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EC number: 947-452-3 | 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts
- EC Number:
- 947-452-3
- Molecular formula:
- not applicable
- IUPAC Name:
- Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts
- Test material form:
- solid: particulate/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: abbaye de Bellefontaine (49122 Bégrolles en Mauges, France).
-Weight at study initiation: 2,588 kg.
-Housing: the rabbits were individually housed in polystyrene cages :
0,35 x 0,55 x 0,32 m. Each cage was equipped with a food container and a water bottle.
-Diet: the animals were fed ad libitum with a certified pelleted diet Rabbit Diet SOC (Special Diets Services Ltd, witham, Essex, England) during the study.
-Water: the animals had free access to _tap water filtered with Millipore filters in water bottles.
-Acclimation period: 7 days. During this period, the animals were observed daily.
ENVIRONMENTAL CONDITIONS
-Temperature (°C): 18°C ± 3 °C
-Humidity (%): 50 ± 20 %.
-Air changes (per hr): The incoming, non-recycled air, was filtered by ani absolute filter.
-Photoperiod (hrs dark / hrs light): The light/dark cycle was 12 hours per day.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 g - Duration of treatment / exposure:
- Single injection
- Observation period (in vivo):
- 5 days
- Number of animals or in vitro replicates:
- 6 rabbits
- Details on study design:
- SCORING SYSTEM
CORNEA
-Opacity: degree of density (area most dense taken for reading)
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre), details of iris clearly visible: 1
Easily discernible translucent area, details of iris slightly obscured: 2
Nacreous areas, no details of iris visible, size of pupil barely discernible: 3
Opaque cornea, iris not discernible through the opacity: 4
-Area of cornea affected
No ulceration or opacity: 0
One quarter or less but not zero: 1
Greater than one quarter, but less than half: 2
Greater than half, but less than three quarters: 3
Greater than three quarters, up to whole area: 4
IRIS
Normal: 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia, or injection, any of these or any combination thereof, iris still reacting to light (sluggish reaction is positive): 1
No reaction to light, haemorrhage, gross destruction (any or all of these): 2
CONJUNCTIVAE
-Redness: (refers to palpebral and bulbar conjunctivae, excluding cornea and iris).
Blood vessels normal 0
Some blood vessels definitely hyperaemic (injected): 1
Diffuse, crimson colour, individual vessels not easily discernible: 2
Diffuse beefy red: 3
-Chemosis: lids and/or nictating membrane
No swelling: 0
Any swelling above normal (includes nictating membrana): 1
Obvious swelling with partial eversion of lids: 2
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4
-Discharge:
No discharge: 0
Any amount different from normal (does not include small amounts observed in inner canthus of normal animals): 1
Discharge with moistening of the lids and hairs, just adjacent to lids: 2
Discharge with moistening of the lids and hairs, in a considerable area around the eye: 3.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: #1, #2, #3, #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: #1, #2, #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- iris score
- Basis:
- animal: #4, #6
- Time point:
- 24/48/72 h
- Score:
- 0.67
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #1, #6
- Time point:
- 24/48/72 h
- Score:
- 2
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #2, #5
- Time point:
- 24/48/72 h
- Score:
- 1
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: #3, #4
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Reversibility:
- fully reversible within: 5 d
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal: #2, #4, #5, #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: unrinsed eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: unrinsed eye
- Irritant / corrosive response data:
- One hour after instillation of the test sample a swelling with lids about half closed occurred.
Redness of the conjunctivae and iridial and corneal reactions could not be recorded due to the staining of the eye by the compound.
On Day 1, the swelling disappeared in four animals and decreased in the two others. Some blood vessels were hyperaemic in two animals and a diffuse crimson colour was observed in four animals.
A moderate circumcorneal hyperaemia of the iris was observed in three animals.
A diffuse area of opacity covered an area between 1/4 and 1/2 of the cornea in four animals and less than 1/4 in one animal.
On Day 2, chemosis disappeared in five animals, redness decreased in two anhnals. The iridial reaction disappeared in one animal and the surface area of opacity decreased in three animals.
On Day 3, the iridial reactions disappeared in all animals and the corneal reactions in four animals. The ocular reactions were similar on Day 4 and had disappeared on Day 5.
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified according to the CLP classification (EC 1272/2008)
- Conclusions:
- The substance was found to be not irritating for rabbit eye according to the CLP classification (EC 1272/2008).
- Executive summary:
An acute eye irritation study was performed with the test sample after instillation into the conjunctival sac of six New-Zealand rabbits according to the OECD Guideline 405 (1981).
The scores obtained related to the effects observed into the treated eye were used to calculate the mean scores 24/48/72 h. Corneal opacity were 0.67 in four animals (#1, #2, #3 and #6), 1 in animal #4 and 0 in animal #5. Iris scores were 0 in three animals (#1, #2 and #5), 0.33 in animal #3 and 0.67 in two animals (#4 and #6). Conjunctival erythema (redness) scores were 2 in two animals (#1 and #5), 1 in two animals (#2 and #5) and 1.33 in two animals (#3 and #4). Conjunctival oedema (chemosis) were 0 in four animals (#2, #4, #5 and #6), 1.33 in animal #1 and 0.33 in animal #3. All the effects observed were fully reversible within 5-day observation period after the test item application.
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