. At the time of testing in-vitro test were not available
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study following official guidelines, GLP compliant, performed on a similar substance
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)
- EC Number:
- 278-127-8
- EC Name:
- Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-)
- Molecular formula:
- C40H22CrN4O10S2.H.2Na
- IUPAC Name:
- Trisodium bis[(E)-3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonate]chromate(3-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- The substance is the trisodium form of the target substance (disodium form)
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Source: Interfauna UK Ltd Wyton, Huntingdon, England- Age at study initiation: adult- Weight at study initiation: the animals were weighed immediately before application of the test substance- Housing: the rabbits were individually housed in stainless steel cages with flat rod bases or plastica cages with perforated bases, under standardised conventional conditions. - Diet (e.g. ad libitum): Standard diet "Ssniff K4" approx. 100-120g per animal/day; once a day in the morning- Water (e.g. ad libitum): tap water ad libitum- Acclimation period: prior to use the animals were acclimated for approx. one week in the animal room-Identification of the animals: the rabbits were identified by individual ear marks (tattoos) and cage cardsENVIRONMENTAL CONDITIONS- Temperature (°C): 21+/-1.5°C- Humidity (%): 60-80%- Air changes (per hr):12-15 times per hour- Photoperiod (hrs dark / hrs light):from 6 am to 6 pm, 12 hours artifical illumination
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- pulverized
- Controls:
- other: the other eye served as control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100ul (ca. 34 mg)
- Duration of treatment / exposure:
- 24h
- Observation period (in vivo):
- 1h, 24h, 48h, 72h, 7d, 14d, 21d
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- PROCEDURE:After gently pulling the lower lid away from the eyeball a volume of 100ul of the pulverised test substance-equivalent to approx. 34 mg- was placed into the conjunctival sac of one eye of each of three rabbits. The lids were than getnly held together for about on second in oirder to limit loss of the material. The other eye remained untreated and served as contro.l 24 hours after instillation of the test substance the treated eye was rinsed with normale saline.SCORING SYSTEM: for each animal the Draize scores (cornea, iris, conjunctivae, erythema and swelling and discharge) and the Mcdonald score (aqueous humor) were used. For each animal the Draize scores recorded approx. 24, 48 and 72h after application were added up. The total of these three values was divided by 3 to give the irritation index.TOOL USED TO ASSESS SCORE:optical instrument (hand slit lamp) and fluorescin.Only effects persisting for more than 24 hours were included in the evaluation
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #1
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 21d
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #2
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 0.7
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Remarks:
- swelling
- Basis:
- animal #3
- Time point:
- other: 24,48 and 72h
- Score:
- ca. 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- The substance was tested for eye irritation following OECD 405 and resulted to be irritant to the eye with classification H319 Category 2A.
- Executive summary:
The irritant/corrosive potential of the test substance was studied on the eye of rabbit in accordance with the OECD Guideline 405 for Testing of Chemicals. Exposure of the test substance to the eye caused reactions of the mucous membranes and effects of the cornea in all three animals. Additionally in all three animals the iris was transiently affected and discharge occured. In one animal signs was fully reversible within 21 days, in the second animal corneal signs did not prove to be completely reversible within 21 days and in the third animal a slight erythema was observed on day 21. This evidence indicates that the product may be considered as "severely irritating to the eye".
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